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BACKGROUND: To assess the lipid-lowering effects and safety of atorvastatin 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 United States. We enrolled 108 patients with total cholesterol (TC) of [is greater than or equal to] 200 mg/dL, serum triglycerides (TG) [is greater than or equal to] 200 and [is less than or equal to] 800 mg/dL, and apolipoprotein B (apo B) [is greater than or equal to] 110 mg/dL. Patients were randomly assigned to receive atorvastatin 10 mg once daily (n = 55) or immediate-release niacin 1 g three times daily for 12 weeks (n = 53). Patients were stratified based on low-density lipoprotein cholesterol (LDL-C): Patients with LDL-C [is greater than or equal to] 135 mg/dL were considered to have combined hyperlipidemia and patients with LDL-C [is less than] 135 mg/dL were considered to have isolated hypertriglyceridemia. The primary outcome measure was percent change from baseline in LDL-C. Other lipid levels were evaluated as secondary parameters. RESULTS: Atorvastatin reduced LDL-C 30% and TC 26% from baseline, and increased high-density lipoprotein cholesterol (FIDL-C) 4%. Total TG were reduced 17%. Niacin reduced 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 [is less than] 0.05, favoring atorvastatin), as well as a significant difference in the improvement in HDL-C (P [is less than] 0.05, favoring niacin). The effect of atorvastatin was relatively consistent between patients with combined hyperlipidemia and isolated hypertriglyceridemia, whereas there was more variability between these strata in the niacin treatment group. Atorvastatin was better tolerated than niacin. CONCLUSION: Atorvastatin may allow patients with combined hyperlipidemia to be treated with monotherapy and offers an efficacious and well-tolerated alternative to niacin for the treatment of patients with isolated hypertriglyceridemia. Am J Med. 1998;104:137-143. [C] 1998 by Excerpta. Medica, Inc.