Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029, India.
Singapore Med J. 2013 Feb;54(2):90-5. doi: 10.11622/smedj.2013031.
We aimed to assess the efficacy of fixed dose combination of atorvastatin plus ezetimibe in Indian patients with dyslipidaemia.
A double-blind study was conducted to assess the effect of fixed dose combination of ezetimibe 10 mg plus atorvastatin 10 mg on lipid profile, oxidised low-density lipoprotein (ox-LDL), high-sensitivity C-reactive protein (hsCRP) and soluble intercellular cell adhesion molecule (sICAM) in dyslipidaemic patients with or at high risk of coronary artery disease, and compare it with atorvastatin 10 mg monotherapy. 30 patients were randomised to receive ezetimibe plus atorvastatin or atorvastatin once daily for four weeks.
Of the 30 patients, 10 men and 5 women (mean age 54.3 ± 1.6 years) received ezetimibe plus atorvastatin, while 13 men and 2 women (mean age 53.7 ± 2.8 years) received only atorvastatin. The combination treatment significantly reduced total cholesterol (percentage treatment difference -14.4 ± 6.5, 95% confidence interval [CI] -1.0 to -27.7; p = 0.041) and LDL cholesterol (LDL-C; percentage treatment difference -19.9 ± 6.1, 95% CI -7.4 to -32.4; p = 0.003) compared to atorvastatin monotherapy. 13 patients on combination treament achieved the National Cholesterol Education Program target for LDL-C as compared to 9 patients on atorvastatin monotherapy (p = 0.032). Significant reductions in very low-density lipoprotein cholesterol, triglyceride, ox-LDL and sICAM were observed with combination treatment compared to atorvastatin monotherapy. However, no significant change was seen in high-density lipoprotein cholesterol or hsCRP levels between the two groups.
Combination treatment with atorvastatin and ezetimibe had relatively better lipid-lowering and anti-inflammatory efficacy than atorvastatin monotherapy.
我们旨在评估阿托伐他汀与依折麦布固定剂量复方制剂在伴有血脂异常的印度患者中的疗效。
进行了一项双盲研究，以评估依折麦布 10mg 加阿托伐他汀 10mg 固定剂量复方制剂对伴有或有冠心病高危因素的血脂异常患者的血脂谱、氧化型低密度脂蛋白（ox-LDL）、高敏 C 反应蛋白（hsCRP）和可溶性细胞间黏附分子（sICAM）的影响，并与阿托伐他汀 10mg 单药治疗进行比较。将 30 例患者随机分为每日接受依折麦布加阿托伐他汀或阿托伐他汀治疗 4 周。
30 例患者中，10 例男性和 5 例女性（平均年龄 54.3 ± 1.6 岁）接受依折麦布加阿托伐他汀治疗，而 13 例男性和 2 例女性（平均年龄 53.7 ± 2.8 岁）仅接受阿托伐他汀治疗。联合治疗显著降低总胆固醇（治疗差异百分比-14.4 ± 6.5，95%置信区间[CI] -1.0 至-27.7；p = 0.041）和 LDL 胆固醇（LDL-C；治疗差异百分比-19.9 ± 6.1，95%CI -7.4 至-32.4；p = 0.003），与阿托伐他汀单药治疗相比。联合治疗组有 13 例患者达到了国家胆固醇教育计划 LDL-C 目标，而阿托伐他汀单药治疗组有 9 例患者达到了目标（p = 0.032）。与阿托伐他汀单药治疗相比，联合治疗可显著降低极低密度脂蛋白胆固醇、甘油三酯、ox-LDL 和 sICAM。然而，两组高密度脂蛋白胆固醇或 hsCRP 水平均无显著变化。
与阿托伐他汀单药治疗相比，阿托伐他汀与依折麦布联合治疗具有更好的降脂和抗炎作用。
