EFFECTS OF SUCCESSIVE DOSE INCREASES OF POLICOSANOL ON THE LIPID PROFILE OF PATIENTS WITH TYPE-II HYPERCHOLESTEROLEMIA AND TOLERABILITY TO TREATMENT

This randomized, double-blind, placebo-controlled study was conducted in 22 patients with type II primary hypercholesterolaemia to investiga te the efficacy, safety and tolerability of two successive dose increa ses of policosanol. Patients with elevated serum low-density-lipoprote in cholesterol (LDL-C) and total cholesterol after a diet-only period received randomly, under double-blind conditions, placebo or policosan ol at 5 mg once-a-day for 8 weeks. After this period, dosage was doubl ed to 5 mg twice-a-day for the next 8 weeks and then again doubled to 10 mg twice-a-day. It was found that the LDL-C was reduced significant ly by 11.3%, 21.9% and 31.2%, while total cholesterol was also reduced significantly by 8%, 14.1% and 23% respectively in these three period s. Serum high-density-lipoprotein cholesterol (HDL-C) was increased by 7.8%, 7.2% and 8.7%, respectively, while in the placebo group a downw ard shirt was observed. The LDL-C to HDL-C ratio was reduced significa ntly by 15.3%, 25.6% and 34.6%, while the total cholesterol to HDL-C r atio was also reduced significantly by 12.5%, 18.4% and 27.1%, respect ively. Triglycerides and VLDL-C values did not change significantly. T he reduction LDL-C, total cholesterol, LDL-C to HDL-C, and total chole sterol to HDL-C ratios showed a dependence on the successive dose incr eases. Policosanol was very well tolerated. No patient discontinued th e trial. No disturbances of clinical or blood biochemistry variables a ttributable to treatment were observed. Adverse effects reported were mild and transient, and no significant differences between groups were found.