Halal Research Center of IRI, FDA, Tehran, Iran.
Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Sci Rep. 2018 Dec 14;8(1):17887. doi: 10.1038/s41598-018-36204-7.
The aim of this meta-analysis of randomized placebo-controlled clinical trials was to assess the effect of ezetimibe on plasma lipoprotein(a) concentrations. Only randomized placebo-controlled trials investigating the impact of ezetimibe treatment on cholesterol lowering that include lipoprotein(a) measurement were searched in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases (from inception to February 26, 2018). A random-effects model and generic inverse variance method were used for quantitative data synthesis. Sensitivity analysis was conducted using the leave-one-out method. A weighted random-effects meta-regression was performed to evaluate the impact of potential confounders on lipoprotein concentrations. This meta-analysis of data from 10 randomized placebo-controlled clinical trials (15 treatment arms) involving a total of 5188 (3020 ezetimibe and 2168 control) subjects showed that ezetimibe therapy had no effect on altering plasma Lp(a) concentrations (WMD: -2.59%, 95% CI: -8.26, 3.08, p = 0.370; I = 88.71%, p < 0.001). In the subgroup analysis, no significant alteration in plasma Lp(a) levels was observed either in trials assessing the impact of monotherapy with ezetimibe versus placebo (WMD: -4.64%, 95% CI: -11.53, 2.25, p = 0.187; I = 65.38%, p = 0.005) or in trials evaluating the impact of adding ezetimibe to a statin versus statin therapy alone (WMD: -1.04%, 95% CI: -6.34, 4.26, p = 0.700; I = 58.51%, p = 0.025). The results of this meta-analysis suggest that ezetimibe treatment either alone or in combination with a statin does not affect plasma lipoprotein(a) levels.
本荟萃分析旨在评估依折麦布对血浆脂蛋白(a)浓度的影响，纳入了随机安慰剂对照临床试验。在 PubMed-Medline、SCOPUS、Web of Science 和 Google Scholar 数据库中检索了（从创建到 2018 年 2 月 26 日）研究依折麦布治疗对胆固醇降低作用且包含脂蛋白(a)测量的随机安慰剂对照试验。采用随机效应模型和通用逆方差法进行定量数据合成。采用逐一剔除法进行敏感性分析。采用加权随机效应荟萃回归评估潜在混杂因素对脂蛋白浓度的影响。该荟萃分析纳入了 10 项随机安慰剂对照临床试验（15 个治疗组），共 5188 例（3020 例依折麦布治疗，2168 例安慰剂对照）受试者的数据，结果显示依折麦布治疗对改变血浆 Lp(a)浓度没有影响（WMD：-2.59%，95%CI：-8.26，3.08，p=0.370；I=88.71%，p<0.001）。在亚组分析中，无论是评估依折麦布单药治疗与安慰剂对照的影响（WMD：-4.64%，95%CI：-11.53，2.25，p=0.187；I=65.38%，p=0.005），还是评估依折麦布联合他汀类药物与单独他汀类药物治疗的影响（WMD：-1.04%，95%CI：-6.34，4.26，p=0.700；I=58.51%，p=0.025），血浆 Lp(a)水平均无显著变化。该荟萃分析结果表明，依折麦布单独或联合他汀类药物治疗不影响血浆脂蛋白(a)水平。
