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RESTORE-IMI 1: Relebactam-based therapy has more favorable renal safety profile vs. colistin
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SAN FRANCISCO — Relebactam has a more favorable renal safety profile than colistin when used in combination with imipenem/cilastatin in patients with drug-resistant bacterial infections, according to phase 3 findings presented at IDWeek.
“Imipenem/cilastatin plus relebactam (IMI/REL) offers a new option for the treatment of extremely drug-resistant gram negatives, including Pseudomonas and carbapenem-resistant Enterobacteriaceae (CRE),” Keith Kaye, MD, MPH, director of clinical research in the division of infectious disease at the University of Michigan, told Infectious Disease News. “It has demonstrated efficacy in treating invasive resistant infections and also is quite safe, particularly compared to colistin-based regimens.”
Prior results from the RESTORE-IMI 1 study showed that IMI/REL was comparable to colistin-based therapy (IMI+CST) in patients with drug-resistant infections, including those caused by CRE.
Kaye and colleagues reported additional results from the phase 3 trial in adults with infections caused by at least one imipenem-nonsusceptible pathogen that is IMI/REL- and CST-susceptible. They randomly assigned patients to treatment with IMI/REL or IMI+CST in a 2:1 ratio for 5 to 21 days for complicated intra-abdominal infection and complicated urinary tract infection and for 7 to 21 days in hospital-acquired/ventilator-associated bacterial pneumonia.
Study findings for 47 patients (31 IMI/REL; 16 IMI+CST) showed that a significantly smaller percentage of patients in the IMI/REL treatment arm experienced nephrotoxicity compared with patients in the IMI+CST arm, a difference of –45.9% (95% CI, –69.1% to –18.4%) during the study and a 14-day follow-up.
According to Kaye and colleagues, no patients in the IMI/REL cohort experienced stage 3 acute kidney injury or failure, compared with 31.3% and 25% of patients in the IMI+CST cohort, respectively. Patients in the IMI/REL group had fewer renal adverse events and discontinuation because of renal events, the researchers reported.
“The results from the RESTORE trial are particularly informative since they mirror how IMI/REL will likely be used in real-world settings,” said Kaye, who is also an Infectious Disease News Editorial Board member. “This agent is a welcomed addition to the antibiotic armamentarium for ID clinicians.” – by Bruce Thiel and Erin Michael
Reference:
Brown M, et al. Abstract 1951. Presented at: IDWeek; Oct. 3-7, 2018; San Francisco.
Disclosures: Kaye reports being a consultant and research contractor for Merck & Co. and serving as a consultant for Melinta, Achaogen and Allergan. Please see the abstract for all other authors’ relevant financial disclosures.