Efficacy and safety of eravacycline: A meta-analysis.

ABSTRACT

OBJECTIVES: This study was conducted to evaluate the efficacy and safety of eravacycline, a recently approved fluorocycline for treatment of complicated intra-abdominal infections (cIAIs). METHODS: PubMed, EMBASE and three trial registries were searched for randomised controlled trials (RCTs) comparing the efficacy and safety of eravacycline versus comparators. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated using random-effects models. The study outcomes included clinical response, all-cause mortality and adverse events (AEs). RESULTS: Three RCTs (1128 patients) with cIAIs were included. There were no significant differences in clinical response in the modified intention-to-treat (ITT) (OR, 0.91, 95% CI 0.62-1.35; I2 = 0%), microbiological ITT (OR, 0.93, 95% CI 0.61-1.41; I2 = 0%) and clinically evaluable (OR, 0.98, 95% CI 0.55-1.75; I2 = 0%) populations or in all-cause mortality (OR, 1.18, 95% CI 0.16-8.94; I2 = 0%). Eravacycline was associated with significantly greater odds of total AEs (OR, 1.55, 95% CI 1.20-1.99; I2 = 0%) and nausea (OR, 5.29, 95% CI 1.77-15.78; I2 = 1.70%) but the increase in vomiting was non-significant (OR, 1.44, 95% CI 0.73-2.86; I2 = 1.70%). There were no significant differences in serious AEs or discontinuation due to AEs. CONCLUSION: This meta-analysis of RCTs found similar clinical efficacy and mortality for eravacycline compared with carbapenems for treatment of cIAIs. However, the odds of total AEs and specifically nausea was higher with eravacycline, while no significant differences were observed in vomiting (although numerically higher), serious AEs or discontinuation due to AEs.