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首页> 外文期刊>Current therapeutic research, clinical and experimental. >A randomized, double-blind, placebo-controlled study of the efficacy and tolerability of policosanol in adolescents with type II hypercholesterolemia
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A randomized, double-blind, placebo-controlled study of the efficacy and tolerability of policosanol in adolescents with type II hypercholesterolemia

机译：一项随机，双盲，安慰剂对照的研究，研究了多考二十醇在II型高胆固醇血症青少年中的疗效和耐受性

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Background: Atherosclerosis begins in childhood and is influenced by risk factors for coronary heart disease (CHD), of which hypercholesterolemia is crucial. The rationale for treating hypercholesterolemia in childhood is to limit atherosclerosis development, for which adherence to a cholesterol-lowering diet is the first-choice therapy. Nevertheless, pharmacological intervention with bile acid-binding resins may be prescribed for patients older than 10 years, mainly those with family history of CHD, multiple risk factors, and/or severe hypercholesterolemia. Resins are effective and tolerable in this population, but their clinical use has been limited because of poor compliance due to unpalatability; other effective cholesterol-lowering drugs have not been recommended in this population because of the potential impact of drug-related adverse effects such as increases in transaminases, myopathies, and gastrointestinal disturbances. Thus, the need for safer, easy-to-take, and effective cholesterol-lowering agents for this population continues. Policosanol is a mixture of higher primary aliphatic alcohols purified from sugar cane wax with cholesterol-lowering effects proven in patients with type II hypercholesterolemia and dyslipidemia due to type 2 diabetes mellitus. Policosanol shows good safety and tolerability profiles, with no evidence of drug-related adverse events (AEs) to date. This background supports the idea that policosanol could be a good candidate for treating hypercholesterolemia in children and adolescents, but it requires clinical demonstration. Objective: This 12-week study was undertaken to investigate the cholesterol-lowering effects and tolerability of policosanol in hypercholesterolemic patients aged 11 to 19 years. Methods: In this randomized, double-blind, placebo-controlled study, after 4 weeks of dietary stabilization, adolescents with type II hypercholesterolemia were randomly assigned (1:1 ratio) to receive placebo or policosanol 5-mg tablets once daily for 12 weeks. Physical examinations were performed, and lipid profiles and blood samples were obtained at baseline and after 6 and 12 weeks of therapy. The treatment was considered effective if mean reductions of low-density lipoprotein cholesterol (LDL-C) were >15%. In addition, the percentages of patients reaching final values of LDL-C <3.4 mmol/L and optimal values of <2.8 mmol/L were also evaluated. The doses were doubled if LDL-C values were < greater-than-or-equal-to >3.4 mmol/L after 6 weeks of therapy. The incidence of AEs and compliance with study medications were also evaluated after 6 and 12 weeks of treatment. Results: Fifty-five patients were enrolled in the study (28 policosanol, 27 placebo). Twenty-three patients (17 placebo, 6 policosanol) required dose titration at 6 weeks. After 12 weeks of therapy, policosanol significantly decreased LDL-C with respect to baseline and placebo (both P < 0.001), showing a mean reduction of 32.6%. Total cholesterol (TC) and TC/high-density lipoprotein cholesterol (HDL-C) and LDL-C/HDL-C ratios were reduced by 21.9%, 27.8%, and 37.2%, respectively, in the policosanol group (P < 0.001, compared with baseline and placebo). HDL-C rose 10.1% (P < 0.001), compared with baseline and placebo. Triglycerides were unaffected by policosanol. LDL-C, TC, and both atherogenic ratios were reduced significantly in the policosanol group (P < 0.001), and significant increases in HDL-C values were observed at the 6-week interim checkup (P < 0.001 vs baseline, P < 0.01 vs placebo). Twenty-five (89.3%) of 28 patients in the policosanol group showed LDL-C reductions >15% compared with 2 (7.4%) of 27 patients in the placebo group (P < 0.001). In addition, 26 (92.8%) of 28 policosanol patients reached LDL-C values <3.4 mmol/L compared with 4 (14.8%) of 27 patients in the placebo group (P < 0.001). Likewise, the response rate for achievement of optimal values (LDL-C <2.8 mmol/L) was also larger in the policosanol group (20/28; 71
机译：背景：动脉粥样硬化始于儿童期，并受冠心病（CHD）危险因素的影响，其中高胆固醇血症至关重要。治疗儿童高胆固醇血症的基本原理是限制动脉粥样硬化的发展，为此，坚持降低胆固醇的饮食是首选疗法。但是，对于年龄超过10岁的患者，主要是有冠心病家族史，多种危险因素和/或严重高胆固醇血症的患者，可以开具胆汁酸结合树脂的药理干预措施。树脂在该人群中是有效且可耐受的，但由于难食性导致依从性差，因此其临床用途受到限制;在该人群中，未推荐使用其他有效的降低胆固醇的药物，因为与药物相关的不良反应有潜在的影响，例如转氨酶升高，肌病和胃肠道疾病。因此，对该人群仍需要更安全，易于服用和有效的降胆固醇药。 Policosanol是从甘蔗蜡中纯化的高级伯脂肪族醇的混合物，具有降低胆固醇的作用，已在II型高胆固醇血症和2型糖尿病导致的血脂异常患者中得到证明。泊可索醇显示出良好的安全性和耐受性，迄今尚无药物相关不良事件（AE）的证据。这种背景支持这样的观点，即波多固醇可以是治疗儿童和青少年高胆固醇血症的良好候选者，但需要临床证明。目的：这项为期12周的研究旨在调查11至19岁高胆固醇血症患者的降胆固醇作用和波多固醇的耐受性。方法：在这项随机，双盲，安慰剂对照的研究中，稳定饮食4周后，将II型高胆固醇血症的青少年随机分配（以1：1的比例）以接受安慰剂或5毫克多考可醇的片剂，每天一次，持续12周。进行了身体检查，并在治疗基线和治疗6周和12周后获得了血脂和血样。如果低密度脂蛋白胆固醇（LDL-C）的平均减少幅度> 15％，则认为该治疗有效。此外，还评估了达到LDL-C最终值<3.4 mmol / L和最佳值<2.8 mmol / L的患者百分比。如果治疗6周后LDL-C值<大于等于3.4 mmol / L，剂量应加倍。治疗6周和12周后，还评估了AE的发生率和对研究药物的依从性。结果：55名患者入选了该研究（28 policosanol，27安慰剂）。 23例患者（17例安慰剂，6例二十二醇）在6周时需要剂量滴定。治疗12周后，波多固醇相对于基线和安慰剂显着降低LDL-C（均P <0.001），显示平均降低32.6％。二十烷醇组的总胆固醇（TC）和TC /高密度脂蛋白胆固醇（HDL-C）和LDL-C / HDL-C比率分别降低了21.9％，27.8％和37.2％（P <0.001 ，与基线和安慰剂相比）。与基线和安慰剂相比，HDL-C上升了10.1％（P <0.001）。甘油三酸酯不受policosanol的影响。波多固醇组的LDL-C，TC和两个动脉粥样硬化发生率均显着降低（P <0.001），并且在6周的中期检查中观察到HDL-C值显着增加（P <0.001 vs基线，P <0.01与安慰剂）。二十烷醇组的28名患者中有25名（89.3％）表现出LDL-C降低> 15％，而安慰剂组的27名患者中有2名（7.4％）（P <0.001）。此外，在28名波多固醇患者中，有26名（92.8％）的LDL-C值<3.4 mmol / L，而在安慰剂组中，这27名患者中有4名（14.8％）（P <0.001）。同样，在多二十烷醇组中，达到最佳值（LDL-C <2.8 mmol / L）的响应率也更大（20/28; 71）。

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