No Evidence To Support Screening Young Athletes

–More questions raised about key study suggesting ECG screening can save lives There is no good evidence to support screening young athletes to prevent sudden cardiac arrest, concludes a new analysis published in the BMJ. The analysis also raises new and troubling questions about a key Italian study that has been the main study used…

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New Company Bets Hundreds Of Millions Of Dollars On A Genetic Strategy To Resurrect A CETP Inhibitor

–But skeptics think CETP inhibitors are a dead end A new company is betting hundreds of millions of dollars that it can snatch victory from the jaws of defeat. Over the last decade no class of drugs has undergone a reversal of fortune as dramatic as the cholesterol ester transfer protein (CETP) inhibitors, the once…

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FDA Ends Niacin and Fenofibric Acid Combinations With Statins

–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins…

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Orexigen Terminates Another Cardiovascular Outcomes Trial

Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment…

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New Analysis Of Old Study Delivers Another Blow To Traditional Diet Advice

–Replacing saturated fat with vegetable oils lowered cholesterol but didn’t improve outcomes A new analysis from a long-forgotten study dating to the 1960s adds to mounting doubts over a cornerstone of dietary advice for more than 50 years: the demonization of saturated fat in the diet. Although in recent years the nutritional establishment has retreated…

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USPSTF Updates Aspirin for Primary Prevention Recommendation

–But many experts think the evidence base is slim at best. The U.S. Preventive Services Task Force (USPSTF) finalized the update to its guidelines regarding the use of aspirin for the primary prevention of cardiovascular disease and colorectal cancer. The USPSTF is now recommending that people between the ages of 50 and 59 who are at increased…

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FDA Expands Metformin Label

— The diabetes drug can now be used in more patients with reduced kidney function The FDA on Friday greatly expanded the indication for the type 2 diabetes drug metformin. Until now use of metformin in patients with reduced kidney function had not been recommended. The new label states that metformin “can be used safely…

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FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels

The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the  saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that…

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Not So Rare, FH Is Truly Risky Lipid Disorder

–Not all elevated is LDL is equally dangerous CHICAGO — Familial hypercholesterolemia (FH), a condition that has long been overshadowed by more common cardiovascular diagnoses, has now found the spotlight in the big tent as a hot and even controversial topic. The new interest is driven by important advances in understanding the genetics of the…

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ACCELERATE Puts the Brake on CETP Inhibition

–No benefit with evacetrapib despite increase in HDL and decrease in LDL The fat lady hasn’t sung, the referee hasn’t counted up to 10, but it’s sure not looking good for the once highly promising class of drugs known as the CETP inhibitors. Bang the Drum Slowly, and Play the Fife Lowly Following the crash…

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How Does HOPE-3 Change Thinking About Primary Prevention?

–The study lends strong support for statins but delivers a mixed message for antihypertensives. The widely reported results of HOPE-3 may bolster the case for primary prevention with statins and blood pressure drugs. But the trial also makes clear that the benefits, though real, are also modest, and may not be evenly distributed between statins…

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How Should SPRINT Influence High Blood Pressure In Children And Adolescents?

–Editorialists say pediatric hypertension in children is ready for a ‘paradigm shift’ Last year’s influential— and highly controversial— SPRINT trial should be used to better inform and influence our understanding and management of hypertension in children, write two influential physicians who have played a key role in the cardiovascular guidelines for children and adolescents. They…

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Court Decision In Patent Battle Threatens PCSK9 Drug

—-One analyst thinks the decision might take Praluent off the market. A jury’s decision last week in a patent case might possibly lead to the removal of one of the new PCSK9 inhibitor cholesterol lowering drugs from the US market, according to a Wall Street analyst who has been closely following the case. Amgen, which…

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New Evidence Fitness Trackers Don’t Actually Track Fitness

–Little agreement found when 12 wearable devices were compared to gold standards Fitness trackers have not been found to help people improve the way they exercise, an article in the Sunday New York Times noted in a summary of the case against wearable fitness trackers, pointing up technical and even philosophical limitations of the devices….

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A Novel Way To Think About Primary Prevention, Death, And Statins

A new paper offers a novel way to think about disease prevention. The way we think– and talk– about disease prevention now is complicated and confusing. A key ingredient in the decision to take statins for the prevention of cardiovascular disease, for instance, is the estimation of 10-year cardiovascular risk. This single number, which represents…

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Confusion In The Age Of Genetic Information

(Updated)– We may live in the age of information but we really have no idea how to use all that information, especially when it comes to health. One new study, published in the BMJ, is a good illustration of this principle. “There are high expectations that advances in genetics will usher in a new era…

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Studies Spotlight Role Of Triglycerides, Put HDL In The Background

Two new studies provide more evidence tilting the balance in favor of triglycerides rather than HDL playing a causative role in cardiovascular disease. But it is still too early to know whether the findings of any of the studies will point to useful new methods to prevent and treat disease. In the first study, published…

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The Door Opens Wider For Drug Companies To Make Off-Label Claims

The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA.  The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…

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Controversial, Ill-Fated Obesity Drug Trial Published In JAMA

The final– but now largely useless– results of the cardiovascular safety trial of the obesity drug Contrave have now been published in JAMA, one year after the trial’s dramatic and scandalous crash and burn. By way of background: Contrave is a combination of naltrexone and bupropion marketed as a weight loss drug by Orexigen and…

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Large Genetic Studies Support Role For Triglycerides In Cardiovascular Disease

Two  papers published in the New England Journal of Medicine offer new genetic evidence to support the increasingly accepted though still controversial view that triglycerides play an important causal role in cardiovascular disease. If fully validated the new findings could lead to new drugs to prevent and treat cardiovascular disease, though others caution that there…

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Best Selling Smartphone Blood Pressure App Gave Wrong Results

A best-selling smartphone app that purported to measure blood pressure actually delivered highly inaccurate results, according to a research letter in JAMA Internal Medicine.  The finding could cause genuine medical harm for the large number of people who use the app. In addition, the study adds new fuel to the fiery debate about the reliability…

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Shedding Light On The Hearts Of Pro Basketball Players

Every time an athlete dies on the field there is renewed interest in the controversial topic of preparticipation screening. One key limitation in the field is that there is little or no good data about what constitutes a healthy heart in athletes. Now a new study published in JAMA Cardiology provides an extraordinarily detailed look…

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Vulnerable Plaque: The Paradigm That Failed

Is it a hallowed paradigm or a hype-othesis? The “holy grail” of cardiology is to stop heart attacks before they happen by identifying– quickly, noninvasively, and specifically– those coronary artery lesions that result in heart attacks. The key theoretical underpinning driving this goal has been the vulnerable plaque hypothesis, which holds that the vast majority…

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Slow Down. Don’t Sprint To More Aggressive BP Treatment

Two editorialists in Annals of Internal Medicine urge caution in interpreting and adopting the findings of the SPRINT (Systolic Blood Pressure Intervention Trial), which last year  showed a benefit for a more aggressive approach to blood pressure therapy. The trial found improved outcomes in  high risk patients treated to a target of of 120 mm…

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FDA Turns Down Expanded Indication For Zetia And Vytorin

The FDA has turned down Merck’s application to expand the indication for its cholesterol-lowering drug ezetimibe (Zetia and Vytorin, Merck).  This means there’s still no end in sight for this drug’s very long and very winding road. Ezetimibe is now indicated to reduce LDL cholesterol in people with hyperlipidemia. The proposed new indication was for…

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