Choi Nam-Kyong, Solomon Daniel H, Tsacogianis Theodore N, Landon Joan E, Song Hong Ji, Kim Seoyoung C
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Institute of Environmental Medicine, Medical Research Center, Seoul National University, Seoul, Republic of Korea.
J Bone Miner Res. 2017 Mar;32(3):611-617. doi: 10.1002/jbmr.3019. Epub 2017 Feb 7.
Limited head-to-head comparative safety and effectiveness data exist between denosumab and zoledronic acid in real-world healthcare. We aimed to examine the safety and effectiveness of denosumab compared to zoledronic acid with regard to risk of serious infection and cardiovascular disease (CVD) and osteoporotic fracture. We conducted a cohort study using claims data (2009-2013) from a US commercial insurance plan database. We included patients aged ≥50 years who were newly initiated on denosumab or zoledronic acid. The primary outcomes were (1) hospitalization for serious infection; (2) composite CVD endpoint including myocardial infarction, stroke, coronary revascularization, and heart failure; and (3) nonvertebral osteoporotic fracture including hip, wrist, forearm, and pelvic fracture. To control for potential confounders, we used 1:1 propensity score (PS) matching. Cox proportional hazards models compared the risk of serious infection, CVD, and osteoporotic fracture within 365 days after initiation of denosumab versus zoledronic acid. After PS matching, a total of 2467 pairs of denosumab and zoledronic acid initiators were selected with a mean age of 63 years and 96% were female. When compared with zoledronic acid, denosumab was not associated with an increased risk of serious infection (HR 0.81; 95% confidence interval [CI], 0.55 to 1.21) or CVD (HR 1.11; 95% CI, 0.60 to 2.03). Similar results were obtained for each component of CVD. The risk of osteoporotic fracture was also similar between groups (HR 1.21; 95% CI, 0.84 to 1.73). This large population-based cohort study shows that denosumab and zoledronic acid have comparable clinical safety and effectiveness with regard to the risk of serious infection, CVD, and osteoporosis fracture within 365 days after initiation of medications. © 2016 American Society for Bone and Mineral Research.
在现实医疗环境中，地诺单抗和唑来膦酸之间的直接对比安全性和有效性数据有限。我们旨在研究地诺单抗与唑来膦酸相比，在严重感染风险、心血管疾病（CVD）和骨质疏松性骨折方面的安全性和有效性。我们使用来自美国商业保险计划数据库的索赔数据（2009 - 2013年）进行了一项队列研究。我们纳入了年龄≥50岁且新开始使用地诺单抗或唑来膦酸的患者。主要结局包括：（1）因严重感染住院；（2）复合CVD终点，包括心肌梗死、中风、冠状动脉血运重建和心力衰竭；（3）非椎体骨质疏松性骨折，包括髋部、腕部、前臂和骨盆骨折。为控制潜在混杂因素，我们采用1:1倾向评分（PS）匹配。Cox比例风险模型比较了开始使用地诺单抗与唑来膦酸后365天内严重感染、CVD和骨质疏松性骨折的风险。PS匹配后，共选择了2467对地诺单抗和唑来膦酸起始使用者，平均年龄为63岁，96%为女性。与唑来膦酸相比，地诺单抗与严重感染风险增加无关（风险比[HR] 0.81；95%置信区间[CI]，0.55至1.21）或CVD（HR 1.11；95% CI，0.60至2.03）。CVD的各个组成部分也得到了类似结果。两组之间骨质疏松性骨折的风险也相似（HR 1.21；95% CI，0.84至1.73）。这项基于大量人群的队列研究表明，在开始用药后365天内，地诺单抗和唑来膦酸在严重感染、CVD和骨质疏松性骨折风险方面具有相当的临床安全性和有效性。© 2016美国骨与矿物质研究学会
