关于阿巴罗帕拉肽与特立帕肽在骨质疏松症女性中的相对有效性和安全性的现实证据可能有助于指导治疗决策。经过18个月的治疗,abaloparatide在预防非椎骨骨折方面与特立帕肽相当,使髋部骨折的风险降低了22%,并证明了类似的心血管安全性。使用合成代谢或抗吸收药物可以降低骨质疏松性骨折的风险。除了对照临床试验的疗效和安全性数据,关于相对有效性和安全性的真实世界证据可能有助于为治疗决策提供信息.
背景:在治疗开始后的19个月期间,评估了阿帕罗肽与特立帕肽对非椎骨骨折(NVF)发生率和心血管安全性的真实世界有效性(NCT04974723)。
方法:匿名的美国患者声称来自SymphonyHealth的数据,集成Dataverse(IDV)®,2017年5月1日至2019年7月31日,包括年龄≥50岁的女性,服用≥1份阿巴罗帕肽或特立帕肽处方,且先前没有合成代谢疗法。大多数人参加了商业和医疗保险健康计划。索引是在识别期间分配的初始处方的日期。在1:1倾向得分匹配的队列中,索引日期后第一个NVF的时间,主要不良心血管事件(MACE),和MACE+心力衰竭(HF)在队列之间使用Cox比例风险模型进行比较。
结果:倾向评分匹配每个队列产生11,616名患者。总体中位年龄(四分位距)为67(61,75)岁,25.6%有骨折史。超过19个月,335名服用阿巴罗帕肽的患者和375名服用特立帕肽的患者有NVF(风险比[95%置信区间]:0.89[0.77,1.03]),121和154名患者,分别,髋部骨折[HR(95%CI):0.78(0.62,1.00)]。队列之间的MACE和MACE+HF发生率相似。
结论:治疗18个月后,在预防NVF方面,abaloparatide与特立帕肽具有可比性,并且在队列之间证明了相似的心血管安全性.
Real-world evidence on the comparative effectiveness and safety of
abaloparatide versus teriparatide in women with osteoporosis may help inform treatment decisions. Following 18 months of treatment,
abaloparatide was comparable to teriparatide for prevention of nonvertebral fractures, resulted in a 22% risk reduction for hip fractures, and demonstrated similar cardiovascular safety. Osteoporotic fracture risk can be reduced with anabolic or antiresorptive medications. In addition to efficacy and safety data from controlled clinical trials, real-world evidence on comparative effectiveness and safety may help inform treatment decisions.
BACKGROUND: The real-world effectiveness of
abaloparatide versus teriparatide on nonvertebral fracture (NVF) incidence and cardiovascular safety during the 19-month period after treatment initiation were evaluated (NCT04974723).
METHODS: Anonymized US patient claims data from Symphony Health, Integrated Dataverse (IDV)®, May 1, 2017 to July 31, 2019, included women aged ≥ 50 years with ≥ 1 prescription of abaloparatide or teriparatide and no prior anabolic therapy. Most were enrolled in commercial and Medicare health plans. Index was the date of the initial prescription dispensed during the identification period. In 1:1 propensity score matched cohorts, time to first NVF following index date, major adverse cardiovascular events (MACE), and MACE + heart failure (HF) were compared between cohorts using a Cox proportional hazards model.
RESULTS: Propensity score matching yielded 11,616 patients per cohort. Overall median age (interquartile range) was 67 (61, 75) years, and 25.6% had a fracture history. Over 19 months, 335 patients on
abaloparatide and 375 on teriparatide had a NVF (hazard ratio [95% confidence interval]: 0.89 [0.77, 1.03]), and 121 and 154 patients, respectively, had a hip fracture [HR (95% CI): 0.78 (0.62, 1.00)]. The MACE and MACE + HF rates were similar between cohorts.
CONCLUSIONS: Following 18 months of treatment,
abaloparatide was comparable to teriparatide for prevention of NVF and similar cardiovascular safety was demonstrated between cohorts.