Ixekizumab Effective for Genital Psoriasis

Ixekizumab Effective for Genital Psoriasis

SAN ANTONIO — Genital psoriasis is a disturbing condition, with half of patients in one study reporting a powerful negative effect on sexual activity and health. Treatment with ixekizumab, a biologic therapy that targets interleukin 17A, significantly improved multiple endpoints in an international phase IIIb study.

“Ixekizumab is an efficacious treatment for moderate to severe genital psoriasis, providing rapid clearance of genital skin. It improves genital itch and minimizes how often genital psoriasis limits the frequency of sexual activity,” said Allison Potts Bleakman, PhD, principal clinical research scientist at Eli Lilly and Company, Indianapolis, Indiana.

Reporting these benefits here at the Sexual Medicine Society of North America (SMSNA) Fall 2017 Scientific Meeting, Dr Bleakman described the heavy physical and sexual burden of genital psoriasis.

“Genital psoriasis affects up to 63% of patients with plaque psoriasis, much more than people realize, and can have a significant impact on quality of life and sexual health,” she said. To date, few data have been published on the efficacy of biologic therapy on genital involvement.

Patients in the current study reported multiple genital psoriasis symptoms. Itch and stinging/burning were the two most bothersome symptoms, and itch and discomfort the two most common ones.

“Importantly, nearly all patients reported genital psoriasis has an impact on their sexual health, and the majority reported impacts to their general well-being and activities,” she said.

Study Details

The randomized, double-blinded, placebo-controlled phase IIIb study evaluated the effect of ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A, compared with placebo on genital psoriasis and on genital psoriasis-related sexual function during 12 weeks of treatment.

The genital areas of interest were labia majora, labia minor, and perineum in women and penis, scrotum and perineum in men.

Overall, 149 patients with moderate to severe genital psoriasis were randomly assigned to either 80 mg ixekizumab (after a starting dose of 160 mg) or placebo every 2 weeks. The population was primarily male (76%), with a mean duration of psoriasis of about 12 years.

Primary and major secondary endpoints included the percentage of patients at week 12 achieving a 0 or 1 score in the 6-point static Physician’s Global Assessment of Genitalia scale, a 0 or 1 score in the 6-point overall static Physician’s Global Assessment scale, or an improvement of 3 or more points on the 11-point genital itch numeric rating scale for patients with a baseline score of at least 3. At baseline, the static Physician’s Global Assessment (genital score) was 3.5 on the 6-point scale.

The sexual activity endpoint was a score of 0 or 1 on the 5-point sexual frequency questionnaire item 2 for patients with a baseline score of 2 or more. Sexual frequency questionnaire item 2 determines how genital psoriasis affects the frequency of sexual activity.

Ixekizumab Significantly Improved All Endpoints

Ixekizumab was superior to placebo for the primary and many secondary endpoints at week 12, and significant improvements vs placebo were observed as early as week 1, the authors said. At week 12, the following benefits were noted:

• Achievement of clear or almost clear genital skin for 73% of ixekizumab-treated patients vs 8% of the placebo group (P < .001).

• Clinically meaningful improvements in genital itch for 60% vs 8%, respectively (P < .001).

• Little to no effect of genital psoriasis on frequency of sexual activity for 78% vs 21%, respectively (P < .001).

Frequencies of treatment-emergent adverse events through week 12 were 56.0% in the ixekizumab group and 44.6% in the placebo group. Mostly mild or moderate in severity, these included upper respiratory tract infections, injection site reactions, headache, oropharyngeal pain, and pruritus.

Significant Improvement in Sexual Health

Dr Bleakman also reported the effect on sexual health in greater detail, derived from in-depth semistructured interviews with 20 patients (mean age, 45 years; 55% women) with moderate to severe genital involvement. Patients reported having psoriasis for a mean time of 18 years and genital involvement for 7.5 years. More than 90% reported currently experiencing moderate to severe overall psoriasis and genital psoriasis.

“Our interviews were intended to elicit information about genital psoriasis symptoms and their impact,” she said.

Overall, the most common symptoms were itch (100%), discomfort (100%), redness/erythema (95%), stinging/burning (95%), pain (85%), and scaling (75%). Of these, patients spontaneously reported itch and redness/erythema most frequently (90% and 50%, respectively), and on probing, reported discomfort (70%), stinging/burning (50%), pain (45%), and scaling (50%). In addition, cracking was spontaneously reported by 30% of patients.

Respondents said they were most bothered by itch (40%) and stinging/burning (40%) and indicated that symptom severity often depended on their activities and/or the weather.

These physical manifestations had consequences for sexual activity. During the qualitative interviews, 45% of patients said they were currently not sexually active. Most (90%) reported at least one effect of genital psoriasis on sexual health. The most common sexual effects were worsening of symptoms after sexual activity (80%), negative physical effects on sexual experience (80%), decreased sexual frequency (80%), avoidance of sexual relationships (75%), and reduced sexual desire (55%).

For half the patients, genital psoriasis affected satisfaction with their sex lives “quite a bit” (25%) or “very much” (25%). Effects on mood/emotion (95%), physical activities (70%), and daily activities (60%) were also reported.

“The burden of symptoms associated with genital psoriasis is considerable,” Dr Bleakman concluded. “Nearly all patients reported at least one negative impact of genital psoriasis on sexual aspects of their quality of life.”

Dr Bleakman encouraged clinicians to query any patient with psoriasis about genital involvement, as an effective treatment is available.

“Disabling” Condition

John Mulhall, MD, director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan Kettering Cancer Center in New York City, commented that genital psoriasis can be a “disabling” condition for which treatments are very much needed.

“Imagine a young man, with perfect erectile function, who’s met a nice girl, then must drop his pants and show this scaly stuff on his penis. While very dense plaques can be uncomfortable, just having to disclose this condition to a partner, in itself, is a barrier to sexual health,” he said told Medscape Medical News.

“Anything you put in the way of comfortable, non-stress-inducing sexual activity can lead to erectile dysfunction, so these men are often referred to us with [erectile dysfunction] from their medical doctor. It’s a complex situation,” he commented.

Dr Mulhall indicated that this study is the first he has seen on the topic, and he predicted that ixekizumab could have a “direct impact on this population.”

The study was funded by Eli Lilly and Company. Dr Bleakman is employed by the company. Dr Mulhall had no relevant disclosures.

Sexual Medicine Society of North America (SMSNA) Fall 2017 Scientific Meeting: Abstracts 012, 203, and 204. Presented October 27, 2017.

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Double-Kiss Crush Stenting Better for Complex LM Bifurcations

Double-Kiss Crush Stenting Better for Complex LM Bifurcations

DENVER, CO — For patients with unprotected true distal bifurcation lesions of the left main artery, a technically challenging two-stent double-kissing (DK) crush technique was associated with a halving of target lesion failure (TLF) rates at 1 year compared with provisional stenting, results of the DKCRUSH-V trial show^[1].

Dr Shao-Liang Chen

Among 484 patients randomly assigned to DK crush stenting or provisional stenting, the respective rates of TLF (a composite of cardiac death, target vessel MI, and/or target lesion revascularization) at 1 year were 5.0% and 10.7%, translating into a hazard ratio for DK crush of 0.42 (P=0.02).

DK crush was also associated with significantly lower rates of target vessel MI (0.4% vs 2.9%, P=0.03) and definite or probable stent thrombosis (0.4% vs 3.3%, P=0.02), according to Dr Shao-Liang Chen (Nanjing Medical University, China).

“These results indicate that double-kissing crush may be a better option for these patients,” he said. Chen presented the data October 30, 2017 at TCT 2017, and the study was published online at the same time in the Journal of the American College of Cardiology.

Don’t Try This at Home

But the DK crush technique is not for the novice or the faint of heart: primary operators in the study were required to have more than 300 PCIs per year for the previous 5 years under their belts, including at least 20 left main PCIs per year, and each was observed by the steering committee while they performed from three to five DK crush procedures to ensure that they had the procedure down pat.

In their published report, Chen and colleagues acknowledged that the technique “requires training, experience, and attention to procedural detail,” including careful rewiring of the side branch, sequential postdilation with noncompliant balloons at high pressure before each kissing inflation, and final proximal optimization technique after kissing-balloon inflation.

Nonetheless, the procedure, when it can be accomplished, is highly successful, commented Dr Cindy Grines (Hofstra/Northwell Medical Center, Hempstead, New York), in an interview with theheart.org | Medscape Cardiology.

“I personally find it difficult to get a wire to cross three layers of stent—you have to cross the original stent plus two layers of crushed stent, so sometimes I have not been successful at doing that,” she said. “But if you are successful and you can do the kissing balloon, then the stent coverage in the carina is superior to other methods of managing a bifurcation lesion.”

Grines was an invited discussant at a briefing where Chen presented that data prior to a late-breaking clinical-trials session.

Beats the Pants Off Culotte Stenting

Chen and colleagues had previously shown in the DKCRUSH-III randomized trial^[2] that the two-stent technique was associated with lower rates of target lesion revascularization compared with provisional stenting in non–left main coronary bifurcation lesions.

They also reported in 3-year follow-up results from that study that the technique resulted in lower rates of target vessel revascularization, stent thrombosis, and a composite end point of major adverse cardiac events compared with culotte stenting for distal left main bifurcation lesions^[3].

In DKCRUSH-V, the investigators tested DK crush and provisional stenting head-to-head in a randomized trial, the first of its kind. They enrolled 482 patients from 26 centers in China, Indonesia, Thailand, Italy, and the US with true distal left main bifurcation lesions (Medina classification 1,1,1 or 0,1,1). The patients were randomized to receive PCI with either DK crush (240 patients) or provisional stenting (242).

As noted, TLF at 12 months was significantly lower among patients who underwent DK crush. The benefit was driven by reductions in target vessel MI (0.4% vs 2.9%, P=0.003) and clinically driven target lesion revascularization (3.8 vs 7.9%, P=0.006) rather than cardiac death (1.2 % vs 2.1%, P=0.48).

The reduction in target vessel MI itself was driven by significant reductions with DK crush in definite or probable stent thrombosis (0.4% vs 3.3%, P=0.02).

The reduction in TLF at 1 year with DK crush was observed both in patients with simple and complex lesions, but the difference was statistically significant only among those patients with complex lesions (7.0% vs 18.2%; HR 0.68, 95% CI 0.5–0.54).

Chen acknowledged that the study was limited by the use of intravascular ultrasound guidance in less than half of all patients and less use of proximal optimal technique and final kissing inflation in the provisional-stenting group.

In addition, he emphasized that the findings of this study don’t apply to left main lesions with less than 50% diameter stenosis of the side branch. For patients with these lesions, provisional stenting should remain the standard of care, Chen said.

Guilt-Free Stenting?

Following Chen’s presentation, Dr Antonio Colombo (San Raffeale Hospital, Milan, Italy), an invited discussant, expressed skepticism about the true benefits (or lack thereof) of the DK crush technique vs more conventional stenting.

“I’m not totally convinced about the findings, despite the fact that they seem to be supported by the data. To me, the message is that I will not feel guilty if I plant two stents in the bifurcation, provided I’ve done a good job. Nevertheless, I think most 1,1,1 Medina should require provisional stenting unless the side branch is large,” he said.

Discussant Dr David Hildick-Smith (Brighton and Sussex University Hospitals, UK) noted that although angiography was planned at 13 months of follow-up, some patients had angiography performed between 11 and 12 months of follow-up, “so there must have been some angiographically driven revascularization, which is a shame.”

The DKCRUSH-V trial was funded by a grant from the National Science Foundation of China and jointly supported by Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Chen, Colombo, and Hildick-Smith reported no relevant financial relationships. Grines discloses within the past 12 months she has had a financial interest/arrangement or affiliation with Abbott Vascular and Volcano Corp.

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Earning Power for Advanced Practice Nurses Keeps Growing

Earning Power for Advanced Practice Nurses Keeps Growing

Most advanced practice registered nurses (APRNs) saw their compensation continue to grow in 2016, with six-figure pay now the norm across all categories, according to the 2017 Medscape APRN Salary Report.

The biggest pay hikes belonged to clinical nurse specialists (CNSs), who received $102,000 last year, 7.4% more than in 2015. Certified registered nurse anesthetists (CRNAs) and nurse practitioners (NPs) registered smaller gains, 3.4% and 2.9%, respectively, while compensation for nurse-midwives (NMs) slipped 1%.

Table 1. APRNs Move Deeper Into Six-Figure Pay

APRN Category	2014	2015	2016
CNSs	$95,000	$95,000	$102,000
CRNAs	$170,000	$176,000	$182,000
NMs	$99,000	$104,000	$103,000
NPs	$102,000	$103,000	$106,000
Source: Medscape

 

Fewer than 10% of those in each APRN category reported receiving less gross income in 2016 than 2015.

All categories of APRNs outearned RNs, who reported $80,000 in compensation last year.

Higher income for APRNs on the whole understandably translated into more contentment with their paychecks. The percentage of CNSs who said they were compensated fairly, for example, rose from 54% in 2014 to 68% in 2016.

Table 2. Okay With Their Pay

APRN Category	2014	2015	2016
CNSs	54%	54%	68%
CRNAs	73%	72%	76%
NMs	58%	61%	64%
NPs	61%	63%	66%
Source: Medscape

 

A small but significant percentage of APRNs are getting paid through incentive programs that reward productivity or performance on quality-of-care measures. NPs (20%) were most likely to receive incentive pay, while CRNAs (11%) were least likely.

The Medscape survey suggests that self-employment for APRNs is still in its infancy despite these clinicians gaining more and more professional autonomy. Twenty-two states and Washington, DC, for example, allow NPs to treat patients without physician oversight. However, only 4% of NPs reported that they own their own practice. CRNAs were most likely to be self-employed, at 11%. Healthcare attorney Carolyn Buppert told Medscape Medical News that the data “reflect the current trend away from clinician-owned practices” in the era of Big Box medicine.

All these findings emerge from an online survey completed by 3417 APRNs earlier this year. This group consisted of 2036 NPs, 567 CNSs, 501 CRNAs, and 313 NMs.

The full survey results are available online.

Follow Robert Lowes on Twitter @LowesRobert

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Think Beyond the Bladder for Interstitial Cystitis/Bladder Pain Syndrome

Think Beyond the Bladder for Interstitial Cystitis/Bladder Pain Syndrome

SAN ANTONIO — When evaluating women with pelvic pain, consider the vestibule, says a urologist and sexual medicine specialist who says clinicians should stop ignoring this underappreciated component of the female anatomy.

Many women diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS) actually have provoked vestibulodynia disorder (PVD), which is not a bladder disorder and which needs different treatment, according to Rachel Rubin, MD, from the Center for Vulvovaginal Disorders in Washington, DC.

“Women with interstitial cystitis/bladder pain syndrome may have underlying PVD as the pathophysiology and not intrinsic bladder pathology. Treatment of PVD, in turn, may improve bladder symptoms,” Dr Rubin said here at the Sexual Medicine Society of North America (SMSNA) Fall 2017 Scientific Meeting.

There is wide clinical overlap between PVD and IC/BPS, as both conditions may include dyspareunia, chronic pelvic pain, and lower urinary tract symptoms. Patients with PVD are diagnosed by having confirmed vestibular pain and positive cotton swab (Q-tip) testing. IC/BPS, in contrast, is a diagnosis of exclusion, and tests that confirm PVD are frequently not performed on patients with bladder complaints, Dr Rubin said.

“Most urologists and gynecologists are not even trained to know what the vestibule is. It’s a part of the female anatomy that a lot of people ignore. You cannot exclude a problem with the vestibule if you don’t know that it exists,” Dr Rubin said in an interview with Medscape Medical News.

In a study she reported here, based on a series of 75 women diagnosed with PVD, 49 achieved at least 40% improvement in pain after appropriate treatment; 33% of this subset had been previously diagnosed with IC/BPS and had not improved with treatment. Treatment of PVD resulted in improvements in bladder symptoms previously attributed to IC/BPS, Dr Rubin noted.

Just What, and Where, Is the Vestibule?

The vestibule is tissue located at the opening of the vagina, surrounding the urethral meatus. The vestibule is essentially the female version of the male urethra. Embryologically, it is the same as the bladder and is differentiated from the vulva and the vagina. Within the vestibule are glands that produce lubricant akin to preejaculate in men. The tissue is androgen-dependent, requiring testosterone to stay healthy, she explained.

Although the vestibule is a distinct entity, it is not recognized as such by most clinicians. “No one teaches about this to medical students or residents: what it is, how to examine it, and what to do about it,” she said. “They just want to stick the speculum into the vagina, and when you do that, you don’t see this tissue.”

The way to examine the vestibule, she said, is to move the labia minora to the side and touch the tissue with a Q-tip. Touching the outside of the vulva or inside the vagina elicits no pain, but a light touch to the vestibule can be quite painful for women with PVD. The pain with the test is often described as burning and cutting, similar to what these women describe with intercourse or tampon insertion, but it can also be more generalized pelvic pain.

Dr Rubin emphasized that this examination, so frequently bypassed, is very simple. “It’s not rocket science,” she said. “It’s a Q-tip around the vagina.”

PVD can result from hormonal changes, inflammation, neurological factors, and hypertonic pelvic floor muscles. Deficiency in testosterone is especially common, mostly in younger women receiving oral contraceptives and in menopausal women. Pelvic muscle health is also a big factor. When pelvic floor muscles are tight and overactive, pain can be referred to the vestibule, and this can mimic bladder pain symptoms, she said.

“The pelvis is a bowl of muscles holding the bladder up. If it’s irritated, it causes the bladder ‘next door’ to sense pain,” she said. “But it’s not actually the bladder that has problem; it’s the tissue around and nearby the bladder that’s the problem.”

Survey Responses

The researchers emailed a web-based survey to 233 patients diagnosed with PVD to learn about their symptoms and treatment experience. Of the 75 women who responded, 49 (65%) reported having at least 40% improvement in their pain after treatment for PVD. Fifteen of the women who responded to PVD treatment had previously been diagnosed with IC/BPS and had not responded to the corresponding treatment.

Many of the women also reported having been erroneously diagnosed with vulvodynia, hypertonic pelvic floor muscles, endometriosis, and irritable bowel syndrome.

Half the women had seen three to five physicians before receiving an accurate diagnosis, and 20% had seen 5 to 10 physicians. More than 10% of women had visited at least 10 clinicians. The vast majority (92%) sought help from gynecologists, whereas 71% saw urologists and 53% saw primary care physicians.

The 49 patients with pain improvement of 40% or more after a PVD diagnosis reported their initial pain/bother symptoms to be dyspareunia (96%); burning, rawness, or cutting in the pelvis (76%); pain with tampon insertion (51%); generalized vulvar pain (49%); urinary frequency (37%); urinary urgency (33%); bladder pain (30%); and relief of bladder pain with voiding (12%).

For their PVD diagnosis, 50% were considered to have hormonally mediated PVD treatable by cessation of hormonal contraceptives (if currently using) and topical estradiol/testosterone creams. Other PVD pathophysiologies included neuro-proliferative PVD (63%), which is treated with vulvar vestibulectomy, and pelvic floor hypertonicity (44%), treated in part with physical therapy. Lidocaine, botulinum toxin into the pelvic floor muscles, nerve blocks, capsaicin, and pain desensitization were other treatments these women received.

Among the 49 patients with more than 40% improvement in pain after treatment for PVD, 88% reported their symptoms improved by at least 60%.

Conversely, under a previous diagnosis of IC/BPS and guideline-based treatment, 71% reported a magnitude improvement of less than 20% in bladder symptoms. These treatments included bladder instillations (69%), “IC diet” (69%), pentosan polysulfate sodium (Elmiron, Janssen Pharmaceutical; 63%), other medications (69%), physical therapy (50%), hydrodistention (38%), and long-term antibiotics (38%).

“The patients had tried many things for their bladder symptoms, but most did not get better under IC/BPS treatments. Then, we fixed their vestibule and most patients were 60% to 100% better. Everyone improved,” Dr Rubin reported.

She emphasized the need to heal the vestibular tissue with local hormonal therapy and to relax the pelvic floor through physical therapy. “You fix the local tissue problem, and the muscles around it,” she said.

The investigators’ recommendation was that providers of women’s health should be trained in performing vestibular Q-tip testing, and PVD should be excluded as a diagnosis in patients suspected of having IC/BPS. “Gynecologists and urologists need to learn how to manage these patients. We can make them better,” she said.

Think Beyond the Bladder

Session moderator Irwin Goldstein, MD, director of San Diego Sexual Medicine in California, agreed that problems with the vestibule largely go unrecognized and that clinicians should look beyond the bladder. “I think a lot of people who are thoughtful, who don’t have a bias toward the need to see this [IC/BPS] as a bladder disorder, will see that it’s not a bladder disorder. It’s actually outside the bladder,” he told Medscape Medical News.

“You can have bladder symptoms when the urethra is made irritated by the vestibular gland surrounding it, or because of pelvic floor issues, or because of psychosocial issues…. We are identifying alleviation of symptoms without dealing with the bladder,” he said.

“The key here is not to put the patient in a box, to not [believe you have to] get bladder distention, or intravesical infiltration,” Dr Goldstein suggested. “Ok, you have bladder symptoms, but there are lots of potential reasons for this. Let’s check them all out. Among other things, get a vulvoscopy, where you can examine the anatomy of the patient under magnification. This should be part of your work-up.”

Dr Rubin and Dr Goldstein have disclosed no relevant financial relationships.

Sexual Medicine Society of North America (SMSNA) Fall 2017 Scientific Meeting: Abstract 011. Presented October 27, 2017.

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Spinal Anesthesia for Spine Surgery May Improves Outcomes, Cost

Spinal Anesthesia for Spine Surgery May Improves Outcomes, Cost

BOSTON — Use of spinal anesthesia instead of general anesthesia for spine surgery improved patient recovery and reduced costs by nearly 10%, according to the results of a single-institution study presented here at Anesthesiology 2017 from the American Society of Anesthesiologists.

More than half of the higher cost of general anesthesia was linked to time in the operating room, the researchers reported.

“We found that there were some pretty consistent findings across the board in terms of spinal versus general [anesthesia],” said Matthew Morris, from Montefiore Medical Center in New York, who presented the study. Morris and members of the research team are also affiliated with the Albert Einstein College of Medicine in New York.

With spinal anesthesia “you can get out of the operating room in a short amount of time, you can get out of the [post anesthesia care unit (PACU)] in a short amount of time,” Morris said.

The researchers noted that general anesthesia (GA) has “traditionally been preferred, perhaps in part due to surgeon preference, anesthesiologist comfort level, and patient perception of the standard of care.” Yet previous research indicates that spinal anesthesia (SA) is a safe alternative to GA for these procedures.  

“However, a lack of research comparing these two modalities in terms of cost and clinical outcomes precludes a determination of their relative cost-effectiveness,” the authors say.

Therefore, Morris and colleagues retrospectively examined demographic and clinical data for 188 patients who underwent lumbar laminectomy or discectomy procedures performed by a single surgeon between 2012 and 2016. Patients were grouped based on type of anesthesia.

The investigators looked at estimated blood loss, incidence of dural tears, anesthesia time, operating room time, and surgical time. Postoperative data analyzed included PACU time, pain scores, analgesic use, incidence of nausea and vomiting, urinary retention, spinal headache, and 30-day readmission.

Costs were calculated using hospital expenses directly related to patient care. “”The team worked with hospital finance staff and looked at variable expenses that could be subject to change. They looked at direct costs — like the anesthesiologist’s fee — rather than overhead costs.

A total of 97 patients received SA and 91 received GA. The SA group spent less time in the operating room (138 ± 6 vs 177 ± 17 min, P < .05), in the PACU (212 ± 15 vs 259 ± 29 min, P < .05), and under anesthesia (149 ± 5 vs 180 ± 7 min, P < .05) than the GA group.

The SA group also reported less postoperative pain (0.64/10 ± 0.38 vs 3.13/10 ± 0.81, P < .05) and required fewer opioids (1.13 ± 0.36 vs 4.30 ± 0.86 doses, P < .05).  

Net costs were $8,446.14 ± 269.99 with SA and $9,284.75 ± 436.58 with GA (P < .05), for a savings of 9.93%.

However, Elisabeth Abramowicz, MD, professor of clinical anesthesiology at New York Medical College, said she was troubled by what she saw as a higher rate of dural tears in the surgery using SA. There were 4.12 ductal tears in the SA group and 2.2 in the GA group (P < .453). The researchers concluded that the incidence of dural tears was similar in both groups.

“I don’t care if you save $50 per cases,” said Dr Abramowicz, who was not involved in the study. “This is a big deal that has to be addressed.”

Morris said that the choice between the two types of anesthesia should depend on how comfortable the surgical team is with either approach. “If you feel uncomfortable doing (SA), you shouldn’t,” he said. “If you feel comfortable doing this, it is absolutely safe and effective and can save on hospital costs.”

The authors have disclosed no relevant financial relationships.

Anesthesiology 2017 from the American Society of Anesthesiologists: Abstract 2051. Presented October 23, 2017.

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Too Few Women Treated for Vulvovaginal Atrophy, Dyspareunia

Too Few Women Treated for Vulvovaginal Atrophy, Dyspareunia

PHILADELPHIA — For menopausal women with vulvovaginal atrophy, cost and worries about the risks associated with estrogen therapy are among the main barriers to treatment, according to results from a recent survey of obstetrician/gynecologists (ob/gyns) and primary care physicians.

But just as problematic is the hesitation on the part of some clinicians to ask women about problems such as painful intercourse, despite how severely dyspareunia can affect a woman’s quality of life, said Sheryl Kingsberg, PhD, from MacDonald Women’s Hospital, University Hospitals Cleveland Medical Center, who is president-elect of the North American Menopause Society (NAMS).

Of the 64 million postmenopausal women in the United States, at least half suffer from vulvovaginal atrophy, she reported here at the North American Menopause Society (NAMS) 2017 Annual Meeting. But only about 7% are taking prescription therapies.

Genitourinary syndrome of menopause, which includes vulvovaginal atrophy, is underdiagnosed and undertreated, Dr Kingsberg told Medscape Medical News.

“The most bothersome symptoms are going to be dyspareunia or dryness, which lead to pain with sexual activity,” she explained. “Not only do women not realize that this is related to menopause, they don’t know that this is an appropriate topic to bring up with their doctor.”

“The clinician often thinks, ‘if my patient had a symptom, she would tell me,’ ” Dr Kingsberg pointed out. “But women should not be expected to be the ones to go to their clinician and say, ‘I have vulvovaginal atrophy, and I’d like to be treated.’ “

For their study, Dr Kingsberg and colleagues invited 2424 ob/gyns and primary care physicians to complete a survey on their attitudes and behaviors related to vulvovaginal atrophy.

To be eligible, physicians had to work in a community-based practice, treat at least 15 patients a month with vulvovaginal atrophy, and see at least 50 (for ob/gyns) or 25 (for primary care physicians) menopausal women a month.

Participants received $23 for answering the 23 questions. Most respondents were men (64%) and were 40 to 59 years of age (66%).

Of the 945 respondents, 369 ob/gyns and 276 primary care physicians completed the survey.

The ob/gyns reported seeing an estimated 111 menopausal women per month, 55% of whom reported symptoms of vulvovaginal atrophy. Of the 99 menopausal women primary care physicians saw, on average, each month, 44% reported symptoms.

Overall, 49% of the women with vulvovaginal atrophy were prescribed treatment, 24% were advised to use an over-the-counter treatment, 14% were provided no treatment, 10% were advised to make a behavioral or lifestyle change to manage symptoms, and 3% were offered vaginal laser therapy.

Ob/gyns were more likely than primary care physicians to prescribe a therapy (53% vs 43%), and wrote more prescriptions each month (44 vs 35).

However, ob/gyns and primary care physicians were equally likely to prescribe medications on the basis of their effectiveness (77% ob/gyns vs 76% primary care physicians) or on the basis of out-of-pocket costs (33% vs 34%).

Ob/gyns and primary care physicians who prescribed medications for vulvovaginal atrophy were most likely to do so because of patient preference (28% vs 30%) and ease of use of the product (29% vs 28%).

However, ob/gyns were more likely than primary care physicians to disagree or strongly disagree that over-the-counter products are best for treating vulvovaginal atrophy (72% vs 47%).

The prescriptions chosen differed by specialty. Ob/gyns were more likely to prescribe estradiol vaginal cream (Estrace, Allergan), an estradiol vaginal insert (Vagifem, Novo Nordisk), an estrogen agonist/antagonist (Osphena, Duchesnay USA Inc), or an estradiol vaginal ring (Estring, Pfizer). In contrast, primary care physicians were more likely to prescribe conjugated estrogen (Premarin, Pfizer), dehydroepiandrosterone supplements, or compounded vaginal estrogens.

Table 1. Medications Prescribed for Vulvovaginal Atrophy

Prescription	Ob/gyns, %	Primary Care Physicians, %
Estradiol vaginal cream	31	25
Estradiol vaginal insert	15	12
Estrogen agonist/antagonist	9	7
Estradiol vaginal ring	6	5
Conjugated estrogen	30	38
Compounded vaginal estrogen	6	8
DHEA supplement	1	2

Further, “84% of the specialty physicians queried considered it important to use the lowest effective dose of hormone therapy when treating women experiencing [vulvovaginal atrophy] symptoms,” the researchers report.

Out-of-pocket costs were cited as a barrier to treatment by more ob/gyns than primary care physicians (64% vs 51%), as were concerns about risks related to estrogen therapy (59% vs 51%).

These were also the primary reasons women discontinued treatment, the respondents reported.

Table 2. Common Reasons Given for the Discontinuation of Treatment

Reason	Ob/gyns, %	Primary Care Physicians, %
Cost	77	61
Symptom improvement	52	59
Concerns about long-term estrogen exposure	47	54

Cost Barrier

“It’s nice when research confirms our biases, and my bias was that one of the biggest barriers to treating this is cost, because vaginal estrogens are typically not covered well,” said Karen Adams, MD, director of the menopause and sexual medicine program at Oregon Health & Science University in Portland.

“It’s incredibly frustrating, especially when their husbands’ testosterone patches are $2. It’s really quite appalling,” Dr Adams told Medscape Medical News.

Physicians have a responsibility to be transparent with patients about costs from the start, she added.

“It’s going to upset our patients if we write them something, they go to the pharmacy and it costs them $150, they call us back, and we’re clueless,” she explained. “We’re going to provide better care if we have the conversation with patients upfront.”

Dr Adams agrees with Dr Kingsberg that painful intercourse is not taken as seriously as it should be for such a burdensome medical problem.

“It’s really reflected in the billing codes,” she said. “The ‘dyspareunia’ code is typically not covered because it’s considered a lifestyle issue. ‘Dyspareunia due to a medical condition’ is usually better covered, but dyspareunia itself is a medical condition, so this distinction makes no sense at all.”

Clinicians do not pay enough attention to midlife sexuality, or female sexuality in general, said Dr Kingsberg.

“Vulvovaginal atrophy is a true medical condition, and it interferes with many things beyond sexuality,” she told Medscape Medical News. The tremendous economic costs of vulvovaginal atrophy and dyspareunia, and their potential to derail a relationship when not treated, have tremendous economic costs, she pointed out.

“What we know clinically is that when sex is good, it has about 20% added value, but when sex is bad, it is hugely, inordinately powerful, draining a relationship 50% to 70%,” Dr Kingsberg said. “Bad sex does way more to subvert an otherwise good relationship than good sex can support an average one. Across the board, it’s something we should treat.”

This research was funded by TherapeuticsMD. Dr Kingsberg holds stock in Viveve, is a speaker for Valeant, and has served as a consultant or on the advisory board of Amag Pharmaceuticals, Duchesnay, Emotional Brain, EndoCeutics, Materna Medical, Nuelle, Palatin Technologies, Pfzer, Shionogi, TherapeuticsMD, Valeant Pharmaceuticals, and Viveve. Dr Adams has disclosed no relevant financial relationships.

North American Menopause Society (NAMS) 2017 Annual Meeting: Abstract S9. Presented October 12, 2017.

Follow Medscape Ob/Gyn on Twitter @MedscapeObGyn and Tara Haelle @tarahaelle

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Gastric Cancer Risk Doubled With Long-term PPI Use

Gastric Cancer Risk Doubled With Long-term PPI Use

Use of a proton-pump inhibitor (PPI) after Helicobacter pylori eradication more than doubles the risk for gastric cancer, according to a population-based study from Hong Kong.

The “clear dose-response and time-response” trend in PPI use and gastric cancer risk observed suggests the need for “caution when prescribing long-term PPIs to these patients even after successful eradication of H. pylori,” write Wai Keung Leung, MBChB, MD, from Queen Mary Hospital, Hong Kong, and colleagues.

The study was published online October 31 in Gut.

The researchers point out, however, that this was an observational study, which can’t prove cause and effect.

H pylori eradication has been shown to reduce the risk for gastric cancer by 33% to 47%, but many patients develop gastric cancer even after eradication of H pylori. PPI therapy, “although generally considered safe,” is associated with worsening gastric atrophy, particularly in H pylori–infected patients, the researchers point out. A recent meta-analysis found a 43% increased risk for gastric cancer among long-term PPI users, but it is was unable to adjust for H pylori, the major confounding factor.

Using a territory-wide health database in Hong Kong, Dr Leung and colleagues compared the risk for gastric cancer in PPI users and histamine-2 receptor antagonist (H2RA) users among 63,397 adults successfully treated with a 7-day course of triple therapy to eradicate H pylori between 2003 and 2012. 

“PPIs are much more potent than H2RA in terms of gastric acid suppression, and previous studies did not reveal any association between gastric cancer development and H2RA. Hence, H2RA was selected as a negative control exposure in our study,” the researchers explain.

During a median follow-up of 7.6 years, 153 (0.24%) people developed gastric cancer after H pylori eradication therapy, mostly in noncardia regions (62%). None of the patients with gastric cancer tested positive for H pylori at diagnosis, but all had long-standing gastritis. The median age at cancer diagnosis was 71.4 years, and the median time from H pylori eradication to gastric cancer was 4.9 years.

After propensity score adjustment, people taking PPIs at least weekly had a greater than twofold increased risk for gastric cancer development (hazard ratio [HR], 2.44; 95% confidence interval [CI], 1.42 – 4.20). The propensity score–adjusted absolute risk difference between PPI use and non-PPI use was 4.29 excess gastric cancer cases per 10,000 person-years.

H2RA users had no increased risk (HR, 0.72; 95% CI, 0.48 – 1.07), which “further supports the specific role of PPIs on gastric cancer development,” the researchers say.

After stratification by tumor site, PPI use was only significantly associated with an increased risk for noncardia gastric cancer (HR, 2.59; 95% CI, 1.42 – 4.72) but not cardia cancer (HR, 1.97; 95% CI, 0.57 – 6.82); “although this result should be interpreted with caution as this subgroup analysis has a relatively small number of cardia cancers,” the researchers say.

Gastric cancer risk increased with longer duration of PPI use. The HR was 5.04 (95% CI, 1.23 – 20.61) for 1 year of use or longer, 6.65 (95% CI, 1.62 – 27.26) for 2 years of use or longer, and 8.34 (95% CI, 2.02 – 34.41) for 3 years use or longer.

More frequent use was also associated with greater risk. When compared with the reference group (less than weekly use), gastric cancer risk progressively increased with more frequent PPI use. The HR was 2.43 (95% CI, 1.37 – 4.31) for weekly to less than daily use, increasing to 4.55 (95% CI, 1.12 – 18.52) for daily PPI use.

The results remained significant by various sensitivity analyses.

A strength of the study is its use of data from a large population-based database with complete information on subsequent diagnoses and drug prescriptions, which minimizes selection, information, and recall biases, the researchers say. Use of strict exclusion criteria as well as propensity score adjustment to control for potential confounders and restricting the sample to patients with successful H pylori eradication are other strengths.

In terms of study weaknesses, the researchers  lacked information on some risk factors, such as diet, family history, and socioeconomic status.  And despite the large sample of more than 63,000 H pylori–infected patients, the small number of gastric cancer cases did not allow for any “meaningful evaluation of the dosage effect and role of different PPIs,” the researchers say. 

The team also notes that PPIs users may have a higher chance of undergoing endoscopy than non-PPI users, leading to discovery of more gastric cancers due to surveillance bias.

Despite these limitations, Dr Leung and colleagues write that, to their knowledge, “this is the first study to demonstrate that long-term PPIs use, even after H. pylori eradication therapy, is still associated with an increased risk of gastric cancer. This is likely related to the profound acid suppression of PPIs that worsens atrophic gastritis, particularly in those patients with established gastric atrophy as a result of chronic H. pylori-induced inflammation.”

The study had no specific funding. Dr Leung has received honorarium for attending advisory board meetings of Takeda and Abbott Laboratories.

Gut. Published online October 31, 2017.

Follow Medscape Oncology on Twitter: @MedscapeOnc

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Federal and State Probes Target Insulin Drugmakers, Pharma Middlemen

Federal and State Probes Target Insulin Drugmakers, Pharma Middlemen

With the price of a crucial diabetes drug skyrocketing, at least five states and a federal prosecutor are demanding information from insulin manufacturers and the pharmaceutical industry’s financial middlemen, seeking answers about their business relationships and the soaring price of diabetes drugs.

Attorneys general in Washington, Minnesota and New Mexico issued civil investigative demands this year and are sharing information with Florida and California, according to various corporate financial filings.

Insulin makers Eli Lilly, Novo Nordisk, Sanofi and top pharmacy benefit manager CVS Health are targets in the state investigations. Several of the financial filings note that the state and federal prosecutors want information regarding specific insulins for specific dates in relation to “trade practices.”

They appear to be looking into potentially anti-competitive business dealings that critics have leveled at this more than $20 billion niche market of the pharmaceutical industry, according to analysts and court filings reviewed by Kaiser Health News. These include whether drugmakers and middlemen in the supply chain have allowed prices to escalate in order to increase their profits.

Source: KHN

At the same time, prominent class-action lawyers are bringing suits on behalf of patients. Steve Berman, an attorney best known for winning a multibillion-dollar settlement from the tobacco industry, alleged collusion and said it was time to break up the “insulin racket.”

The price of insulin — a lifesaving drug — has reached record highs as Eli Lilly, Novo Nordisk and Sanofi raised prices more than 240 percent over the past decade to often over $300 a vial today, with price rises frequently in lockstep, according to information technology firm Connecture.

Those prices take a toll on patients like 21-year-old Hunter Sego, who needs about four vials a month for his Type 1 diabetes. When he went to the pharmacy last year, the drug was no longer on a preferred tier and the price had risen to $487 a vial, compared with about $200 from a few years ago. Insurance companies often take drugs off a preferred list in response to pharmaceutical price rises to discourage overuse, a business strategy that leaves patients stuck in the middle.

“I was absolutely floored,” Sego said.

The DePauw University junior began skipping doses, knowing that his parents were paying cash until they met their health plan’s high deductible. Sego lost weight and felt lethargic, and his grades suffered. Sego’s college football coach finally called his mother to ask what was going on.

“I have to watch him like a hawk because I know he is trying to save money,” said his mother, Kathy Sego.

Last year, before the states took action, the U.S. Attorney’s Office for the Southern District of New York, one of the nation’s most powerful federal prosecutors, issued civil investigative demands to Eli Lilly, Novo Nordisk, Sanofi and Express Scripts, according to financial filings.

“There is enough concern about competition in the drug industry to have galvanized forces at the state and federal level to create specific pictures of abuse,” said Diana Moss, president of the American Antitrust Institute after hearing of the investigative demands.

Attorneys general use the legally binding demands to collect evidence, such as documents and emails, and testimony to help “piece together any number of stories about potential competitive harm,” Moss said.

Insulin prices have risen at regular intervals for years, Connecture’s research shows, but the trend has become more pronounced in the past few years. For example, in the final months of 2007, Sanofi’s Lantus cost $88.20 per vial and Novo Nordisk’s Levemir $90.30 a vial. Today, after increasing in tandem over the years, Lantus costs $307.20 per vial and Levemir runs $322.80 for the same amount, based on average wholesale prices.

The increases “don’t all happen on the same exact day, but they happen pretty close to each other on the calendar,” said Jim Yocum, senior vice president of federal contracts with Connecture. “I don’t know of any other industry where such regular price increases have been the norm.”

The United States is one of the few developed countries without regulations on prescription drug pricing. So, one of the few tools available for the government to curb price increases is to show fraudulent or anti-competitive practices.

Late last year, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) asked the Department of Justice and the Federal Trade Commission to investigate, noting “the potential coordination by these drug makers may not simply be a case of ‘shadow pricing,’ but may indicate possible collusion.”

Spokespeople for Eli Lilly, Novo Nordisk and Sanofi said in separate statements that each company sets prices independently. Novo Nordisk’s Ken Inchausti added: “We monitor market dynamics and our competitors’ pricing through public and subscription databases that track list prices.”

Each of the pharmaceutical companies said it is committed to ensuring patients have access to medicine. Novo Nordisk, which makes Novolog and Levemir, also pledged to limit price increases. Eli Lilly has announced a discounted insulin program.

State and federal prosecutors often begin investigations because of consumer and whistleblower complaints, several civil and antitrust attorneys said, and gripes about rising insulin prices have been roiling the online diabetes community for the past few years.

Indeed, James Tierney, former attorney general of Maine and a lecturer at Harvard Law School, said the civil investigative demands are not uncommon and the companies “may be totally innocent.”

It’s difficult to know exactly what the state and federal prosecutors are looking for, though, Tierney said. The investigations are often sealed from the public, revealed primarily when public companies acknowledge receiving them in their financial filings.

Nearly all of the federal and state officials declined to confirm or deny the investigations, except Washington and New Mexico officials, who confirmed the existence of the civil investigative demands.

Still, clues about the insulin investigations can be pieced together from corporate filings. They focus on issues like pricing and business relationships. Several ask for information about specific insulins regarding certain years.

In January — at about the same time states began filing civil demands — the first of a handful of potential class-action lawsuits that were national in scope were filed.

A U.S. district judge combined Berman’s suit and several other national cases last month, adding the pharmacy benefit managers, or PBMs (Express Scripts, CVS and UnitedHealth Group with its division OptumRx) as defendants.

Berman and the other attorneys declined interview requests. But attorneys at Keller Rohrback, one of the firms whose case was rolled into Berman’s, explained the reason for adding the PBMs in a May letter to the court: “The PBM defendants play a central role in the scheme — selling formulary access in exchange for ‘rebates’ or other payments” from the manufacturers.

Rebates, or negotiated discounts, occur when a manufacturer sets a list price and then agrees to pass money back to the PBMs in return for something, generally a spot on the formulary that determines which drugs can be purchased.

The PBMs say their negotiations ensure drugs are affordable, and two of them pointed fingers back at the drugmakers.

Express Scripts spokesman Brian Henry declined to comment on the investigations or lawsuit but stated in an email that “if prices have gone up in lockstep, that is because they have been priced by the drug makers in lockstep.” UnitedHealth did not respond to questions. And CVS Health called the lawsuit without merit.

CVS spokesman Michael DeAngelis said in an email: “Pharmaceutical companies alone are responsible for the prices they set in the marketplace for the products they manufacture. Nothing in our agreements prevents drug manufacturers from lowering the prices of their insulin products and we would welcome such an action.”

Such lawsuits generally take years to resolve. In the meantime, the suits and the investigations may provide answers to the demands of lawmakers like Sen. Amy Klobuchar (D-Minn.), who sent a letter to drugmakers in July asking for an explanation for the “extreme price increases.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

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Timeline: Insulin Market Under Scrutiny

Timeline: Insulin Market Under Scrutiny

The price of lifesaving diabetes drugs has skyrocketed over the past decade. And patients aren’t the only ones who have noticed. Five states and a federal prosecutor are demanding information from insulin manufacturers and the pharmaceutical industry’s financial middlemen.

Below, we detail when legal action related to insulin drugs began, with links to documents.

March 2016

The U.S. Attorney’s Office for the Southern District of New York launches the first of several civil investigative demands (CIDs), beginning with Sanofi and Novo Nordisk.

Novo Nordisk establishes federal demand (p. 82) The note, like those of Eli Lilly and Sanofi, establishes that the federal prosecutor is interested in the company’s business relationships with pharmacy benefit managers and demands information on specific insulins. View entire document on DocumentCloud

The federal prosecutor’s demand of Novo Nordisk specifies information is needed regarding insulins Novolog, Novolin and Levemir, according to the company’s annual report; Sanofi reports the request for information is also in relation to pharmacy benefit managers and regarding top-selling insulin drug Lantus as well as Apidra since 2006, according to the company’s annual 20-F filing.

July 2016

Eli Lilly discloses that the U.S. Attorney’s Office for the Southern District of New York issued a CID also for information related to pharmacy benefit managers, according to its July 2016 quarterly filing.

August 2016

Express Scripts receives a CID from the U.S. Attorney’s Office for the Southern District of New York. It too notes the federal prosecutor is asking for information about relationships. No specific drugs are named, according to the company’s 2016 annual report.

November 2016

Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) ask the Department of Justice and the Federal Trade Commission to investigate whether insulin makers have colluded or engaged in anti-competitive behavior.

January 2017

Minnesota’s attorney general launches what appears to be the first state investigation, issuing civil investigative demands to Sanofi and Novo Nordisk.

Sanofi specifies information is needed regarding insulin drugs Lantus and Toujeo, according to the company’s 20-F filing. Novo Nordisk reports the state lawmaker wants information relating to “pricing and trade practices” since January 2008 to present regarding insulins Levemir and Tresiba, according to the company’s annual report.

On Jan. 30, attorney Steve Berman of Hagens Berman files initial complaint in the U.S. District Court of Massachusetts against insulin makers Novo Nordisk, Sanofi and Eli Lilly. He alleges an “organized scheme to drive up prices at the expense of patients who need insulin drugs to live.” The case later transfers to New Jersey.

February 2017

Berman’s lawsuit is transferred to New Jersey and combined with a related case filed by attorney James Cecchi, representing patients against the insulin makers.

March 2017

Washington’s attorney general issues a CID to Sanofi echoing Minnesota’s request and specifying the request is for insulin drugs Lantus, Toujeo, Apidra and Soliqua from 2005 to present, according to the company’s half-year financial report.

Frank Barnett and other patients file suit March 8 in the U.S. District Court of New Jersey against the insulin manufacturers, notably adding the nation’s largest pharmacy benefit managers Express Scripts, CVS Health and UnitedHealth Group as defendants.

The Rebate Game (p. 37) Attorneys allege that the relationship between drug manufacturers and pharmacy benefit managers harms patients and allows for rising insulin prices. View entire document on DocumentCloud

Julia Boss, the Type 1 Diabetes Defense Foundation and other patients file suit on March 17 in the U.S. District Court of New Jersey against the three big insulin manufacturers as well as the pharmacy benefit managers.

April 2017

CVS Health receives a CID from Washington’s AG seeking information regarding pricing and rebates for insulin and epinephrine products connected to a pending investigation. Under the bullet item “Insulin Products Investigation,” CVS states that the Washington attorney general’s office will share information with the attorneys general of California, Florida and Minnesota, which filed a CID in July.

Scott Christensen and other patients file suit April 20 in the U.S. District Court of New Jersey alleging violations of the Sherman Antitrust Act. Defendants include Novo Nordisk, Eli Lilly, Sanofi, Express Scripts, CVS Health, UnitedHealth Group with its PBM division OptumRx.

May 2017

Eli Lilly does not specify drugs but confirms it has a received a CID from Washington’s attorney general about the “pricing of our insulin products and our relationships with pharmacy benefit managers.” It also states New Mexico’s attorney general issued a CID related to “the pricing of our insulin products,” according to its quarterly financial filing.

July 2017

CVS Health receives a CID from Minnesota’s AG seeking information regarding pricing and rebates for insulin and epinephrine products connected to a pending investigation, according to a quarterly filing.

Eli Lilly says it has received a CID from Minnesota’s AG “relating to the pricing and sale of our insulin products.” California and Florida’s attorneys general requested information related to pricing of insulin products, according to its quarterly filing.

Sen. Amy Klobuchar (D-Minn.) sends letters to insulin manufacturers asking for “an explanation of the extreme price increases” of insulin. Eli Lilly, Sanofi and Novo Nordisk each respond.

September 2017

On Sept. 18, U.S. District Judge Brian Martinotti appoints Steve Berman and James Cecchi as interim lead counsel over a suit that combines the various civil lawsuits filed since the beginning of 2017 into one behemoth potential class-action suit. Martinotti notes that the team of Berman and Cecchi “has successfully tried similar claims against comparable defendants.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

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Eczema Can Predict Severity of Asthma Hospitalization

Eczema Can Predict Severity of Asthma Hospitalization

BOSTON — A family history of asthma and a patient’s own history of atopic dermatitis might help predict the “severity” of a hospital stay, according to a small study.

That information could help identify which children are at risk and inform treatment, lead researcher Mona Liu, MD, a pediatric resident at Children’s Hospital of Los Angeles, told Medscape Medical News.

It might also encourage more aggressive treatment or earlier tailoring of management to keep children from entering the hospital in the first place, she said here at the American College of Allergy, Asthma & Immunology 2017 Annual Scientific Meeting.

A more severe stay can include admission to an intensive care unit, a longer stay, more hours of continuous albuterol use, and more oxygen use.

Dr Liu and her colleagues examined the relation between medical history, allergic reactions, and a child’s hospital experience after an asthma attack.

Medical History

The study involved 39 children 1 to 17 years of age who were admitted to the Children’s Hospital of Los Angeles because of asthma.

Average age in the cohort was 7 years, and 56% of the children were Hispanic.

The researchers looked at factors such as the medications used for control and the family, medical, atopic, and environmental history.

They tested the children for allergies to grass, dust, cockroach, dog, cat, mold, ragweed, and other common allergens, but found no significant link between the number of allergies and the level of treatment required in the hospital.

A family history of asthma was more common in patients admitted to the ICU than in those just admitted to the hospital (62% vs 14%; P = .04).

In addition, a history of atopic dermatitis was linked with a longer hospital stay (P = .05) and more continuous albuterol (P = .017).

“For patients without a history of eczema, the median length of stay was 3 days, and those with a history of eczema, the median length of stay was 4 days,” Dr Liu reported.

This study suggests risk factors that may identify children with more severe asthma hospitalization.

The association between eczema and asthma in this study is interesting, said Luz Fonacier, MD, head of allergy and training program director at the NYU Winthrop Hospital in Mineola, New York. Atopic dermatitis is a systemic disease, and inflammation involves multiple organ systems, she pointed out.

“This study suggests risk factors that may identify children with more severe asthma hospitalization,” she told Medscape Medical News.

If these findings are confirmed in a larger study, physicians might be able to identify kids on admission, or even in the emergency department, as having significant eczema, and therefore at risk for a longer hospital stay, said Brian Kelly, MD, from Boys Town National Research Hospital in Omaha, Nebraska.

“We could monitor them earlier and maybe identify decompensation earlier,” he told Medscape Medical News.

Given that family history of asthma was also shown to be predictive of a longer ICU stay, those questions must be asked, he said.

Dr Liu said her team is recruiting patients for a larger study to confirm their findings.

The study was supported by Sunair Children’s Foundation. Dr Liu, Dr Fonacier, and Dr Kelly have disclosed no relevant financial relationships.

American College of Allergy, Asthma & Immunology (ACAAI) 2017 Annual Scientific Meeting: Abstract 5204. Presented October 29, 2017.

Follow Medscape on Twitter @Medscape and Marcia Frellick @mfrellick

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Climate Change Harms Health Worldwide as Millions Swelter

Climate Change Harms Health Worldwide as Millions Swelter

OSLO (Reuters) – Climate change has caused severe harm to human health since the year 2000 by stoking more heat waves, the spread of some mosquito-borne diseases and under-nutrition as crops fail, scientists said on Tuesday.

Scant action to slow global warming over the past 25 years has jeopardized “human life and livelihoods”, they wrote in a report published in The Lancet, online October 31.

“The human symptoms of climate change are unequivocal and potentially irreversible,” said the report, titled Lancet Countdown and drawn up by 24 groups, including universities, the World Bank and the World Health Organization (WHO).

Many governments are now trying to cut their greenhouse gas emissions under the 2015 Paris climate agreement, though U.S. President Donald Trump has weakened the pact by saying the United States, the world’s second biggest greenhouse gas polluter after China, will pull out.

“This (report) is a huge wake-up call,” Christiana Figueres, chair of the Lancet Countdown’s high-level advisory board and the United Nations’ climate chief at the Paris summit, told Reuters. “The impacts of climate change are here and now.”

Among its findings, the report said an additional 125 million vulnerable people had been exposed to heat waves each year from 2000 to 2016, with the elderly especially at risk.

Labor productivity among farm workers fell by 5.3% since the year 2000, mainly because sweltering conditions sapped the strength of workers in nations from India to Brazil.

The report, based on 40 indicators of climate and health, said climate change seemed to be making it easier for mosquitoes to spread dengue fever, which infects up to 100 million people a year.

The number of undernourished people in 30 countries across Africa and Asia rose to 422 million in 2016 from 398 million in 1990, it said.

“Undernutrition is identified as the largest health impact of climate change in the 21st century,” the report added.

“GLIMMERS OF HOPE”

But despite the overall gloom, Anthony Costello, a director at WHO and co-chair of the Lancet Countdown study, said there were “significant glimmers of hope” in the situation.

The number of weather-related disasters such as hurricanes and floods rose 46% since 2000, but the number of deaths remained stable, suggesting that societies were improving protection measures against environmental catastrophes.

Almost 200 nations will meet in Bonn, Germany, from Nov. 6-17 to work on a “rule book” for the 2015 Paris climate agreement for shifting from fossil fuels.

The Lancet Countdown study did not estimate the total number of deaths from climate change. The WHO has previously estimated there could be 250,000 extra deaths a year between 2030 and 2050 because of climate change.

Nick Watts, executive director of the Lancet Countdown, said there could be a few benefits from warmer temperatures, such as fewer deaths from winter cold in nations from Russia to Canada.

“But those numbers are . . . almost negligible,” he said compared to the overall harm from global warming.

The Lancet study also said that the air in 87% of all cities, home to billions of people, exceeded pollution guidelines set by the WHO. Fossil fuels release both toxins and heat-trapping carbon dioxide when burnt.

Johan Rockstrom, director of the Stockholm Resilience Centre and who was not involved in the Lancet study, said the report could bolster efforts to limit pollution in cities from Beijing to Mexico City.

“Air pollution is in a way an old issue,” he said, referring to decades of efforts to limit smog. “But it’s potentially coming to the forefront again as the most rapid vehicle to get action on climate change.”

SOURCE: http://bit.ly/2iMshND

Lancet 2017.

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DARE: Drug-Eluting Balloon Takes on DES for Stent Restenosis

DARE: Drug-Eluting Balloon Takes on DES for Stent Restenosis

DENVER, CO — A drug-eluting balloon proved to be the match of a drug-eluting stent for treatment of any in-stent restenosis, offering the potential to spare patients from receiving yet another stent^[1].

In a multicenter randomized trial, the balloon (SeQuent Please paclitaxel-eluting balloon, BBraun Melsungen, Germany) was demonstrated to be noninferior to the Xience everolimus-eluting stent at treating in-stent restenosis occurring in either DES or older, bare-metal stents.

Dr Jose PS Henriques

“The drug-eluting balloon appears to be an alternative therapy for any in-stent restenosis, negating the need for additional stenting,” said Dr Jose PS Henriques (Academic Medical Center, Amsterdam, the Netherlands) on behalf of colleagues in the Drug-Eluting Balloon for In-Stent Restenosis (DARE) trial.

The balloon is approved and has been in use in Europe for some time now but has not gotten the nod for coronary artery interventions from the US Food and Drug Administration. “I wish that our US FDA was listening, because we really would like to see this technology in the United States,” said Dr Roxana Mehran (Mount Sinai Medical Center, NY), who moderated a briefing where Henriques discussed the results prior to his presentation of the data here at TCT 2017.

“I feel that drug-coated balloons are important technologies for us to have in our armamentarium of treating in-stent restenosis,” Mehran said in an interview with theheart.org | Medscape Cardiology. “Putting in new layers of stent after stent, making club sandwiches out of our patients’ arteries, is not the best answer—we know that. Brachytherapy doesn’t work, and sending a patient for bypass surgery for a small vessel is not really the best possible therapy.”

DARE to Do Better

Back in the not-so-good old days of standalone balloon angioplasty, 6-month restenosis rates higher than 40% were seen in some studies. The advent of coronary artery stents in general and drug-eluting stents in particular has improved outcomes, but in-stent restenosis is still seen in anywhere from 3% to 20% of patients, Henriques said.

In the DARE trial, results of which are published online in JACC: Cardiovascular Interventions, investigators at eight sites throughout the Netherlands enrolled 278 patients with restenosis of either DES or bare-metal stent. The investigators defined restenosis as a greater than 50% diameter stenosis on visual assessment in-stent and/or <5 mm out of the stent. Patients with all types of restenosis lesions were eligible, including those with ostial, left main, bifurcation, chronic total occlusion, saphenous vein grafts, and arterial graft lesions.

Following pretreatment with dual antiplatelet therapy (aspirin and clopiodgrel, prasugrel [Effient, Lilly/Daiichi-Sankyo], or ticagrelor [Brilinta, AstraZeneca]), patients in each trial arm underwent predilation with the goal of full expansion of the previously implanted stent.

Patients who were assigned to the drug-eluting-balloon procedure had a balloon with the same diameter as the last predilation balloon. The balloon was inflated at a pressure of 6 to 8 atm for at least 30 seconds or, optimally, for 60 seconds. The protocol allowed for treatment of very long lesions with two or more drug-eluting balloons with a small overlap.

For patients randomized to the DES arm, investigators chose a stent size that could be deployed to the same diameter as the predilation balloon. The stent length was determined adding 2 to 3 mm to each end of the original stent’s length.

It took 5 years to accrue enough patients to reject the null hypothesis of inferiority with 80% power. The investigators eventually enrolled and randomized a total of 278 patients, 137 to the drug-eluting-balloon arm and 141 to the DES arm.

For the primary end point of 6-month in-segment minimal lumen diameter, 105 patients in the drug-eluting-balloon arm (77%) and 115 in the DES arm (82%) completed angiographic follow-up.

Baseline minimal lumen diameter was virtually identical in the two arms, at 0.78 mm in the drug-eluting-balloon arm, compared with 0.79 mm in the DES arm.

The postprocedural minimal lumen diameter favored the DES arm (1.72 mm vs 1.84 mm, P=0.005), but there was no difference in the primary end point at 6 months, with an in-segment minimal lumen diameter of 1.71 mm for drug-eluting-balloon vs 1.74 mm for DES (P=0.65).

In addition, in-segment late loss at 6-month angiographic follow-up was significantly less with the drug-eluting-balloon, at 0.17 mm vs 0.45 mm with the DES (P<0.001).

The point estimate of the difference in minimal lumen diameter between drug-eluting-balloon and DES was -0.03 mm, and the 95% lower confidence limit was -0.16, meeting the criterion for noninferiority (P<0.0001).

An analysis of the mean difference in 6-month minimal lumen diameter in major subgroups (in-stent restenosis stent type, diabetes status, sex, restenosis type, or reference vessel diameter) showed no significant differences.

Although the trial was not powered to detect clinical end points, an exploratory analysis found no significant differences between the arms in deaths, MI, strokes, target vessel revascularization, CABG, PCI interventions, or composite MACE.

Diminishing Returns

An interventional cardiologist who was not involved in the study told theheart.org | Medscape Cardiology that an effective alternative to stent-in-stent for treating restenosis would be welcome.

“When you have repeated episodes of restenosis, you can start with a vessel that’s 3 mm in diameter, and then when it restenoses and you place a second stent inside there, all of a sudden, even if you have a great stent result, you can be down to 2.5 mm, and then the next time you need to treat it for restenosis you’re down to a very tiny lumen, and that’s the problem with trying to treat in-stent restenosis with more stenting,” said Dr Cindy Grines (Hofstra/Northwell Medical Center, Hempstead, NY). Grines was an invited discussant at the briefing.

 Dr David J Cohen (Saint Luke’s Health System, Kansas City, Missouri) also an invited discussant, echoed the comments of Mehran and Grines when he remarked that “this type of device obviously being similar in performance to drug-eluting stents would be a very, very welcome addition to our armamentarium, because one of the things we really don’t like to do as coronary interventionalists is to line up multiple stents inside of each other—that just becomes a self-perpetuating problem. So the ability to treat these patients reasonably well without needing more stents I think is tremendous advantage in the long run.”

The DARE trial was sponsored by the University of Amsterdam with support from BBraun Medical. Henriques disclosed an unrestricted research grant from BBraun. Disclosures for the coauthors are listed in the paper. Mehran discloses within the past 12 months she has had a financial interest/arrangement or affiliation with Abiomed, Abbott Vascular, CardioKinetix, Spectranetics, AstraZeneca, Bayer, Eli Lilly, Novartis, OrbusNeich, Medtronic, Bristol-Myers Squibb, Claret Medical, Janssen, Osprey Medical, the Medicines Company, Boston Scientific, Shanghai Braccosine, Elixer, and Medscape. Grines discloses within the past 12 months she has had a financial interest/arrangement or affiliation with Abbott Vascular and Volcano Corp. Cohen discloses within the past 12 months he has had a financial interest/arrangement or affiliation with Abbott Vascular, AstraZeneca, Boston Scientific, Edwards Lifesciences, Medtronic, Merck/Schering Plough, Corvia Medical, and Svelte Medical.

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Type 3c Diabetes Misdiagnosed; Patients at Risk of Complications

Type 3c Diabetes Misdiagnosed; Patients at Risk of Complications

Patients with a form of diabetes due to pancreatic dysfunction are commonly misdiagnosed as having type 2 diabetes, resulting in poor glycemic control and suboptimal care, the first large-scale analysis of this underrecognized form of the disease indicates.

Diabetes of the exocrine pancreas, also known as type 3c diabetes, arises when pancreatic inflammation, neoplasia, or resection results in beta-cell dysfunction, affecting the production of insulin.

As it occurs in individuals of a similar age group, type 3c diabetes may be misdiagnosed as type 2 diabetes. Those with type 3c diabetes require insulin therapy more urgently than those with type 2, so the consequence of this misdiagnosis are delays in delivering appropriate treatment, which can lead to nerve, eye, and kidney damage, say the authors of the new study, led by Dr Chris Woodmansey of the University of Surrey, Guildford, United Kingdom, and colleagues, which was published online in Diabetes Care on October 23.

In their analysis of more than 30,000 cases of incident diabetes in the United Kingdom, type 3c diabetes was almost twice as common as type 1 diabetes but was misdiagnosed as type 2 diabetes in over 87% of patients.

Type 3c diabetes patients were approximately 1.5 times as likely to have poor glycemic control than those with type 2 diabetes and were almost 10 times more likely to use insulin.

“Greater awareness of type 3c diabetes within the medical profession is required immediately to improve management of this disease, which now has a higher incidence than type 1 diabetes in adults,” said senior author Simon de Lusignan, MD, PhD, department of clinical and experimental medicine, University of Surrey, in a press release.

He added that the misdiagnosis of type 3c diabetes, particularly as type 2 diabetes, puts the short- and long-term health of patients at risk and “builds on our previous work that suggests that failure to flag the right diagnosis is associated with lower-quality care.”

Almost 90% of Type 3c Diabetes Misdiagnosed as Type 2

Type 3c diabetes has been estimated to account for 9% of diabetes cases among hospitalized patients. However, there has been no previous systematic assessment of the rates of prior pancreatic disease among diabetes patients in primary care.

The researchers therefore conducted a retrospective study of data from the Royal College of General Practitioners Research and Surveillance Centre, which covers over 2 million primary-care patients from which data are extracted once weekly, including information on acute hospital admissions.

They assessed all adult patients diagnosed with diabetes between 2005 and 2016 and then further determined who had a prior diagnosis of pancreatic disease. Specifically, they looked at acute pancreatitis, alongside chronic pancreatitis, pancreatic cancer, hemochromatosis, cystic fibrosis, and surgical pancreatic resection.

During the study period, there were 31,789 new diagnoses of adult-onset diabetes, with a median follow-up time of 4.5 years from the date of diagnosis.

Of these diagnoses, 559 followed pancreatic disease, including 361 after acute pancreatitis and 198 following chronic pancreatic disease.

The 559 cases of diabetes following pancreatic disease were mostly classified incorrectly by physicians as type 2 diabetes (87.8%). It was very uncommon that the correct diagnosis of diabetes of the exocrine pancreas, or type 3c, was made (2.7%); 7.7% were misclassified as having type 1 diabetes.

The median age at diagnosis for type 3c diabetes was 59 years, and 58.9% were male. The median body mass index among these patients was 29.2 kg/m².

Type 3c diabetes patients had higher mean HbA_1c levels than those with type 2 diabetes at presentation (P = .002) and at 1 year (P < .001) and at 5 years (P < .001) following diagnosis. There were no HbA_1c differences between those diagnosed after acute pancreatitis vs chronic pancreatic disease.

Poor glycemic control was also more common among type 3c diabetes patients than type 2 diabetes patients at 1 year following diagnosis, at 40.3% vs 32.5% (P < .001) and an adjusted odds ratio for poor control of 1.3 (P = .001).

And at 5 years after diagnosis, type 3c diabetes patients were still more likely to have poor glycemic control than type 2 diabetes patients, at 61.9% vs 46.3% (P < .001) and an adjusted odds ratio of 1.7 (P < .001).

Among type 2 diabetes patients, insulin use was 1.4% at 1 year and 4.1% at 5 years following diagnosis.

This compared with 16.3% and 29.6%, respectively (P < .001 for both), in those patients diagnosed with type 3c disease.

This yielded adjusted odds ratios for insulin use in type 3c diabetes patients of 9.6 at 1 year and 9.9 at 5 years (P < .001 for both).

Calling for greater awareness of type 3c diabetes, the researchers write: “Clinicians should elicit whether a patient has any history of pancreatic disease when they first present with diabetes and consider the diagnosis of diabetes of the exocrine pancreas.”

Helping GPs to Make the Correct Diagnosis in Diabetes

The researchers say they were surprised to find that the incidence of type 3c diabetes was higher than that for adult-onset type 1 diabetes, at 2.59 per 100,000 person-years vs 1.64 per 100,000 person-years (P < .001), although still substantially lower than that for type 2 diabetes, at 142.89 per 100,000 person-years.

This shows that this underrecognized form of diabetes is more common than previously thought, they say.

“This is the largerst study to include all forms of diabetes of the exocrine pancreas to date, and to our knowledge the only study to systematically identify pancreatic disease in a cohort of people with newly diagnosed diabetes,” they note.

“Diabetes following pancreatic disease is frequently labeled type 2 diabetes but follows a markedly different clinical course, with worse glycemic control and a markedly greater requirement for insulin.”

“[It] must be appropriately recognized to tailor management, including choice of antihyperglycemic therapy and consideration of malabsorption requiring pancreatic enzyme and vitamin D prescription,” they conclude.

Speaking to Medscape Medical News, Dr de Lusignan said that he hopes these latest findings will help general practitioners to make the correct diagnosis when they are treating a patient with a history of pancreatic disease.

He also sees them as adding another piece to the jigsaw in terms of furthering understanding of diabetes. Dr de Lusignan said: “I think, over time, we will see more and more subdivisions of diabetes and this, to me, is a really interesting step on that journey.”

No funding declared. Dr Woodmansey reports no relevant financial relationships. Dr Lusignan heads a diabetes Real World Evidence Centre funded by Eli Lilly and reports a research grant from AstraZeneca; neither are directly related to this study. Disclosures for the coauthors are listed in the paper.

Diabetes Care. 2017;40:1486–1493. Abstract

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One in 10 Opioid Overdosers Treated With Naloxone Die

One in 10 Opioid Overdosers Treated With Naloxone Die

WASHINGTON, DC — About 10% of people who overdose on opioids and are treated with naloxone die within a year, new research shows.

The reason for the study was to get a concrete statistic to share with people who overdose that would spur them to get help for their addiction, which the “vast majority” don’t seek, said investigator Scott Weiner, MD, director of the comprehensive opioid response and education program at Brigham and Women’s Hospital in Boston.

“Now I tell patients that you have a one in 10 chance you will be dead within a year,” he told Medscape Medical News. “I want it to hit home. I want them to understand the scope of the problem.”

Dr Weiner and his colleagues tracked more than 12,000 naloxone administrations in Massachusetts over 30 months, which averages out to about 406 each month.

Of the people who received the opioid overdose antidote from emergency medical services personnel, 6.5% died the same day, Dr Weiner reported here at the American College of Emergency Physicians (ACEP) 2017 Scientific Assembly.

Just under 10% of people who received naloxone died within a year, and half of those died within a month.

And of those who died within a year, about 40% died outside a hospital.

“That, to me, means that people are dying before healthcare can get to them,” Dr Weiner explained. These are the people who using opioids at home, by themselves, and are found dead. “That’s where bystander naloxone needs to come into play. If friends and family know someone is using, they need to have naloxone.”

Congress is considering legislation that would allow naloxone to be sold over the counter, which makes sense because naloxone “is a much safer medication than Tylenol,” he pointed out. Currently, the loved ones of opioid users can obtain it through a physician’s standing order, but “it’s still a little circuitous.”

People who abuse opioids should be considered to be at extremely high risk, and should receive interventions — such as buprenorphine, counseling, and referral to treatment — before they are discharged from the hospital, he added.

A related study presented at the meeting indicates that more than half the patients who present to the emergency department with opioid misuse problems suffer from mental health issues and high rates of early childhood trauma exposure.

Results from a recent ACEP poll of 1261 emergency physicians suggest that the number of patients seeking opioids in emergency departments has increased or remained the same in the past year.

Virtually every emergency physician in the country is affected by the opioid crisis, said ACEP President Paul Kivela, MD, from the Napa Valley Emergency Medical Group in California, who presented the poll results.

According to 57% of respondents, detox and rehabilitation facilities are rarely or never accessible, which leads to few referral options.

“It’s been a problem for a long time, and the majority of emergency physicians out there say there are no treatment programs for these patients,” said Dr Kivela. “We need to expand our capabilities or scope of care.”

He said he is pleased that President Trump has declared the opioid crisis a public health emergency, and hopes the federal government will provide financial and other resources to help tackle the epidemic.

It’s heartbreaking and shameful that people who genuinely want help can’t get it.

The study findings and poll results are “extremely relevant” to what emergency physicians experience every day, said Angela Mattke, MD, from US Acute Care Solutions in Cleveland.

Several years ago, she handled about one opioid overdose each month, she told Medscape Medical News. “Now I see several a shift.”

“Because naloxone is now so widely available, I’m seeing fewer overdoses,” she added. “Frequently, I do have patients who would like addiction treatment, but there are no resources available. It’s heartbreaking and shameful that people who genuinely want help can’t get it.”

Dr Weiner is a shareholder and member of the scientific advisory board for General Emergency Supplies and Epidemic Solutions. Dr Kivela and Dr Mattke have disclosed no relevant financial relationships.

American College of Emergency Physicians (ACEP) 2017 Scientific Assembly: Abstract 402. Presented October 30, 2017.

Follow Medscape on Twitter @Medscape and Maureen Salamon @maureensalamon

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On the Front Line of HIV Care at ANAC 2017

On the Front Line of HIV Care at ANAC 2017

The mechanics of keeping people with HIV in care so they achieve viral suppression will be a topic of much discussion at the upcoming Association of Nurses in AIDS Care (ANAC) 2017 in Dallas.

“One of the biggest issues is retaining people in care,” said Jeff Kwong, DNP, from the Columbia University School of Nursing in New York City, who is the incoming ANAC board chair and cochair of the conference.

And “nurses are in the ideal role/position to help keep patients engaged in care,” he told Medscape Medical News.

There will be plenaries on innovative approaches like the Project ECHO telemedicine model, which links specialists with rural general practitioners, and there will be oral abstract sessions on partnerships between community-based organizations and local house/ball culture, which is the underground community of gay, lesbian, bisexual, and transgender young people, especially those of color.

“Working with the house/ball community is one of the sessions I’m looking forward to,” Dr Kwong told Medscape Medical News. “It’s a unique community, and one that often does not get a lot of focus at conferences.”

Leaders in nursing will bring their expertise and share real-life experiences about the clinical impact of programs for hard-to-reach populations.

There will be sessions on the opioid crisis, looking at not only the overlap between HIV and hepatitis C risk in people who inject drugs, but also examining strategies relevant to both nurses and policy makers. A case study of the impact HIV testing at a Federally Qualified Health Center had on the epidemic will be presented by nurses from Atlanta. And there will be sessions on working with patients affected by stress, trauma, and “difficult life circumstances,” which can interfere with wellbeing and the ability to adhere to treatment.

The care continuum as it relates to adolescents with HIV will be addressed by Vincent Guilamo-Ramos, PhD, RN, NP, from New York University in New York City. And the overall HIV care continuum will be addressed by Ed Gardner, MD, from the University of Colorado Denver.

Strategies and solutions for the prevention of HIV will be explored, including PrEP programs led by nurses and by peer navigators. And a roundtable will specifically address the PrEP needs of black men who have sex with men.

Discussions about issues related to the aging of the HIV population — something nurses could not have imagined when the ANAC was founded — will examine comorbidities such as hepatitis C, HIV-associated neurocognitive disorder, cardiovascular disease, and tuberculosis.

“It’s amazing that we’re celebrating our thirtieth year. It speaks to the need and role of our organization,” said Dr Kwong. “We remain the key organization and voice for nurses in the epidemic.”

Context of Care

This year, nurses will also discuss how they can help their patients in light of current political and funding realities. “We have sessions designed to address the new sociopolitical environment we’re living in,” said Dr Kwong.

The medical director of Planned Parenthood will speak about reproductive rights and health, he told Medscape Medical News.

And the critical role safety-net providers play in expanding access to care and addressing disparities in outcomes will be addressed by Raegan McDonald-Mosley, MD, chief medical officer at Planned Parenthood.

Nurses, Dr Kwong noted, are “front-line clinicians.”

A preconference reception celebrating the organization’s thirtieth year, to be held at the George W. Bush Presidential Library and Museum, will include a discussion of the value of the President’s Emergency Plan for AIDS Relief (PEPFAR), which was President Obama’s signature HIV program.

Then, the opening plenary will “review the scientific and sociocultural contexts in which nurses practiced during the pretreatment years of 1981 to 1987.” During her presentation, Ella Pritchard Curry, PhD, RN, founder of the ANAC, will address the work that nurses have done as “leaders and providers in expert HIV nursing practice, advocacy, education, policy, and research.”

Dr Kwong is on the speaking bureau for Gilead Sciences.

Follow Medscape Nurses on Twitter @MedscapeNurses and Heather Boerner @HeatherBoerner

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FDA Approves Acalabrutinib (Calquence) for Mantle Cell Lymphoma

FDA Approves Acalabrutinib (Calquence) for Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) granted an accelerated approval today to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

“For patients who have not responded to treatment or have relapsed, acalabrutinib provides a new treatment option that has shown high rates of response for some patients in initial studies,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Acalabrutinib is a second-generation Bruton’s tyrosine kinase (BTK) inhibitor that is described as being more selective in targeting alternative kinases than first-generation products such as ibrutinib (Imbruvica, Pharmacyclics and Janssen).

The new approval of acalabrutinib is based on results from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment. In the trial, the overall response rate was 81% (40% complete responses and 41% partial responses).

Common adverse events of acalabrutinib include headache, diarrhea, bruising, fatigue, and myalgia, as well as anemia, thrombocytopenia, and neutropenia.

Serious side effects include hemorrhage, infections, and atrial fibrillation. Second primary malignancies have occurred in some patients receiving acalabrutinib.

As a drug that has received an accelerated approval, acalabrutinib must be further studied to verify and further establish its clinical benefits; AstraZeneca is currently conducting a trial for that purpose.

Mantle cell lymphoma is a fast-growing type of non-Hodgkin lymphoma. “Mantle cell lymphoma is a particularly aggressive cancer,” observed Dr Padzur.

It represents 3% to 10% of all cases of non-Hodgkin lymphoma in the United States, according to the National Cancer Institute of the National Institutes of Health.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick.

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