Background: This systematic review and meta-analysis aimed to evaluate the efficacy and cardiovascular safety of romosozumab compared with placebo. Methods: Randomized controlled trials (RCTs) were searched from Medline, EMBASE, Cochrane Central, and Web of Science until July 2022. Primary outcomes included the change in bone mineral density (BMD) from baseline at month 6. The secondary outcomes were the change of bone turnover markers (N-terminal propeptide of type 1 procollagen (P1NP); C-terminal telopeptide of type 1 collagen (CTX)) from baseline at month 3, and the incidence of cardiovascular adverse events for the total follow-up period. Results: A total of 7 RCTs on 8,370patients were included. Romosozumab showed better effects in improving BMD in both lumbar spine and femoral neck at month 6 (standardized mean difference, SMD 2.20 [95% CI: 1.89-2.52], SMD 0.63 [95% CI: 0.41-0.86]). In contrast to placebo, romosozumab significantly increased PINP levels and reduced CTX levels at month 3 (SMD 0.93 [95% CI: 0.65-1.22], SMD −1.03 [95% CI: −1.23~ −0.82]. However, there was no significant difference in the composite incidence of cardiovascular adverse events and major adverse cardiovascular events (OR 1.16 [95% CI: 0.82-1.65], OR 1.08 [95% CI: 0.75-1.56]). Conclusion: This analysis showed that romosozumab significantly improved BMD compared to placebo and was beneficial for change in bone turnover markers. There is no significant difference in the incidence of cardiovascular adverse events compared to placebo.
목차
ABSTRACT 연구 방법 검색 전략 및 문헌 선정 데이터 추출 및 통계 분석 연구 결과 문헌 선택 및 환자 특성 효과 및 안전성 비교 질 평가 고찰 결론 감사의 말씀 이해상충 References
키워드
Bone mineral density (BMD)cardiovascular diseases (CVDs)CTXosteoporosisromosozumab
저자
최서용 [ Seo-Yong Choi | 한양대학교 약학대학 ]
김정민 [ Jeong-Min Kim | 한양대학교 약학대학 ]
오상현 [ Sang-Hyeon Oh | 한양대학교 약학대학 ]
천승현 [ Seunghyun Cheon | 한양대학교 약학대학 ]
정지은 [ Jee-Eun Chung | 한양대학교 약학대학 ]
Corresponding Author