Department of Biostatistics and Computing, Graduate School of Yonsei University, Seoul, Korea.
Health Insurance Review and Assessment Service, Wonju, Korea.
Yonsei Med J. 2024 Jan;65(1):19-26. doi: 10.3349/ymj.2023.0285.
There are few studies in the literature on the dosage of statin that equivalently reduces low-density lipoprotein cholesterol (LDL-C) compared to an ezetimibe combination and whether such regimens have differences in safety. We compared the lipid-modifying efficacy and safety of 5 mg rosuvastatin/10 mg ezetimibe to those of 20 mg rosuvastatin.
A literature search was conducted using the PubMed, EMBASE, Cochrane, Web of Sciences, and SCOPUS databases up to December 2021. Human studies investigating the two aforementioned regimens with a randomized controlled design were selected. Outcome variables included the percentage reduction in LDL-C and other lipid parameters and rates of composite adverse events (AEs), including muscle-related symptoms. A random-effects meta-analysis was performed after heterogeneity testing between studies.
Seven studies were included in this meta-analysis. The percentage LDL-C reduction did not differ between the combination and monotherapy groups [standardized mean difference (SMD) 0.08; 95% confidence interval (CI) -0.09 to 0.26; =0.35]. The risk of composite AEs (odds ratio 0.50; 95% CI 0.15 to 1.72; =0.27) of the combination was not different compared to the monotherapy group. The percentage of total cholesterol reduction was greater in the combination group (SMD 0.22; =0.02), whereas that of triglyceride reduction and high-density lipoprotein cholesterol elevation did not differ between the two groups.
This meta-analysis showed that 5 mg rosuvastatin/10 mg ezetimibe had largely comparable lipid-modifying efficacy and tolerability as 20 mg rosuvastatin.
文献中关于他汀类药物剂量的研究很少,与依折麦布联合用药相比,能同等程度降低低密度脂蛋白胆固醇(LDL-C),并且不清楚这些方案在安全性方面是否存在差异。我们比较了 5 毫克瑞舒伐他汀/10 毫克依折麦布与 20 毫克瑞舒伐他汀的降脂疗效和安全性。
检索了PubMed、EMBASE、Cochrane、Web of Sciences 和 SCOPUS 数据库,检索截至 2021 年 12 月,纳入了使用随机对照设计比较上述两种方案的人类研究。主要转归变量包括 LDL-C 及其他血脂参数的降低百分比和复合不良事件(AE)发生率,包括肌肉相关症状。在研究间存在异质性时进行了随机效应荟萃分析。
本荟萃分析纳入了 7 项研究。联合治疗组与单药治疗组的 LDL-C 降低百分比无差异[标准化均数差(SMD)0.08;95%置信区间(CI)-0.09 至 0.26;=0.35]。与单药治疗组相比,联合治疗组复合 AE 的风险(比值比 0.50;95%CI 0.15 至 1.72;=0.27)无差异。联合治疗组总胆固醇降低百分比更大(SMD 0.22;=0.02),而甘油三酯降低和高密度脂蛋白胆固醇升高百分比在两组间无差异。
本荟萃分析显示,5 毫克瑞舒伐他汀/10 毫克依折麦布与 20 毫克瑞舒伐他汀相比,具有相当的调脂疗效和可耐受性。