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匹伐他汀与辛伐他汀治疗高胆固醇血症患者的疗效比较:一项随机对照临床试验的荟萃分析。

Comparative efficacy of pitavastatin and simvastatin in patients with hypercholesterolemia: a meta-analysis of randomized controlled clinical trials.

作者信息

Ma Ning, Cui Lianqun

机构信息

Department of Cardiology, Shandong Provincial Hospital, Shandong University, Heze, Shandong, People's Republic of China ; Department of Cardiology, Heze Municipal Hospital, Heze, Shandong, People's Republic of China.

Department of Cardiology, Shandong Provincial Hospital, Shandong University, Heze, Shandong, People's Republic of China.

出版信息

Drug Des Devel Ther. 2015 Mar 31;9:1859-64. doi: 10.2147/DDDT.S67448. eCollection 2015.

Abstract

BACKGROUND

Simvastatin is a statin used to lower low-density lipoprotein cholesterol, but has limitations in patients on complicated regimens due to concerns about drug-drug interactions. Pitavastatin is a newly developed statin with limited drug-drug interactions. We conducted a meta-analysis to compare the clinical efficacy of simvastatin and pitavastatin in the control of hypercholesterolemia.

METHODS

Randomized clinical trials comparing the efficacy of pitavastatin and simvastatin were identified by searching PubMed (2000-2014) and EMBASE (2000-2014). The primary outcome subjected to meta-analysis was percent change in low-density lipoprotein cholesterol compared with baseline.

RESULTS

Four clinical trials were selected for meta-analysis. A total of 908 patients treated with pitavastatin (2 or 4 mg/day) and 381 patients treated with simvastatin (20 or 40 mg/day) were included in the final statistical analysis. No statistically significant difference was identified between treatment with pitavastatin 4 mg/day and treatment with simvastatin 40 mg/day for 12 weeks (mean difference -0.66; 95% confidence interval -2.92, 1.61; P=0.57). Similarly, no statistically significant difference was observed between pitavastatin 2 mg/day and simvastatin 20 mg/day for 4 weeks (mean difference -2.19; 95% confidence interval -0.11, 4.49; P=0.06). Treatment with pitavastatin was noninferior to simvastatin in all of the secondary outcomes and the safety profile was similar between the two statins.

CONCLUSION

Pitavastatin is noninferior to simvastatin in lowering low-density lipoprotein cholesterol.

摘要

背景

辛伐他汀是一种用于降低低密度脂蛋白胆固醇的他汀类药物,但由于担心药物相互作用,在接受复杂治疗方案的患者中存在局限性。匹伐他汀是一种新开发的他汀类药物,药物相互作用有限。我们进行了一项荟萃分析,以比较辛伐他汀和匹伐他汀在控制高胆固醇血症方面的临床疗效。

方法

通过检索PubMed(2000 - 2014年)和EMBASE(2000 - 2014年)确定比较匹伐他汀和辛伐他汀疗效的随机临床试验。进行荟萃分析的主要结局是与基线相比低密度脂蛋白胆固醇的变化百分比。

结果

选择四项临床试验进行荟萃分析。最终统计分析纳入了总共908例接受匹伐他汀(2或4毫克/天)治疗的患者和381例接受辛伐他汀(20或40毫克/天)治疗的患者。每天服用4毫克匹伐他汀治疗12周与每天服用40毫克辛伐他汀治疗之间未发现统计学上的显著差异(平均差异 -0.66;95%置信区间 -2.92,1.61;P = 0.57)。同样,每天服用2毫克匹伐他汀治疗4周与每天服用20毫克辛伐他汀治疗之间也未观察到统计学上的显著差异(平均差异 -2.19;95%置信区间 -0.11,4.49;P = 0.06)。在所有次要结局方面,匹伐他汀治疗不劣于辛伐他汀,并且两种他汀类药物的安全性概况相似。

结论

在降低低密度脂蛋白胆固醇方面,匹伐他汀不劣于辛伐他汀。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1123/4386788/64cc43056ca1/dddt-9-1859Fig1.jpg

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