Gosank

Jumat, 02 Maret 2018

MS Drug Daclizumab (Zinbryta) Pulled From the Market

Biogen and AbbVie are voluntarily taking daclizumab (Zinbryta) for relapsing multiple sclerosis (MS) off the market worldwide because of mounting concerns about safety, including reports of severe liver damage and immune-related conditions, the companies announced today.

Their announcement comes the same day that the European Medicines Agency (EMA) announced an “urgent review” of daclizumab after seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.

Given the nature and complexity of adverse events being reported, and the limited number of patients being treated, characterizing the evolving benefit/risk profile of daclizumab will not be possible going forward, Biogen and AbbVie said in a press statement.

Therefore, the voluntary worldwide withdrawal of the drug “is in the best interest of patients,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in the statement.

Daclizumab, given as a once-monthly injection for adults with relapsing forms of MS, is currently available in the European Union, United States, Switzerland, Canada, and Australia.

Daclizumab was approved by the US Food and Drug Administration (FDA) in May 2016.

The FDA cautioned, however, that daclizumab should be used only in patients who have not responded to one or two prior therapies because it carries serious safety risks, including potentially severe liver damage and immune conditions.

Daclizumab was cleared for use in the European Union in July 2016. However, in June 2017, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) launched a review of daclizumab after the death, from fulminant liver failure, of a patient who was treated with the drug in an ongoing observational study, as well as four cases of serious liver injury.

In July 2017, the EMA restricted use of daclizumab to patients who experience highly active relapsing MS despite having undergone a full and adequate course of treatment with at least one disease-modifying therapy (DMT) or patients with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs.

The EMA also advised against using daclizumab in patients with preexisting hepatic disease or hepatic impairment and in patients with autoimmune diseases other than MS.

PRAC recommended further restrictions on daclizumab in October 2017.

Biogen and AbbVie said they will continue to work collaboratively with regulatory authorities in the withdrawal of daclizumab and with healthcare providers who have patients using the drug.

For more Medscape Neurology news, join us on Facebook and Twitter

Source link

MI Risk Higher in Apple-Shaped Women Than Men

A new study provides further evidence that higher waist size and waist-to-hip ratio signal a greater risk for myocardial infarction (MI) than general obesity, especially in women.

Compared with body mass index (BMI), waist-to-hip ratio was an 18% stronger predictor of MI in women and a 6% stronger predictor of MI in men.

“The general message is that excess weight matters but that women who indeed have an apple shape might be at an even greater risk. So it’s about increased awareness not only among the women themselves but also among physicians,” study author, Sanne AE Peters, PhD, from the George Institute for Global Health, University of Oxford, United Kingdom, said in an interview.

“One might argue that we need more intensive screening, particularly among women with an apple shape, to try and really identify their increased risk of heart disease and, for example, to start interventions whether they’re lifestyle interventions to lose weight or to start other preventive strategies,” she added.

Peters noted that previous studies have indeed shown that central adiposity might be a stronger risk factor than overall obesity, but there have been studies that have shown the opposite — that it actually does not matter where adiposity is measured.

“The critical new thing in our work is that we’ve looked at sex differences between both central and overall adiposity and the risk of heart disease and what we found is that central adiposity is actually an even stronger risk factor for heart disease in women than in men,” she said.

The study, published online February 28 in the Journal of the American Heart Association, involved 265,988 female and 213,622 male participants aged 40 to 69 years (mean, 56 years) in the prospective UK Biobank study between 2006 and 2010. Exclusion criteria included a history of cardiovascular disease or BMI less than 15 kg/m² or greater than 60 kg/m².

Participants completed questionnaires on their lifestyle, environment, and medical history and had blood, urine, and saliva collected. Physical measurements included weight, height, hip circumference, waist circumference, and waist-to-hip ratio.

At study entry, the mean waist circumference, waist-to-hip ratio, and waist-to-height ratio, respectively, were 85 cm (33.46 inches), 0.82, and 0.52 in women and 97 cm (38.18 inches), 0.93, and 0.55 in men.

During a mean follow-up of 7.1 years, there were 5710 MIs, of which 28% were in women.

In both sexes, there was an approximate log-linear relationship between measures of general and central adiposity and the risk for incident MI.

In Cox regression models, a 1–standard deviation increase in BMI was associated with a hazard ratio (HR) for MI of 1.22 in women (95% CI, 1.17 – 1.28) and 1.28 in men (95% CI, 1.23 – 1.32; P for interaction = .15).

A 1–standard deviation higher waist circumference was more strongly linked with MI risk in women than in men, although the difference just reached statistical significance (P for interaction = .048). The HR was 1.35 in women (95% CI, 1.28 – 1.42) and 1.28 in men (95% CI, 1.23 – 1.33).

The association was even stronger with an increase of 1–standard deviation in waist-to-hip ratio, with an HR for MI of 1.49 in women (95% CI, 1.39 – 1.59) and 1.36 in men (95% CI, 1.30 – 1.43; P for interaction = .001).

Finally, the link between a 1–standard deviation higher waist-to-height ratio and the risk for MI was similar between women (HR, 1.34; 95% CI, 1.27 – 1.40) and men (HR, 1.33; 95% CI, 1.28 – 1.38; P for interaction = .38).

Gina Lundberg, MD, a preventive cardiologist from Emory University in Atlanta, Georgia, who was not involved in the study, said the results aren’t that surprising because it’s known that metabolic syndrome, which includes a waist circumference over 40 inches for men or 35 inches for women as one of its five criteria, is more common in women than men, and more dangerous.

“To me the little pearl here is when clinicians are seeing women, particularly when they’re going from 45 to 55 and are gaining weight or they feel they’re gaining it in the abdomen, to not just dismiss it like, ‘Oh, that’s benign,'” because it isn’t benign,” she said. “The waist-to-hip ratio is important, it is a marker for increased heart disease — and it may be that if we can’t help the woman lose weight in the belly, we need to pay a little more attention to the blood pressure that’s not ideal or to the cholesterol that’s not ideal, and make sure we’re aggressively following all of her risk factors.”

Some diets, including low-carbohydrate diets, have been promoted as helping shed excess belly fat, but Lundberg said we’ve yet to crack the mystery of how to lose weight in specific body regions.

“But I do think that an overall plant-based, calorie-appropriate diet with the 30 minutes a day of exercise, whether it’s 10 minutes 3 times a day or continuous, is the healthier lifestyle pattern that we should be employing with our patients,” she said.

Both Peters and Lundberg point out that one of the practical considerations with tracking central adiposity is that it can be difficult to determine exactly where to measure waist circumference, particularly in those who are severely obese.

“Our study protocol said it had to be measured at the naval,” but “whatever you decide it should be consistent and should be at a predefined point because otherwise you can’t track changes over time or waist-to-hip ratio from one individual to another,” Peters said.

As to the biological basis for women’s excess MI risk associated with central adiposity, the investigators note that genome-wide association studies of fat distribution have identified several genes with a stronger effect in women than in men that are known to be associated with other metabolic pathways, including lipid traits and insulin resistance.

Additional insights into adiposity may be gained from the UK Biobank, which is collecting large amounts of data on body fat distribution by using MRI.

“Ultimately what we want to do is to move beyond just the tape measure and the scale and the height measure to use, for example, imaging-derived measurements of body fat distribution to actually classify patients into very specific body shapes and body fat distributions,” Peters said. “Because even if you’re a person with an apple shape, it may be that the way the fat surrounds the organs, surrounds the liver, surrounds all the critical places in the body, those differences will still be there and that’s something you can’t quantify using just a tape measure.”

Peters is supported by a UK Medical Research Council Skills Development Fellowship. Lundberg reported no financial disclosures.

J Am Heart Assoc. Published online February 28, 2018. Abstract

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

Source link

Buried in Budget Bill: Gifts for Some Healthcare Providers

When President Donald Trump signed the last-minute budget deal into law earlier this month, the news coverage emphasized how the bill boosted military funding, provided tens of billions in disaster aid and raised the debt ceiling.

But buried deep in the 652-page legislation was a repeal of a limit on Medicare coverage of physical and occupational therapy. It received little public attention, but to the American Physical Therapy Association, this headline was decades in the making.

The group had spent 20 years lobbying to reverse a component of the Balanced Budget Act of 1997, which would have limited patients to $2,010 worth of occupational therapy a year, and another $2,010 of physical therapy and speech-language pathology. Each time the limit was about to kick in, APTA managed to postpone its implementation — sometimes for just months, sometimes for another year or so.

Justin Moore, APTA’s CEO, quit his job as a physical therapist in Missouri and moved to Washington, D.C., in 1999 specifically to lobby Congress full time about staving off these so-called therapy caps. He recalls recruiting thousands of physical therapists to protest on Capitol Hill, long hours lobbying in congressional offices and eleventh-hour victories to keep the cap from taking effect.

Just hours after Trump signed the sweeping bill, Moore joked: “I’ve got to figure out what to do next,” celebrating the victory with cupcakes in his Virginia office.

It’s a story of one long-fought battle, marked by legislative twists and convolutions, procrastination and budgeting witchcraft. But it provides a window into the bizarre world of the way much of health care financing gets done in Washington — as an afterthought and via backroom negotiations.

“This is a miniature version of what we also have as the inefficiencies of health policy and health care,” said Thomas Miller, a resident fellow at the conservative American Enterprise Institute, a Washington think tank. “We do a lot of things that burn up resources and energy, and we treat them as a big deal, and that tends to keep you down in the trenches, shooting at things in front of you and not looking at the larger picture.”

In their enthusiasm to pass a budget this month, Congress included permanent dissolution of the therapy caps — 277 pages into the bill. The bill contained several other measures meant to placate medical constituencies by fulfilling their financial requests: for instance, forestalling payment cuts to so-called Disproportionate Share Hospitals, which treat higher proportions of low-income patients, and continuing a payment bump to certain rural home health providers.

An Arbitrary Amendment

The therapy cap came as an amendment to the 1997 budget bill, part of a “big push to reform entitlements,” recalled Katherine Hayes, health policy director at the D.C.-based Bipartisan Policy Center, who worked at the time for Rhode Island Republican Sen. John Chafee, then the chair of the Senate subcommittee on health care.

Its inclusion was somewhat arbitrary — “an assignment … to get some savings in the health sector,” recalls Sen. Ben Cardin (D-Md.), who at the time was a junior member of the House Ways and Means Committee, where the proposal originated.

Others recalled some concern that Medicare was paying too much for physical therapy and a hope that limiting coverage might help control these costs.

Since lawmakers “had to reach the target [for savings], it went into the package. Once it went into the package, it was enacted and became law,” said Cardin, who has introduced numerous bills over the years attempting to repeal the caps.

Almost immediately, backlash came from a small but impassioned therapy contingent, willing to devote the bulk of its lobbying resources to this one issue, with effect. Lawmakers on both sides of the aisle balked when it came to actually implementing the caps.

Over the years, that resistance translated into Capitol Hill rallies, starring speakers such as Maine Republican Sen. Susan Collins, who would wear and remove baseball caps — metaphorically “lifting the cap,” Moore recalled. It also meant full-court-press phone-a-thons from the nation’s physical therapy community, calling on Congress to extend the delay, usually by attaching legislative language to whatever must-pass spending bill or health care funding measure was moving through the pipeline.

The therapy lobby kept the legislative patches going, but efforts always stopped short of a full repeal, many recalled. This solution allowed lawmakers to have it both ways: They did not have to take a generous popular benefit, physical therapy, away from voters. But they continue to support a budget amendment aimed at taming runaway spending.

“For a number of years, we thought [the cap] was not a thoughtful approach,” said Cybele Bjorklund, who worked from 1995 to 2015 as a Democratic staffer in Congress. “Many Republicans also realized pretty early on this was not good policy. But again — nobody wanted to then pay to get rid of it.”

And so, sidestepping imposition of the therapy cap was achieved by adding the delay into a hodgepodge of small health initiatives, known as the “extenders,” which are addressed every few years. In 2006, Congress switched from delaying the cap to simply allowing for easy exceptions for patients who needed therapy beyond the stipulated limits.

On the balance sheet for the budget bill that passed this month, the nonpartisan Congressional Budget Office estimated the permanent therapy cap repeal will cost more than $6 billion over the next decade.

A Few Hiccups And, Ultimately, Repeal

The ups and downs of the therapy cap provision kept APTA in business — providing fodder to mobilize their members and resulting in increasing lawmakers’ interest in a permanent deal, Moore said. Political gamesmanship and partisan bickering resulted in brief lapses — in late 2003, for a month in 2006 and in early 2010 — when lawmakers failed to patch together a bill in time.

Meanwhile, the estimated cost of forestalling or mitigating therapy caps grew more expensive each time around.

An effort to incorporate repeal of the caps into the 2010 Affordable Care Act failed, partially, Bjorklund recalled, because Democrats wanted the sweeping health law as a money saver. That meant every penny counted, and even a few billion dollars represented deadweight.

In 2015, a proposed Senate amendment to a larger bill on doctor payments again would have ended the therapy caps. It was ruled out of order after falling two votes short of a motion to waive concerns about its relevance.

That exhaustive 20-year effort laid the groundwork for this month’s deal. When Bjorkland heard that therapy caps could be on the table for this year’s budget bill?

“I remember saying, ‘Please, just get rid of it, will you? Finish it off!’” she said.

Source link

Trump Says He Has Spoken With Sessions About Suing Opioid Companies

WASHINGTON (Reuters) – U.S. President Donald Trump said on Thursday that he had spoken with U.S. Attorney General Jeff Sessions about bringing a lawsuit against companies involved in the opioid business.

“I’ve also spoken with Jeff (Sessions) about bringing a lawsuit against some of these opioid companies,” Trump said at a ‘summit’ hosted by the White House on the nation’s opioid crisis. “Hopefully we can do some litigation against the opioid companies.”

Hundreds of states, counties and cities have sued drugmakers and distributors, saying the manufacturers have deceptively marketed opioids and distributors have failed to take action against indications the painkillers were diverted for improper uses.

On Tuesday, Sessions announced that the federal government would seek reimbursement from major drug companies and distributors to recoup costs from the opioid epidemic. The Justice Department will file a “statement of interest” in consolidated litigation on opioids.

It was not immediately clear whether, in his remarks at the summit, Trump was referring to that Justice Department action or pressing for further steps.

According to the Centers for Disease Control and Prevention, 42,000 people died from opioid overdoses in 2016, the last year with publicly available data.

Source link

Diastolic but Also RV Dysfunction Predict TAVR Survival

New research highlights the impact of left ventricular diastolic dysfunction (LVDD) on mortality risk after transcatheter aortic valve replacement (TAVR) but also how deadly right ventricular dysfunction (RVD) can be.

In the first of two papers, Swiss researchers report that baseline LVDD is associated with a two- to fourfold increased all-cause mortality risk at 1 year with advancing stages of diastolic dysfunction and that this effect is independent of systolic LV function.

In the second paper, patients with baseline RVD had nearly three times the risk for cardiovascular death at 1 year as those with normal RV function (20.1% vs 7.1%; adjusted hazard ratio [HR], 2.94; 95% CI, 2.02 – 4.27).

RV function recovered in more than half (57.4%) of patients evaluated a median of 2 days after TAVR, but an increasing risk for death remained in patients with recovered RVD, new-onset RVD, and persistent RVD (adjusted HRs, 2.16, 3.93, and 8.74, respectively).

This gradient of risk observed for both RVD and diastolic dysfunction will need to be corroborated in larger studies with more patients, but it suggests that RV and LV function should be considered in risk assessment before and after TAVR, senior author, Thomas Pilgrim, MD, Bern University Hospital, Switzerland, told theheart.org | Medscape Cardiology.

RVD has been associated with all-cause mortality after cardiac surgery and in patients with heart failure, but smaller trials using inconsistent definitions of RVD have produced mixed results in patients undergoing TAVR.

Pilgrim noted that RVD has been “a bit neglected in the past” and that part of the impetus for conducting the study was the recent European Society of Cardiology statement on the management of acute RV failure and the American Society of Echocardiography and European Association of Cardiovascular Imaging guidelines for the evaluation of RVD.

“After TAVR, everybody cares about paravalvular regurgitation and procedural gradient, but nobody cares about the right ventricle, and I think this is something that should change once you read this article,” he said.

LVDD is widely recognized as a predictor of mortality in surgical patients, but Pilgrim noted that LVDD defined by using the latest echocardiographic guidelines was present at baseline in 70% of patients, far surpassing prior prevalence estimates of about 15%.

Patricia Pellikka, MD, Mayo Clinic, Rochester, Minnesota, coauthor of a related editorial, cautioned in an interview that diastolic dysfunction in these elderly TAVR patients could be related to comorbidities, such as lung disease, pulmonary hypertension, and obstructive sleep apnea, and that just having long-standing LV aortic stenosis could potentiate RV impairment.

Still, Pellikka said the papers underscore the importance of considering all available transthoracic echocardiographic evidence in selecting patients for early, life-saving aortic valve replacement.

“We really need to be careful that we’re not offering therapy too late when patients aren’t going to derive the maximum benefit because we’ve waited for symptoms that may be vague in the first place and still vague at follow-up, and meanwhile right ventricular dysfunction and diastolic dysfunction are progressing,” she said.

The studies, led by Masahiko Asami, MD, Bern University Hospital, were published online February 28 in JACC: Cardiovascular Interventions and February 14 in JACC: Cardiovascular Imaging, respectively.

Role of RVD

To evaluate the role of RVD, the researchers examined data from 1116 (mean age, 82 years) in the prospective Swiss TAVI registry who underwent TAVR for severe aortic stenosis (AS) at their institution between August 2007 and December 2015 and had transthoracic echocardiographic data.

Cutoff values for abnormal RV function were fractional area change less than 35%, tricuspid annular plane systolic excursion less than 1.7 cm, and systolic movement of the RV lateral wall by tissue Doppler imaging of less than 9.5 cm/s.

RVD was found in 29.1% of patients at baseline. These patients were significantly more likely to be men, to have a history of atrial fibrillation or bypass surgery, and to have a lower LV ejection fraction and transvalvular gradient. They also had higher pulmonary artery pressures and were more likely to have concomitant moderate or severe mitral and tricuspid regurgitation.

A composite of all-cause death, disabling stroke, and myocardial infarction occurred in 29.6% of patients with RVD vs 14.7% of patients with normal RV function (adjusted HR, 2.08; 95% CI, 1.57 – 2.76), driven by a higher rate of all-cause mortality (26.2% vs 11.1%; adjusted HR, 2.48; 95% CI, 1.82 – 3.38). Patients with RVD also had a higher rate of stage 3 kidney injury (adjusted HR, 2.43; 95% CI, 1.28 – 4.61).

The higher mortality risk emerged within the first 30 days of TAVR (9% vs 2.2%; HR, 4.62; 95% CI, 2.51 – 8.50).

In multivariate analysis, RVD was the strongest independent predictor of cardiovascular death at 1 year (HR, 2.51; 95% CI, 1.64 – 3.86).

“You would certainly not perform open-heart surgery in patients with severe right ventricular dysfunction, but I think for TAVR there’s not a cutoff where you would think, ‘Well, you don’t perform TAVR anymore because of right ventricular dysfunction’,” Pilgrim said. “You’d still do it, but it gives you a very good picture on the prognosis and on the expected outcomes of those patients.”

New-onset RVD was found in 12.1% of patients after TAVR, but exactly why this occurred is unclear. Most of these patients did not have an obvious periprocedural complication that would explain it, although it’s possible they had borderline RVD before TAVR and then it just “pushed them over into right ventricular dysfunction,” Pilgrim said.

LVDD

The investigators turned to 777 patients from the same Swiss TAVI registry to examine LVDD by using four cutoffs:

Annular e’ velocity (septal e’ < 7 cm/s or lateral e’ < 10 cm/s);
Average E’ ratio > 14;
Left atrium maximum volume index > 34 mL/m²; and
Peak tricuspid regurgitation velocity > 2.8 m/s.

LVDD, defined as the presence of more than half of all parameters, was documented in 545 patients and classified as grade 1 in 18%, grade 2 in 36.3%, and grade 3 in 19.1%. In all, 145 patients were excluded from the analysis because they had only one or two discrepant variables available to grade.

Similar to their RVD counterparts, patients with LVDD were more likely to be male, to have a history of bypass surgery or myocardial infarction, and to have concomitant moderate or severe mitral or tricuspid regurgitation. Patients with LVDD also had a lower LV ejection fraction, but there were no significant differences in aortic valve area or transvalvular gradient.

Compared with patients with normal diastolic function, patients with LVDD had a risk for all-cause death at 1 year that increased with worsening stages of LVDD from grade 1 (16.3%; adjusted HR, 2.32; 95% CI, 1.15 – 4.66) to grade 2 (17.9%; adjusted HR, 2.58; 95% CI, 1.43 – 4.67) to grade 3 (27.6%; adjusted HR, 4.21; 95% CI, 2.25 – 7.86).

The mortality difference emerged as early as 30 days after TAVR in patients with LVDD grade 3 but continued during mid-term follow-up and was strongly driven by differences in cardiovascular death (adjusted HR, 7.53; 95% CI, 3.17 – 17.9).

The effect of LVDD on 1-year mortality was independent of systolic LV function in a sensitivity analysis that included only patients with an LV ejection fraction of 50% or greater (LVDD grade 2 adjusted HR, 2.57; 95% CI, 1.30 – 5.08; LVDD grade 3 adjusted HR, 3.66; 95% CI, 1.46 – 9.18). The data “underscores the applicability of LVDD as a viable tool for risk stratification in AS patients,” the authors write.

LVDD grades 1, 2, and 3 independently predicted death at 1 year, with adjusted HRs of 2.36, 2.58, and 4.41, respectively. LVDD grade 3 was the strongest predictor of mortality, followed by body mass index of 20 kg/m² or less, diabetes, chronic obstructive pulmonary disease, and peripheral vascular disease.

“The long-term effect of LVDD on survival may be related to the protracted regression of LV hypertrophy,” while “LV stiffness may further exacerbate the effect of persistent volume overload,” the researchers write. Prior studies have suggested an additive effect of LVDD and paravalvular regurgitation after TAVR, while more moderate aortic regurgitation has been independently associated with an increased risk for mortality at 2 years.

In the accompanying editorial, Pellikka and Ratnasari Padang, MBBS, PhD, also from the Mayo Clinic, note that the study included 107 patients with moderate or severe mitral regurgitation, which can induce changes in transmitral Doppler patterns resembling those with advanced DD. Baseline mitral regurgitation is also a known predictor of worse outcome after TAVR and may have confounded the relationship.

In addition, they write, “Significant mitral annulus calcification, a common finding in elderly patients with AS, was not specified, and can lead to reduction in mitral orifice area and restriction of mitral annulus movement with consequent elevation of E/e’. These patients should have been excluded.”

Still, Pellikka and Padang conclude that “baseline diastolic function evaluated by echocardiography provided important prognostic information beyond standard risk factors alone.”

Pilgrim reported receiving research grants to his institution from Edwards Lifesciences, Symetis, and Biotronik; speaker fees from Boston Scientific; and travel expense reimbursement from St Jude Medical. Asami and Pellikka have disclosed no relevant financial relationships.

JACC Cardiovasc Imaging. Published online February 14, 2018. Abstract

JACC Cardiovasc Interven. Published online February 28, 2018. Abstract, Editorial

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

Source link

People Often Underestimate Calorie Intake

Brits are underestimating how many calories we are eating each day, figures reveal.

Experts say it could be hampering efforts to cut rising obesity levels.

Health officials are planning a campaign next month to persuade us to cut down on our calorie intake.

Underestimating Our Calorie Intake

A survey of 4,452 adults asked men and women to log their calorie consumption.

On average, men said they consumed 2,065 calories but were actually taking on board 3,119 calories.

Women estimated their calorie consumption at a modest 1,570 when the actual figure was 2,393.

Recommendations say that a typical man need around 2,500 calories a day to maintain his weight. For a woman, that figure is around 2,000 calories.

‘We Don’t Want to Say We Are Fat Slobs’

A Public Health England spokesman tells us that they want to make people more “calorie aware about their main meals” in a March health campaign

Tam Fry, from the National Obesity Forum, says under-reporting of calorie intake has always been a problem. “We’ve all got fatter in the course of time,” he tells us. “People now say they eat far less than they actually do, and that’s understandable because nobody wants to say ‘I have an unhealthy diet and I am a fat slob’ because I eat the wrong things.

“They put down what they think the researchers would want to hear.”

‘Concentrate on Nutrition Rather Than Calories’

Linia Patel, a registered dietitian and spokesperson for the British Dietetic Association (BDA), says it’s no wonder we struggle to accurately recall how many calories we are consuming. “You’ll cook and you’ll have a bite to eat, nibbling away on cheese or a cracker and you’ll almost not even think of that as food because you almost only count as food that which you actually sit down to eat.

“So, I think there’s a lot of mindless eating.”

Linia Patel’s advice is not to become obsessed with calories but to concentrate on the nutritional value of what we eat instead.

SOURCES:

Evaluating calorie intake, Bailey R, Data Science Campus

Tam Fry, National Obesity Forum

Lina Patel, British Dietetic Association

Public Health England

Source link

Exercising to Death: The Rare Risk of Rhabdo

Nancy Weindruch wouldn’t have called herself an athlete in 2015, but she was a regular gym-goer who loved to ski, golf, and do yoga. She was excited to try something new when her sister invited her to a cycling class for the first time. Within 15 minutes of getting on the bike, she knew she was in way over her head.

The lights were dim. The music was blaring. Everyone was in sync with the high-energy, intense exercise — except her. “The instructor was encouraging everyone to give it your all, and I was looking around the room and thinking, ‘I can’t do this.’ I realized very quickly my body didn’t have the endurance for this,” Weindruch recalls.

She was on the opposite side of the room from the door, too embarrassed to get up and leave and unsure she could unlock her shoes from the bike without causing a disruption. So the then-30-year-old sat down on the bike, turned its resistance to the lowest level, and slowly pedaled through the rest of the class.

“When I got off the bike I felt weak in my legs, but I didn’t really think anything of it,” Weindruch recalls. “I just figured it was a new class for me and it will pass.”

Three days later, she could hardly walk and was struggling to sit in a chair. “My intuition kicked in, and I thought something isn’t right,” she says.

A quick Google search turned up a story about a 30-year-old woman who had similar muscle pain after a cycling class and was hospitalized with something called rhabdomyolysis, or rhabdo for short. Weindruch didn’t have all the symptoms described in the story, but she had enough that she went straight to the emergency room.

Once there, lab results confirmed she too had rhabdo. She was admitted to the hospital for a week. “The pain was so excruciating that it contributed to nausea,” Weindruch recalls. “It was unbearable. The worst pain I’ve ever experienced.”

The disorder is dangerous but rare. In one study, 22 people out of 100,000 were known to have it.

What Is Rhabdo?

Rhabdomyolysis is a syndrome involving muscle breakdown and damage. When muscles are injured, they release their contents, including a muscle enzyme, into the bloodstream. The enzyme can harm the kidneys and can cause kidney failure in up to 40% of cases. It also can harm the kidneys’ ability to remove urine and other waste.

Rhabdo can be even more dangerous in children when they’re pushed to extremes in sports or other physical activities.

Patients generally recover when they get prompt treatment, but the condition can lead to death in rare cases.

The syndrome has three classic symptoms, but not all are always present. They are:

Many things can cause rhabdo, including trauma, drug use, statins, severe dehydration, and extreme temperatures. But the growth in exercise-induced rhabdo is getting more attention.

“It can happen with any intense exercise if it involves repetitive motion of a muscle and new movement,” says Maureen Brogan, MD, an associate professor of medicine at New York Medical College in Valhalla, NY.

Brogan wrote an article on the subject in The American Journal of Medicine in 2016, saying rhabdo brought on by cycling class was a “public health concern.” She says she came to see it as that after six patients came to her hospital’s ER, and all involved people trying a cycling class for the first time. Each of them had received a free class pass. When she searched medical literature, 42 of the 46 cases she found also involved people going to cycling class for the first time.

“Those are the patients that were most at risk because they may not be conditioned and are using and engaging new muscle groups for the first time at an intense rate,” she says. “So even if you were a different type of athlete like a runner, and then you switch to biking and use quadriceps and gluteus maximus muscles at an intense rate — that first time, you may be at risk of getting rhabdo.”

Brogan says people who stop cycling for some time and then go back at the same rate are at risk, too.

“(Cycling) is great exercise if you are conditioned for it,” she says. “But you burn 600 to 900 calories in one class. You wouldn’t go out and run 6 to 9 miles on your first day of running. If you did that, you wouldn’t be able to walk either.”

What We Know About Rhabdo

In her article, Brogan says things that raise your chance of having rhabdo are exercise intensity, a person’s conditioning, hydration, and body temperature.

Researchers say it’s tough to know how many people are affected by rhabdo, but in theory, any type of muscle injury can cause it. Several studies cite incidents connected to cycling class. A review of patients between 2010 and 2014 at one New York City hospital uncovered 29 rhabdo cases, 14 connected to cycling. Study author, Todd S. Cutler, MD, an assistant professor of medicine at Weill Cornell Medicine in New York City, says all 14 patients had similar stories.

“These were people who had either never done this before, or it had been a long time since they had done this, and they would usually make comments like, ‘I’m in pretty good shape’ or ‘I’m surprised this happened to me because I exercise.’ The point being that these were fit people,” Cutler says.

Military training is also connected to rhabdo cases. A 2012 study found it happening 7 to 8 times a year out of 10,000 military members. A 2010 study of military personnel in basic training found about 22 cases of it per 100,000 recruits each year.

Professional athletes have reported getting the condition too. Professional snowboarder Amy Purdy took to Instagram in 2016 to tell fans she was hospitalized with the condition, which she called “crazy” and “scary.” She says she got it after going to a CrossFit gym for the first time and doing intense pullups after not doing them for a few months.

“It wasn’t until 72 hours later, I was back in my hometown with friends at a restaurant around 11 at night. I told them I worked out too hard a few days ago, and my arms wouldn’t straighten all the way. I then took my jacket off and instantly noticed swelling around my elbows on both arms,” she recalls.

She remembered something similar happening to a friend and rushed to the hospital.

“The doctors were convinced I didn’t have it because my arms were only slightly swollen. They decided to test me anyway,” Purdy says. “That whole experience was one of that hardest experiences of my life!”

She says it’s important for people to know that rhabdo can happen to anyone, no matter how often you work out or how in shape you are.

“If you push your body to failure and keep going, you are at risk. Listen to your body. It knows best,” Purdy says. “And if you find yourself going on days with overly stiff and sore muscles and you notice swelling, get to the hospital ASAP. It may not be rhabdo, but a simple blood test can tell.”

Alexis Colvin, MD, an orthopedic surgeon at Mount Sinai Hospital in New York City and the chief medical officer for the U.S. Open Tennis Championships, says she’s also heard of cases connected to marathons and ultramarathons. “There is definitely more awareness of it with the popularity of people looking for different ways of challenging themselves,” she says.

In her article, Brogan describes three first-time cycling class-related cases that she felt reflected patients not seen widely in the medical literature — either because of their young age or the severity and quick onset of their symptoms:

· A 20-year-old man who regularly exercised

· A 33-year-old woman who got rhabdo after just 15 minutes on a cycling bike

· A 33-year-old woman whose case was so extreme, she needed hemodialysis

All these patients needed physical therapy.

“These three cases are all shocking. That is why I had to write about them. I want the public to know that you are at risk for going into kidney failure if you get rhabdo, and it is important to know how to prevent this from happening. Start (cycling) slowly,” Brogan says.

What to Do About Rhabdo

Experts say rhabdo shouldn’t scare people away from exercise or have them thinking they are in danger if they hit the gym. The syndrome is rare and happens in small numbers. But doctors say you should be cautious about rigorous exercise when you are just starting out.

“If you are going to engage in a high-intensity exercise regimen for the first time, you should start out at a level you can handle. If working with a trainer or exercise coach, they should have you do levels of increasing intensity over time, and not hit people so hard the first time out that they end up overworking their muscles to a degree they aren’t trained for. Those are the people who end up in trouble,” Cutler says.

It’s not uncommon to feel muscle soreness after working out, so how do you know if you’re dealing with rhabdo? Colvin says the pain seems extreme or out of proportion with the workout, and you would have it within a few days of the intense exercise.

“It’s about the trend in how you are feeling. In most typical recoveries, people tend to start to move in the right direction, but with rhabdo, that isn’t the case. Untreated, it will most likely get worse,” she says.

Brogan says be careful if you accept a free pass for an intense exercise class or try one for the first time. Her other recommendations include:

· Stay well-hydrated before, during, and after the exercise.

· Don’t allow your body to get too hot, since being overheated can help bring on rhabdo.

· Don’t take your first class in a heated exercise room.

· Tell the instructor you are new, and ask for advice when just starting out.

· Take breaks, and work at a slower speed.

· Avoid non-steroidal anti-inflammatory drugs like ibuprofen, since they can also help bring on kidney injury.

· After trying an intense exercise for the first time, wait a few days before working out again, because symptoms can take a few days to appear or worsen.

If you’ve recovered from rhabdo, Brogan says, there are no guidelines about how to go back to exercise. Many patients she speaks with have a fear of exercise after they recover. “I still speak to one patient who says her legs still just don’t feel the same,” Brogan says.

Purdy says it took her a long time to heal. “Take it slow. I spent months in rehab before I could lift even the lightest of weights again. It’s not something to take lightly,” she says.

In Weindruch’s case, she was in the hospital for a week, getting pain medication and IV fluids. Doctors monitored her kidneys and vital signs, and it took several days for her pain to pass and her dark brown urine to return to its normal color.

Three years later, the now 33-year-old is still prone to dehydration but has returned to exercising. She sticks to low-impact options like the elliptical, walking, or yoga.

“It’s not that I’m traumatized. I just think it is a matter of listening to your body,” Weindruch says. “In our society, you see a lot of really intense physical activity, which is awesome, but I don’t think our bodies are meant to go from 0 to 60 unless you have done the proper training — at least not mine.”

Source link