The main goal of
hypercholesterolemia management for coronary prevention is to reduce serum
low-density lipoprotein cholesterol (
LDL-C) levels. D-003 is a mixture of high molecular weight
aliphatic acids purified from sugarcane wax, while
policosanol is a
cholesterol-lowering
drug purified from the same source, consisting in a mixture of higher aliphatic
alcohols. No previous comparative study of both drugs in humans has been reported. This randomized, double-blind study compares the efficacy and tolerability of D-003 and
policosanol (5 and 10 mg/day) in patients with type II
hypercholesterolemia. After a baseline period, 100 patients were randomized to D-003 or
policosanol both at 5 mg/day and 10 mg/day, for 8 weeks. D-003 and
policosanol 5 mg/day reduced (p < 0.0001)
LDL-C by 26.9% and 20.9%, respectively. These reductions increased with 10 mg/day (35.1% for D-003, 25.1% for
policosanol. The reductions of
LDL-C achieved with D-003 5 mg/day and 10 mg/day were greater (p < 0.05 and p < 0.001, respectively) than with
policosanol. The frequency of patients treated with D-003 (5 mg/day) reaching
LDL-C reductions > or = 15% (22/25, 88%) was greater (p < 0.01) than with
policosanol (5 mg/day) (19/25, 76%), and the same was true for D-003 10 mg/day (25/25, 100%) and
policosanol (22/25, 88%; p < 0.01). D-003 and
policosanol (5 mg/day) also lowered (p < 0.001) total
cholesterol (TC) (16.2% and 13.5%, respectively), and increased
high-density lipoprotein cholesterol (HDL-C) by 15.3% (D-003) and 6.7% (
policosanol).
At 10 mg/day, D-003 and
policosanol reduced (p < 0.001) TC (21.3% and 16.0%, respectively), while HDL-C was increased by 17.3% and 9.8%, respectively, D-003 being more effective than
policosanol. Treatments did not affect
triglycerides. Both drugs were well tolerated, with D-003 tolerated as well as
policosanol. Three patients discontinued the study, none due to adverse events (AEs). Seven patients (three from the D-003 group and four from the
policosanol group) experienced mild AEs. In conclusion, D-003 (5 and 10 mg/day) administered to patients with type II
hypercholesterolemia was more effective than
policosanol in lowering
LDL-C and TC, and in increasing HDL-C. D-003 could be useful for treating type II
hypercholesterolemia, but this subject deserves further clinical research.