Big Sugar Tips The Balance Of The Research Scale Reply

It might seem obvious: people who drink sugar-sweetened beverages are more likely to gain weight or to be obese. Most research supports this intuitive finding. The big exception: when researchers receive support from the sugar and beverage industries they are much less likely to make the connection.

Researchers in Germany and Spain conducted a systematic review of systematic reviews (yep) examining the association between sugar-sweetened beverages and weight gain and obesity.

Click here to read the full post on Forbes.

Sugar Sweetened Beverages

 

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Cardiology in 2013: Like A Wrecking Ball 1

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball.

The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

Miley Cyrus- Note: Cropped from larger image

The Old Guidelines

3 More Retractions For Emory Cardiology Group Reply

Three more articles from R. Wayne Alexander’s research group at Emory have been retracted in the last two months. Three papers were retracted in 2011, bringing the group’s current total to 6. (News about the recent retractions was first reported on Retraction Watch.)

Click here to read the full post on Forbes.

 

R Wayne Alexander
R Wayne Alexander

 

Studies Suggest You Can Help Your Heart By Walking More And Eating More Fiber 1

It probably won’t come as a surprise, but walking more and eating more fiber are probably good for your heart. That’s the conclusion of two new studies, but because the studies relied on observational data it should be emphasized that they are incapable of demonstrating cause and effect. And it’s by no means clear that most people are willing to undertake the effort needed to achieve effective lifestyle changes like these.

Walking

In the first study, published in the Lancet, researchers analyzed data from 9,300 people with impaired glucose tolerance (and therefore at high risk for developing diabetes) and with existing cardiovascular disease or at high risk for CV disease.

Eating

In the second paper, published  in BMJ, investigators performed a systematic review of studies examining the effect of dietary fiber on cardiovascular and coronary heart disease.

Click here to read the full post on Forbes.

 

Keep Moving 

 

Missing High Blood Pressure Guideline Turns Up In JAMA Reply

After  years of delay and many twists and turns, the hypertension guideline originally commissioned by the NIH has now finally been published in JAMA. The evidence-based document contains a major revision of hypertension treatment targets and includes new and somewhat simplified recommendations for drug treatment.

The previous US hypertension guideline was published more than a decade ago. After many delays the new guideline was ready for publication earlier this year, but then the NIH decided to get out of the guidelines business. The American Heart Association and the American College of Cardiology assumed responsibility for the development and publication of cardiovascular guidelines and last month published four new cardiovascular guidelines, with the notable exception of the hypertension guideline. As an accompanying JAMA editorial explains:  “Rather than go through an additional review process with the AHA and the ACC the authors decided to publish their guideline in JAMA on their own.”

The big headline of the new guideline is an important change in treatment targets.

Click here to read the full story on Forbes.

Original illustration by Max Husten

Original illustration by Max Husten

New Trial Confirms Role For Pradaxa In Venous Thromboembolism Reply

A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for the treatment of  deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is currently approved only for the treatment of stroke prevention in patients with non-valvular atrial fibrillation.

In RE-COVER II 2,589 patients with acute VTE were  randomized to dabigatran or warfarin following standard heparin treatment for 5 to 11 days. At 6 months the rate of recurrent VTE and related deaths was 2.3% in the dabigatran group versus 2.2% in the warfarin group (HR 1.08, CI 0.64 – 1.80; p<0.001 for noninferiority). There were no significant differences in the incidence of deaths, adverse events, and acute coronary syndromes.

Click here to read the full post on Forbes.

 

Pradaxa

Behind The Curtain: Study Reveals Big Role of Medical Communication Companies Reply

Everyone knows that medical information flows out of medical centers and schools, research institutions and the NIH, pharmaceutical companies, journals and medical societies. But one important information source — medical communication companies (MCCs)– “are among the most significant but least analyzed health care stakeholders,” according to Sheila Rothman and colleagues. In a new report in JAMA they set out to explore the important but poorly understood role of MCCs.

Until recently little has been known about these companies. But in recent years, either as a result of legal settlements with the government or public pressure, 14 pharmaceutical and device companies have published their grant awards on the internet. In 2010, the authors report, the 14 companies gave $170 million to MCCs, “more funds than any other recipient, including academic medical centers, professional associations, and research organizations.” Almost all the MCCs were for-profit companies. The top recipient of industry funds was Medscape/WebMD, which received more than $20,000,000, representing 12% of all awards to the MCCs.

Click here to read the full post on Forbes.

Blank "Caution" sign

 

Case Closed: Multivitamins Should Not Be Used 1

The editorialists are fed up: “Enough is enough.” Writing about three new papers in the Annals of Internal Medicine that find no benefits for the use of multivitamins — only the latest in a long line of negative findings — Eliseo Guallar and colleagues write:

…we believe that the case is closed— supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.

In the first paper,  Stephen Fortmann and colleagues performed an updated systematic evidence review of vitamin and mineral supplements for the US Preventive Services Task Force (USPSTF).

In the second paper, investigators from the Physicians Health Study II randomized nearly 6,000 physicians 65 years of age or older to  a multivitamin or a placebo.

In the third paper, Gervasio Lamas and his fellow investigators in the NIH’s Trial to Assess Chelation Therapy (TACT) randomized 1,708 patients who had had a heart attack to a multivitamin supplement or placebo.

Click here to read the full story on Forbes.

 

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Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J Reply

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee suggests that the companies have made progress resolving earlier problems.

Merck’s new drug application for vorapaxar (Zontivity is the proposed trade name) will be discussed on January 15 for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI).

On January 16 the panel will discuss the supplemental new drug application for J&J’s Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome.

Click here to read the full story on Forbes.

English: Logo of the .

Dispatch From The Wild Frontier Of The Statin Wars Reply

The long simmering controversy over the relative benefits and harms of statins has heated to a high boil with the release of the new AHA/ACC US guidelines. But nowhere is the battle more intense right now than in Australia where, according to the National Heart Foundation, a TV show may be the cause of 2,000 heart attacks and strokes over the next five years.

The show was a 2-part documentary  (click here for part 1 and part 2) broadcast in October on the Australian ABC network about dietary fat and cholesterol.

The program, wrote Amy Corderoy, the health editor of the Sydney Morning Herald, “claimed the causal link between saturated fat, cholesterol and heart disease was ‘the biggest myth in medical history’… [and described statins] as toxic and potentially deadly.”

Catalyst delved into a raging debate: has dietary guidance telling us to avoid fats pushed us towards more harmful sugar and carbohydrates instead?

But the program also went a step further, arguing cholesterol was just an innocent bystander in the body’s attempts to deal with the sugar-damage. It was not a big leap to claim statins were dangerous, and the research supporting them fraudulent.

Click here to read the full post on Forbes.

 

Heart of the Matter screen shot

 

 

FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific Reply

The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the vote was 13-1.

Click here to read the full story on Forbes.

 

Watchman_2

 

 

 

Boston Scientific May Face A Tough FDA Panel Reply

On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response letter and earlier this year a scandal broke out when the American College of Cardiology cancelled a prestigious late-breaking clinical trial presentation of the PREVAIL trial after the company broke an embargo by giving trial results to investors.

Wells Fargo analyst Lawrence Biegelsen predicts that the panel will be “contentious” but that ultimately the device will be approved next year. Although the trial missed one of its three c0-primary endpoints, the FDA reviewers emphasis on “the totality of the data” suggests a more benign FDA perspective, he writes.

One knowledgeable observer, Sanjay Kaul, who has served on several FDA panels, thinks the panel will indeed be contentious….

Click here to read the full post on Forbes.

 

Sanjay Kaul
Sanjay Kaul

 

European Air Pollution Standards May Need To Be Strengthened Reply

A large new analysis published in the Lancet has found a strong association between long-term exposure to air pollution and the risk of dying. The results suggest that European standards for air quality may need to be strengthened.

The European Study of Cohorts for Air Pollution Effects (ESCAPE) analyzed data from 22 European  studies, including 367,251 participants followed for an average of 13.9 years. Nearly 30,000 deaths from natural causes occurred during followup. ESCAPE is the first large multi center study to examine long-term exposure to air pollution and mortality across many different European settings….

Click here to read the full story on Forbes.

 

Red Desert

 

Why Is Actelion Suppressing Phase III Data? 2

I highly recommend a terrific article by Ian Parker in this week’s New Yorker about Merck’s efforts to develop a novel insomnia drug, suvorexant. Normally I don’t write about non-cardiology topics but I want here to call attention to one small, almost tangential detail buried in the middle of the story. It’s not about the Merck drug but about another orexin antagonist from Actelion, almorexant:

“At the time, Jed Black, the Stanford sleep specialist, was on a two-year leave of absence, working full time on almorexant, the rival drug made by Actelion. Phase III trials of the drug were under way. This work has not been published, and Black cannot discuss it, although he recently described almorexant as having ‘an absolutely remarkable profile’ that was likely to outperform zolpidem in sleep maintenance.

But, in early 2011, Actelion announced that it was halting the drug’s development, because of an undisclosed possible safety issue. Merck’s scientists speculated about the nature of the concerns, and feared for the future of suvorexant. Black said that the problem was ‘straightforward,’ but that Actelion had decided to pause and take its time. ‘I don’t think almorexant needs re-tinkering at the molecular level,’ he said, implying a problem of drug delivery. Black, who is back at Stanford, suspects that almorexant will be launched, and is certain that such drugs will eventually become dominant. (GlaxoSmithKline recently published results, from Phase II studies, of its own orexin antagonist.)”

The time frame is not entirely clear, but it appears that Actelion has been actively suppressing phase III data about almorexant for several years at least.

Click here to read the full post on Forbes.

 

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Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants Reply

A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of the new agents. Although warfarin is inexpensive, it has numerous interactions with other drugs and foods and requires regular monitoring and dose adjustments. The new agents can be taken once or twice a day and do not require dose changes.

Christian Ruff and colleagues combined data from the nearly 72,000 patients randomized in the four large mega-trials: RE-LY, which studied dabigatran (Pradaxa, Boehringer-Ingelheim); ROCKET AF, which studied rivaroxaban (Xarelto, Johnson & Johnson); ARISTOTLE, which studied apixaban (Eliquis, Pfizer and BristolMyers Squibb); and ENGAGE-AF-TIMI 48, which studied edoxaban (Daiichi Sankyo).

Click here to read the full post on Forbes.

Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck Drug? Reply

Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the company believes may predict a positive response to the drug. And the trial will be one of the first to utilize the much-discussed “adaptive” trial design, starting as a phase 2B study and then possibly expanding to a phase 3 study after an interim analysis of the trial data.

But if GENETIC-AF represents the very model of a modern drug, it also serves as a good example of the pitfalls of drug development. Because this drug has been around for a very long time and has had a very troubled history.

Click here to read the full story on Forbes.

 

Michael Bristow, Arca Biopharma President and CEO

 

Stents Lose In Comparisons With Surgery And Medical Therapy Reply

Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive and that some of the growth in PCI may have been unwarranted.

Click here to read the full post on Forbes.

 

New Guideline Recommends Conservative Treatment for Heart Patients with Anemia Reply

The American College of Physicians (ACP) is recommending more conservative use of transfusions and erythropoiesis-stimulating agents (ESAs) in anemia patients with heart disease. But the authors of the new clinical practice guidelines, published in the Annals of Internal Medicine, acknowledge that the evidence base is too flimsy to support firm conclusions.

“Overall,” wrote the authors, “despite the epidemiologic and biologically plausible association of anemia with poor outcomes, we did not find consistent evidence that anemia correction improves outcomes in patients with heart disease…” The poor outcomes of heart patients with anemia have prompted aggressive treatment strategies, but “it is unclear whether these strategies improve outcomes.”

Click here to read the full post on Forbes.