Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Department of Thyroid Breast Surgery, The Second Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, China.
Clin Ther. 2024 Oct;46(10):799-807. doi: 10.1016/j.clinthera.2024.07.008. Epub 2024 Aug 23.
Although various randomized controlled trials (RCTs) have evaluated the effect of raloxifene on apolipoproteins and lipoprotein(a) concentrations in postmenopausal women, the results have been inconsistent and inconclusive. Therefore, we conducted this meta-analysis of RCTs to investigate the effect of raloxifene administration on apolipoproteins and lipoprotein(a) [Lp(a)] concentrations in postmenopausal women.
Two independent researchers systematically searched the scientific literature (including PubMed/Medline, Scopus, Web of Science, and EMBASE) for English-language randomized controlled trials (RCTs) published up to June 2024. We included RCTs reporting the impact of raloxifene on apolipoprotein A-I (ApoA-I), apolipoprotein B (ApoB), and Lp(a) levels in postmenopausal women. The primary outcome of interest was change in Lp(a), and the secondary outcomes were changes in ApoA-I and ApoB.
The present meta-analysis incorporated 12 publications with 14 RCT arms. The comprehensive outcomes derived from the random-effects model revealed a statistically significant increase in ApoA-I (WMD: 6.06 mg/dL, 95% CI: 4.38, 7.75, P < 0.001) and decrease in ApoB concentrations (WMD: -8.48 mg/dL, 95% CI: -10.60, -6.36, P < 0.001) and Lp(a) (WMD: -3.02 mg/dL, 95% CI: -4.83, -1.21, P < 0.001) following the administration of raloxifene in postmenopausal women. In the subgroup analyses, the increase in ApoA-I and the decrease in ApoB and Lp(a) levels were greater in RCTs with a mean participant age of ≥60 years and a duration of ≤12 weeks.
The current meta-analysis of RCTs demonstrates that treatment with raloxifene reduces ApoB and Lp(a) levels while increasing ApoA-I levels in postmenopausal women. Since these effects on lipid components are associated with a reduced risk of cardiovascular disease (CVD), raloxifene could be a suitable therapy for postmenopausal women who are at an increased risk of CVD and have other medical indications for raloxifene administration.
尽管多项随机对照试验（RCT）已经评估了雷洛昔芬对绝经后妇女载脂蛋白和脂蛋白（a）浓度的影响，但结果不一致且没有定论。因此，我们进行了这项对 RCT 的荟萃分析，以调查雷洛昔芬给药对绝经后妇女载脂蛋白和脂蛋白（a）[Lp（a）]浓度的影响。
两位独立的研究人员系统地检索了科学文献（包括 PubMed/Medline、Scopus、Web of Science 和 EMBASE），以获取截至 2024 年 6 月发表的英文随机对照试验（RCT）。我们纳入了报告雷洛昔芬对绝经后妇女载脂蛋白 A-I（ApoA-I）、载脂蛋白 B（ApoB）和 Lp（a）水平影响的 RCT。主要结局为 Lp（a）的变化，次要结局为 ApoA-I 和 ApoB 的变化。
本荟萃分析纳入了 12 项研究，涉及 14 个 RCT 组。来自随机效应模型的综合结果显示，ApoA-I 显著升高（WMD：6.06mg/dL，95%CI：4.38，7.75，P<0.001），ApoB 浓度降低（WMD：-8.48mg/dL，95%CI：-10.60，-6.36，P<0.001）和 Lp（a）降低（WMD：-3.02mg/dL，95%CI：-4.83，-1.21，P<0.001），在绝经后妇女中给予雷洛昔芬后。在亚组分析中，在平均参与者年龄≥60 岁且持续时间≤12 周的 RCT 中，ApoA-I 的升高和 ApoB 和 Lp（a）水平的降低更为明显。
本 RCT 荟萃分析表明，雷洛昔芬治疗可降低绝经后妇女的 ApoB 和 Lp（a）水平，同时升高 ApoA-I 水平。由于这些对脂质成分的影响与心血管疾病（CVD）风险降低相关，因此雷洛昔芬可能是一种适合患有 CVD 风险增加且有其他雷洛昔芬给药医学指征的绝经后妇女的治疗选择。
