FDA: Drug-induced Reduction of Triglycerides and/or HDL in Statin-treated Patients No Help for CV Risk
Written by Editor   
Sunday, May 15, 2016 12:00 AM

Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for their combined use with statins to treat high cholesterol.  Based on several large cardiovascular outcome trials the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events.

"Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets and fenofibric-acid [delayed-release] capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn," a document filed in the Federal Registry states.

The same reasoning was cited for pulling its approval of Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin).


Source:  http://www.medscape.com/viewarticle/862022