ATMOSPHERE: Heart Failure Trial Poisoned By Controversy

–Aliskiren raised regulatory pandemonium as it crashed in trials When it comes to interrupting the renin-angiotensin system, the third time was definitely not the charm. Following the enormous success of the ACE inhibitors and angiotensin-receptor blockers, there were early high expectations for a third class of drugs, the direct renin inhibitors. Those hopes were dashed…

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After a Decade, CABG Pulls Ahead of Meds for HF

–Life-saving benefit of CABG now clear in long-term trial follow-up Finally, after 10 years of follow-up, the life-saving benefits of coronary artery bypass graft (CABG) surgery in heart failure patients with coronary artery disease are clear. More than 15 years ago, the NIH funded the original STICH trial to answer a question that was already…

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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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US DOJ Expands Investigation Into Phony Novartis Speaking Events

— The government wants Novartis to turn over documents on 80,000 separate speaking events. The US Department of Justice is seeking to greatly expand its investigation of Novartis “for engaging in a nationwide kickback scheme, spanning 10 years, to induce doctors to write prescriptions for certain of its cardiovascular (‘CV’) drugs.” Last week the DOJ…

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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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Top HF Expert Decries ‘Unbelievable Folly’ of Clinical Trials and Guidelines

–Milton Packer, MD, calls the system to test and evaluate heart failure drugs dysfunctional The system is completely broken, writes heart failure specialist Milton Packer, MD, in an editorial in Circulation: Heart Failure. The results of important clinical trials are not being incorporated into guidelines quickly, intelligently, or consistently, Packer argued. The most important reason…

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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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LVADs Prolong Life But Sow Confusion

–Patients with LVADs and their caregivers suffer from confusion and uncertainty at the end of life.  More and more people with advanced heart failure are receiving left ventricular assist devices (LVADs) as destination therapy. Now clinicians who treat these patients are reporting that the patients and their caregivers are suffering from an extraordinary amount of…

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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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How Many People Really Have Familial Hypercholesterolemia– And Does It Matter?

A new study estimates that about 834,000 adults in the US have genetically high cholesterol levels, otherwise known as familial hypercholesterolemia (FH). The prevalence of FH, which the authors calculate as 1 in 250 American adults, is twice the size of earlier assumptions. But the authors acknowledge that the criteria for FH used in their…

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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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Theranos Ignored Red Flags On Its Blood Clot Tests

Beleaguered laboratory company Theranos sent out unreliable blood clot tests on at least 81 patients, according to an article by John Carreyrou and Christopher Weaver in the Wall Street Journal. Theranos, a former darling of Wall Street, Silicon Valley, and high technology medicine enthusiasts, has been the subject of a series of embarrassing revelations in…

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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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Top Line Results Favor Victoza In Large Cardiovascular Outcomes Trial

Novo Nordisk today announced top-line positive results of the LEADERS trial, the cardiovascular outcomes trial testing its diabetes drug Victoza (liraglutide). Liraglutide is a GLP-1 inhibitor used to help achieve glucose control in patients with type 2 diabetes. 9,340 people with type 2 diabetes were randomized to liraglutide or placebo in LEADERS for 3.5 –…

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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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At the FDA Rob Califf Will Champion Clinical Trials

Everyone wants to know what Rob Califf is going to do at the FDA. His critics say he’s going to hand the car keys over to industry and allow them to drive the agenda. Or, as one reporter tweeted: Hey, is that the sound of the FDA approving things faster? Must be because the Senate…

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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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