INTRODUCTION: Eravacycline is a recently approved fluorocycline for treatment of complicated intra-abdominal infections (cIAIs). We conducted this study to evaluate its efficacy and safety.METHODS: PubMed, EMBASE, and three trial registries were searched for randomized 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 (1,128 patients) with cIAIs were included. There were no significant differences in clinical response in the modified intention-to-treat (ITT) population (OR, 0.91; 95% CI, 0.62 to 1.35; I2=0%), microbiological ITT population (OR, 0.93; 95% CI, 0.62 to 1.41; I2=0%) and clinically evaluable population (OR, 0.98; 95% CI, 0.55 to 1.75; I2=0%) or all-cause mortality (OR, 1.18; 95% CI, 0.16 to 8.94; I2=0%). Eravacycline was associated with significantly greater odds of total AEs (OR, 1.55; 95% CI, 1.20 to 1.99; I2=0%) and nausea (OR, 5.29; 95% CI, 1.77 to 15.78; I2=1.70%) but the increase in vomiting was not significant (OR, 1.44; 95% CI, 0.73 to 2.86; I2=1.70%). There were no significant differences in serious AEs or discontinuation due to AEs.CONCLUSIONS: This meta-analysis of RCTs found similar clinical efficacy and mortality with eravacycline compared to carbapenems for the treatment of cIAI. However, the odds of total AEs and specifically nausea occurred more with eravacycline, while no significant differences were observed in vomiting (although numerically higher), serious AEs, or drug discontinuation due to AEs.
Efficacy and Safety of Eravacycline: A Meta-analysis
Bassetti, Matteo
2021-01-01
Abstract
INTRODUCTION: Eravacycline is a recently approved fluorocycline for treatment of complicated intra-abdominal infections (cIAIs). We conducted this study to evaluate its efficacy and safety.METHODS: PubMed, EMBASE, and three trial registries were searched for randomized 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 (1,128 patients) with cIAIs were included. There were no significant differences in clinical response in the modified intention-to-treat (ITT) population (OR, 0.91; 95% CI, 0.62 to 1.35; I2=0%), microbiological ITT population (OR, 0.93; 95% CI, 0.62 to 1.41; I2=0%) and clinically evaluable population (OR, 0.98; 95% CI, 0.55 to 1.75; I2=0%) or all-cause mortality (OR, 1.18; 95% CI, 0.16 to 8.94; I2=0%). Eravacycline was associated with significantly greater odds of total AEs (OR, 1.55; 95% CI, 1.20 to 1.99; I2=0%) and nausea (OR, 5.29; 95% CI, 1.77 to 15.78; I2=1.70%) but the increase in vomiting was not significant (OR, 1.44; 95% CI, 0.73 to 2.86; I2=1.70%). There were no significant differences in serious AEs or discontinuation due to AEs.CONCLUSIONS: This meta-analysis of RCTs found similar clinical efficacy and mortality with eravacycline compared to carbapenems for the treatment of cIAI. However, the odds of total AEs and specifically nausea occurred more with eravacycline, while no significant differences were observed in vomiting (although numerically higher), serious AEs, or drug discontinuation due to AEs.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.



