Comparative effectiveness and cardiovascular safety of romosozumab versus teriparatide in patients with osteoporosis: a population-based cohort study.

IF 4.2 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Osteoporosis International Pub Date : 2024-12-01 Epub Date: 2024-09-25 DOI:10.1007/s00198-024-07255-6

Soichiro Masuda, Toshiki Fukasawa, Shuichi Matsuda, Satomi Yoshida, Koji Kawakami

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Abstract

This study compared the effectiveness and cardiovascular safety of romosozumab and teriparatide. The main finding was that there were no significant differences between the two drugs in fracture prevention and risk of major adverse cardiac events. This suggests that romosozumab and teriparatide are comparable options for treating osteoporosis.

Purpose: This study aimed to determine the preventive effects of romosozumab versus teriparatide on fractures and the risk of cardiovascular events in patients initiating these drugs.

Methods: We conducted an active comparator, a new user cohort design, with confounding controlled by inverse probability of treatment weighting using a Japanese administrative claims database (March 2019 to October 2022). This cohort study included 49,104 patients aged 50 years or older who initiated romosozumab (n = 16,125) or teriparatide (n = 32,979) for osteoporosis. The study exposure was the initiation of romosozumab or teriparatide. Effectiveness outcomes were nonvertebral fracture and hip fracture. The safety outcome was major adverse cardiac events (MACE). Follow-up period was 365 days.

Results: The weighted incidence rate difference (IRD) for nonvertebral fracture between romosozumab versus teriparatide was -0.08 (95% confidence interval [CI], -0.34 to 0.17) events per 100 person-years (weighted hazard ratio [HR], 0.95 [95% CI, 0.81 to 1.12]); weighted IRD for hip fracture was 0.00 (95% CI, -0.16 to 0.16) events per 100 person-years (weighted HR, 0.99 [95% CI, 0.76 to 1.29]); and weighted IRD for MACE was -0.06 (95% CI, -0.20 to 0.09) events per 100 person-years (weighted HR, 0.90 [95% CI, 0.68 to 1.19]).

Conclusion: In patients with osteoporosis, there was no significant difference in the prevention of nonvertebral fracture and hip fracture between romosozumab and teriparatide. In addition, the risk of MACE was comparable between the two drugs.

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罗莫司单抗与特立帕肽对骨质疏松症患者的有效性和心血管安全性比较：一项基于人群的队列研究。

这项研究比较了罗莫索单抗和特立帕肽的有效性和心血管安全性。主要发现是这两种药物在预防骨折和主要不良心脏事件风险方面没有显著差异。这表明，罗莫索单抗和特立帕肽是治疗骨质疏松症的可比选择。目的：本研究旨在确定罗莫索单抗与特立帕肽对开始服用这两种药物的患者的骨折预防效果和心血管事件风险：我们使用日本行政索赔数据库（2019 年 3 月至 2022 年 10 月）进行了一项主动比较研究，这是一项新用户队列设计，通过治疗的反概率加权控制混杂因素。这项队列研究纳入了49104名年龄在50岁或50岁以上、开始使用罗莫索单抗（16125人）或特立帕肽（32979人）治疗骨质疏松症的患者。研究对象为开始使用罗莫索单抗或特立帕肽的患者。疗效结果为非椎体骨折和髋部骨折。安全性结果为主要心脏不良事件（MACE）。随访期为365天：romosozumab与特立帕肽的非椎体骨折加权发病率差异（IRD）为-0.08（95%置信区间[CI]，-0.34至0.17）次/100人年（加权危险比[HR]，0.95[95% CI，0.81至1.12]）。12]）；髋部骨折加权IRD为每100人年0.00（95% CI，-0.16至0.16）例（加权HR，0.99[95% CI，0.76至1.29]）；MACE加权IRD为每100人年-0.06（95% CI，-0.20至0.09）例（加权HR，0.90[95% CI，0.68至1.19]）：在骨质疏松症患者中，罗莫单抗和特立帕肽在预防非椎体骨折和髋部骨折方面没有明显差异。此外，两种药物的MACE风险相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Osteoporosis International 医学-内分泌学与代谢

CiteScore

8.10

自引率

10.00%

发文量

224

审稿时长

3 months

期刊介绍： An international multi-disciplinary journal which is a joint initiative between the International Osteoporosis Foundation and the National Osteoporosis Foundation of the USA, Osteoporosis International provides a forum for the communication and exchange of current ideas concerning the diagnosis, prevention, treatment and management of osteoporosis and other metabolic bone diseases. It publishes: original papers - reporting progress and results in all areas of osteoporosis and its related fields; review articles - reflecting the present state of knowledge in special areas of summarizing limited themes in which discussion has led to clearly defined conclusions; educational articles - giving information on the progress of a topic of particular interest; case reports - of uncommon or interesting presentations of the condition. While focusing on clinical research, the Journal will also accept submissions on more basic aspects of research, where they are considered by the editors to be relevant to the human disease spectrum.