Comparison of the efficacy, safety and tolerability of policosanol versus fluvastatin in elderly hypercholesterolaemic women

Objective: To compare the efficacy and tolerability of policosanol with that of fluvastatin in older hypercholesterolaemic women. Design and Setting: Randomised, single-blind, parallel-group study performed at a single centre in Cuba. Patients and Participants: 70 women aged 60 to 80 years with type II hypercholesterolaemia. Methods: Patients were randomised after 4 weeks' dietary stabilisation on a step-one cholesterol-lowering diet to treatment with policosanol (10mg) or fluvastatin (20mg) tablets once daily for 8 weeks. Results: Policosanol significantly lowered low density lipoprotein cholesterol (LDL-C) [29.2%, p < 0.001], total cholesterol (TC) [19.3%, p <0.001], triglycerides (7%, p < 0.05) and the ratios of LDL-C (39.8%, p < 0.001) and TC (31.6%, p < 0.001) to high density lipoprotein cholesterol (HDL-C), and significantly increased HDL-C (19.8%, p < 0.001). Fluvastatin significantly lowered LDL-C (22.9%, p < 0.001), TC (16.7%, p < 0.001), triglycerides (8.2%, p < 0.05), LDL-C/HDL-C (28.4%, p < 0.001) and TC/HDL-C (22.8%, p < 0.001), and significantly increased HDL-C (9.2%, p < 0.001). Policosanol was more effective than fluvastatin in reducing LDL-C (p < 0.01), TC/HDL-C (p < 0.01) and LDLC/HDL-C (p < 0.001) as well as in increasing HDL-C (p < 0.01). Policosanol, but not fluvastatin, significantly increased lag time for LDL lipid peroxidation (36.5%, p < 0.001) and significantly decreased the diene peroxidation rate (15.5%, p < 0.05). Both treatments were well tolerated. Five fluvastatin, but no policosanol, recipients discontinued the study, three because of adverse events (chest pain and gastric discomfort, skin rash, and dizziness). Overall, three policosanol and five fluvastatin recipients reported adverse events during the study. Conclusions: The cholesterol-lowering effects of policosanol 10 mg/day administered for 8 weeks to older women with type II hypercholesterolaemia were slightly better than those of fluvastatin 20 mg/day with respect to the extent of the changes in LDL-C, atherogenic indices and HDL-C levels. In addition, policosanol, but not fluvastatin, significantly inhibited the susceptibility of LDL to undergo lipid peroxidation in this particular study population, Nevertheless, further studies in larger populations and with higher dosages must be conducted to corroborate the present results.