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依泽替米贝/辛伐他汀联合治疗与强化降脂治疗策略在伴有和不伴有代谢综合征的糖尿病患者中的疗效和安全性比较。

The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid-lowering treatment strategies in diabetic subjects with and without metabolic syndrome.

机构信息

Hospital CIMA San Jose, Escazu and Universidad de Ciencias Medicas, Sabana Oeste, San Jose, Costa Rica.

出版信息

Diabetes Obes Metab. 2013 Jun;15(6):513-22. doi: 10.1111/dom.12059. Epub 2013 Jan 25.

Abstract

AIMS

The objective was to assess the consistency of effect of switching to ezetimibe/simvastatin 10/20 mg versus doubling the baseline statin dose (to simvastatin 40 mg or atorvastatin 20 mg) or switching to rosuvastatin 10 mg across subgroups of subjects with (n = 617) and without (n = 191) metabolic syndrome (MetS).

METHODS

This was a post hoc analysis of a randomized, double-blind, 6-week study of adults 18-79 years with cardiovascular disease and diabetes mellitus with low-density lipoprotein cholesterol (LDL-C) ≥70 and ≤160 mg/dl. The percent change in LDL-C and other lipids was estimated within each subgroup separately. Safety and tolerability were assessed.

RESULTS

In subjects with MetS, percent changes in LDL-C and other lipids were greater with ezetimibe/simvastatin versus doubling baseline statin or numerically greater versus switching to rosuvastatin, except high-density lipoprotein cholesterol and apolipoprotein (Apo) AI (mean percent changes in LDL-C were: -22.49% ezetimibe/simvastatin, -9.64% doubled baseline statin and -19.20% rosuvastatin). In subjects without MetS, percent changes in LDL-C, total cholesterol and Apo B were greater with ezetimibe/simvastatin versus doubling baseline statin or numerically greater versus switching to rosuvastatin (mean percent changes in LDL-C were: -25.14% ezetimibe/simvastatin, -4.75% doubled baseline statin and -19.75% rosuvastatin). Safety profiles were generally similar.

CONCLUSION

These results showed that switching to ezetimibe/simvastatin 10/20 mg was more effective at reducing LDL-C, total cholesterol and Apo B versus doubling the baseline statin dose to simvastatin 40 mg or atorvastatin 20 mg or switching to rosuvastatin 10 mg regardless of MetS status. These results were generally similar to those of the full cohort.

摘要

目的

评估与他汀类药物加倍剂量(增至辛伐他汀 40mg 或阿托伐他汀 20mg)或换用瑞舒伐他汀 10mg 相比,依折麦布/辛伐他汀 10/20mg 转换治疗在伴有(n=617)和不伴有(n=191)代谢综合征(MetS)亚组人群中的疗效一致性。

方法

这是一项随机、双盲、6 周研究的事后分析,纳入了年龄在 18-79 岁之间、伴有心血管疾病和糖尿病且 LDL-C 水平为 70-160mg/dl 的成年人。分别在每个亚组内估计 LDL-C 和其他脂质的百分比变化。评估安全性和耐受性。

结果

在伴有 MetS 的人群中,与他汀类药物加倍剂量或换用瑞舒伐他汀相比,依折麦布/辛伐他汀使 LDL-C 和其他脂质的百分比变化更大,除了高密度脂蛋白胆固醇(HDL-C)和载脂蛋白(Apo)AI(LDL-C 的平均百分比变化为:依折麦布/辛伐他汀-22.49%,他汀类药物加倍剂量-9.64%,瑞舒伐他汀-19.20%)外。在不伴有 MetS 的人群中,与他汀类药物加倍剂量或换用瑞舒伐他汀相比,依折麦布/辛伐他汀使 LDL-C、总胆固醇和 ApoB 的百分比变化更大(LDL-C 的平均百分比变化为:依折麦布/辛伐他汀-25.14%,他汀类药物加倍剂量-4.75%,瑞舒伐他汀-19.75%)。安全性概况总体相似。

结论

这些结果表明,与他汀类药物加倍剂量至辛伐他汀 40mg 或阿托伐他汀 20mg 或换用瑞舒伐他汀 10mg 相比,无论 MetS 状态如何,依折麦布/辛伐他汀 10/20mg 转换治疗降低 LDL-C、总胆固醇和 ApoB 的效果更优。这些结果与全队列的结果基本一致。

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