Eficácia e segurança de romosozumabe para o tratamento de osteoporose grave em mulheres na pós-menopausa: revisão sistemática e meta-análise em rede
DOI:
https://doi.org/10.34019/1982-8047.2023.v49.41803Keywords:
Conservadores da Densidade Óssea, Fraturas por Osteoporose, Osteoporose, Osteoporose Pós-Menopausa, Avaliação de Resultados em Cuidados de SaúdeAbstract
Background: Osteoporosis is a major cause of morbidity and mortality, especially in the elderly and postmenopausal women, due to increased bone fragility and greater susceptibility to fractures. Objective: To evaluate the efficacy and safety of romosozumab, compared to pharmacological treatments currently available in the Unified Health System of Brazil for the management of postmenopausal women with severe osteoporosis and high risk of fractures. Methods: A systematic review was carried out followed by indirect meta-analyses, searching for randomized controlled trials (RCTs) in PubMed, EMBASE, and Cochrane Library, and by manual search. Risk of bias (RoB 2.0) and quality of evidence (GRADE) were assessed. Indirect frequentist meta-analyses were carried out for outcomes related to fractures, bone mineral density, and safety. Results: Seven RCTs (n= 19,951 woman) were included in this review. Romosozumab (RR: 0,52, IC 95%: 0,43-0,64) (high certainty of evidence) and romosozumab followed by alendronate (RR: 0,64, IC 95%: 0,49-0,84) (high certainty of evidence) reduced non-vertebral fractures compared with alendronate. Conclusion: This review identified that romosozumab or romosozumab followed by alendronate are effective and safe compared to alendronate.
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