Alsheikh-Ali, Alawi A. MD., et al. – Are the label warnings about increased risk of adverse events with statin and niacin combinations valid? >Summary: A comparison review of the rate of adverse event reports (AERs) received by the United States Food and Drug Administration from 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 prevalence of concomitant niacin-ER therapy in the statin-associated AERs was also calculated. Outcomes: The amount 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 used alone. The rates of liver and rhabdomyolysis AERs associated with lovastatin/niacin-ER were similar to those of the other statins or niacin-ER uses alone and lower than those associated with simvastatin alone. The incidence of niacin-ER use in statin-associated AERs was less than 1%. The findings indicate that statins can safely be used in combination as indicated in the national guidelines
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