OBJECTIVE: To compare the efficacy and safety of atosiban and terbutaline for the inhibition of preterm labor. METHODS:Two hundred and forty-nine women diagnosed with preterm labor at 23-33 weeks of gestation were enrolled of whom 245 women received treatment, 116 with atosiban and 129 withterbutaline. At randomization, women were stratified by gestational age (< or =28 weeks and >28 weeks). Atosiban (iv bolus dose of 6.75 mg, then 300 microg/min for 3 h and 100 microg/min thereafter) and terbutaline (5-20 microg/min) were administered by iv infusion for 13-18 h. Re-treatment with study drug or an alternative tocolytic agent was allowed. Tocolytic effectiveness was assessed in terms of the number of women undelivered after 48 hours and 7 days and efficacy and tolerability in terms of the number of women remaining undelivered and not requiring alternative tocolytic therapy after 48 hours and 7 days of starting therapy. Safety was assessed in terms of maternal side effects and neonatal morbidity. RESULTS:Tocolytic effectiveness at 48 hours was 86.1% vs 85.3%; p=0.783, and after 7 days it was 76.5% vs 67.4%; p=0.067, in the atosiban and terbutaline groups, respectively. Tocolytic efficacy and tolerability after 48 hours was 72.2% vs 68.2%; p=0.51 and after 7 days was 55.6% vs 43.4%; p=0.08 in the atosiban and terbutaline groups, respectively. Overall, there were fewer clinically important adverse events with atosiban than with terbutaline. CONCLUSIONS: The efficacy of atosiban in the inhibition of preterm labor was shown to be comparable to terbutaline. Atosiban had a superior safety profile compared with terbutaline in terms of maternal and fetal adverse events, and comparable infant outcomes.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of atosiban and terbutaline for the inhibition of preterm labor. METHODS: Two hundred and forty-nine women diagnosed with preterm labor at 23-33 weeks of gestation were enrolled of whom 245 women received treatment, 116 with atosiban and 129 with terbutaline. At randomization, women were stratified by gestational age (< or =28 weeks and >28 weeks). Atosiban (iv bolus dose of 6.75 mg, then 300 microg/min for 3 h and 100 microg/min thereafter) and terbutaline (5-20 microg/min) were administered by iv infusion for 13-18 h. Re-treatment with study drug or an alternative tocolytic agent was allowed. Tocolytic effectiveness was assessed in terms of the number of women undelivered after 48 hours and 7 days and efficacy and tolerability in terms of the number of women remaining undelivered and not requiring alternative tocolytic therapy after 48 hours and 7 days of starting therapy. Safety was assessed in terms of maternal side effects and neonatal morbidity. RESULTS: Tocolytic effectiveness at 48 hours was 86.1% vs 85.3%; p=0.783, and after 7 days it was 76.5% vs 67.4%; p=0.067, in the atosiban and terbutaline groups, respectively. Tocolytic efficacy and tolerability after 48 hours was 72.2% vs 68.2%; p=0.51 and after 7 days was 55.6% vs 43.4%; p=0.08 in the atosiban and terbutaline groups, respectively. Overall, there were fewer clinically important adverse events with atosiban than with terbutaline. CONCLUSIONS: The efficacy of atosiban in the inhibition of preterm labor was shown to be comparable to terbutaline. Atosiban had a superior safety profile compared with terbutaline in terms of maternal and fetal adverse events, and comparable infant outcomes.
Authors: Isabelle Fabry; Peter De Paepe; Jan Kips; Sebastian Vermeersch; Luc Van Bortel Journal: Eur J Clin Pharmacol Date: 2010-11-16 Impact factor: 2.953
Authors: Amie Wilson; Victoria A Hodgetts-Morton; Ella J Marson; Alexandra D Markland; Eva Larkai; Argyro Papadopoulou; Arri Coomarasamy; Aurelio Tobias; Doris Chou; Olufemi T Oladapo; Malcolm J Price; Katie Morris; Ioannis D Gallos Journal: Cochrane Database Syst Rev Date: 2022-08-10