Recipe For Disaster: The New US Dietary Guidelines

The science of nutrition is a disaster. For a variety of very good reasons it is nearly impossible to perform high quality, long term randomized controlled trials to provide satisfactory answers to most of the pressing questions of the day. But many experts are convinced they do know the answer to many of these questions….

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Study Shows Why Sham Controls Are Necessary For Device Trials

— If we can melt the ice-caps then surely we can understand our own fallibility, says one UK cardiologist. The strongest known force in the universe is the ability of the human mind to deceive itself. If we know something to be true then we find the evidence to prove it. There is no better…

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Precision Medicine, Stuck In Second Grade, Flunks Test Of Clinical Utility

One of the great scientific achievements of the past generation has been the identification and characterization of the genetic underpinnings for many diseases. By combining genetic information with other forms of research doctors have been able to reach a much deeper understanding of many diseases. In a few cases genetic information has proved useful in screening…

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Rat Study Links Neural Tube Defects To Lower PCSK9 Levels

(Updated) PCSK9 may play an important role in neural tube development (NTD), a new study in rats suggests. The study, published in Scientific Reports, found that PCSK9 levels were significantly reduced in rat embryos with NTDs. The main focus of the paper was to identify biomarkers that could be used for the prenatal detection of NTDs, since there are now…

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Paper Raises More Questions About Salt Restriction In Heart Failure

Sodium restriction is a cornerstone of heart failure management, but many people would be surprised to learn that there is no good supporting evidence for the practice. In the 2009 heart failure guidelines sodium restriction in heart failure received a Class I recommendation (recommended), but this was based only on expert consensus (a C level of evidence of…

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Meta-Analysis Gives More Support To Aggressive Blood Pressure Treatment

A large new meta-analysis offers fresh support to the growing movement in favor of more aggressive treatment to lower high blood pressure. The findings are consistent with and extend the results of the recently reported NIH SPRINT trial, which found substantial clinical benefits for a systolic blood pressure target of 120 mm Hg instead of 140…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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Amgen Denies Rumors About PCSK9 Inhibitors (Updated)

(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports…

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FDA Panel Turns Down Expanded Indication For Ezetimibe

An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret…

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Live Blog: The FDA Advisory Panel On IMPROVE-IT

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Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe

You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the  cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to…

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PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years

Treatment with Entresto (the combination of sacubitril and valsartan, formerly known as LCZ 696) instead of an ACE inhibitor will add approximately one to two years of life for most people taking the drug, according to new estimates published in the New England Journal of Medicine. Because of the time and population limitations of clinical trials it…

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Amgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary

CVS Health announced today that Amgen’s Repatha will be the only PCSK9 inhibitor on the CVS/Caremark formulary. This gives Amgen its first big win among the pharmacy benefits managers against Sanofi’s Praluent in the battle over the market for the powerful but expensive new cholesterol-lowering drugs. Previously Express Scripts had announced that both drugs would be placed…

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Experts Question Role For At-Home Statin Intolerance Test

A small laboratory company, Boston Heart Diagnostics, has introduced and is promoting “the first and only at-home saliva laboratory developed test” that it says will help identify people who are likely to experience side effects from taking a statin. The company claims the genetic test “helps patients understand how their bodies will process a statin…

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Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…

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Merck Reveals That Its 30,000 Patient CETP Trial Will Continue

Despite rumors to the contrary the story of the CETP inhibitors isn’t quite over. Merck today announced that the REVEAL trial will continue. After a series of disappointing and often spectacular failures, REVEAL is the last remaining phase 3 trial of a CETP inhibitor still underway. REVEAL is a 30,000 patient trial studying Merck’s anacetrapib. In the announcement Merck said the…

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Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding

A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit…

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SPRINT Will Change But Not Revolutionize Blood Pressure Treatment

After all the hype and hoopla it turns out that the SPRINT trial  will in all likelihood really have a significant impact on clinical practice and future guidelines, but it also also seems clear that it will not bring about a revolution, as some have recently speculated, in the treatment of high blood pressure. That’s the broad  consensus emerging from hypertension…

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Lancet Sprints To The Front With A Blood Pressure Meta-Analysis

A new meta-analysis published in the Lancet on Friday lends fresh support to calls for more intensive blood pressure treatments. The publication comes only days before the highly anticipated presentation of the NIH’s SPRINT trial at the American Heart Association, which is also expected to offer support for stricter blood pressure control. Blood pressure goals were relaxed after the ACCORD…

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New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs

More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…

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Should Doctors Tell Patients They Are Walking Time Bombs?

Updated– Should doctors tell patients that they are walking time bombs? We all know this is a commonly used metaphor. When it comes to the heart people are often told they have a “ticking” time bomb. Here’s one recent very public example from a story about statins by Jane Brody in the New York Times: “My friend Richard…

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Studies Suggest Flu Vaccines May Be Less Effective In People Taking Statins

Two new studies published in the Journal of Infectious Diseases offer preliminary evidence that the flu vaccine may not work as well in people taking statins. But there is widespread agreement among experts that the association, much less a demonstration of cause and effect, has not been proven, and that current clinical practice should not be changed because…

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Coming Attraction: Looking Forward To SPRINT At The AHA Next Month

Back in September the NIH tantalized the medical community with a preliminary announcement of the results of a major clinical trial, SPRINT (Systolic Blood Pressure Intervention Trial). The NIH said SPRINT was a “landmark trial” that could “save lives,” but their claims were impossible to evaluate since they only gave the slightest hint of the actual results. On November…

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Amgen Requires Patients in Repatha Copay Program To Surrender Their Privacy

(This story was updated on October 23 with a statement from Amgen. It was again updated on October 27 with new information about Amgen’s patient privacy policy for a second drug, Enbrel.) (For an important followup to this story please see:  Amgen Takes The Pledge To Respect Patient Privacy) The tumult over the new cholesterol…

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New Analysis Finds Small But Significant Advantage For Low Carb Diets

A new meta-analysis finds that low-carb diets are more effective than low-fat diets in weight loss and reducing cardiovascular risk. The study finding suggests “that a low-carb diet should be the first line approach for weight management,” said the first author of the study, Jonathan Sackner-Bernstein. But the difference between the two dietary approaches was not…

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