–“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 and the removal from the market of two niacin-statin combination products.
“The FDA actions are appropriate and important,” said Steve Nissen (Cleveland Clinic). “There is no evidence for any meaningful benefit for addition of niacin or fibric acid derivatives to statins. There are also significant harms associated with these drugs. In the absence of benefits, there remain only harms. Unfortunately, these drugs continue to be prescribed to large numbers of patients. Hopefully FDA’s actions will significantly reduce inappropriate use.”
The two combination products that are being withdrawn from the market are Advicor and Simcor, which combine niacin extended-release with lovastatin and simvastatin, respectively. Both are manufactured by AbbVie. The withdrawn indications for coadminstration with statins involve Niaspan (niacin extended-release) tablets from AbbVie and its generic equivalents and Trilipix (fenofibric acid) DR, also from AbbVie, and its generic equivalents.
The FDA said that the changes were “based on the collective evidence from several large cardiovascular outcome trials,” including ACCORD, AIM-HIGH, and HPS2-THRIVE. The FDA said that “the totality of the 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.”
The FDA move signals the final stage of a dramatic reversal of fortune for lipid drugs using niacin and fibrates. The AbbVie drugs, in particular, had been enormously successful, though their use diminished as a result of the large clinical trials cited by the FDA.
”This action by the FDA seems appropriate and is consistent with the recent disappointing randomized controlled trial evidence,” said Michael Blaha (Johns Hopkins). “We might ask – why were the indications for these drugs granted in the first place? This shows how far we have come in the evaluation of lipid-lowering drugs. It is now firmly established that improvements in the simple lipid profile are not enough, and that clear evidence of benefit on clinical outcomes is needed for routine use of lipid-lowering drugs as add-on to statin therapy.”