PMID- 16444910 OWN - NLM STAT- MEDLINE DCOM- 20060327 LR - 20131121 IS - 0378-6501 (Print) IS - 0378-6501 (Linking) VI - 31 Suppl DP - 2005 TI - A comparison of the effects of D-003 and policosanol (5 and 10 mg/day) in patients with type II hypercholesterolemia: a randomized, double-blinded study. PG - 31-44 AB - 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. FAU - Castano, G AU - Castano G AD - Medical Surgical Research Center, Havana City, Cuba. FAU - Mas, R AU - Mas R FAU - Fernandez, L AU - Fernandez L FAU - Illnait, J AU - Illnait J FAU - Mendoza, S AU - Mendoza S FAU - Gamez, R AU - Gamez R FAU - Fernandez, J AU - Fernandez J FAU - Mesa, M AU - Mesa M LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - Switzerland TA - Drugs Exp Clin Res JT - Drugs under experimental and clinical research JID - 7802135 RN - 0 (Anticholesteremic Agents) RN - 0 (D-003 sugarcane wax acid mixture) RN - 0 (Fatty Acids) RN - 0 (Fatty Alcohols) RN - 142583-61-7 (policosanol) RN - 97C5T2UQ7J (Cholesterol) SB - IM MH - Aged MH - Anticholesteremic Agents/administration & dosage/adverse effects/*therapeutic use MH - Cholesterol/blood MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Fatty Acids/adverse effects/*therapeutic use MH - Fatty Alcohols/administration & dosage/adverse effects/*therapeutic use MH - Female MH - Humans MH - Hyperlipoproteinemia Type II/*drug therapy MH - Male MH - Middle Aged EDAT- 2006/02/01 09:00 MHDA- 2006/03/28 09:00 CRDT- 2006/02/01 09:00 PHST- 2006/02/01 09:00 [pubmed] PHST- 2006/03/28 09:00 [medline] PHST- 2006/02/01 09:00 [entrez] PST - ppublish SO - Drugs Exp Clin Res. 2005;31 Suppl:31-44.