Cefepime-taniborbactam superior to meropenem in treating complicated UTIs and acute pyelonephritis: NEJM
Carbapenem-resistant Enterobacterales species and multidrug-resistant Pseudomonas aeruginosa pose significant global health threats. Cefepime–taniborbactam is an investigational β-lactam and β-lactamase inhibitor combination with activity against these organisms.
A study published in The New England Journal of Medicine (NEJM) concluded that Cefepime-taniborbactam was more effective than meropenem in treating complicated urinary tract infections involving acute pyelonephritis and had a safety profile comparable to meropenem.
In this phase 3 trial, researchers assigned hospitalized adults with complicated UTIs to receive either cefepime-taniborbactam or meropenem for seven days, with the possibility of extending treatment for an additional seven days if bacteremia was present. The composite success rate on days 19-23 in the microbiologic intention-to-treat population determined the primary outcome. After confirming non-inferiority, a prespecified superiority analysis was conducted.
Key findings from the study are:
- Six hundred sixty-one patients underwent randomization; 436 of these were included in the microITT population.
- Patients' mean age was 56, and nearly 38 % were 65 or older.
- In the microITT population, UTI, acute pyelonephritis and bacteremia were detected in 57.8%, 42.2% and 13.1%, respectively.
- 70.6 % in cefepime–taniborbactam and 58 % in the meropenem group had composite success.
- Considering the primary outcome, Cefepime–taniborbactam was superior to meropenem with a treatment difference of 12.6 percentage points.
- Differences in treatment response were sustained at late follow-up (when Cefepime–taniborbactam had higher composite success and clinical success.
- In the Cefepime–taniborbactam and the meropenem groups, adverse events occurred in 35.5% and 29.0% of patients, respectively.
- Adverse events included headache, diarrhoea, constipation, hypertension, and nausea. The frequency of SAEs was similar for both groups.
Concluding further, Cefepime-taniborbactam demonstrated superior efficacy to meropenem in managing complicated urinary tract infections with acute pyelonephritis while exhibiting a safety profile similar to that of meropenem. The study received funding from Venatorx Pharmaceuticals.
Reference:
Florian M. Wagenlehner et al.
Cefepime–Taniborbactam in Complicated Urinary Tract Infection
N Engl J Med 2024; 390:611-622
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