Effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia associated with type 2 diabetes mellitus.

G Castaño, R Menéndez, R Más, A Amor, J L Fernández, R L González, M Lezcay, E Alvarez
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Abstract

In this pilot, randomized, double-blind study, we compared the effects of policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia and type 2 diabetes mellitus. After 4 weeks on a cholesterol-lowering diet, 36 patients were randomized to policosanol (10 mg/day) or lovastatin (20 mg/day) tablets o.i.d. for 8 weeks. Policosanol significantly (p < 0.001) lowered serum low-density lipoprotein-cholesterol (LDL-C) (29.9%), total cholesterol (21.1%), triglycerides (13.6%) and the LDL-C/high-density lipoprotein-cholesterol (HDL-C) (36.7%) and total cholesterol/HDL-C (28.9%) ratios and significantly (p < 0.01) increased HDL-C (12.5%). Lovastatin significantly (p < 0.001) lowered LDL-C (25%), total cholesterol (18%), triglycerides (10.9%) and the LDL-C/HDL-C (30.4%) and total cholesterol/HDL-C ratios (23.9%) and significantly (p < 0.01) raised HDL-C (8.3%). Policosanol was more effective (p < 0.05) than lovastatin in reducing both ratios and in increasing (p < 0.05) HDL-C. Policosanol, but not lovastatin, significantly raised the lag time (20.9%) of Cu+2-induced LDL peroxidation and total plasma antioxidant activity (24.2%) (p < 0.05). Both policosanol and lovastatin significantly decreased the propagation rate (41.9% and 41.6% respectively, p < 0.001), maximal diene production (8.3% and 5.7%) and plasma levels of thiobarbituric acid reactive substances (9.7% and 11.5%, p < 0.001). Both treatments were well tolerated. Only one patient in the lovastatin group withdrew from the trial due to adverse events. In conclusion, policosanol and lovastatin administered short term to patients with dyslipidemia secondary to type 2 diabetes were effective in lowering cholesterol and in inhibiting the extent of lipid peroxidation. Policosanol (10 mg/day) was slightly more effective than lovastatin (20 mg/day) in reducing the LDL-C/HDL-C and total cholesterol/HDL-C ratios, in increasing HDL-C levels and in preventing LDL oxidation. Nevertheless, since this was a pilot study, further clinical studies performed in larger sample sizes of diabetic patients are needed for definitive conclusions.

脂质甾醇和洛伐他汀对2型糖尿病合并血脂异常患者血脂及脂质过氧化的影响
在这项随机双盲试验中,我们比较了胆甾醇和洛伐他汀对血脂异常和2型糖尿病患者血脂和脂质过氧化的影响。在4周的降胆固醇饮食后,36名患者被随机分配到胆甾醇(10毫克/天)或洛伐他汀(20毫克/天)片,每次服用8周。甘草甾醇显著(p < 0.001)降低血清低密度脂蛋白-胆固醇(LDL-C)(29.9%)、总胆固醇(21.1%)、甘油三酯(13.6%)、LDL-C/高密度脂蛋白-胆固醇(HDL-C)(36.7%)和总胆固醇/HDL-C(28.9%)比值,显著(p < 0.01)升高HDL-C(12.5%)。洛伐他汀显著(p < 0.001)降低LDL-C(25%)、总胆固醇(18%)、甘油三酯(10.9%)、LDL-C/HDL-C(30.4%)、总胆固醇/HDL-C(23.9%),显著(p < 0.01)升高HDL-C(8.3%)。在降低这两个比率和升高HDL-C方面,胆甾醇比洛伐他汀更有效(p < 0.05)。甘草甾醇显著提高了Cu+2诱导LDL过氧化的滞后时间(20.9%)和血浆总抗氧化活性(24.2%)(p < 0.05),而洛伐他汀不显著提高(p < 0.05)。甘草甾醇和洛伐他汀均显著降低了繁殖率(分别为41.9%和41.6%,p < 0.001)、最大二烯产量(分别为8.3%和5.7%)和血浆硫代巴比妥酸活性物质水平(分别为9.7%和11.5%,p < 0.001)。两种治疗方法均耐受良好。洛伐他汀组中只有一名患者因不良事件退出试验。综上所述,短期给予2型糖尿病继发性血脂异常患者糖醇和洛伐他汀可有效降低胆固醇和抑制脂质过氧化程度。在降低LDL- c /HDL-C和总胆固醇/HDL-C比率、增加HDL-C水平和防止LDL氧化方面,胆甾醇(10毫克/天)比洛伐他汀(20毫克/天)略微有效。然而,由于这是一项初步研究,需要在更大的糖尿病患者样本中进行进一步的临床研究才能得出明确的结论。
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