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Cardiovascular Safety of Romosozumab Versus Other Anti-Osteoporosis Medications in Patients with Osteoporosis: A Nationwide Health Insurance Claims Database Study in Japan
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DOI：10.1007/s00223-026-01572-0.png)
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Abstract
En 中文
Romosozumab (Rmab) is a potent anti-osteoporosis agent with dual effects on bone resorption and formation. Although superior to alendronate in fracture reduction, cardiovascular safety concerns have been raised. This study compared cardiovascular disease (CVD) incidence between Rmab and other anti-osteoporosis medications (AOMs) using Japan's National Database of Health Insurance Claims. Patients aged ≥ 50 years initiating Rmab, parathyroid hormone analogues (PTH), denosumab (Dmab), or bisphosphonates (BP) between March 2019 and March 2023 were identified. Outcomes were acute myocardial infarction, ischemic heart disease, and cerebrovascular disease occurring within 570 days of initiation or within 180 days after discontinuation. Patients with prior myocardial infarction or cerebrovascular disease were excluded. Hazard ratios (HRs) were derived from Cox regression with inverse probability weighting using propensity scores. The study included 25,584 men and 236,467 women receiving Rmab; 50,688 and 289,132 on PTH; 50,319 and 460,182 on Dmab; and 232,484 and 1,144,757 on BP. Cumulative incidence of outcomes was highest with PTH, followed by Dmab, BP, and lowest with Rmab. Compared with PTH, adjusted HRs for Rmab in men were 0.49 for acute myocardial infarction, 0.59 for ischemic heart disease, and 0.70 for cerebrovascular disease. Compared with Dmab, HRs were 0.62, 0.62, and 0.59, respectively. Versus BP, HRs were 0.68, 0.74, and 0.72. All HRs were similarly below 1.0 in women. After adjustment for baseline characteristics, no excess incidence of cardiovascular events was observed among patients receiving Rmab compared with those receiving other AOMs.
Keywords:
Anti-osteoporosis medications
Cardiovascular safety
Romosozumab
Osteoporosis
Nationwide health insurance claims database study
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