–But most experts say their study is highly flawed Once again, a group of cholesterol skeptics has published an inflammatory attack on the cholesterol hypothesis. But critics say that the paper is deeply flawed and should not be used to influence treatment or policy decisions. In a paper published in BMJ Open, Uffe Ravnskov, MD,…
Clinical Trial Expert’s Deep Dive Into The Important New Liraglutide Trial
June 13, 2016 by Leave a Comment
–Sanjay Kaul plunges into the LEADER data pool There will be a lot of discussion in the near future about the LEADER trial, the large new trial assessing cardiovascular outcomes with liraglutide (Victoza, Novo Nordisk). The trial is the latest in a series of large CVOTs with new diabetes drugs showing benefit— or at least…
First PCSK9 Outcome Trial Results Pushed Back To 2017
June 8, 2016 by Leave a Comment
Uptake of the new drugs likely to lag without strong outcomes data. Uptake of the new drugs likely to lag without strong outcomes data.Uptake of the new drugs likely to lag without strong outcomes data. (Updated) –Uptake of the new drugs likely to lag without strong outcomes data. There’s probably nothing more eagerly awaited in…
FDA Proposes Voluntary Sodium Cuts by Food Industry
June 1, 2016 by Leave a Comment
–AMA, AHA, ACC, etc voice support, but not everyone agrees. After decades of discussion and inaction, the FDA today took a first concrete step toward reducing sodium levels in the general population: It issued draft guidance for voluntary sodium reduction targets for the food industry. The FDA said that the new recommendations come from “leading…
Women with Migraine Face Increased CV Risk
May 31, 2016 by Leave a Comment
–But clinical implications are unclear since there’s no known mechanism Women who have migraine headaches have a significantly increased risk of cardiovascular disease, according to new results from a large observational study published in the BMJ. Earlier studies have established a strong link between migraine and stroke, which the the new study now extends to…
New Anticoagulant May Cut VTE In Medically Ill
May 27, 2016 by Leave a Comment
–Generally positive results for Portola’s betrixaban, despite missed key endpoint Betrixaban may yet become the first new oral anticoagulant to gain approval for extended venous thromboembolism (VTE) prophylaxis in the important and underserved group of medically-ill patients, even though its pivotal trial was damaged by a self-inflicted statistical wound. There were consistent differences in favor of…
The American Heart Association’s Strong Stance Against Science
May 25, 2016 by 8 Comments
Once again the American Heart Association has taken a strong stance against science. Of course, that’s not how the AHA phrases it. In its own words the AHA says it “strongly refutes the findings” of a “flawed study” which “you shouldn’t use… to inform yourself about how you’re going to eat.” But in fact the…
Flu Vaccine May Benefit Heart Failure Patients
May 24, 2016 by Leave a Comment
–Studies find fewer hospitalizations and less dementia after vaccination Two new observational studies offer new evidence that heart failure patients may benefit from the flu vaccine. The studies were presented in Florence, Italy, at the Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure. In the first study Kazem Rahimi (University of…
Study Suggests Salt Restriction Only Beneficial In People With Hypertension
May 22, 2016 by 3 Comments
–More questions raised about broad efforts to restrict salt; AHA condemns study A large new analysis offers more evidence that broad salt restriction doesn’t benefit most people and may even harm some people. The study did find that salt restriction may be beneficial to the minority of people with high blood pressure who also consume…
ASGR1 Gene Tied to Heart Health
May 18, 2016 by 1 Comment
(Updated) –May have stronger impact than PCSK9 variants on disease risk A large new study from Iceland has identified variants in a gene that appear to have powerful cardioprotective effects, perhaps an first early step toward a novel therapy for heart disease prevention and treatment. The gene, ASGR1, was identified by the well known genetic…
You Say Potato, I Say Worthless Epidemiology
May 17, 2016 by 3 Comments
(Updated) –Observational study links potatoes to high blood pressure Depending on your position in the dietary wars, potatoes are now either a newly-confirmed nutritional villain or an innocent victim of overzealous and misapplied epidemiology. A new study, published in The BMJ, is the first to establish a direct link between potato consumption and blood pressure….
Noted Skeptic Calls For More Randomized Nutrition Trials
May 10, 2016 by 2 Comments
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…
Pioneering Lipoprotein Researcher Richard Havel Dead
May 6, 2016 by Leave a Comment
–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…
Experts Foresee Major Role For Generic Crestor
May 2, 2016 by Leave a Comment
— 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…
No Evidence To Support Screening Young Athletes
April 20, 2016 by Leave a Comment
–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…
New Company Bets Hundreds Of Millions Of Dollars On A Genetic Strategy To Resurrect A CETP Inhibitor
April 20, 2016 by 2 Comments
–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…
FDA Ends Niacin and Fenofibric Acid Combinations With Statins
April 17, 2016 by 4 Comments
–“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…
Orexigen Terminates Another Cardiovascular Outcomes Trial
April 13, 2016 by Leave a Comment
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…
New Analysis Of Old Study Delivers Another Blow To Traditional Diet Advice
April 13, 2016 by 2 Comments
–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…
USPSTF Updates Aspirin for Primary Prevention Recommendation
April 11, 2016 by 1 Comment
–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…
FDA Expands Metformin Label
April 10, 2016 by Leave a Comment
— 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…
FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels
April 6, 2016 by Leave a Comment
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…
Not So Rare, FH Is Truly Risky Lipid Disorder
April 3, 2016 by Leave a Comment
–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…
ACCELERATE Puts the Brake on CETP Inhibition
April 3, 2016 by Leave a Comment
–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…
How Does HOPE-3 Change Thinking About Primary Prevention?
April 2, 2016 by 5 Comments
–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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