Safety and efficacy of atosiban: a systematic review and a meta-analysis of randomized controlled trials and observational studies

Background: Atosiban has shown ameliorative effects in preterm birth (PTB), repeated implantation failure, and breech delivery by suppressing contractions, but its safety profile has not been fully established. Methods: : Published randomized controlled trials and observational studies was electronically searched from inception to September 1, 2022. Our primary outcomes were maternal adverse events and neonatal comorbidities. Random effects model was used for data synthesis, and pooled risk ratios (RRs) with corresponding 95% confidence intervals (CIs) were calculated. Results: : 43 studies comprising 11,772 patients were identified eligible. The incidence of maternal adverse events in atosiban group and controls were 4.0% and 12.4%, respectively. Overall, the risk of maternal adverse events and the discontinuation of treatment due to adverse events were significantly lower with atosiban compared with controls (RR 0.38, 95% CI [0.23, 0.61], P < 0.0001; RR 0.11, 95% CI [0.04, 0.29], P < 0.00001; respectively). The incidence of neonatal comorbidities was similar, and a higher risk of neonatal apnoea was observed in atosiban group compared with controls (RR 1.40, 95% CI [1.04, 1.90], P = 0.03). Conclusion: Atosiban has comparable efficacy and substantial better safety profile in the management of PTB, in vitro fertilization-embryo transfer (IVF-ET) and external cephalic version (ECV) compared with controls. Additionally, awareness of the presence of neonatal apnoea is required. In clinical practice, the appropriate treatment regimen needs to be selected according to the local circumstances and the individual patient condition.