Entresto Gets Boost in Updated HF Guidelines

–Valsartan/sacubitril earns Class I recommendation Cardiology groups in the U.S. and Europe have updated their heart failure guidelines to include much-awaited recommendations for Entresto (the combination of valsartan and sacubitril manufactured by Novartis). The new guidelines offer broad support for the new drug. Since its approval last summer Entresto has struggled to gain a foothold…

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Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug

–The company plans to perform 40 clinical trials in 5 years with Entresto. Novartis announced today an enormous clinical trial program with its promising but slow starting heart failure drug Entresto (valsartan/sacubitril). The company said it would perform 40 clinical trials with the drug in the next five years. The Fortifying Heart Failure clinical evidence and…

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Noted Skeptic Calls For More Randomized Nutrition Trials

Defying conventional wisdom Ioannidis says we need more negative trials to clear away all our misconceptions about nutrition Defying conventional wisdom Ioannidis says we need more negative trials to clear away all our misconceptions about nutritionDefying conventional wisdom Ioannidis says we need more negative trials to clear away all our misconceptions about nutritionDefying conventional wisdom…

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Increasing Support For Generic Drugs And Therapeutic Substitution

–But some physicians, perhaps influenced by industry, remain skeptical. Generic drugs and therapeutic substitution (replacing a drug without a generic equivalent with a different but closely related drug in the same general class) are two key ingredients in most recipes to hold down health care costs. Now a package of articles and commentary in JAMA…

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Pioneering Lipoprotein Researcher Richard Havel Dead

–Nobel laureates Brown and Goldstein say when they were starting out Havel taught them 90% of what they knew Richard Havel, a scientist who helped create the entire entire modern field of research in lipoprotein metabolism, died last month. In response to the news scientists in the field have poured extravagant praise on the man…

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Social Media And Medical Journals: The Streetlight Effect

–Another study tests the wrong approach to social media in medical publishing    Here’s the main problem with a new study published in the Journal of the American Heart Association: they measured the wrong thing with the wrong method. In their new paper the researchers randomized new studies appearing in Circulation to receive social promotion…

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On Road To Bankruptcy A Stent Company Invested in Marty Leon’s VC Fund

More questions are being raised about the research and financial activities of Palmaz Scientific, the bankrupt medical device company founded by Julio Palmaz, the co-inventor of the stent. In the middle of severe financial troubles that eventually brought the company to  bankruptcy Palmaz Scientific found enough money to invest in a venture capital fund. The VC Fund,…

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Experts Foresee Major Role For Generic Crestor

— Finally there’s a challenger to the long reign of Lipitor The FDA approval on Friday of the first generic version of Crestor (rosuvastatin calcium) marks the end of an era and the beginning of a major shift in cardiovascular medicine. Over time, as the price of the drug drops with generic competition, it seems…

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New Cardio Drugs Off To Very Slow Start

–Heart failure experts divided over how and when to use Entresto To many long-time observers, the approval last year of two new cholesterol drugs and a heart failure drug appeared to herald a rebirth of the cardiovascular marketplace after a long period of dormancy. But so far in 2016, those new drugs have hardly made…

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Stent Pioneer’s Company In Bankruptcy And Under Investigation

–Julio Palmaz hasn’t been able to recreate his earlier success A company founded by stent pioneer Julio Palmaz has declared bankruptcy and is being investigated for misconduct, according to the San Antonio Express-News. Palmaz, along with Richard Schatz, was the inventor of the enormously successful Palmaz-Schatz stent marketed by Johnson & Johnson. In March Palmaz…

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Companies Plan To Study Diabetes Drug In Heart Failure Population

–New attention paid to the intersection of heart failure and diabetes Boehringer Ingelheim and Eli Lilly announced on Wednesday that they were planning two separate outcomes trials to test the effect of the diabetes drug empagliflozin (Jardiance) in patients with chronic heart failure. The trials herald a remarkable shift in emphasis, since there have been…

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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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PNAS Paper By Prominent Cardiologist And Dean Retracted

A 2002 PNAS paper has been retracted by its authors, including senior author Pascal Goldschmidt, a prominent cardiologist and Dean of the University of Miami School of Medicine. News of the retraction was reported by Retraction Watch on Tuesday. The paper, “Deficient Smad7 expression: A putative molecular defect in scleroderma,”has been cited 198 times, Retraction Watch reported. Here is…

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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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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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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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