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A Clinical Review and Critical Evaluation of Imipenem-Relebactam: Evidence to Date
Toni A Campanella1, Jason C Gallagher2
1Department of Pharmacy, Jefferson Health Northeast, Philadelphia, PA, USA.
Abstract:
Imipenem-relebactam (I-R) is a novel beta-lactam/beta-lactamase inhibitor combination given with cilastatin. It is indicated for the treatment of complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired or ventilator-associated bacterial pneumonia. A literature search was completed to evaluate the evidence to date of I-R. I-R has in vitro activity against multidrug-resistant organisms including carbapenem-resistant Pseudomonas aeruginosa and extended-spectrum beta-lactamase and carbapenem-resistant Enterobacterales. It was granted FDA approval following the promising results of two phase II clinical trials in patients with complicated urinary tract infections and complicated intra-abdominal infections. The most common adverse drug events associated with I-R were nausea (6%), diarrhea (6%), and headache (4%). I-R is a new beta-lactam/beta-lactamase inhibitor combination that will be most likely used for patients with multidrug-resistant gram-negative infections in which there are limited or no available alternative treatment options.
Insights
Imipenem-relebactam (I-R) offers a new treatment for complex infections caused by multidrug-resistant bacteria. This beta-lactam/beta-lactamase inhibitor combination shows promising results against challenging gram-negative pathogens.
Area of Science:
- Infectious Diseases
- Pharmacology
- Microbiology
Background:
- Imipenem-relebactam (I-R) is a novel combination therapy.
- It is indicated for complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired or ventilator-associated bacterial pneumonia.
- I-R combines a beta-lactam antibiotic with a beta-lactamase inhibitor, administered with cilastatin.
Purpose of the Study:
- To evaluate the current evidence for imipenem-relebactam (I-R).
- To assess the efficacy and safety of I-R against multidrug-resistant organisms.
- To understand the clinical utility of I-R in treating serious bacterial infections.
Main Methods:
- A comprehensive literature search was conducted.
- Evidence from clinical trials and in vitro studies was reviewed.
- Safety and efficacy data were analyzed.
Main Results:
- I-R demonstrates in vitro activity against multidrug-resistant organisms, including carbapenem-resistant *Pseudomonas aeruginosa* and carbapenem-resistant Enterobacterales.
- FDA approval was granted based on positive Phase II trial results for complicated urinary tract and intra-abdominal infections.
- Common adverse events included nausea (6%), diarrhea (6%), and headache (4%).
Conclusions:
- Imipenem-relebactam (I-R) represents a significant advancement in treating infections caused by difficult-to-treat gram-negative bacteria.
- It is a valuable option for patients with limited or no alternative treatments for multidrug-resistant infections.
- The drug's profile supports its use in specific clinical scenarios involving resistant pathogens.
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