Abstract
This study reports an integrated analysis of three randomized controlled trials to compare the clinical efficacies and safety of the ceftazidime-avibactam (CAZ-AVI) combination and meropenem in the treatment of adult patients with complicated intra-abdominal infections (cIAIs). Overall, a total of 1677 patients (CAZ-AVI: 835 patients; meropenem: 842 patients) were included in this analysis. CAZ-AVI had a clinical cure rate at test of cure in the clinically evaluable (CE) population similar to that of meropenem (OR, 0.88; 95% CI, 0.58-1.32; I(2) = 0%). Similar trends were also observed in the modified intent-to-treat (MITT) population (OR, 0.80; 95% CI, 0.59-1.09; I(2) = 0%) and microbiological evaluable (ME) population (OR, 0.73; 95% CI, 0.32-1.68; I(2) = 0%). In terms of clinical cure rate at the end of treatment, the efficacy of CAZ-AVI was comparable to that of meropenem in the CE population (OR, 0.77; 95% CI, 0.47-1.25; I(2) = 0%), MITT population (OR, 0.70; 95% CI, 0.47-1.06; I(2) = 5%), and ME population (OR, 1.26; 95% CI, 0.39-4.08; I(2) = 0%). CAZ-AVI had a similar risk of (i) treatment emergent adverse events (TEAEs) (OR, 1.03; 95% CI, 0.79-1.36; I(2) = 38%), (ii) any serious adverse events (OR, 0.97; 95% CI, 0.67-1.40; I(2) = 0%), (iii) discontinuation of study drug due to TEAE (OR, 2.14; 95% CI, 1.00-4.57), and iv) all-cause mortality (OR, 1.66; 95% CI, 0.78-3.53; I(2) = 0%) when compared with meropenem. In conclusion, CAZ-AVI had comparable efficacy and safety profile to those of meropenem in the treatment of cIAI.