Pons P, Rodríguez M, Robaina C, Illnait J, Más R, Fernández L, Fernández J C
Plaza Polyclinical Centre, Havana, Cuba.
Int J Clin Pharmacol Res. 1994;14(1):27-33.
This randomized, double-blind, placebo-controlled study was conducted in 22 patients with type II primary hypercholesterolaemia to investigate the efficacy, safety and tolerability of two successive dose increases of policosanol. Patients with elevated serum low-density-lipoprotein cholesterol (LDL-C) and total cholesterol after a diet-only period received randomly, under double-blind conditions, placebo or policosanol at 5 mg once-a-day for 8 weeks. After this period, dosage was doubled 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 significantly 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 periods. Serum high-density-lipoprotein cholesterol (HDL-C) was increased by 7.8%, 7.2% and 8.7%, respectively, while in the placebo group a downward shift was observed. The LDL-C to HDL-C ratio was reduced significantly by 15.3%, 25.6% and 34.6%, while the total cholesterol to HDL-C ratio was also reduced significantly by 12.5%, 18.4% and 27.1%, respectively. Triglycerides and VLDL-C values did not change significantly. The reduction of LDL-C, total cholesterol, LDL-C to HDL-C, and total cholesterol to HDL-C ratios showed a dependence on the successive dose increases. Policosanol was very well tolerated. No patient discontinued the trial. No disturbances of clinical or blood biochemistry variables attributable to treatment were observed. Adverse effects reported were mild and transient, and no significant differences between groups were found.
这项随机、双盲、安慰剂对照研究纳入了22例II型原发性高胆固醇血症患者，旨在研究连续两次增加多廿烷醇剂量后的疗效、安全性和耐受性。在仅接受饮食干预一段时间后，血清低密度脂蛋白胆固醇（LDL-C）和总胆固醇升高的患者在双盲条件下随机接受安慰剂或5mg多廿烷醇，每日一次，持续8周。在此期间后，剂量在接下来的8周内加倍至每日两次，每次5mg，然后再次加倍至每日两次，每次10mg。结果发现，在这三个阶段中，LDL-C分别显著降低了11.3%、21.9%和31.2%，而总胆固醇也分别显著降低了8%、14.1%和23%。血清高密度脂蛋白胆固醇（HDL-C）分别升高了7.8%、7.2%和8.7%，而安慰剂组则出现了下降趋势。LDL-C与HDL-C的比值分别显著降低了15.3%、25.6%和34.6%，总胆固醇与HDL-C的比值也分别显著降低了12.5%、18.4%和27.1%。甘油三酯和极低密度脂蛋白胆固醇（VLDL-C）值无显著变化。LDL-C、总胆固醇、LDL-C与HDL-C的比值以及总胆固醇与HDL-C的比值的降低显示出与连续增加剂量有关。多廿烷醇的耐受性非常好。没有患者退出试验。未观察到因治疗导致的临床或血液生化变量的紊乱。报告的不良反应轻微且短暂，各治疗组之间未发现显著差异。
