University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
PGY2 Ambulatory Care Pharmacy Resident, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
Curr Osteoporos Rep. 2021 Feb;19(1):15-22. doi: 10.1007/s11914-020-00652-w. Epub 2021 Jan 7.
Authors review the safety and efficacy of romosozumab for the treatment of osteoporosis as demonstrated in three phase III clinical trials and offer insights into the potential cardiovascular risk associated with its use.
Incidence of new vertebral fracture is dramatically reduced with 12 months of romosozumab use in comparison to both placebo and active bisphosphonate control groups in patients with postmenopausal osteoporosis. Significant non-vertebral anti-fracture benefit was also demonstrated in patients with more severe osteoporosis. Numerical increases in cardiovascular events call into question the safety of romosozumab use, particularly in patients with cardiovascular history or at high cardiovascular risk. Romosozumab has impressive anti-fracture effects in postmenopausal women with high risk for fragility fracture. Despite no significant differences in baseline cardiovascular risk factors between groups, a numerical increase in serious cardiovascular adverse events was demonstrated with romosozumab in randomized trials with no discernable etiology. Until more real-world evidence is available, romosozumab should not be used in patients with a recent cardiovascular event and should be used cautiously in patients with high cardiovascular risk. Romosozumab's place in therapy is likely patients with severe postmenopausal osteoporosis and low cardiovascular risk.
作者综述了罗莫佐单抗治疗骨质疏松症的安全性和疗效，该药物在三项 III 期临床试验中得到了证实，并探讨了其使用与潜在心血管风险的关系。
与安慰剂和活性双膦酸盐对照组相比，使用罗莫佐单抗治疗 12 个月后，绝经后骨质疏松症患者的新发椎体骨折发生率显著降低。在骨质疏松症更严重的患者中，也显著观察到非椎体骨折的获益。心血管事件的数值增加引起了对罗莫佐umab 使用安全性的质疑，特别是在有心血管病史或心血管风险高的患者中。罗莫佐umab 在有脆性骨折高风险的绝经后妇女中具有令人印象深刻的抗骨折作用。尽管随机试验组间基线心血管危险因素无显著差异，但罗莫佐umab 组显示严重心血管不良事件的数值增加，但无明显病因。在更多的真实世界证据出现之前，罗莫佐umab 不应用于近期发生心血管事件的患者，并且应谨慎用于心血管风险高的患者。罗莫佐umab 的治疗地位可能是严重绝经后骨质疏松症和低心血管风险的患者。
