Context: Policosanol is a natural substance derived from sugar cane that is advertised for its lipid-lowering effects as a nonprescription drug. More than 80 placebo-controlled or comparative trials, performed mostly by a single research institute, suggest that policosanol at doses of 5 to 40 mg/d has lipoprotein-lowering effects comparable with statins. Objectives: To determine the lipoprotein-lowering effects of Cuban sugar cane-derived policosanol and to establish, if effective, dose-dependency up to 80 mg/d in patients with hypercholesterolemia or combined hyperlipidemia. Design, Setting, and Participants: A multicenter(lipid outpatient clinics and general practitioners in Germany), randomized, double-blind, placebo-controlled, parallelgroup trial conducted from September 29, 2000, to May 10, 2001, of patients with hypercholesterolemia or combined hyperlipidemia having baseline low-density lipoprotein cholesterol(LDL-C) levels of at least 150 mg/dL(≥3.88 mmol/L) and either no or 1 cardiovascular risk factor other than known coronary heart disease, or baseline LDL-C levels of between 150 and 189 mg/dL(3.88-4.89 mmol/L) and 2 or more risk factors. Interventions: Open-label 6-week placebo and diet run-in phase followed by a double-blind 12-week treatment phase after randomization to 5 groups: 10, 20, 40, or 80 mg/d of policosanol or placebo. Main Outcome Measure: The percentage change of LDL-C, with changes in other lipoproteins as secondary outcome measures. Results: A total of 143 patients were randomized to 5 equal groups and were analyzed on an intention-to-treat basis. In none of the 5 treatment groups did LDL-C levels decrease more than 10%from baseline. No statistically significant difference between policosanol and placebo was observed. A nonparametric test analyzing dose-dependency yielded nonsignificant results. In none of the secondary outcome measures, namely total cholesterol, high-density lipoprotein cholesterol(HDL-C), very low-density lipoprotein cholesterol, triglycerides, lipoprotein(a), and ratio of total or LDL-C to HDL-C, were there any significant effects of policosanol. Policosanol was tolerated well without serious adverse events. Conclusion: In patients with hypercholesterolemia or combined hyperlipidemia, the sugar cane-derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo. Context: Policosanol is a natural substance derived from sugar cane that is advertised for its lipid-lowering effects as a nonprescription drug. More than 80 placebo-controlled or comparative trials, performed mostly by a single research institute, suggest that policosanol at doses of 5 to 40 mg / d has lipoprotein-lowering effects comparable with statins. Objectives: To determine the lipoprotein-lowering effects of Cuban sugar cane-derived policosanol and to establish, if effective, dose-dependency up to 80 mg / d in patients with hypercholesterolemia or combined hyperlipidemia. Design, Setting, and Participants: A multicenter (lipid outpatient clinics and general practitioners in Germany), randomized, double-blind, placebo-controlled, parallelgroup trial conducted from September 29, 2000, to May 10, 2001, of patients with hypercholesterolemia or combined hyperlipidemia having baseline low-density lipoprotein cholesterol (LDL-C) levels of at least 150 mg / dL (≥3.88 mmol / L) and either no or 1 cardiovascular risk factor other than known coronary heart disease, or baseline LDL-C levels between 150 and 189 mg / dL (3.88-4.89 mmol / L) and 2 or more risk factors. Interventions: Open-label 6-week placebo and diet run-in phase followed by a double-blind 12-week treatment phase after randomization to 5 groups: 10, 20, 40, or 80 mg / d of policosanol or placebo. Main Outcome Measure: The percentage change of LDL- with changes in other lipoproteins as secondary outcome measures. A total of 143 patients were randomized to 5 equal groups and were analyzed on an intention-to-treat basis. In none of the 5 treatment groups did LDL-C levels decrease more than A nonparametric test analyzing dose-dependency yielded non-quantifiable results. In none of the secondary outcome measures, to total cholesterol, high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein chPolypeptides are tolerated well without serious adverse events. Conclusion: In patients with hypercholesterolemia or combined hyperlipidemia, the sugar cane-derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo.