Mirkin A, Mas R, Martinto M, Boccanera R, Robertis A, Poudes R, Fuster A, Lastreto E, Yañez M, Irico G, McCook B, Farré A
Eva Perón Hospital, Rosario, Argentina.
Int J Clin Pharmacol Res. 2001;21(1):31-41.
This randomized, double-blind, multicenter placebo-controlled study was conducted to investigate the efficacy and tolerability of policosanol, a cholesterol-lowering drug purified from sugar cane wax, in women who had experienced menopause and showed elevated serum total cholesterol and low density lipoprotein (LDL)-cholesterol levels despite a 6-week standard lipid-lowering diet. Thus, 56 eligible patients were randomized to receive placebo or policosanol 5 mg/day for 8 weeks and the dose was doubled to 10 mg/day during the next 8 weeks. Policosanol (5 and 10 mg/day) significantly decreased LDL-cholesterol (17.3% and 26.7%, respectively), total cholesterol (12.9% and 19.5%) as well as the ratios of LDL-cholesterol to high-density lipoprotein (HDL)-cholesterol (17.2% and 26.5%) and total cholesterol to HDL-cholesterol (16.3% and 21.0%) compared with baseline and placebo. HDL-cholesterol levels were significantly raised by 7.4% at study completion. No significant changes occurred in the lipid profile of the placebo group. The drug was safe and well tolerated. No drug-related adverse effects were observed. None of the patients administered policosanol but three of those administered placebo withdrew from the trial because of adverse effects: one due to a serious hypertensive status, one because of an allergic reaction (pruritus plus skin rash) and one due to gastrointestinal disturbances (nauseas plus vomiting). Eleven placebo patients reported 24 adverse effects compared with six policosanol patients who reported seven adverse effects (p < 0.05). In addition, five placebo (17.9%) and 13 policosanol patients (46.4%) (p < 0.05) reported improvements in habitual symptoms and health perception during the study. In conclusion, policosanol was effective and well tolerated in hypercholesterolemic postmenopausal women, showing additional benefits in the health perception of the study patients.
本随机、双盲、多中心、安慰剂对照研究旨在调查从甘蔗蜡中提纯的降胆固醇药物多廿烷醇对绝经后女性的疗效和耐受性。这些女性尽管接受了为期6周的标准降脂饮食，但血清总胆固醇和低密度脂蛋白（LDL）胆固醇水平仍升高。因此，56名符合条件的患者被随机分为两组，分别接受安慰剂或5毫克/天的多廿烷醇治疗，为期8周，接下来的8周剂量加倍至10毫克/天。与基线和安慰剂相比，多廿烷醇（5毫克/天和10毫克/天）显著降低了LDL胆固醇（分别降低17.3%和26.7%）、总胆固醇（分别降低12.9%和19.5%）以及LDL胆固醇与高密度脂蛋白（HDL）胆固醇的比值（分别降低17.2%和26.5%）和总胆固醇与HDL胆固醇的比值（分别降低16.3%和21.0%）。研究结束时，HDL胆固醇水平显著升高了7.4%。安慰剂组的血脂谱无显著变化。该药物安全且耐受性良好。未观察到与药物相关的不良反应。接受多廿烷醇治疗的患者中无人因不良反应退出试验，但接受安慰剂治疗的患者中有3人因不良反应退出：1人因严重高血压状态，1人因过敏反应（瘙痒加皮疹），1人因胃肠道不适（恶心加呕吐）。11名接受安慰剂治疗的患者报告了24例不良反应，而6名接受多廿烷醇治疗的患者报告了7例不良反应（p<0.05）。此外，5名接受安慰剂治疗的患者（17.9%）和13名接受多廿烷醇治疗的患者（46.4%）（p<0.05）报告在研究期间习惯性症状和健康感知有所改善。总之，多廿烷醇对高胆固醇血症绝经后女性有效且耐受性良好，在研究患者的健康感知方面显示出额外益处。
