Safety of Lovastatin/Extended Release Niacin Compared With Lovastatin Alone, Atorvastatin Alone, Pravastatin Alone, and Simvastatin Alone (from the United States Food and Drug Administration Adverse Event Reporting System)

Recent national guidelines support combination drug therapy targeting multiple lipid abnormalities. Current drug labeling warns of an increased risk of adverse events with statin and niacin combinations. These recommendations have been based solely on case reports. We compared the rates of adverse event reports (AERs) received by the United States Food and Drug Administration (1999 to March 2005) associated with the combination of lovastatin/niacin-extended release (ER) with those of lovastatin or niacin-ER alone, and other commonly used statins. The following AERs were considered: events that were fatal, life-threatening, or resulted in hospitalization (serious AERs), hepatotoxicity (liver AERs), and rhabdomyolysis (rhabdomyolysis AERs). We also calculated the prevalence of concomitant niacin-ER therapy in statin-associated AERs. The rate of serious AERs associated with the combination lovastatin/niacin-ER was similar to that of lovastatin or niacin-ER alone, and significantly less than that of atorvastatin or simvastatin. Likewise, the rates of liver and rhabdomyolysis AERs associated with lovastatin/niacin-ER were similar to those of the other statins or niacin-ER alone and lower than those of simvastatin-associated rhabdomyolysis reports (p <0.01). Concomitant niacin-ER use in statin-associated AERs was rare (≤1%). In conclusion, these findings do not support a clinically significant adverse drug interaction between niacin-ER and statins and should encourage the safe use of this combination in appropriate high-risk patients, as recommended by the national guidelines.