Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Efficacy and Cardiovascular Safety of Romosozumab: A Meta-analysis and Systematic Review

Romosozumab의 효과 및 심혈관계 안전성: 체계적 문헌고찰 및 메타분석

  • Seo-Yong Choi (College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University) ;
  • Jeong-Min Kim (College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University) ;
  • Sang-Hyeon Oh (College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University) ;
  • Seunghyun Cheon (College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University) ;
  • Jee-Eun Chung (College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University)
  • Received : 2023.05.27
  • Accepted : 2023.06.13
  • Published : 2023.06.30
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Abstract

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.

Keywords

Acknowledgement

본 연구는 과학기술정보통신부/한국연구재단 이공분야기초연구사업의 지원으로 수행되었으며(과제번호: 2022R1F1A1075439) 이에 감사드립니다.

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