Slouching Toward Phase 3: Progress Report On New Cholesterol Drugs At The AHA

The American Heart Association meeting in Dallas this year brought new phase 2 data about several promising new cholesterol drugs. But before jumping on any bandwagons it would be good to remember that even for the drugs most far along in development we still haven’t seen any phase 3 data. In addition, it bears repeating that the…

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The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT

Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi),…

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After Long Wait, Updated US Cardiovascular Guidelines Now Emphasize Risk Instead Of Targets

Original illustration by Max Husten

Updated cardiovascular health guidelines were released today by  the American Heart Association (AHA) and the American College of Cardiology (ACC). The guidelines are designed to provide primary care physicians with evidence-based expert guidance on cholesterol, obesity, risk assessment, and healthy lifestyle. The new guidelines reinforce many of the same messages from previous guidelines, but also…

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Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa

On Wednesday an FDA advisory  panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions…

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News From Our ‘Statin Civilization’: High-Dose Statins Found To Reduce Gum Disease Inflammation

In addition to their well-known benefits in heart disease, high-dose statins appear to reduce gum inflammation caused by periodontal disease, a new report published in the Journal of the American College of Cardiology shows. The findings offer more evidence that heart disease and gum disease may be linked, and also help support the view that statins achieve at least…

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Small Study Suggests Statins May Blunt Benefits Of Exercise

A small study is raising big questions about whether statins may blunt the beneficial effects of exercise. The study has been published online in the Journal of the American College of Cardiology and was the subject of a New York Times blog today. … The authors concluded: “Given the strong independent cardio-protective effects of increasing cardiorespiratory fitness or lowering LDL, the benefits…

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FDA Approves Combination Of Ezetimibe And Atorvastatin

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…

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Unconventional Analysis Finds Threshold For LDL Reduction With Statins

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…

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HPS2-THRIVE: A ‘Disappointing But Clear’ Result

The results of HPS2-THRIVE were “disappointing but clear,”  said Jane Armitage, who presented the results this morning at the ACC in San Francisco. HPS2-THRIVE randomized 25,673 high-risk patients who could tolerate niacin to either placebo or extended-release niacin plus laropiprant (Tredaptive, Merck), an anti-flushing agent, in addition to background therapy. The primary endpoint was the time to…

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Study Casts Doubt On Value Of Genetic Testing For Familial Hypercholesterolemia

A new study published online in the Lancet suggests that one of the main screening plans that relies on genetic tests will fail to identify a substantial portion of people with familial hypercholesterolemia. Investigators from the UK and Belgium analyzed DNA from several cohorts of FH and non-FH patients. Their chief finding was that a large percentage…

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