–“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…
New Evidence Fuels Concerns About The Safety Of Niacin
July 16, 2014 by Leave a Comment
The string of failures– for HDL therapies in general and for niacin in particular– continues unabated. The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects. ……
HPS2-THRIVE: A ‘Disappointing But Clear’ Result
March 9, 2013 by Leave a Comment
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…
HPS2-THRIVE Coming Attraction: First Look At What Went Wrong With Niacin
February 27, 2013 by Leave a Comment
In a few weeks, on March 9, the main results of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study will be presented in San Francisco at the annual meeting of the American College of Cardiology. These results have been eagerly awaited since Merck’s brief announcement in December that the trial had not met its primary endpoint…
Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program
January 22, 2013 by Leave a Comment
Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. Read my…
Merck Starts To Suspend Worldwide Availability Of Tredaptive
January 11, 2013 by Leave a Comment
In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. Click here to read the full story on Forbes….
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…
HPS2-THRIVE: No Benefit, Signal Of Harm For Niacin Therapy
December 20, 2012 by 3 Comments
The largest-ever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm. Merck announced today that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not meet its primary endpoint. In that study, the combination of a statin and Merck’s niacin compound, Tredaptive, a combination of extended-release…
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