Two NEJM Papers Spotlight Promising But Early New Cardio Drugs

Now that cardiologists and other doctors are comfortable talking about PCSK9 inhibitors they can start preparing to add a new mouthful of a therapeutic target to their vocabulary: angiopoietin-like-3 (ANGPTL3). Two papers published in the New England Journal of Medicine by industry researchers provide a snapshot of promising but still early research on two new drugs that target…

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Should Everyone With Heart Failure Get Aggressive Treatment?

–A Conversation About Heart Failure With Milton Packer And Richard Lehman (Part 2) This is the second installment of an ongoing discussion about heart failure between Milton Packer, who has been leading major heart failure clinical trials for decades, and Richard Lehman, a retired UK GP who writes a blog for the BMJ website. (Click…

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Dissecting The Press Release For A Failed Stem Cell Trial

–Stem cell therapy supporters can’t acknowledge that it might not work. Stem cells have never been shown to have any clinical benefit in patients with heart disease. But there is mounting anecdotal evidence that they may have serious adverse effects on the reasoning and objectivity of the medical researchers, biotechnology executives and investors who get…

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End of the Road for CETP Inhibitors?

With the publication of the ACCELERATE trial in the New England Journal of Medicine the long train of bad and disappointing news for the once-promising approach of CETP inhibition remains unbroken. More than 12,000 high-risk patients were randomized in ACCELERATE to evacetrapib or placebo. In 2015 the trial was prematurely terminated for futility; the main…

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A Conversation About Heart Failure With Milton Packer And Richard Lehman

Milton Packer and Richard Lehman are both 66 years of age. Packer has been leading major heart failure clinical trials for decades. Lehman is a retired UK GP who writes a blog for the BMJ website. The two have agreed to answer questions and participate in a discussion about their different ideas and perspectives about…

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Study Fuels Debate Over When to Start Cholesterol Screening

–For younger adults, study finds low yield of 10-year risk-based screening A new study provides ammunition to supporters of a conservative approach to initiating cholesterol tests in younger adults. But proponents of a more aggressive approach argue that the interpretation does not take into account the enormous burden of cardiovascular disease as people grow older….

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Recent Blow Ups Spark Call For Overhaul Of Clinical Trials

[Updated] –Trial leaders say they need to get down into the weeds of trial details. Large international trials are under fire. In recent weeks, as I’ve reported, serious questions have been raised about three major heart failure trials. There is no reason to believe these are the only trials about which questions will be raised…

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Another Acute Heart Failure Drug Fails In Large Clinical Trial

–In RELAX-AHF-2 serelaxin didn’t improve clinical outcomes. Yet another promising drug for acute heart failure has failed to improve long-term outcomes. In the RELAX-AHF-2 trial 6,600 patients hospitalized for acute heart failure were randomized to a 48-hour infusion of serelaxin or placebo. There was no significant difference between the two groups in either of the…

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Rigorous Study Debunks Alarms That Statins Cause Muscle Problems

(Updated, May 2, May 4) –The authors say muscle problems with statins are an example of the ‘nocebo’ effect. A new study helps debunk the widespread belief that statins cause muscle-related pain and weakness in large numbers of patients. The “nocebo effect” may be the cause of the epidemic of muscle pain among statin users,…

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As Another Trial Goes Bust Investigators Call For Major Changes In International Trials

–Why were so many ineligible patients in Eastern Europe enrolled in TRUE-AHF? A new analysis of the recent TRUE-AHF trial offers strong evidence that large numbers of patients from Eastern Europe were ineligible for the trial and should not have been enrolled. The analysis doesn’t change the main finding of the trial, but it does…

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Serious Questions Raised About Integrity Of International Trials

–TOPCAT analysis is the ‘smoking gun’ for trouble from ‘offshoring’ trials. Large international randomized controlled trials, the cornerstone of modern medicine, are in big trouble. As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries…

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Principal Investigator Defends SPRINT Against Critics

–Blood pressure experts disagree about the NIH ‘Landmark’ Trial. Since the first announcement of its preliminary results the SPRINT trial has been the focus of intense controversy. One major focus of contention revolves around the precise technique used to measure blood pressure in the trial. As in all recent large outcome trials in hypertension, blood…

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Concerns Over New Cardiac Blood Test Spark Intense Twitter Discussion

–Cardiologists fear the new high sensitivity troponin test will lead to lots of unnecessary testing. Along with many other cardiologists, Sek Kathiresan (Massachusetts General Hospital and Broad Institute) is worried that a new and improved diagnostic test will have disastrous unintended effects. Kathiresan expressed his concern on Twitter yesterday in response to my summary of a…

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Single Blood Test Rapidly Rules Out MI in Chest Pain

–New high-sensitivity troponin tests may ease perpetual ED dilemma Only a small percentage of emergency department chest pain patients turn out to have acute myocardial infarction (AMI). Now a new blood test can help identify a significant number of patients who are extremely unlikely to have AMI and who can therefore be safely discharged immediately….

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Can SPRINT Be Used To Inform Hypertension Treatment?

–The landmark trial results are not easy to apply to clinical practice. Since the first breathless announcement of its preliminary results, SPRINT trial has been viewed as a landmark trial serving to establish a more aggressive approach to blood pressure management. It is now becoming increasingly clear, however, that the application of SPRINT in the…

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Abbott Pulls Troubled Absorb Stent From European Market

(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from…

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Pendulum Swings Further Away From Vitamin D Supplements

A new randomized controlled trial offers no support for the use of increasingly popular vitamin D supplements to prevent cardiovascular disease or reduce mortality. But the trial, published in JAMA Cardiology, is also not the last word on the subject and leaves open the possibility that vitamin D may be found beneficial in the future…

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More Bad News For The Once Promising Bioresorbable Stent

(Updated) –Problems for the Absorb BVS stent just won’t disappear Bad news for the Absorb BVS stent continues to accumulate, though defenders of the device keep looking for a silver lining. When it was approved in the US last summer the novel device appeared to have a bright future, with many prominent interventional cardiologists predicting…

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Interventional Cardiologists Face Major Obstruction In Treatment Of Total Blockages

–Deep divisions over how CTO patients should be treated. In recent years ambitious interventional cardiologists have started to perform PCI on chronic total occlusions (CTOs), though these lesions have long been recognized as among the most difficult to successfully treat. Many other physicians, including some prominent interventional cardiologists, have expressed grave concerns about this expansion…

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Controversial Pharma CEO To Chair AHA Charity Ball

–The Wizard of Oz-themed ball seeks to raise $2 million on the yellow brick road. The American Heart Association’s annual Heart & Stroke Ball will be chaired by John Thero, the CEO of Amarin Corporation, the controversial pharmaceutical company. Amarin manufactures the prescription fish oil product Vascepa for which it is aggressively seeking an expanded indication…

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TV Ads Pushed Inappropriate Use of Testosterone

–Study: prescriptions spiked in direct response to blizzard of ‘Low T’ ads Television ads for testosterone products were highly successful, leading to dramatic increases in the number of men taking testosterone drugs, according to a new study published in the Journal of the American Medical Association. J. Bradley Layton (University of North Carolina, Chapel Hill)…

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Ebbinghaus Study May Help Refute Doctor Google

–No neurocognitive adverse effects linked to very low LDL levels Reaching very low LDL levels with a PCSK9 inhibitor was not associated with any increase in neurocognitive adverse events, according to the largest and most rigorous study to assess the topic to date. Small and preliminary studies have raised concerns over the possibility of the…

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FOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?

–Doctors and patients now must wrestle with a modestly effective but expensive drug. As it turns out the PCSK9 inhibitor saga ends not with a bang but a whimper. The results of the highly anticipated FOURIER trial show that the drugs work, though not as powerfully as many had hoped and expected. The question now…

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Scott Gottlieb’s Sham Ideology Rejects Clinical Trials

Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…

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For Scott Gottlieb, Business Trumps Health

Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…

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