Castaño G, Fernández L, Mas R, Illnait J, Fernández J, Mesa M, Alvarez E, Lezcay M
Medical and Surgical Research Center, National Center for Scientific Research, Havana, Cuba.
Int J Clin Pharmacol Res. 2002;22(2):55-66.
This randomized, double-blind study was undertaken to compare the efficacy and tolerability of policosanol and Octa-60 in patients with type II hypercholesterolemia. After 4 weeks on a diet, 110 patients were randomized to policosanol or Octa-60 5 mg tablets once a day for 5 weeks. The dose was then doubled to 10 mg/day for the next 5 weeks. Policosanol 5 and 10 mg/day significantly lowered low-density lipoprotein-cholesterol (LDL-C) (p<0.0001 and p<0.00001), the main efficacy variable, by 18.6% and 30.2%, while Octa-60 significantly reduced (p<0.05) LDL-C by 10.0% at study completion only. The frequency of policosanol patients reaching reductions of LDL-C > or = 15% after 5 mg/day (37/55; 67.3%) and 10 mg/day (47/55; 88.7%) was greater (p<0.01 and p<0.01) than in the Octa-60 group, which was 5/55 (9.1%) and 20/55 (36.4%). Likewise, the frequency of patients reaching LDL-C values of <3.4 mmol/l at study completion was greater (p<0.001) in the policosanol group (39/55, 70.9%) than in the Octa-60 group (6/55, 10.9%). Policosanol 5 and 10 mg/day significantly lowered (p<0.00001) total cholesterol (TC) (13.4% and 20.4%), LDL-C/high-density lipoprotein-cholesterol (HDL-C) (22.1% and 37.0%) and TC/HDL-C (17.2% and 28.2%). Octa-60 at 10 mg/day lowered (p<0.05) TC (8.7%), LDL-C/HDL-C (12.6%) and TC/HDL-C (9.4%). HDL-C was increased (p<0.001 and 0.0001) by policosanol 5 and 10 mg/day (5.6% and 12.5%) but was unchanged by Octa-60. In both groups, triglycerides remained unchanged. Both treatments were safe and well tolerated. Octa-60, but not policosanol, significantly increased glucose and alanine aminotransferase, but individual values were within the normal range. Four patients (two from each group) discontinued the trial, but only one (in the Octa-60 group) did so because of an adverse event (AE) (skin rash). Overall, three patients (all from the Octa-60 group) reported AEs. In conclusion, original policosanol at 5 and 10 mg/day, but not Octa 60, was effective in patients with type II hypercholesterolemia. Thus, policosanol reached the efficacy criterion for LDL-C reduction in both steps, while Octa-60 failed to reach this goal. In addition, policosanol was better tolerated than Octa-60.
本随机双盲研究旨在比较聚多卡醇与辛伐他汀在II型高胆固醇血症患者中的疗效和耐受性。经过4周饮食控制后，110例患者被随机分为两组，分别每日服用一次聚多卡醇或5毫克辛伐他汀片，持续5周。随后的5周将剂量加倍至每日10毫克。聚多卡醇每日5毫克和10毫克显著降低了主要疗效变量低密度脂蛋白胆固醇（LDL-C）（p<0.0001和p<0.00001），降幅分别为18.6%和30.2%，而辛伐他汀仅在研究结束时显著降低（p<0.05）LDL-C，降幅为10.0%。每日服用5毫克（37/55；67.3%）和10毫克（47/55；88.7%）聚多卡醇的患者使LDL-C降低≥15%的频率高于辛伐他汀组，后者分别为5/55（9.1%）和20/55（36.4%）（p<0.01和p<0.01）。同样，研究结束时LDL-C值<3.4 mmol/l的患者频率在聚多卡醇组（39/55，70.9%）高于辛伐他汀组（6/55，10.9%）（p<0.001）。聚多卡醇每日5毫克和10毫克显著降低（p<0.00001）总胆固醇（TC）（13.4%和20.4%）、LDL-C/高密度脂蛋白胆固醇（HDL-C）（22.1%和37.0%）以及TC/HDL-C（17.2%和28.2%）。辛伐他汀每日10毫克降低（p<0.05）TC（8.7%）、LDL-C/HDL-C（12.6%）以及TC/HDL-C（9.4%）。聚多卡醇每日5毫克和10毫克使HDL-C升高（p<0.001和0.0001）（5.6%和12.5%），而辛伐他汀对HDL-C无影响。两组的甘油三酯均无变化。两种治疗均安全且耐受性良好。辛伐他汀，但聚多卡醇未，显著升高血糖和丙氨酸转氨酶，但个体值均在正常范围内。4例患者（每组2例）中断试验，但仅1例（辛伐他汀组）因不良事件（皮疹）中断。总体而言，3例患者（均来自辛伐他汀组）报告了不良事件。总之，每日5毫克和10毫克的原研聚多卡醇对II型高胆固醇血症患者有效，而辛伐他汀无效。因此，聚多卡醇在两个阶段均达到了降低LDL-C的疗效标准，而辛伐他汀未达到该目标。此外，聚多卡醇的耐受性优于辛伐他汀。
