Objectives: A large retrospective database study was conducted to assess the incidence rate of treatment-emergent renal impairment/failure, seizure, and hemolytic anemia in doripenem and imipenem intravenous (IV)-exposed patients treated for complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) in US hospitals.
Methods: Using the Premier Perspective™ Database (PPD), which maintains hospital discharge records for over 309 million patients, the incidence rate of treatment-emergent renal impairment/failure, seizure, and hemolytic anemia in the doripenem-treated compared with imipenem IV-treated population was examined.
Results: The unadjusted doripenem rate ratio (RR) for renal impairment/failure relative to imipenem IV was 1.13 [95% confidence interval (CI) 1.07-1.21; p < 0.0001]. The unadjusted doripenem rate ratio for seizure relative to imipenem IV was 0.74 (95% CI 0.52-1.05; p = 0.07). In the comparative safety analysis, adjusted incidence rates of renal impairment/failure between doripenem-exposed patients and a propensity score-matched comparator cohort of imipenem IV-exposed patients showed no statistically significant difference in cUTI [RR = 1.02; 95% CI 0.93-1.12; p = 0.71] or cIAI (RR = 1.17; 95% CI 1.00-1.36; p = 0.05). Likewise, there was no statistically significant difference in adjusted incidence rates for seizures in doripenem-treated versus matched imipenem-treated patients for cUTI (RR = 0.69; 95% CI 0.41-1.14; p = 0.15) or cIAI (RR = 0.45; 95% CI 0.15-1.41; p = 0.17). No hemolytic anemia events were observed in this study.
Conclusions: In this large retrospective cohort study of US hospitalized patients, no statistically significant differences in the adjusted relative rates of renal impairment/failure and seizure were observed between doripenem and a propensity score-matched comparator cohort of imipenem IV patients in the treatment of cUTI and cIAI.
Keywords: cIAI; cUTI; doripenem; imipenem; renal impairment; seizure.