Department of Endocrinology and Metabolism, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
Calcif Tissue Int. 2023 Aug;113(2):175-185. doi: 10.1007/s00223-023-01085-0. Epub 2023 Apr 26.
Osteoporosis and hyperlipidemia are closely correlated and statins might be associated with a decreased risk of fracture. We aimed to investigate the association between proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) therapy and the risk of fracture. The PubMed, Cochrane library, and EMBASE databases were systematically searched from the inception dates to October 22, 2022. Randomized clinical trials (RCTs) that addressed to fracture events of participants using alirocumab, evolocumab, bococizumab or inclisiran, with a follow-up of ≥ 24 weeks were included. Meta-analyses were conducted to calculate the odds ratio (OR) with 95% confidence intervals (CIs) for major osteoporotic fracture, hip fracture, osteoporotic non-vertebral fracture, and total fracture. 30 trials assessing PCSK9i among 95, 911 adults were included. There were no significant associations between PCSK9i therapy and the risk of major osteoporotic fracture [OR 1.08 (95% Cl 0.87-1.34), p = 0.49], hip fracture [OR 1.05 (95% Cl 0.73-1.53), p = 0.79], osteoporotic non-vertebral fracture [OR 1.03 (95% Cl 0.80-1.32), p = 0.83], and total fracture [OR 1.03 (95% Cl 0.88-1.19), p = 0.74] over a period of 6-64 months. No significant associations were detected in any of the sensitivity analyses and subgroup analyses stratified by the type of PCSK9i, follow-up duration, age, sex, sample size, and patient profile. Pooled results of our meta-analysis showed that exposure to PCSK9i was not associated with reduced risks of fracture in the short term.
骨质疏松症和高脂血症密切相关，他汀类药物可能与骨折风险降低有关。我们旨在研究前蛋白转化酶枯草溶菌素/糜蛋白酶 9 抑制剂（PCSK9i）治疗与骨折风险之间的关系。系统地检索了 PubMed、Cochrane 图书馆和 EMBASE 数据库，检索时间从建库至 2022 年 10 月 22 日。纳入了使用阿利西尤单抗、依洛尤单抗、波考立舒单抗或inclisiran 治疗参与者骨折事件的随机临床试验（RCT），随访时间≥24 周。进行荟萃分析以计算优势比（OR）及其 95%置信区间（CI），用于主要骨质疏松性骨折、髋部骨折、骨质疏松性非椎体骨折和总骨折。纳入了 30 项评估 PCSK9i 的 RCT，共纳入 95911 名成年人。PCSK9i 治疗与主要骨质疏松性骨折风险[OR 1.08（95%CI 0.87-1.34），p=0.49]、髋部骨折[OR 1.05（95%CI 0.73-1.53），p=0.79]、骨质疏松性非椎体骨折[OR 1.03（95%CI 0.80-1.32），p=0.83]和总骨折[OR 1.03（95%CI 0.88-1.19），p=0.74]之间无显著相关性，随访时间为 6-64 个月。在任何敏感性分析和按 PCSK9i 类型、随访时间、年龄、性别、样本量和患者特征分层的亚组分析中，均未发现显著相关性。我们的荟萃分析汇总结果表明，在短期内，暴露于 PCSK9i 与骨折风险降低无关。
