Richard B. Johnson, Jr., MD

Internal Medicine
Kerrville, TX 830 315-5599

FDA on Niacin and Fibrates with Statins

FDA on Niacin and Fibrates with Statins

This week (April 2016) there was new information about the use of niacin with statins and the use of fibrates with statins.

Statins, Niacin, Fibrate

The FDA has withdrawn its approval for the use of statins with either niacin or fenofibric acid, because there is no evidence for any meaningful benefit for the addition of niacin or fenofibric acid to statins.

This is based on the collective evidence from the following outcome trials:



This trial randomized 5518 patients with diabetes mellitus and treated them with simvastatin (Zocor) and with either a placebo (nothing) or with fenofibrate (Tricor). After 4.7 years, there was no difference in the primary outcome: nonfatal heart attack, nonfatal stroke, or death from either a heart attack or stroke.


This study was designed to test whether raising HDL cholesterol (the good cholesterol) and lowering triglycerides in people with known heart and vascular disease and well controlled LDL cholesterol (the bad cholesterol) would reduce the risk of repeat heart and vascular problems. There were 3414 patients treated with simvastatin (Zocor) and either a placebo or niacin (Niaspan 2000 mg daily).

The trial was stopped early after 32 months. There was no difference in cardiac disease, however, there was an increase in the number of strokes (0.7% with placebo and 1.6% with niacin).


In this study there was 25,673 patients with known vascular disease who were treated either with a placebo or with niacin (2000 mg daily) and laropiprant (a drug used in combination with niacin to reduce blood cholesterol). All were treated with a statin. After 3.9 years, the treated group did have a lower LDL cholesterol and a higher HDL cholesterol, but had no difference in major vascular events (13.2% and 13.7%)

Therefore, based on these three studies, the FDA does not indorse the use of either fibrates or niacin with a statin.

Niacin does lower triglycerides and LDL cholesterol while raising HDL cholesterol. Likewise the fibrates also causes these changes in the cholesterol profile. It has been expected that this change in cholesterol would be beneficial. However, when the outcomes of heart attacks and or stroke are measured, there is no benefit in adding either class of medication to a statin.

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