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瑞舒伐他汀、辛伐他汀和阿托伐他汀在2型糖尿病合并血脂异常患者中的安全性和疗效比较评估。

A comparative evaluation of safety and efficacy of rosuvastatin, simvastatin, and atorvastatin in patients of type 2 diabetes mellitus with dyslipidemia.

作者信息

Adsule Samir Maruti, Baig Mirza Shiraz, Gade P R, Khandelwal P N

机构信息

Department of Pharmacology, Govt. Medical College, Aurangabad, India.

出版信息

Int J Diabetes Dev Ctries. 2009 Apr;29(2):74-9. doi: 10.4103/0973-3930.53124.

Abstract

AIM

To evaluate and compare the safety and efficacy of rosuvastatin, simvastatin, and atorvastatin in patients of type 2 diabetes mellitus with dyslipidemia.

MATERIALS AND METHODS

This open-label, randomized, parallel group, comparative, prospective study of 12-weeks duration included 60 patients of type-2 diabetes with dyslipidemia having good glycemic control with fixed dose combination of tablet glimepiride + metformin and divided into three groups of twenty each. Group-1 patients have received tablet rosuvastatin 10 mg once daily, group-2 received tablet atorvastatin 10 mg once daily, and group-3 received tablet simvastatin 10 mg once daily for 12 weeks each. The levels of serum cholesterol, serum triglyceride, LDL, VLDL, and HDL were assessed at baseline and at the end of 12 weeks.

RESULTS

The mean serum cholesterol, serum triglyceride, LDLc, and VLDLc levels were significantly reduced on therapy (P<0.001). Simultaneously, the mean levels of HDL were highly significantly increased (P<0.001) after therapy for 12 weeks with rosuvastatin, atorvastatin, and simvastatin. Reduction of LDL levels in rosuvastatin group was statistically significant when compared with those of simvastatin group (P< 0.05) but was statistically nonsignificant when compared with atorvastatin group (P> 0.05).

CONCLUSION

10 mg of rosuvastatin was comparable to 10 mg of atorvastatin and more efficacious than 10 mg simvastatin in reducing LDL levels after 12 weeks of therapy in patients of type 2 diabetes mellitus with dyslipidemia.

摘要

目的

评估并比较瑞舒伐他汀、辛伐他汀和阿托伐他汀在2型糖尿病合并血脂异常患者中的安全性和疗效。

材料与方法

这项为期12周的开放标签、随机、平行组、比较性前瞻性研究纳入了60例2型糖尿病合并血脂异常患者,这些患者通过格列美脲+二甲双胍固定剂量联合用药实现了良好的血糖控制,并被分为三组,每组20例。第1组患者每日服用一次10毫克瑞舒伐他汀片,第2组患者每日服用一次10毫克阿托伐他汀片,第3组患者每日服用一次10毫克辛伐他汀片,疗程均为12周。在基线和12周结束时评估血清胆固醇、血清甘油三酯、低密度脂蛋白、极低密度脂蛋白和高密度脂蛋白水平。

结果

治疗后血清胆固醇、血清甘油三酯、低密度脂蛋白胆固醇和极低密度脂蛋白胆固醇水平显著降低(P<0.001)。同时,使用瑞舒伐他汀、阿托伐他汀和辛伐他汀治疗12周后,高密度脂蛋白的平均水平显著升高(P<0.001)。与辛伐他汀组相比,瑞舒伐他汀组低密度脂蛋白水平的降低具有统计学意义(P<0.05),但与阿托伐他汀组相比无统计学意义(P>0.05)。

结论

在2型糖尿病合并血脂异常患者中,治疗12周后,10毫克瑞舒伐他汀在降低低密度脂蛋白水平方面与10毫克阿托伐他汀相当,且比10毫克辛伐他汀更有效。

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