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Real-world pharmacovigilance investigation of imipenem/cilastatin: signal detection using the FDA Adverse Event
Peng Jia1, Yusen Zhou2, Yuan Gao1
1Department of Hepato-Biliary and Pancreato-Splenic Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.
Background:
Although imipenem/cilastatin (IMI/CIL) has demonstrated favorable therapeutic efficacy against various infections, the incidence of potential adverse events (AEs) has escalated in parallel with its increased utilization and has been documented in clinical trials. However, a comprehensive understanding of real-world implications remains lacking.
Methods:
By conducting a comprehensive search in the FDA Adverse Event Reporting System (FAERS) database, AE reports associated with IMI/CIL as the primary suspect (PS) were selected for analysis, spanning from the first quarter of 2004 to the fourth quarter of 2023. Utilizing disproportionality analysis techniques, potential signals of AE s were identified through reported odds ratio (ROR), proportional report ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM). The obtained results were systematically classified using Medical Dictionary for Regulatory Activities (MedDRA).
Result:
From the first quarter of 2004 to the fourth quarter of 2023, a total of 2,574 reports documenting AEs associated with IMI/CIL were obtained, with more than half (n = 1,517, 58.94%) involving individuals aged over 60 years old. Descriptive analysis was conducted based on age groups and time to onset, revealing that the majority of AEs occurred within 3 days. Adverse drug reactions caused by IMI/CIL were classified into 24 system organ classes (SOCs) at the preferred term (PT) level. Furthermore, previously unreported and clinically significant AEs such as cerebral atrophy, and delirium were also identified at the PT level.
Conclusion:
This study offers a more comprehensive insight into the monitoring, supervision, and management of adverse drug reactions associated with IMI/CIL. Clinicians should pay further attention to the implications of numerous AEs and their corresponding signal intensities, as well as unrecorded signals of severe AEs. This holds significant value in enhancing the clinical safety profile of IMI/CIL.
Insights
Imipenem/cilastatin (IMI/CIL) use is linked to adverse events (AEs), particularly in older adults. This study identified new safety signals, including cerebral atrophy and delirium, improving IMI/CIL safety monitoring.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background:
- Imipenem/cilastatin (IMI/CIL) is effective for infections but associated with adverse events (AEs).
- Real-world data on IMI/CIL's safety profile is limited despite increased utilization.
- Clinical trials have documented AEs, but comprehensive real-world understanding is lacking.
Purpose of the Study:
- To comprehensively analyze real-world adverse event (AE) data for imipenem/cilastatin (IMI/CIL).
- To identify potential safety signals and previously unreported AEs associated with IMI/CIL.
- To enhance the clinical safety profile and management of IMI/CIL.
Main Methods:
- Utilized FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q4 2023.
- Employed disproportionality analysis (ROR, PRR, BCPNN, EBGM) to detect AE signals.
- Classified identified AEs using Medical Dictionary for Regulatory Activities (MedDRA).
Main Results:
- Analyzed 2,574 IMI/CIL-associated AE reports, with 58.94% in individuals over 60.
- Most AEs occurred within 3 days of IMI/CIL administration.
- Identified significant AEs including cerebral atrophy and delirium, alongside 24 system organ classes.
Conclusions:
- Provides enhanced insights into monitoring and managing IMI/CIL adverse drug reactions.
- Highlights the need for clinical attention to AE signal intensities and unrecorded severe AEs.
- Aims to improve the overall clinical safety of imipenem/cilastatin therapy.
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