Gosank: Mei 2017

Rabu, 31 Mei 2017

Tak Ingin Terperosok ke Lubang yang Sama, Wiranto Janji Bangun Kekuatan Merata

Gagal Total di Piala Sudirman, PBSI Dipanggil Menpora

DETIKSPORT | Jumat 26 Mei 2017, 23:45 WIB
Tim bulutangkis Indonesia gagal total saat berlaga di Gold Coast, Australia. Induk olahraga tepok bulu, PBSI, akan dipanggil Menpora, Imam Nahrawi.

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Pelatnas Wushu Kini Lebih Nyaman dan Asyik karena Benar-Benar Terpusat

Jakarta – Pemusatan latihan wushu untuk SEA Games 2017 agak berbeda dari biasanya. Dibandingkan dua tahun lalu, kali ini wushu melakukan pelatnas tersentral di Jakarta.

Pelatnas wushu untuk SEA Games 2017 mendatang digelar di Jakarta, dengan berpusat di GOR Simprug Pertamina. Langkah ini disebut atlet wushu putri Lindswell Kwok sebagai perubahan yang positif. Sebab sebelumnya, meski berlabel pemusatan latihan, latihan digelar terpisah-pisah.

“Sekarang digabung semua di Jakarta. Dulu kan desentralisasi ada yang Yogyakarta, Jakarta, dan Medan. Tapi tahun ini kita dikumpulkan semua di satu tempat di Jakarta,” kata Lindswell di sela-sela latihan di Gedung PP ITKON Senayan, Rabu (31/5/2017) kemarin.

Dengan latihan tersentral, sistem latihan wushu menjadi lebih tertata. Masing-masing atlet mendapat kesempatan ditangani pelatih dari China. Tak ayal suasana latihan pun jadi lebih kondusif dan nyaman.

Atmosfer cair sudah terlihat di sela-sela latihan fisik sore kemarin di Gedung PP ITKON. Dilatih oleh pelatih fisik Kelana Sukma, ada nuansa santai dari para atlet taolu. Mereka sempat bercanda ketika salah seorang atlet yang kelelahan dengan santai menenggak minuman, sementara sebagian yang lain sedang berpuasa.

“Ya, jadi lebih enak sih dan nyaman. Seperti kesempatan dilatih oleh pelatih dari China semua dapat. Kalau dulu yang di Jakarta dan Yogyakarta kan tidak dapat (cuma di Medan). Jadi harusnya sih sudah lebih merata dan adil. Semua dapat susah dan senangnya,” ujar Lindswell.

“Ya harapannya (hasilnya) jadi lebih baik lah,” tuntasnya.

(raw/mfi)

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ADA 2017 Scientific Sessions Rich With Clinical Trials

Fans of diabetes clinical trials rejoice: The American Diabetes Association (ADA) 2017 Scientific Sessions is your meeting.

Of course, the annual ADA conference always offers cutting-edge research on just about every aspect of diabetes for scientists, clinicians, other professionals, patients, and financial stakeholders. But this year, the number of major clinical trial results — in both type 2 and type 1 diabetes — is especially notable if not record-setting, ADA chief scientific and medical officer William T Cefalu, MD, told Medscape Medical News.

“I’ve never seen a more packed scientific sessions as far as things I want to see and exciting new research,” the Louisiana endocrinologist said.

The meeting will take place Friday, June 8, through Tuesday, June 13, in San Diego, California

Type 2 Diabetes Trials: More CV Outcomes

Perhaps the most anxiously awaited of the major trials will be the cardiovascular-outcomes trial for the sodium glucose cotransporter-2 (SGLT2) inhibitor canagliflozin (Invokana, Janssen Pharmaceuticals), the Canagliflozin Cardiovascular Assessment Study (CANVAS). The 2-hour session on June 12 will include results from the sibling trials CANVAS and the CANVAS renal-end-points trial (CANVAS-R), both sponsored by Janssen Research & Development.

Since the landmark 2015 EMPA-REG trial demonstrated a major reduction in both all-cause and cardiovascular death among high-risk patients taking another SGLT2 inhibitor, empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), the diabetes community has debated whether that survival benefit is a class effect.

Results from CANVAS and CANVAS-R could help answer that question. “I think a lot of people will be interested in that,” Dr Cefalu said, adding, “I’ll be looking to see if this is a class effect or if it’s selective for one particular agent in the class.…This is a study that could actually alter and inform clinical decision making if it’s positive.”

In addition to the cardiovascular and renal results, the CANVAS data may also provide additional information about safety concerns, including diabetic ketoacidosis, which has been reported with all SGLT2 inhibitors, and both increased fracture and amputation risks reported with canagliflozin specifically.

“The important thing to note here,” Dr Cefalu said, is “we know that at least one of this class has a favorable cardiovascular benefit, which has to be weighed against any risks, as with any medication.”

Another major randomized trial involving type 2 diabetes, also to be presented in an hour-long session on Monday, is Novo Nordisk’s DEVOTE, comparing the cardiovascular safety of the long-acting insulin degludec (Tresiba) vs insulin glargine (Lantus, Sanofi) in high-risk patients.

Dr Cefalu commented, “We know from the [Outcome Reduction with an Initial Glargine Intervention (ORIGIN)] trial that glargine was neutral on cardiovascular end points. Now, with another long-acting insulin, the question is whether they are equal on cardiovascular outcomes and if so, what is the benefit of one vs the other regarding hypoglycemia and other risks. This is interesting because it’s a head-to-head study of two basal insulins [and effects] on cardiovascular disease.”

Type 1 Diabetes Trials: Treatment and Possible Prevention

A special 2-hour symposium on Sunday afternoon will be devoted to the Reducing With Metformin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) international multicenter trial, sponsored by the JDRF. Enrolling patients with type 1 diabetes aged 40 and older, the study’s primary end point is progression of carotid intima-media thickness at 3 years.

“There is residual [cardiovascular] risk with type 1 despite all the advances in therapy.…If metformin really has a beneficial effect, I think that would be incredibly important,” Dr Cefalu commented.

And on the prevention side, results of three major trials will be presented in one 2-hour session Monday afternoon, all looking at whether intervention in the earliest stages of type 1 diabetes — either new-onset or antibody positivity — can slow or prevent progression to full insulin dependence.

The three trials are the Type 1 Diabetes TrialNet Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (National Institutes of Health), Imatinib in New-Onset Type 1 Diabetes (University of California, San Francisco, and JDRF) and DIABPREV-IT trial with glutamic acid decarboxylase (GAD) vaccine (Lund University)

Of the TrialNet study, Dr Cefalu said, “If it’s positive, it will be fantastic. If it’s negative, hopefully, it will inform us.” Overall, he said, “These are three type 1 prevention trials being presented at the same symposium, which will be very exciting. If any one of these trials turn out, it could move us toward more translational results.”

Lipid-Lowering in Both Diabetes Types

Yet another major clinical trial, being presented on Sunday morning, involves the use of alirocumab (Praluent, Sanofi/Regeneron) in both type 1 and type 2 diabetes: Sanofi’s Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM–Insulin).

Results for that will be presented, along with a discussion of the Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM–Dyslipidemia).

Together, the two ODYSSEY studies are the first to examine the effect of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor on safety, tolerability, and glycemia in addition to lipid management exclusively in diabetes populations.

The President’s Oral Abstracts: A Potpourri

Of the eight oral abstracts selected from among hundreds to be presented Tuesday morning in a special President’s Oral Abstract session, the more clinical ones include a comparative-effectiveness trial of major depression treatment in type 2 diabetes, a look at heart-failure hospitalization among new users of SGLT2 inhibitors, a trial of a human glucagon receptor antibody for improving glycemic control in type 1 diabetes, and efficacy and safety of oral basal insulin in type 2 diabetes.

Politics a’ Plenty

For attendees who seek some politics with their medical science, there are several agenda items: A symposium on Saturday morning and oral abstract session on Monday morning addressing the impact of the Affordable Care Act (ACA) — and its possible successor — on people with diabetes, and a sure-to-be-feisty discussion Saturday afternoon on the rising cost of insulin.

Dr Cefalu declined to comment on that aspect of the meeting, noting, “I’m going to wait and see what happens.…It seems to change every day.”

“A Wealth of Riches”

Of course, all of the above is just a tiny fraction of the hundreds of symposia, current-issues sessions, oral abstracts, posters, professional interest group sessions, special lectures and addresses, and posters covering every imaginable aspect of diabetes science and care delivery, much of it overlapping throughout the four and a half days.

“For me, it seems like there’s so much exciting science. It’s going to be hard to pick which sessions to go to,” Dr Cefalu said. “There are so many things I want to see at the same time. It’s a wealth of riches here.”

Dr Cefalu is an employee of the American Diabetes Association. He has no further relevant financial relationships.

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Menang di Mugello Akan Sangat Penting bagi Vinales

Mugello – Maverick Vinales saat ini berada dalam mood yang sangat baik setelah memenangi MotoGP Prancis. Rider Movistar Yamaha itu kini menginginkan kemenangan di MotoGP Italia, yang dia yakini akan sangat penting dalam usaha mengejar gelar juara dunia.

Kemenangan di Le Mans, 21 Mei lalu, mengembalikan Vinales ke puncak klasemen pebalap. Dia kini mengumpulkan 85 poin dari lima seri, di atas Dani Pedrosa (68 poin) dan Valentino Rossi (62 poin).

Seri MotoGP berikutnya adalah MotoGP Italia, yang akan dilangsungkan di Sirkuit Mugello, Minggu (4/6) mendatang. Vinales berharap bisa mempertahankan momentum dan menang lagi.

“Setelah balapan di Le Mans, saya hanya bisa bilang bahwa saya sangat gembira, tim bekerja di level yang luar biasa tinggi, dan saya yakin kami akan terus seperti itu,” tutur Vinales di situs resmi Yamaha Racing.

“Kami punya motor yang sangat bagus untuk sirkuit seperti Mugello, dengan grip yang sangat baik, dan kami harus memaksimalkannya,” imbuhnya.

Pebalap-pebalap Yamaha memang mendominasi di Mugello. Dalam sepuluh balapan terakhir di sana, tujuh di antaranya dimenangi oleh pebalap Yamaha, dua lewat Rossi dan lima lainnya lewat Jorge Lorenzo.

“Dengan kejuaraan yang sekompetitif itu, seri-seri berikutnya akan sangat menentukan dan akan sangat penting untuk merebut kemenangan di Mugello, tentunya saya akan terus berjuang. Kami akan berusaha melakukan yang terbaik seperti biasanya,” kata Vinales.

(mfi/rqi)

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Eat More Chocolate, Have Less Atrial Fibrillation? Hope Springs Eternal

COPENHAGEN, DENMARK — People who regularly consume moderate amounts of chocolate also seem to have a reduced risk for developing atrial fibrillation (AF), according to an analysis, which is being interpreted cautiously, based on a large, prospective cohort study from Denmark^[1].

Lots of published studies have suggested that regular consumption of chocolate, especially dark chocolate, is associated with heart and vascular benefits that include lower rates of cardiovascular events, stroke, and heart failure, possibly due to the confection’s large flavonoid content. But the current analysis is unusual for associating chocolate with less incident AF.

According to the analysis of 55,502 persons in the Danish Diet, Cancer, and Health Study, which enrolled people aged 50 to 64 years between December 1993 and May 1997, consuming chocolate one to three times a month was associated with a 10% risk of incident AF compared with partaking of the treat less than once a month.

But in the study published May 23, 2017 in Heart, the “benefit” appeared to plateau and was only marginally greater with more frequent chocolate consumption. That would be expected because “there’s only so much benefit one can expect,” lead author Dr Elizabeth Mostofsky (Harvard School of Public Health, Boston, MA) told heartwire from Medscape.

And, she said, “Because chocolate entails also a lot of sugar and fat, it’s only beneficial in moderation.” Nevertheless, “there’s so little known about ways to prevent arrhythmia and it’s such a huge public-health burden that any lifestyle factors that we think could be associated with prevention seem to be of interest.”

Message Would Resonate With the Public

In an accompanying editorial^[2], Drs Sean D Pokorney and Jonathan P Piccini (Duke University Medical Center, Durham, NC) agreed that it is “exciting” to imagine public-health announcements encouraging chocolate consumption, as they “would resonate well, and patients might be more than happy to comply with this healthcare advice.”

But the pair wondered whether the idea is “too good to be true,” noting a number of limitations to the study, including that the chocolate consumers were generally healthier and better educated than other participants and that it is not possible to determine whether the incidence of all or only clinically apparent AF is associated with chocolate consumption.

Regardless, Pokorney and Piccini say that the findings are “interesting and warrant further consideration, especially given the importance of identifying effective prevention strategies for AF.”

At baseline in the study, participants completed a 192-item food frequency questionnaire that was validated against two 7-day weight diet records. Each participant was also matched to the Danish National Patient Register to gather data on incident clinically apparent AF or atrial flutter.

Defining a serving of chocolate as about 1 oz, or 30 g, the team found that 12,258 of the >55,000 participants reported consuming chocolate less than once a month, while 22,909 had an intake of one to three servings per month, 10,620 ate one serving per week, 8476 ate two to six servings per week, and 1239 one or more servings per day.

The questionnaire used did not distinguish between milk or dark chocolate, but, as the team notes, in Denmark most of the chocolate consumed is milk chocolate.

Over mean follow-up of 13.5 years, there were 3346 incident cases of AF. In multivariate analysis, the rate of AF was lower for those consuming one to three servings per month, at a hazard ratio of 0.90 (95% CI 0.82–0.98) compared with a chocolate intake of less than one serving per month.

The impact of increased chocolate consumption on the risk of AF subsequently leveled off at an HR 0.83 (95% CI 0.74–0.92) for one serving per week, 0.80 (95% CI 0.71–0.91) for two to six servings per week, and 0.84 (95% CI 0.65 to 1.09) for one or more servings/day P-linear trend<0.0001).

Effect Seen in Both Women and Men

Although incident AF was less common among women than men, the relationship between increased chocolate and a reduced AF incidence remained significant for both men (P for trend=0.002) and women (P for trend=0.017) after researchers took potential confounding factors into account.

Further analysis indicated that the findings were confounded by history of hypertension and cardiovascular disease or by adjustment for caffeine intake and coffee consumption.

The editorialists Pokorney and Piccini pointed to the ongoing Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), a randomized trial looking at whether daily supplements of cocoa extract and/or a standard multivitamin reduces the risk of developing cardiovascular disease and cancer. However, the end points don’t include AF.

“The highest-quality care for AF is to prevent it in the first place. It will be interesting to see if chocolate is an effective preventive therapy,” they write.

This work was conducted with support from grants from the National Heart, Lung, and Blood Institute, the European Research Council, EU 7th Research Framework Program, a KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst, the Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award), and the Danish Cancer Society and the Danish Council for Strategic Research (Aalborg AF-Study Group). The authors report no relevant financial relationships. Pokorney reports modest consulting support from Boston Scientific and Medtronic; modest research support from Gilead, Boston Scientific, Bristol-Myers Squibb, Pfizer, and Janssen Pharmaceuticals. Piccini reports grants for clinical research from ARCA biopharma, Boston Scientific, Gilead, St Jude Medical, and Spectranetics and serving as a consultant to Allergan, Amgen, GlaxoSmithKline, Medtronic. and Spectranetics.

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Pelatnas Wushu Kini Lebih Nyaman dan Asyik karena Benar-Benar Terpusat

Pemusatan latihan wushu untuk SEA Games 2017 agak berbeda dari biasanya. Dibandingkan dua tahun lalu, kali ini wushu melakukan pelatnas tersentral di Jakarta.

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Suicide Risk Significantly Elevated After Psychiatric Discharge

The risk for suicide is strikingly elevated immediately after discharge from a psychiatric facility and remains elevated years later, according to a synthesis of more than 50 years of research on postdischarge suicide rates.

Results from a large meta-analysis show that the postdischarge suicide rate was roughly 100 times the global suicide rate during the first 3 months following discharge, and patients admitted with suicidal thoughts or behaviors had rates almost 200 times the global rate, the researchers report.

This analysis “clarifies the extent and duration of the increased risk of suicide post discharge, finding a significantly higher and much more enduring risk than was generally believed,” Matthew Michael Large, MBBS, of the University of New South Wales, Australia, told Medscape Medical News. “Having been a psychiatric inpatient seems to be the single strongest suicide risk factor.

“Clinicians should not assume that discharged patients who seem to be at low risk of suicide on clinical grounds are not in need of ongoing support and assistance. Health systems need to be designed to facilitate long-term care for discharged patients,” added Dr Large.

The study was published online May 31 in JAMA Psychiatry.

Ongoing Prevention Needed

The research team quantified rates of suicide after discharge from psychiatric care in their analysis of 100 studies with 183 patient samples reporting 17,857 suicides during roughly 4.7 million person-years.

The pooled estimate discharge suicide rate was 484 per 100,000 person-years. The highest rate of suicides committed during the first 90 days following discharge (1132 per 100,000 person-years) were among patients admitted with suicidal thoughts or behaviors (2078 per 100,000).

The pooled suicide rates (per 100,000 person-years) were 654 in studies with follow-up from 3 months to 1 year; 494 in studies with follow-up from 1 to 5 years; 366 in studies with follow-up lasting 5 to 10 years; and 277 in studies with follow-up longer than 10 years, the authors report.

For comparison, the World Health Organization estimated that the global suicide rate was 11.4 per 100,000 person-years in 2012; the US suicide death rate was 13.4 per 100,000 population in 2014.

The analysis suggests that the suicide rate among discharged patients has not decreased in the past 50 years. “This is a disturbing finding considering the increase in community psychiatry and the availability of a range of new treatments during this period,” the authors write.

This study, the investigators note, “suggests that previously admitted patients, particularly those with prior suicidality, remain at a markedly elevated risk of suicide for years and should be a focus of efforts to decrease suicide in the community.”

“Disturbing Trend”

Suicide has proven to be a “stubbornly difficult threat to health,” writes Mark Olfson, MD, MPH, of the Department of Psychiatry, Columbia University and New York State Psychiatric Institute in New York City, in a linked editorial.

“Despite clinical and public health efforts aimed at preventing suicide, the suicide rate in the United States has steadily increased over the past decade,” he notes. “This disturbing trend stands in sharp contrast with 8 of the other 10 leading causes of death in the United States, the rates of which have substantially decreased in recent years. The national increase in suicide rate brings renewed urgency to suicide research and implementation of effective suicide prevention programs.”

The new analysis, said Dr Olfson, provides a clear clinical message: “universal and continuing suicide prevention interventions are needed for patients after psychiatric hospital discharge, with a higher level of clinical monitoring and support for patients during the first few months after hospital discharge and for patients with a history of suicidal behavior.”

To make meaningful progress, “system-wide reforms in monitoring patients after hospital discharge will likely need to be complemented with traditional suicide-specific patient interventions, such as safety planning, crisis lines, crisis counseling services, and on-call mental health services,” Dr Olfson says.

“A greater appreciation of the enduring elevated risk of psychiatric inpatients after discharge might help build support for the clinical resources to reduce the unacceptably large number of individuals who die by suicide each year,” Dr Olfson concludes.

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

JAMA Psychiatry. Published online May 31, 2017. Full text, Editorial

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Solid Tumor Risk in Childhood Cancer Survivors

NEW YORK (Reuters Health) – Doxorubicin and cyclophosphamide increase the risk of subsequent solid malignancies in survivors of childhood cancer, according to results from the Dutch Childhood Cancer Oncology Group LATER study cohort.

“Childhood cancer survivors are at increased risk of developing new malignancies, even decades after treatment has ended,” Jop C. Teepen from Emma Children’s Hospital/Academic Medical Center in Amsterdam told Reuters Health by email. “Physicians who take care of survivors of childhood cancer should be aware of a possible increased risk of second malignancies, not only after radiotherapy, but also after certain chemotherapy treatments.”

Childhood cancer survivors who received radiotherapy face an increased risk of subsequent malignant neoplasms (SMNs). Chemotherapy has been linked to an increased risk of acute myeloid leukemia, but its role in the etiology of solid cancers is less clear.

Teepen and colleagues used data from 6,165 five-year childhood cancer survivors to examine the role of specific chemotherapeutic agents in the later development of solid malignancies.

Overall, the risk of any SMN was 5.2-fold higher among childhood cancer survivors than in the general population (an excess of 20.3 cancers per 10,000 person-years), according to the May 22nd Journal of Clinical Oncology online report.

Excess absolute risks of at least 2.0 per 10,000 person-years were observed for female breast, thyroid, soft tissue sarcoma, and CNS malignancies.

The 25-year cumulative incidences were 3.4% for all solid cancers, 1.5% for female breast cancer, and 1.0% for sarcoma.

Doxorubicin was associated with a dose-dependent increased risk of all solid cancers and female breast cancer, whereas cyclophosphamide was associated with a dose-dependent increased risk of sarcoma.

Ifosfamide also appeared to increase the risk of breast cancer and sarcoma, without a clear dose effect.

As in earlier studies, radiotherapy was a significant risk factor for subsequent solid cancers in childhood cancer survivors.

“It is important that survivors who were treated for childhood cancer in the past are regularly seen by a medical team that is familiar with their potential risks of long-term complications to inform them about their risks and to provide medical care for those survivors who are at highest risk of medical problems,” Teepen said.

“To date only women treated with radiotherapy directed to the chest are eligible for breast cancer surveillance additional to population screening efforts,” he said. “The International Guideline Harmonization Group (IGHG) is currently updating their recommendations for breast cancer surveillance among childhood cancer survivors. New evidence from this and other recent studies will be included in the process to reevaluate the pros and cons of surveillance recommendations.”

Dr. Lucie Turcotte from the University of Minnesota Masonic Children’s Hospital in Minneapolis, who recently reviewed trends in treatment and subsequent neoplasm risk among five-year survivors of childhood cancer, told Reuters Health by email, “The risk for subsequent solid cancers is not unique to survivors of childhood cancer who were treated with radiation. The evaluation of specific chemotherapeutic agents in subsequent malignancy risk is important, particularly as the use of therapeutic radiation continues to decline. This study sets the stage for additional detailed analyses examining chemotherapy-associated risk.”

“The dose-dependent association between doxorubicin and solid cancer risk, specifically breast cancer risk, is interesting,” she said. “This supports the recent finding from the Childhood Cancer Survivor Study that anthracyclines are associated with increased risk of breast cancer in women not treated with chest irradiation.”

“There are not currently specific guidelines for breast cancer screening in women not treated with chest radiation,” Dr. Turcotte said. “This study demonstrates an at-risk population of women treated with high doses of doxorubicin and suggests the need for closer surveillance of this population.”

SOURCE: http://bit.ly/2rBIJU6

J Clin Oncol 2017.

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Oral Ozanimod Looks Safe and Effective in Relapsing MS

NEW ORLEANS — The oral investigational agent ozanimod demonstrated continued efficacy on measures of disease activity among patients with relapsing multiple sclerosis (RMS), in a blinded extension study of the phase 2 RADIANCE Part A trial.

The unadjusted annualized relapse rate was only 0.17, Brett E. Skolnick, PhD, from Receptos, a subsidiary of Celgene, reported here at the Consortium of Multiple Sclerosis Centers (CMSC) 2017 Annual Meeting. Dr Skolnick stepped in for lead investigator, Giancarlo Comi, MD, from Vita-Salute San Raffaele University in Milan, Italy, who had to cancel his trip to the conference.

On May 22, Celgene Corp announced topline results of the phase 3 RADIANCE trial, involving 1313 patients with RMS, showing the trial met its primary endpoint, a reduction in annualized release rate compared with weekly interferon (IFN) β-1a (Avonex) with both 0.5- and 1-mg doses. Reductions were also seen in the secondary endpoints of the number of new or enlarging T2 MRI lesions and number of gadolinium-enhancing lesions over 24 months.

The statement also noted that in a prespecified pooled analysis of the phase 3 RADIANCE and SUNBEAM trials, the time to confirmed disability progression was “very low” across all treatment groups, and treatment with ozanimod was not statistically significantly different from IFNβ-1a.

However, both doses of ozanimod showed a statistically significant reduction in brain atrophy compared with IFNβ-1a in both the SUNBEAM and RADIANCE trials, the company noted. Safety and tolerability in RADIANCE was “consistent” with that seen in SUNBEAM and previous phase 2 trials

Further analyses of the RADIANCE trial are ongoing, the company writes. “In February 2017, Celgene announced positive top-line results from the second active comparator phase 3, SUNBEAM, in RMS,” the statement said. “Detailed results from the RADIANCE and SUNBEAM trials will be presented at an upcoming medical congress.”

A New Drug Application submission to the US Food and Drug Administration, based on the combined SUNBEAM and RADIANCE trials for RMS, is expected by the end of 2017.

Therapeutic Potential

Ozanimod is an oral, selective sphingosine-1 phosphate (S1P) receptor-1 (S1P_1R) and receptor-5 (S1P_5R) modulator in the development for RMS. The increased receptor selectivity of ozanimod and additional pharmaceutical properties are predicted to result in a more favorable safety profile compared with other nonselective and selective S1P receptor modulators.

The therapeutic potential of S1P receptor modulation was demonstrated with fingolimod (Gilenya, Novartis), a nonselective S1P receptor agonist approved for relapsing MS, but there have been concerns about safety, especially in terms of cardiovascular effects, according to experts in the field.

At the CMSC meeting, Dr Skolnick presented data from the 96-week blinded extension portion of the phase 2 RADIANCE Part A trial, which is part of a phase 2/3 clinical trial of ozanimod in adults with RMS.

Results of the 24-week placebo-controlled phase 2 core treatment period demonstrated strong efficacy and favorable safety and tolerability profile (Lancet Neurol. 2016;15:373-381).

The global placebo-controlled RADIANCE trial enrolled patients with relapsing MS who had an Expanded Disability Status Scale score of 0 to 5.0 and had (1) one or more relapses in the previous 12 months or (2) one or more relapses in the past 24 months plus one or more gadolinium-enhancing lesions on MRI in the 12 months before screening.

In phase 2 of the trial, 258 participants were assigned to ozanimod (0.5 mg or 1 mg) or placebo once daily for 24 weeks. The study met its primary endpoint, a reduction in the cumulative number of total gadolinium-enhancing MRI lesions 12 to 24 weeks after treatment initiation.

The mean cumulative number of gadolinium-enhancing lesions at weeks 12 to 24 was 11.1 with placebo vs 1.5 with ozanimod 0.5 mg (odds ratio, 0.16; P < .0001) and 1.5 with ozanimod 1 mg (odds ratio, 0.11; P < .0001). No serious cardiac adverse events were reported.

Two-Year Extension Period, Part A

Dr Skolnick reported the drug’s continued efficacy on MRI and clinical measures of MS disease activity over the 2-plus years of the blinded extension period and noted that ozanimod 1.0 mg was more effective than the 0.5-mg dose.

In the extension period, patients who began receiving ozanimod in the core treatment continued to receive 0.5 mg (n = 85) or 1.0 mg (n = 81) or, if initially on placebo, received ozanimod 0.5 mg (n = 41) or 1.0 mg (n = 42) for the first time. Ozanimod was dose-escalated over 7 days to attenuate first-dose effects (ie, to assure cardiac safety). Completing 96 weeks of treatment were 112 patients (88.9%) receiving ozanimod 0.5 mg and 111 (90.2%) receiving ozanimod 1.0 mg.

At the conclusion of the blinded extension phase, approximately 90% of patients were free of gadolinium-enhancing lesions, and the unadjusted annualized relapse rates were 0.38 with ozanimod 0.5 mg and 0.17 with ozanimod 1.0 mg. In the core study, the rate of 0.24 with ozanimod 1.0 mg in the core study represented a 50% reduction vs the placebo group, and the rate for this group fell further to 0.17, he noted.

MRI and clinical outcomes after 24 weeks of treatment in the core study and after the blinded extension study are shown below.

Table. Outcomes With Ozanimod After 24 Weeks and 2+ Years

Outcome Measure	Placebo-Ozanimod 0.5 mg (Core/Extension)	Placebo-Ozanimod 1.0 mg (Core/Extension)	Ozanimod-Ozanimod 0.5 mg (Core/Extension)	Ozanimod-Ozanimod 1.0 mg (Core/Extension)
Mean number of new gadolinium-positive lesions	4.5/0.4	1.9/0.1	0.4/0.4	0.2/0.2
Number of new or enlarging T2 lesions	10.8/3.2	7.3/1.9	1.4/2.3	0.9/0.7
Unadjusted annualized relapse rate	0.57/0.35	0.41/0.12	0.43/0.38	0.24/0.17

Safety Profile: No Cardiac Issues

Treatment-emergent adverse events (TEAEs) associated with ozanimod over the 2-plus years of the blinded extension phase were consistent with those seen in the core treatment period, with no apparent differences between doses.

At least one TEAE was seen in 79% (0.5 mg) and 76% (1.0 mg) of patients, but none of the serious TEAEs were considered related to the drug. The most common TEAE was increased alanine aminotransferase (ALT) levels, which occurred in 37% to 51%. ALT levels at least three times the upper limit of normal (ULN) occurred in about 5% of patients in the extension period.

“Five patients discontinued the study according to protocol requirements for ALT more than five times the ULN, but all improved or recovered after drug discontinuation,” Dr Skolnick said. Other common TEAEs were nasopharyngitis, upper respiratory tract infection, urinary tract infection, and headache. No cases of macular edema were observed, and there were no serious opportunistic infections, malignancies, or clinically significant pulmonary TEAEs.

Because cardiac safety is a concern with fingolimod, it was important to show the lack of cardiac issues with ozanimod, he said. During the extension phase, patients exhibited no first-dose bradycardia and no second-degree or greater atrioventricular block. Mild blunting of the normal diurnal heart rate was observed. The largest mean decrease in heart rate relative to predose was 3.5 beats/min at hour 6 on day 1, with no associated symptoms.

“The safety and tolerability results suggest a favorable benefit-to-risk profile for ozanimod that awaits confirmation in the ongoing phase 3 trials, RADIANCE Part B and SUNBEAM,” he said.

Safety May Be Selling Point

David E. Jones, MD, assistant professor of neurology at the James Q. Miller MS Clinic of the University of Virginia Health System, Charlottesville, said he welcomes the data on ozanimod, especially on safety.

“It’s a more selective agent than fingolimod in that it only recognizes S1P subtypes 1 and 5. The assumption is that this will be associated with fewer cardiac side effects, and the data we heard today from RADIANCE suggests this is true,” he said. “I think this is important.”

For one reason, starting new patients on fingolimod can be somewhat “burdensome to providers and to patients,” he said, because 6-hour monitoring is recommended to monitor for “first dose phenomenon.” For patients taking β-blockers, calcium-channel blockers, or other drugs that affect heart rate, 24-hour monitoring is recommended. “We admit these patients overnight, so for them, it’s even more of a burden,” he said.

“I would expect ozanimod is equally effective as fingolimod, if not more so, and I think the safety profile will be better,” he said. He also believes the lack of occurrence of macular edema in the study is important because this adverse event occurred in 0.4% of patients in the fingolimod trial.

“Right now, it’s recommended that patients have an ophthalmic evaluation at baseline and 3 to 4 months after starting fingolimod, so this would be another aspect of convenience with this drug,” he offered.

The study was supported by Celgene. Dr Comi disclosed consulting for Almirall, Forward Pharma, Genzyme, Merck, and Novartis and speaking for Biogen, Celgene Corp, EXCEMED, Receptos, Roche, Sanofi, and Teva. Dr Skolnick is employed by Receptos, a subsidiary of Celgene Corp. Dr Jones has consulted for Biogen and Genzyme.

Consortium of Multiple Sclerosis Centers (CMSC) 2017 Annual Meeting. Abstract DX05. Presented May 26, 2017.

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Dana Belum Cair, Rencana Ujicoba Lindswell dkk. Gelap

Para pewushu nomor taolu (seni) yang tergabung dalam pelatnas berencana menjalani ujicoba di China. Namun, mereka tak memiliki dana.

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Emergency Physicians Have Twice the Markup of Internists

The markup for emergency physician care, or the amount charged over what Medicare allows, is twice that of the markup for care by internists, a nationwide analysis of Medicare billing records shows. The findings were published online May 30 in JAMA Internal Medicine.

Tim Xu, MD, MPP, from the Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland, and colleagues analyzed Centers for Medicare & Medicaid Services (CMS) claims from 12,337 emergency medicine physicians at 2707 hospitals and 57,607 internal medicine physicians at 3669 hospitals in all 50 states. They looked at all services provided to Medicare Part B fee-for-service beneficiaries in 2013.

The overall markup ratio for services provided by emergency medicine physicians was 4.4 times the rate Medicare pays (resulting in 340% excess charges). The markup ratio was 2.1 (110% excess charges) for all services performed by internal medicine physicians. For reference, a markup ratio of 3 means if Medicare charges $100 for the service, the hospital charges $300.

Among common emergency department (ED) procedures, the one with the highest median markup ratio was laceration repair at, 7 times (range, 2.0 – 15.0) what Medicare allows. The fee for physician reading of electrocardiograms ranged from the $16 allowed by Medicare to a markup of 1.1 (total of $18) in some EDs and as much as $317 in EDs with a markup ratio of 20 for the service.

The markup ratio also varied by hospital. In 2013, different EDs charged between 1.0 and 12.6 times what Medicare paid for the services. That range was between 1.0 and 14.1 for internal medicine services in the hospitals studied.

“In 2012, the 50 hospitals in the United States with the highest markups charged patients at least 9.2 times what the Medicare program would pay for care,” the authors write.

The wide swings in charges hit the uninsured and out-of-network patients especially hard because they may be liable for the full charges, whereas the insured will likely receive discounts.

Understanding markups is particularly important because the uninsured and out-of-network may be among those most likely to seek care in the ED, the authors write. The urgent nature of ED care also leaves little opportunity to comparison shop, they note.

Researchers also found that often the ED markups were significantly higher than those claimed by internal medicine for the same services.

“For example, the median hospital charged an additional $34 for interpreting an electrocardiogram when performed by an emergency medicine physician ($96; markup ratio, 6.0) relative to an internal medicine physician ($62; markup ratio, 3.9),” the authors explain.

Higher ED markup ratios were linked to hospitals that had for-profit ownership and those that had a greater percentage of uninsured patients, those that had at least 20% African-American or Hispanic populations, and those located in the Southeast. There were no such associations for internal medicine claims among hospitals.

At this time, there is no national legislation that addresses surprise charges for patients, the authors point out.

The authors list three approaches that have been proposed to protect patients: making prices transparent, although they note that comparing prices works better outside acute care situations; capping charges at 125% of the Medicare-allowable amount; and requiring hospitals to bundle ED care with all professional and facility fees and “therefore maintain a pool of employees and contracted physicians who agree to accept reasonable payment rates a priori.”

Dr Xu was supported by an Alpha Omega Alpha Carolyn L. Kuckein Student Research Fellowship. Mr and Mrs John Rodda and The Rodda Family Partnership, Ltd provided support for this research. The researchers have disclosed no other relevant financial relationships.

JAMA Intern Med. Published online May 30, 2017. Abstract

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Pelatnas Wushu Kini Lebih Nyaman dan Asik karena Benar-Benar Terpusat

Jakarta – Pemusatan latihan wushu untuk SEA Games 2017 agak berbeda dari biasanya. Dibandingkan dua tahun lalu, kali ini wushu melakukan pelatnas tersentral di Jakarta.

“Ya harapannya (hasilnya) jadi lebih baik lah,” tuntasnya.

(raw/mfi)

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Novel Drug Shows Promise for Binge Eating Disorder

SAN DIEGO, California ― A novel dopamine and norepinephrine reuptake inhibitor is showing promise in patients with binge eating disorder (BED).

Patients taking dasotraline had significantly fewer episodes of binge eating compared to those taking a placebo, a new phase 2/3 clinical trial showed.

“We are encouraged by these results because there’s still an unmet need in terms of bringing additional treatments that may be potentially efficacious and safe for the treatment of binge eating disorder,” Robert Goldman, PhD, head of global clinical research and medical affairs, Sunovion, told Medscape Medical News.

The research was presented here at the American Psychiatric Association (APA) Annual Meeting.

Uncomfortably Full

BED is characterized by recurrent episodes of compulsive overeating during which individuals consume larger than normal amounts of food and may have the sense that they lack control. Patients with this condition eat when they’re not hungry and often eat to the point of feeling uncomfortably full.

Binge eaters may feel embarrassed by how much they consume, which may contribute to social isolation. BED may lead to weight gain and to health problems related to obesity.

The new study included 317 patients (mean age, 38.2 years). The mean body mass index (BMI) was 34.7. Dr Goldman noted that 75% of study participants were classified as obese (BMI ≥30 or more).

Patients had to have mild to moderate BED, characterized by two or more binge eating days per week for 6 or more months, and three or more binge eating days per week for each of the 2 weeks prior to the trial.

About 84% of the study participants were women. Epidemiologic studies show that the lifetime prevalence of BED is higher among women (3.6%) than among men (2.1%), said Dr Goldman.

At baseline, the mean number of binge eating days per week among study participants was 4.25, and their mean Clinical Global Impression–Severity (CGI-S) score was 4.5.

Participants were randomly allocated to receive either oral dasotraline or placebo taken daily in the morning. The study used “flexible” dosing. The initial dose was 4 mg; the dose could be increased to 6 mg after 2 weeks, and clinicians could opt to increase it to 8 mg at subsequent visits, said Dr Goldman.

Dasotraline has a slow rate of absorption and a long half-life. “You achieve stable plasma concentrations over 24 hours at the once-daily dosing,” commented Dr Goldman.

A mixed model for repeated measures analysis showed that at week 12, the number of binge days per week was reduced by 3.74 in patients taking dasotraline and by 2.75 in the placebo group (for a mean difference of -0.99; 95% confidence interval, -0.65 to -1.33; P < .001).

As for secondary endpoints, 46.5% in the treatment group had at least 4 consecutive weeks in which they did not binge eat, compared to 20.6% of the placebo group (P < .001). As well, scores on the CGI-S and on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating were significantly better in the treatment group compared to the placebo group.

Adverse Events

More participants taking dasotraline had treatment-related adverse events, including insomnia, dry mouth, decreased appetite, and nausea, compared to the placebo group. Weight loss also occurred more frequently in the the treatment group (12.1% vs 0%).

“These adverse events are consistent with other studies in adults and are consistent with the dopamine/norepinephrine pharmacology of the agent, so they’re not surprising,” said Dr Goldman.

He stressed that in the dasotraline group, only 1.3% of participants discontinued the drug because of insomnia, and 1.9% discontinued it because pf anxiety.

Could this drug be used as a weight loss drug? Dr Goldman noted that, should this agent be approved, the label would clearly stipulate its use for treating BED.

He also pointed to a study evaluating the abuse potential of dasotraline, which is also being developed for the treatment of attention-deficit/hyperactivity disorder. That analysis indicated low potential for its abuse compared with the stimulant methylphenidate among recreational stimulant users.

It is not yet clear whether women responded better than men to the agent. “We are doing additional analyses of various subgroups, and that would include sex,” said Dr Goldman. “At this point, I can’t speak about specific subgroup effects.”

Patients with BED sometimes receive psychotherapeutic interventions, often combined with pharmacologic treatment. Lisdexamfetamine dimesylate (Vyvanse, Shire) is the only medication approved by the US Food and Drug Administration to treat BED.

A second confirmatory pivotal trial is being carried out in patients with mild to severe BED.

Another Alternative?

Medscape Medical News approached Sanjeev Sockalingam, MD, associate professor, Department of Psychiatry, University of Toronto, and psychosocial director, Toronto Western Hospital Bariatric Surgery Program, for comment.

Dr Sockalingam emphasized that physicians currently have only one approved medication for the treatment of patients with BED.

“This study provides data suggesting that dasotraline may be another promising treatment alternative. It adds to the limited literature on pharmacological treatments that are beneficial for more severe BED,” he said.

Additional therapeutic options might complement evidence-based psychological treatments for BED, he added.

New treatment options are needed, said Dr Sockalingam, given that BED is associated with an increased risk for other psychiatric disorders and obesity.

He stressed the need for additional research to establish the optimal treatment duration and the long-term safety of this novel agent.

Dr Goldman is an employee of Sunovion. Dr Sockalingam has received an investigator-initiated research grant from Shire Pharmaceuticals.

American Psychiatric Association (APA) 2017 Annual Meeting. Abstract P7-084, presented May 23, 2017.

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Pelatnas Wushu Kini Lebih Nyaman dan Asik karena Benar-Benar Terpusat

Pemusatan latihan wushu untuk SEA Games 2017 agak berbeda dari biasanya. Dibandingkan dua tahun lalu, kali ini wushu melakukan pelatnas tersentral di Jakarta.

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Heightened Zika Virus Threat on Tap for Summer, Experts Say

With summer around the corner, public health officials in the United States are gearing up to combat the threat posed by the Zika virus.

In the coming months, the threat of Zika “will get worse, and the consequences of inaction are very real for pregnant women and their babies,” Claude Jacob, president of the National Association of County and City Health Officials (NACCHO), warned today during a media briefing.

NACCHO, along with the Big Cities Health Coalition (BCHC) and the March of Dimes, held the briefing to discuss the threat posed by the Zika virus this summer.

Zika infections continue to be “widespread in Puerto Rico and the US Virgin Islands, and of course we had outbreaks in Miami and Brownsville, Texas, last year, and we expect more local outbreaks of Zika in this country, the mainland as well as other territories,” said Paul Jarris, MD, chief medical officer of the March of Dimes. The Southern and Gulf Coast regions in the United States are particularly vulnerable to Zika outbreaks.

When it comes to Zika, “we absolutely need to maintain vigilance and funding for Zika as it spreads and we learn more about the effects on pregnancy and newborns,” said Dr Jarris.

It is now known that Zika is responsible not only for microcephaly but also a spectrum of physical and neurologic effects on the fetus and newborn, he explained. “It’s not just spread through mosquitos but also through sexual activity, and it can remain in body fluids for weeks or even months. We know that it causes brain damage, and we are learning that even newborns who appear normal at birth later suffer deterioration in the weeks or months.

“We also recently had a case report about of an adolescent who underwent neurologic changes after a Zika infection. This is a single case, but it’s concerning that this virus may affect developing adolescents,” said Dr Jarris.

According to the Centers for Disease Control and Prevention (CDC), thus far in 2017, 121 cases of Zika have been reported on the US mainland, and an additional 498 have been reported in US territories. In 2016, 10% of the 250 women with confirmed Zika infection delivered a fetus or baby with a Zika-related birth defect.

Funding a Serious Issue

All members of the briefing panel agreed that combating Zika virus will be severely undermined as federal funding wanes.

President Trump’s budget proposal eliminates $2.1 billion from the CDC’s budget, cuts in half funding for the Epidemiology and Laboratory Capacity for Infectious Diseases program, and cuts the Public Health Emergency Preparedness program by $109 million. These cuts will have “lasting damage” to efforts to fight Zika, Jacob said.

Oscar Alleyne, senior advisor for public health programs at NACCHO, said, “Zika funds are not where they should be if we are serious about protecting the lives of people we serve in the community. Failing to fund Zika efforts can and will be catastrophic.”

Zachary Thompson, director, Dallas County Health and Human Services and BCHC member, noted that “boots on the ground” from local health departments are key to getting ahead of Zika this summer, and that takes funding.

In Dallas, he said, a Zika task force is in place and holds monthly meetings. “This is going to be very time consuming in a localized outbreak setting,” he noted, adding that continuous “education and reeducation” of the public regarding Zika and West Nile virus are needed. Health officials in Dallas are going “door to door to raise awareness” and to disseminate Zika information to high-risk populations and the general public, Thompson said.

No one can afford to be complacent when it comes to Zika, he said. His advice: “Use mosquito repellent all day every day” when outdoors.

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Muguruza Dipaksa Main Tiga Set, Wozniacki Menang Double Bagel

Juara bertahan Garbine Muguruza harus bertarung tiga set di babak kedua Prancis Terbuka. Sementara itu, Caroline Wozniacki menang mudah.

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Refractory HCV Responds Well to Three-Drug Combo

Patients who have failed existing treatments for chronic hepatitis C virus (HCV) infection may soon have an effective new salvage option, according to results from POLARIS trials 1 and 4. Now under review by the US Food and Drug Administration, a three-drug pangenotypic regimen with sofosbuvir-velpatasvir-voxilaprevir followed for 12 weeks showed sustained virologic response rates of as much as 98% in refractory chronic HCV. The researchers published their findings online May 31 in the New England Journal of Medicine.

One daily treatment with the first single-pill three-drug combo proved effective in patients with any of the six HCV genotypes and with or without compensated cirrhosis who failed to show sustained virologic response after treatment with direct-acting antivirals (DAAs). DAAs included inhibitors of nonstructural protein 5A (NS5A), which plays a key role in HCV RNA replication. These patients are a continuing concern, as resistance-associated mutational substitutions in the viral genome selected by NS5A inhibitors can extend viral viability long after treatment failure.

“This population of patients has been underrepresented in clinical trials and has limited retreatment options,” Marc Bourlière, MD, chief of hepatogastroenterology, Hôpital Saint-Joseph in Marseille, France, and a group of international researchers conducting the POLARIS-1 and POLARIS-2 trials, write. POLARIS-1 and POLARIS-4 included 747 patients enrolled during 20015 to 2016 across 108 sites in Europe, North America, Australia, and New Zealand.

Although a substantial number of patients had worrisome resistance-associated viral substitutions at baseline, these had no effect on the rates of sustained virologic response to the triple regimen.

The mean age of patients across groups was similar, ranging from 57 to 59 years; more than 75% were men, and 43% had cirrhosis (46% in the active treatment groups).

POLARIS-1 included patients infected with genotype 1 (the most common in North America) and previously treated with an NS5A inhibitor. The researchers randomly assigned patients to receive the three-drug combo (n = 150 patients) or matching placebo (n = 150) once daily for 12 weeks. Those with other HCV genotypes (n = 114) were enrolled in the three-drug group. The three-drug combo consisted of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the protease inhibitor voxilaprevir.

POLARIS-4 included patients with HCV genotype 1, 2, or 3 previously treated with a DAA but not an NS5A inhibitor. The researchers randomly assigned patients to receive sofosbuvir-velpatasvir-voxilaprevir (n = 163) or the older combination sofosbuvir-velpatasvir (Epclusa, Gilead Sciences; n = 151) for 12 weeks. The study enrolled an additional 19 patients with genotype 4 in the three-drug group.

In POLARIS-1, the rate of sustained virologic response was 96% with sofosbuvir-velpatasvir-voxilaprevir and 0% with placebo. In POLARIS-4, the rate of response was 98% with the triple regimen and 90% with two-drug therapy.

The most common adverse events in the POLARIS studies were headache, fatigue, diarrhea, and nausea. In the active-treatment groups in both trials, the percentage of patients who discontinued treatment because of adverse events was 1% or less.

“Most patients are cured with existing very potent regimens, but for the rare patient who has not responded, this regimen gives us a new option,” Andrew Aronsohn, MD, a hepatologist and an associate professor of medicine at the University of Chicago, Illinois, told Medscape Medical News. “Although this new regimen is more than what is needed for most patients, it’s closer than we’ve come in the past to a one-size-fits-all approach. But I suspect it is not something that you would give patients who have never been treated for HCV,” Dr Aronsohn said. Dr Aronsohn is a member of the HCV guidance committee of the American Association for the Study of Liver Diseases.

“These data are very interesting, but there are significant limitations to using this treatment,” David K. H. Wong, MD, an assistant professor of medicine at the University of Toronto, Ontario, Canada, and a hepatologist at Toronto General Hospital, Ontario, Canada, told Medscape Medical News. “If you use the older two-drug regimen, then the three-drug regimen is available for salvage in the few who fail. But if you start with the new triple regimen, there’s nothing left for those who fail. There’s no salvage option.” He added that the vast majority of those who fail treatment do so because they fail to take their medication.

Dr Wong noted that in contrast with older regimens that only work against genotype 1, the newer pangenotypic regimens eliminate the need for type and resistance testing.

The authors agree that the proportion of patients who fail to show sustained virologic with standard treatment is small, but as HCV affects as many as 150 million people globally, the actual numbers are high and will likely grow as more seek treatment. They stress that approved retreatment options for patients previously receiving an NS5A inhibitor are lacking and expect this new regimen will help fill that gap.

Earlier this year, Medscape Medical News reported on two other POLARIS trials, which found that triple therapy for 8 weeks was not as effective as a 12-week regimen. POLARIS-2 and POLARIS-3 included 941 and 219 patients, respectively, at 117 sites. Researchers randomly assigned patients with HCV who were previously unexposed to DAAs to receive the three-drug combination for 8 weeks or the two-drug combination for 12 weeks. A shorter course of treatment is considered desirable to maximize patient compliance with treatment.

Gilead Sciences funded the trials, and numerous authors report various financial ties with one or more of the following private sector companies/organizations: Gilead, Merck, Merck Sharp & Dohme, AbbVie, Bristol-Myers Squibb, Genfit, Intercept Pharmaceuticals, GlaxoSmithKline, Conatus Pharmacueticals, CymaBay, Exalenz, CVS Caremark, Amgen, Tibotec, Lupin, Shanghai Sundise Traditional Chinese Medicine Co, Novartis, Janssen, the Falk Foundation, Idenix Pharmaceuticals, Trek Therapeutics, Orasure Technologies, Discovery Life Sciences, Siemens, MedMira, Ortho Clinical Diagnostics, Johnson & Johnson, Vertex, Mallinckrodt Pharmaceuticals, Roche, Boehringer Ingelheim, Biotest Pharmaceuticals, and Trio Health. Dr Wong and Dr Aronsohn have disclosed no relevant financial relationships.

N Engl J Med. Published online June 1, 2017.

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Muguruza Dipaksa Main Tiga Set, Wozniacki Menang Double Bagel

Paris – Juara bertahan Garbine Muguruza harus bertarung tiga set di babak kedua Prancis Terbuka. Sementara itu, mantan petenis nomor satu dunia Caroline Wozniacki menang mudah.

Muguruza kehilangan set pertama saat menghadapi petenis Estonia, Anett Kontaveit, di lapangan Philippe Chatrier, Roland Garros, Paris, Rabu (31/5/2017). Petenis Spanyol yang jadi unggulan keempat itu akhirnya mampu membalikkan keadaan dan menang 6-7(4), 6-4, 6-2.

Muguruza sempat berada dalam situasi sulit ketika tertinggal 1-3 di set kedua. Namun, dia merebut lima dari enam game terakhir untuk memaksakan digelarnya set penentuan.

“Saya sudah menduga akan menghadapi pertandingan seperti ini karena baru-baru ini saya juga melawan dia, dan saya menontonnya dalam beberapa turnamen sebelumnya,” ujar Muguruza seusai pertandingan.

“Dia bermain bagus, sangat percaya diri. Saya tahu akan menjalani pertarungan sengit, saya kalah dari dia belum lama ini, saya melakukan sesuatu yang berbeda kali ini,” katanya di situs resmi WTA.

Di babak ketiga, Muguruza akan berhadapan dengan petenis Kazakhstan, Yulia Putintseva, yang lolos setelah menundukkan Johanna Larsson (Swedia) dengan skor 6-3, 1-6, 6-3.

Pada pertandingan lainnya, Wozniacki tak menemui hambatan berarti untuk menghabisi petenis Kanada, Francoise Abanda. Petenis Denmark itu cuma butuh 52 menit untuk menang double bagel alias dengan skor 6-0, 6-0.

Muguruza Dipaksa Main Tiga Set, Wozniacki Menang <i>Double Bagel</i>

Foto: Caroline Wozniacki menang mudah di babak kedua Prancis Terbuka (REUTERS/Christian Hartmann)

Lawan yang akan dihadapi Wozniacki di babak selanjutnya adalah petenis Amerika Serikat, CiCi Bellis. Bellis lolos setelah menumbangkan unggulan ke-18 asal Belanda, Kiki Bertens.

Kejutan terjadi saat unggulan keenam Dominika Cibulkova (Slovakia) bertemu Ons Jabeur (Tunisia). Jabeur yang berstatus lucky loser di luar dugaan menang dua set langsung dengan skor 6-4, 6-3. Dia akan menantang Timea Bacsinszky (Swiss) di babak ketiga.

(mfi/raw)

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Maternal Morbidity Rises Sharply in Older Mothers

The risk for potentially life-threatening maternal morbidity, including renal failure, shock, amniotic fluid embolism, and cardiac morbidity, rises sharply among mothers older than 39 years, a new study has found. Moreover, for women 49 years or older, the rate of severe maternal morbidity may be higher than the rate of mortality or serious morbidity among their offspring.

“Counselling of older mothers should include information on both fetal/neonatal risks and maternal risks. Health care providers should be aware of the severe morbidities that can arise among older mothers and that can impact obstetrical care delivery and resource utilization during labor, delivery, and postpartum,” the researchers write.

Sarka Lisonkova, MD, PhD, from the Department of Obstetrics and Gynaecology at the University of British Columbia in Vancouver, Canada, and colleagues report their findings in an article published online May 30 in PLOS Medicine.

The population-based retrospective cohort study included 828,269 singleton births among women aged 15 to 60 years residing in Washington State between January 1, 2003, and December 31, 2013. The researchers analyzed data from two linked population databases: live birth/fetal death certificates, which include data on demographics and pregnancy and birth characteristics, and hospitalization files, which include specific maternal and infant morbidity data.

They compared age-specific rates of maternal mortality and severe morbidity among women aged 15 to 19 years, 20 to 24 years, 25 to 29 years (reference category), 30 to 34 years, 35 to 39 years, 40 to 44 years, and 45 to 49 years. The investigators adjusted for potential confounders including parity, body mass index, and assisted conception.

The adjusted risk difference in overall severe maternal morbidity climbed as women got older compared with mothers aged 25 to 29 years: 0.9% (95% confidence interval [CI], 0.7% – 1.2%) for mothers aged 40 to 44 years, 1.6% (95%, CI 0.7% – 2.8%) for mothers aged 45 to 49 years, and 6.4% for mothers aged 50 years and older (95% CI, 1.7% – 18.2%).

“The absolute rates and [odds ratios] were lower after adjustment for demographic and pre-pregnancy factors but remained elevated for sepsis among teenage mothers and for all other morbidities among older women,” the researchers write.

With respect to specific adverse outcomes, the adjusted analysis showed that mothers aged 35 to 39 years had increased rates of obstetric shock compared with mothers aged 25 to 29 years (adjusted odds ratios [AOR], 2.6; 95% CI 1.5 – 4.5), whereas mothers aged 40 to 44 years had increased rates of amniotic fluid embolism (AOR, 8.0; 95% CI, 2.7 – 23.7).

Mothers aged 45 to 49 years had higher rates of renal failure (AOR, 15.9; 95% CI, 4.8 – 52), complications of obstetric interventions (AOR, 4.7; 95% CI, 2.3 – 9.5), and intensive care unit admission (AOR, 4.8; 95% CI, 2.0 – 11.9).

In addition, the rate of maternal sepsis was significantly higher among teenaged mothers compared with that among mothers aged 25 to 29 years (AOR, 1.2; 95% CI, 1.1 – 1.4).

“Young healthy women can compensate and mask symptoms such as decreased level of consciousness and pathologic hypotension,” the authors explain. “These findings warrant further research into specific risk factors, etiopathogeneses, and compensatory mechanisms among young mothers. They also warrant increased clinical vigilance and a reduced threshold for considering early antibiotics in young mothers presenting with possible signs of infection.”

They continue, “The association between teenage motherhood and most adverse perinatal outcomes disappeared after adjustment for maternal demographic factors, with the exception of the neonatal death rate, which remained 50% higher.”

One author reports receiving an honorarium as a speaker from USB in the last 5 years and receiving a Meeting Grant from the Canadian Hypertension Society. The remaining authors have disclosed no relevant financial relationships.

PLOS Med. Published online May 30, 2017. Full text

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Ramadan, Pelatnas Wushu Jalan Terus

Tim wushu Indonesia terus menggenjot fisik jelang SEA Games 2017. Walau bulan puasa, program latihan terus berjalan namun dengan porsi yang dikurangi.

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Orthorexia Nervosa: When 'Healthy' Eating Turns Dangerous

SAN DIEGO, California – Today’s ever-growing focus on fitness and “clean living” may lead to an increase in cases of a condition known as orthorexia nervosa, according to two presentations here at the American Psychiatric Association (APA) 2017 Annual Meeting.

Orthorexia has been defined as a “pathologic obsession with proper nutrition,” including a strict avoidance of food believed to be unhealthy or impure, that can have serious nutritional and medical consequences.

Unlike anorexia nervosa, body image is usually not a focus for patients with this condition — which is not currently recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

A poster presentation here described the case of a 54-year-old man who presented at the the emergency department following a 3-day water fast, which he underwent because of a belief in “health stuff, herbs, and a super-healthy diet.” The patient was experiencing anion gap metabolic acidosis and severe nausea.

A full workshop was devoted to orthorexia. More case reports were presented, and a discussion was held about possible diagnostic criteria, overlapping symptoms, and the fact there have been no studies into effective treatment.

“Clearly there is more interest in this diagnosis and more case reports coming forward,” session moderator Steven Crawford, MD, codirector of the Center for Eating Disorders at Sheppard Pratt, Towson, Maryland, told Medscape Medical News.

“And as there’s more of a societal focus on healthy eating, the more people who are biologically vulnerable to go in the direction of eating disorders will fall into it.”

Spiritual Purity and “Miraculous Maids”

Although the term “orthorexia nervosa” first appeared in the literature in 1997, its leading symptoms have been around for much longer, according to three residents from the University of Maryland/Sheppard Pratt Psychiatry Program.

During the Middle Ages, self-starvation was employed as a way to achieve spiritual purity, and during the Renaissance, “miraculous maids” were said to have uncommon abilities to starve themselves.

Today, “we are faced with updates on the latest food diet, warnings about certain foods and products, and an ever-changing set of guidelines on how to live a healthier life,” write the investigators. “In this complicated cultural environment, many individuals find it difficult to not worry about their eating habits.”

During her presentation, Yon Park, MD, said that although there has been a significant decline in the popularity of diet pills and the diet industry as a whole, it has been replaced by a movement of “eating clean” and practicing a holistic lifestyle.

“Sugar-free, gluten-free, non-GMO, no pesticides, grass-fed – companies are bombarding consumers with these labels. And they’re adding new lines of products to appeal to this ideology,” said Dr Park, adding that sales of organic foods doubled between 1994 and 2014.

An obsessive focus on all of this can lead orthorexia nervosa, which is characterized by a restrictive diet and ritualized eating patterns.

“Simply put, orthorexia is a fixation on food quality as opposed to food quantity,” said Dr Park. “The social and cultural context could promote certain types of food intake management that ultimately becomes pathological in a person genetically predisposed to [eating] disorders.”

“I Was Afraid to Do Anything”

Copresenter Rebecca Sokal, MD, noted that the condition would likely fit between anorexia nervosa and avoidant restrictive food intake disorder (ARFID), which are both currently in the DSM-5. However, “ARFID doesn’t address the complexity of motivations and behaviors in those with symptoms of orthorexia, and it makes research difficult.”

Although orthorexia is often misdiagnosed as anorexia, patients with the former often flaunt their eating habits instead of hiding them, especially on Instagram, said Dr Sokal. She added that the condition also overlaps with obsessive compulsive disorder, obsessive compulsive personality disorder, and somatoform disorders.

During the session, two case reports were presented. The first patient was a 72-year-old white Buddhist nun who presented with extreme weight loss. “You get afraid of eating because you don’t know what it’ll do to you,” said the patient in a video clip. “Eventually I was afraid to do anything, so I did nothing.”

This patient’s mother had unusual beliefs about eating and started eliminating certain foods herself when she was in her 20s.

In later years, the patient met with a holistic medicine specialist, who diagnosed her as having multiple food allergies. It was recommended that she increase her use of food supplements and that she follow the paleo diet.

Treatment for the patient, who had no history of concern regarding body image, included a gradual reintroduction of all types of food into her diet and discussions to help her recognize her obsessive thoughts.

She starting eating a wide variety of food, including those she once thought would hurt her. She reported being happy with her new curves and became involved in Eating Disorders Anonymous. “She is struggling to find additional resources regarding orthorexia specifically,” said Dr Sokal.

Only Request: Coconut Water

Copresenter Michael Cannon, MD, discussed the second case: a black woman in her 30s who was severely underweight, hypokalemic, and dehydrated upon presentation. After a psychiatric evaluation, she was prescribed olanzapine 5 mg once nightly and lorazepam 0.5 mg three times per day and was involuntarily admitted to the University of Maryland Medical Center.

During early treatment, she only wanted organic coconut water because she believed she had parasites in her gut. She had previously been diagnosed with “leaky gut syndrome” by a naturopathic physician. Total parenteral nutrition was initiated to maintain her health.

Psychotic symptoms included paranoia as to whether her food had been contaminated, fear of mistreatment by staff, performance of several rituals regarding eating and food preparation, and what appeared to be hallucinations.

Her dose of olanzapine was titrated to 20 mg. After several weeks, it was deemed ineffective. Haldol, titrated up to 20 mg, was then substituted. Soon after, the patient started eating more foods and eventually consumed full meals.

The patient was transitioned to therapy with haldol decanoate and was discharged after 4 months. She continues monthly treatments. However, “she intends to return to the care of a naturopath as soon as she has enough money,” reported Dr Cannon.

“Unlike the first case, which sounded like a pure form of this eating disorder, I’m wondering if this was driven more by psychosis,” said an audience member after the presentations.

“Where do you draw the line for orthorexia, especially in the culture that we’re living in?” asked another meeting attendee. “We all know people who have certain preferences. Even in here I’m sure some colleagues would say a plant-based diet is a healthy way to go. So at what point would you say this is a problem?”

Dr Crawford said clinical impairment from these concerns is what is important, whether such impairment is in the form of high levels of distress, deficits in functioning, severe malnutrition, or unintentional weight loss.

He later told Medscape Medical News that orthorexia has not yet been included in the DSM-5 because there has not been enough research about it. “A first step would be to try to get it recognized at least within the ARFID category, so more people can do research and then more details can be fleshed out.”

Eating Disorders and Men

In her poster presentation earlier in the week, Rebecca Olufade, MD, psychiatry resident at the University of Massachusetts, Springfield, noted the case of a male patient with a history of major depressive disorder and suicide attempts. The patient underwent an extreme fast, which he reported was undertaken in the hope it would decrease his chronic pain and constipation.

“Although uncommon for males to present with eating disorders, it is something to be cognizant of,” Dr Olufade and colleagues write. They add that, given the patient’s psychiatric history, his symptoms could have been seen as an intentional suicide attempt only.

“Psychiatrists need to be aware of newer types of eating disorders in order to provide proper assessment and treatment.”

Dr Olufade said that because there is such a high degree of overlap with symptoms of other conditions, she is unsure whether orthorexia should be a distinct diagnosis or whether it should be lumped under something else.

“Is this just part of societal norms and images at this time? Is it a fad? We’re not sure,” she said, adding that collecting more data is extremely important.

Another Form of Anorexia?

Commenting on the presentations, Evelyn Attia, MD, director of the Center for Eating Disorders at New York–Presbyterian Hospital and professor of psychiatry at Columbia University Medical Center, New York City, told Medscape Medical News that eating disorders “fall pretty neatly” into the six diagnostic categories outlined in the DSM-5.

“Anorexia nervosa is a very interesting eating disorder in that it has, over the centuries, looked quite similar yet taken on questions that had to do with the social context of the time,” said Dr Attia. “It’s not uncommon for people with anorexia to adopt popular eating patterns and popular diets.”

She noted that individuals who insist that health is the reason for greatly restricting their diet may stress that their condition is different from anorexia “when in actuality, when we think of the criteria, what they’re describing isn’t that different at all.”

For the case reports presented at the APA meeting, “we have some real questions,” said Dr Attia. “For those pursuing health to a very stringent extent, are we really talking about some new condition with a name clinicians are less familiar with? Or are we talking about good, old-fashioned anorexia nervosa?”

She added that she does not think orthorexia “is ready for prime time,” in the sense of being represented as a diagnosis.

“And I would urge clinicians to think carefully about when weight gets to a dangerous place for these individuals. Does the condition fall more easily under one of the existing eating disorders, making it less likely that we need to come up with yet another one?”

None of the presenters or commenters have disclosed any relevant financial relationships.

American Psychiatric Association (APA) 2017 Annual Meeting. Poster abstract P4-106, presented May 21, 2017; and Afternoon Workshop 5, presented May 23, 2017.

Follow Deborah Brauser on Twitter: @MedscapeDeb .

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Trans, Gender Nonconforming People Report Poorer Health

(Reuters Health) – People who identify as transgender or gender nonconforming may have higher than average rates of poor or fair health, a new study suggests.

“There is little research on this population, because people haven’t been asking them to identify themselves,” said lead author Dr. Carl Streed Jr., of Brigham and Women’s Hospital in Boston.

Transgender describes people whose gender identity differs from the sex they were assigned at birth, while gender nonconforming refers to people who don’t identify solely as male or female.

In a 2015 report, the U.S. National Institutes of Health highlighted the need for better understanding of the lesbian, gay, bisexual and transgender communities.

“These are patients and individuals and communities that need our attention at this point and we should be working with them to better identify what’s going on in their lives,” Streed said.

For the new study, the researchers used data collected in 2014 and 2015 as part of the U.S. Centers for Disease Control and Prevention’s Behavioral Risk Factors Surveillance System. In 2013, the CDC created a series of questions about gender identity, which had been adopted by 28 states and territories when the researchers analyzed their data.

As reported online May 30 in JAMA Internal Medicine, altogether the researchers had survey responses from 315,893 people, including 1,443 who identified as transgender or gender nonconforming.

About 23 percent of transgender and gender nonconforming people reported poor or fair health, compared to about 17 percent of people who did not identify as a gender minority.

Transgender and gender nonconforming people were also more likely to report limitations and problems with memory, concentration and decision-making.

Compared to people who did not identify as a gender minority, those who did were younger and more likely to be low income, unemployed, uninsured, overweight or have unmet medical needs. They were also more likely to report depression.

People identifying as transgender or gender nonconforming were less likely to be non-Hispanic white, partnered, parents or English-speaking.

The health disparities between transgender and gender nonconforming people and others remained significant even after the researchers adjusted the findings for factors that may influence health, such as health insurance status and health behaviors.

Streed said he can only speculate as to why transgender and gender nonconforming people appear to be worse off, but it could be due to minority stress and issues with resilience.

Reuters Health has reported elsewhere this year on research suggesting that doctors in many specialties are often unprepared to account for patients’ needs related to their gender identity.

This new study starts to scratch the surface of the topic, said Dr. John Cullen, director of diversity and inclusion at the Clinical and Translational Science Institute at the University of Rochester Medical Center in New York.

“There are disparities there that we’re not seeing in this paper,” said Cullen, who was not involved with the new research.

For example, he said, there is research showing transgender and gender nonconforming people are at an increased risk for mental health problems and other health conditions like HIV.

All states should be collecting this data, said Cullen, who is also assistant director of the Susan B. Anthony Center at URMC.

“Some of the bigger states on the west coast – California, Oregon and Washington – are not using this model,” he said. As a result, researchers are missing out on that data.

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

JAMA Intern Med 2017.

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Healthy Vascular Aging Rare but Not Impossible for Elderly

(Reuters Health) – Some people who avoid risk factors for heart disease like obesity and diabetes may be able to maintain the blood vessels of a healthy 29-year-old well into old age, a U.S. study suggests.

“Hypertension and increased vascular stiffness are viewed as inevitable parts of aging,” the researchers note. They set out to see whether the age-related decrease in vascular function is avoidable.

They examined data on 3,196 adults age 50 and older to see how their odds of vascular aging (reduced elasticity in blood vessels) was influenced by seven risk factors for heart disease: hypertension, elevated cholesterol, high blood sugar, inactivity, poor diet, obesity and smoking.

Older adults who avoided at least six of these risk factors were 10 times more likely to have flexible, properly functioning blood vessels than their peers who managed to avoid no more than one of these risk factors, the study found.

“Especially staying lean and avoiding diabetes seemed to be very important,” lead study author Teemu Niiranen of Boston University School of Medicine said by email. “This association is thought to be mainly caused by the excess inflammation and neurohormonal imbalances associated with obesity and diabetes.”

None of the participants had cardiovascular disease when they joined the study, but after researchers followed half of them for at least 9.6 years, 391 people developed heart disease. People with healthy arteries were about 55 percent less likely to develop heart disease compared to the rest.

Overall, 566 participants, or almost 18 percent, had evidence of healthy vascular aging. This included about 30 percent of people in their 50s, and 7 percent of individuals in their 60s but just 1 percent of people 70 and older.

In addition to avoiding diabetes and obesity, maintaining healthy cholesterol levels was also a main contributor to healthy vascular aging, researchers report May 30 in the journal Hypertension.

Some other risk factors for heart disease, including smoking, diet and exercise, weren’t independently associated with healthy vascular aging.

The study isn’t a controlled experiment designed to prove how individual risk factors for heart disease directly influence vascular aging.

Limitations of the study include the predominantly white participants, which may mean the results don’t apply to other racial and ethnic groups, the authors note. Researchers also lacked complete data on nutrition and physical activity for all of the participants.

Still, the findings suggest the combined effect of many lifestyle decisions may be able to help some people maintain healthy arteries even with advanced age, the authors conclude.

Increased vascular stiffness, however, is just one aspect of the progression of cardiovascular disease, noted Dr. Christian Delles of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow in the UK.

Other aspects, such as narrowing of the vessels in certain places or the presence of plaque can’t be assessed by tests of vascular stiffness, Delles, who coauthored an editorial accompanying the study, said by email.

But patients who still have healthy arteries may take the study finding as a road map to try to maintain that health as they age, Delles added.

“Controlling risk factors can keep your arteries healthy and it is worth addressing the well known risk factors,” Delles said. “This includes lifestyle measure such as weight reduction, physical exercise and smoking cessation but in most cases also medication such as blood pressure lowering drugs and lipid lowering drugs.”

SOURCE: http://bit.ly/2r8IJtf and http://bit.ly/2sjm4s1

Hypertension 2017.

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Djokovic dan Nadal Melangkah ke Babak Ketiga

Paris – Novak Djokovic dan Rafael Nadal tanpa kesulitan berarti melangkah ke babak ketiga Prancis Terbuka 2017. Baik Djokovic dan Nadal sama-sama menang straight set.

Djokovic lebih dulu memastikan kelolosan saat menghadapi petenis Portugal Joao Sousa di lapangan Suzanne-Lenglen, Rabu (31/5/2017) malam WIB. Djokovic merebut set pembuka dengan mudah, hingga akhirnya menang 6-1, 6-4, dan 6-3 dalam tempo dua jam enam menit.

Petenis Serbia itu mencatatkan 34 pukulan winner, dua kali lipat lebih dari Sousa yang cuma bikin 15 winner. Di babak selanjutnya, unggulan kedua tersebut akan menghadapi petenis nonunggulan asal Argentina, Diego Schwartzman.

Nadal kemudian menyusul jejak Djokovic. Melawan Robin Haase di lapangan Philippe-Chatrier, petenis Spanyol itu menang 6-1, 6-4, dan 6-3 dalam waktu hanya satu jam 49 menit.

Nadal cuma mencatatkan 13 unforced error dan bikin 33 winner. Sedangkan lawannya melakukan 28 unforced error dengan membukukan 24 pukulan winner. Nadal selanjutnya akan menghadapi nonunggulan dari Georgia, yakni Nikoloz Basilashvili.

Juga lolos ke babak ketiga antara lain unggulan keenam Dominic Thiem, kemudian David Goffin dan Grigor Dimitrov yang menempati unggulan ke-10 dan 11 secara berurutan.

(raw/mfi)

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Good News From the Far East for Beleaguered Absorb Scaffold

PARIS, FRANCE — Although unlikely to quell the continuing controversy, extended follow-up from two trials shows just one case of late scaffold thrombosis between 2 and 3 years in select patients implanted with the Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular)^[1,2].

The single case occurred in ABSORB JAPAN on day 810 in a patient who had severe restenosis even after thrombectomy and ballooning and was not on dual antiplatelet therapy (DAPT) at the time of the event, only aspirin, Dr Ken Kozuma (Teikyo University Hospital, Tokyo, Japan) said.

No events occurred between 2 and 3 years in patients treated with the metallic everolimus-eluting stent (Xience, Abbott Vascular), resulting in an overall rate of definite/probable scaffold thrombosis at 3 years of 3.6% for Absorb BVS and 1.6% for Xience.

The 3-year rate of definite/probable scaffold thrombosis was exceedingly low in the second study, ABSORB CHINA, at 0.8% (two events) with Absorb BVS and 0% with Xience, with no new events between 2 and 3 years with either device.

The findings were reported here at a late-breaking trials session at EuroPCR 2017 along with less flattering 12-month data from several European registries, including the Swedish SCAAR and German-Austrian GABI registries showing increased stent thrombosis with the BVS.

Abbott recently advised physicians in Europe that starting May 31, the Absorb and Absorb GT1 BVS systems can be used only in the clinical registry setting at select sites/institutions that will be monitoring the technology until summer 2018.

Based on surprising 2-year results from ABSORB 3 trial showing a significant increase in target lesion failure with the BVS, the FDA announced in March it was investigating the Absorb device and cautioned physicians regarding its use in smaller coronary vessels. Recent data have shown that scaffold thrombosis is reduced with the use of the preparation, sizing, and postdilation (PSP) protocol.

Following the presentation of the new Absorb data, panelist Dr Vinay Bahl (All India Institute of Medical Sciences, New Delhi) said, “It’s good to have long-term data from as many studies as possible because of the concerns raised, but I don’t think we have yet to figure out why there is a difference between the studies from China and Japan as compared with the Absorb studies from the US.”

He said in addition to implantation technique, the “other factor I personally think is important is the continuation of DAPT, because in this part of the world, like in India, most of the patients continue to have clopidogrel because it’s really cheap and the patients are relatively younger, so the bleeding risks are not that high. In both of these studies, 50% of patients were on DAPT as compared with the US studies where it was stopped after 12 months.”

When session chair Dr Ron Waksman (MedStart Heart and Vascular Institute, Washington, DC) polled the audience as to how many would prescribe clopidogrel for 3 years in an Absorb patient, however, less than half raised their hands.

The ABSORB JAPAN protocol called for 1 year of DAPT, but Kozuma said they currently recommend DAPT for 3 or 4 years. He suggested that several factors played a role in scaffold thrombosis, most notably a sizing mismatch, which occurred in three patients with large vessels implanted with smaller scaffolds.

Between 2 and 3 years, the rate of target lesion failure, a composite end point of cardiac death, target vessel MI, and ischemia-driven target lesion revascularization, was 1.6% in both arms. The 3-year target lesion failure rate was 8.9% for Absorb and 5.5% for Xience.

Angiographic late lumen loss at 3 years was within a clinically acceptable range (<0.4 mm) and consistent with that observed in the ABSORB Cohort B study, Kozuma said.

ABSORB CHINA

In ABSORB CHINA, the rate of target lesion failure was 1.3% with Absorb and 0% with Xience between 2 and 3 years, and 5.5% vs 4.7% at 3 years.

Rates were not statistically different between the Absorb and Xience arms for target vessel MI (2.5% vs 0.9%) or ischemia-driven target lesion revascularization (4.2% vs 2.6%).

Dr Davide Capodanno (University of Catania, Italy), who chaired a press conference highlighting the studies, pointed out that ABSORB CHINA has always been an outlier compared with other BVS trials and questioned what may have contributed to the positive findings.

ABSORB CHINA study author Dr Runlin Gao (Fu Wai Hospital, Beijing, China) responded that less than 10% of implantations were in vessels smaller than 2.25 mm.

“The ABSORB CHINA trial selected relatively larger vessels; the mean reference vessel diameter was 2.81 mm, and in other trials such as ABSORB Japan, ABSORB II, or ABSORB 3, the reference vessel diameter was around 2.6 mm or 2.7 mm,” he said. “Another thing is that only 9.2% of patients who received BVS had a vessel diameter less than 2.25 mm” compared with about 15% of patients in other trials.

Given that the Absorb BVS has a relatively thick strut, about 157 µm, implanting in too small a vessel “would result in some problems,” he added.

Gao also noted that almost all patients underwent predilation, postdilation was performed in 63% of BVS patients, and 20% of patients remained on DAPT at 3 years.

Dr Robert de Winter (Academic Medical Center, Amsterdam, the Netherlands), who recently published 2-year data from the AIDA trial showing an increased risk of scaffold thrombosis and target vessel MI with Absorb BVS, commented during the press conference that appropriate sizing may be the most important factor in the PSP protocol.

“We’ve done a preliminary PSP analysis as well, and I tend to agree that sizing may be more important than postdilation,” he said.

ABSORB CHINA and ABSORB JAPAN were sponsored by Abbott Vascular. Gao reported no relevant financial relationships. Kozuma reports honoraria from Abbott Vascular and Terumo and institutional grant/research support from Abbott Vascular and Boston Scientific.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org, follow us on Twitter and Facebook.

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