Following last month’s surprising announcement that the National Heart, Lung, and Blood Institute would no longer issue guidelines, leaders of the American Heart Association and the American College of Cardiology have now announced that are “officially assuming the joint governance, management and public distribution” of the enormously influential cardiovascular prevention guidelines, including the much-delayed and much-anticipated hypertension and cholesterol guidelines (formerly…
Hypertension And Cholesterol Guidelines Delayed Again As NHLBI Gets Out Of The Guidelines Business
June 19, 2013 by Leave a Comment
The National Heart, Lung, and Blood Institute (NHLBI) will no longer issue guidelines, including the much-delayed and much-anticipated hypertension (JNC 8) and cholesterol (ATP IV) guidelines. Instead, the NHLBI will perform systematic evidence reviews that other organizations, including the American Heart Association and the American College of Cardiology, will use as a resource for their own guidelines….
Unconventional Analysis Finds Threshold For LDL Reduction With Statins
April 29, 2013 by Leave a Comment
Using an unconventional mathematical approach, a group of Japanese researchers say there may be no good reason to reduce LDL cholesterol more than 40 mg/dl. Their research letter has been published online in JAMA Internal Medicine. According to the authors, members of the ALICE (All-Literature Investigation of Cardiovascular Evidence) Group, most meta-analyses use linear models…
Lifelong Statin Sentence Now Includes Furloughs
April 2, 2013 by 1 Comment
Although the benefits of statins are among the best documented in all of medicine, continuous lifelong statin therapy is not always easy to achieve in clinical practice. Now a new retrospective study suggests that although clinical events causing temporary cessation of statin therapy occur often, most of these patients are later able to resume statin…
Large Meta-Analysis Finds No Harm Associated With Eggs
January 15, 2013 by 2 Comments
No food has had more ups and downs over the last century or so than the common egg. Following a long period in which eggs were ubiquitous and highly regarded, eggs fell from favor with the rise of concerns over cholesterol. Currently the American Heart Association recommends that people restrict dietary cholesterol to 300 mg…
Should Niacin Still Be Prescribed? William Boden Versus Harlan Krumholz
January 9, 2013 by 1 Comment
In the wake of HPS2-THRIVE many have argued that there is no longer any reason to prescribe niacin. William Boden, the lead investigator of AIM-HIGH and COURAGE, thinks there were enough flaws in the design of the niacin trials to justify the cautious use of niacin in certain circumstances. Says Boden: “There is evidence of…
Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path
January 3, 2013 by 1 Comment
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed…
Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin
November 29, 2012 by Leave a Comment
Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the…
Early Look: New Methods To Enhance Cholesterol Efflux
November 5, 2012 by Leave a Comment
Although clinical trials of HDL-boosting CETP inhibitors have so far failed to produce positive results, many other avenues of HDL-related research remain active. A glimpse at the very early phases of two intriguing lines of research in this area was offered on Monday at the AHA. Apo A-1 is thought to be the key HDL…
PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect Of Atorvastatin
October 31, 2012 by Leave a Comment
When added to low-dose atorvastatin a much-discussed new monoclonal antibody to PCSK9 significantly lowers cholesterol more effectively than atorvastatin alone, according to a phase 2 study published in the New England Journal of Medicine. Earlier this year, in March, the findings of three phase 1 trials demonstrating the cholesterol-lowering effects of the drug in healthy volunteers and…
FDA Panel Recommends Approval Of Mipomersen For Familial Hypercholesterolemia
October 18, 2012 by 1 Comment
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave a weak endorsement to mipomersen, an antisense oligonucleotide inhibitor manufactured by Genzyme, for use in homozygous familial hypercholesterolemia (FH). With its relatively close 9-6 vote, and with its comments, the committee expressed concerns about both the efficacy and safety of the drug, but ultimately the severity of…
FDA Reviewers Recommend Approval For Lomitapide For Homozygous Familial Hypercholesterolemia
October 17, 2012 by 2 Comments
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern that the drug might be used in lower…
FDA Review Raises Safety Concerns About Mipomersen
October 16, 2012 by 1 Comment
An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce…
FDA Reviewers Raise No New Red Flags Over Lomitapide
October 15, 2012 by 1 Comment
FDA reviewers have raised no new concerns about lomitapide ahead of a Wednesday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The FDA today released briefing documents that evaluate the new drug application (NDA) for lomitapide capsules, the microsomal triglyceride transfer protein (MTP) inhibitor from Aegerion Pharmaceuticals for use as an adjunct to a low-fat diet and…
News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD
September 7, 2012 by Leave a Comment
Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…
Survey Finds Significant Drop In Cholesterol Levels In Youths
August 7, 2012 by Leave a Comment
New data from the National Health and Nutrition Examination Survey (NHANES), published in JAMA, show significant and perhaps surprising improvements over the last 20 years in the lipid profile of youths aged 6-19 years. Among the key lipid parameters measured by the survey from 1988-1994 to 2007-2010: Total cholesterol decreased from 165 mg/dL to 160 mg/dL (p<0.001) Prevalence of elevated…
You Know Nothing, Dr. Snow: Why Medicine Can’t Be More Like Facebook
May 18, 2012 by 3 Comments
Medicine can never be like Facebook, despite what Matt Herper argues over at Forbes. Perhaps he was just trolling for hits on a day when everyone is thinking about the Facebook IPO, but Herper proposed, with apparently seriousness, that medicine needs to model itself on the tech world in order to match the kind of…
Large Metaanalysis Finds Statins Effective in Low Risk Patients
May 16, 2012 by Leave a Comment
A very large metaanalysis provides strong evidence that the relative reduction in risk of statins is at least as great in low-risk patients as in high-risk patients. The finding, write the authors, provides evidence that expansion of guidelines to lower risk populations should be considered. In their paper in the Lancet, the the Cholesterol Treatment Trialists’ (CTT)…
Promising Phase 1 Results For New Monoclonal Antibody to PCSK9
March 21, 2012 by Leave a Comment
Promising results from very early studies with an experimental new cholesterol-lowering drug, a monoclonal antibody to PCSK9, have been published in the New England Journal of Medicine. Evan Stein and colleagues report the results of two single-dose studies in which the drug, REGN727, was administered intravenously and subcutaneously to healthy subjects. In a third, randomized, placebo-controlled, dose-ranging…
After a year-long review FDA finds nothing new about vytorin
January 8, 2009 by Leave a Comment
The FDA has finally completed its review of ENHANCE that it started in January 2008. It’s finding: there was no difference in clinical outcome between the vytorin-treated and the simvastatin-treated patients in clinical outcomes, though vytorin, as expected, had greater efficacy in lowering cholesterol. The FDA advises patients that, pending the results of IMPROVE-IT, “patients…
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