A RANDOMIZED TRIAL OF THE EFFECTS OF ATORVASTATIN AND NIACIN IN PATIENTS WITH COMBINED HYPERLIPIDEMIA OR ISOLATED HYPERTRIGLYCERIDEMIA

BACKGROUND: To assess the lipid-lowering effects and safety of atorvas tatin and niacin in patients with combined hyperlipidemia or isolated hypertriglyceridemia. METHODS: We performed a randomized, open-label, parallel-design, active-controlled, study in eight centers in the Unit ed States. We enrolled 108 patients with total cholesterol (TC) of gre ater than or equal to 200 mg/dL, serum triglycerides (TG) greater than or equal to 200 and less than or equal to 800 mg/dL, and apolipoprote in B (apo B) greater than or equal to 110 mg/dL. Patients were randoml y assigned to receive atorvastatin 10 mg once daily (n = 55) or immedi ate-release niacin 1 g three times daily for 12 weeks (n = 53). Patien ts were stratified based on law-density lipoprotein cholesterol (LDL-C ): Patients with LDL-C greater than or equal to 135 mg/dL were conside red to have combined hyperlipidemia and patients with LDL-C <135 mg/dL were considered to have isolated hypertriglyceridemia. The primary ou tcome measure was percent change from baseline in LDL-C. Other lipid l evels were evaluated as secondary parameters. RESULTS: Atorvastatin re duced LDL-C 30% and TC 26% from baseline, and increased high-density l ipoprotein cholesterol (HDL-C) 4%. Total TG were reduced 17%. Niacin r educed LDL-C 2%, TC 7%, increased HDL-C 25%, and reduced total TG 29% from baseline. There was a significant difference in LDL-C reduction, the primary efficacy parameter, between the two treatment groups (P <0 .05, favoring atorvastatin), as well as a significant difference in th e improvement in HDL-C (P <0.05, favoring niacin). The effect of atorv astatin was relatively consistent between patients with combined hyper lipidemia and isolated hypertriglyceridemia, whereas there was more va riability between these strata in the niacin treatment group. Atorvast atin was better tolerated than niacin. CONCLUSION: Atorvastatin may al low patients with combined hyperlipidemia to be treated with monothera py and offers an efficacious and well-tolerated alternative to niacin for the treatment of patients with isolated hypertriglyceridemia. (C) 1998 by Excerpta Medica, Inc.