Immune Checkpoint Inhibitors-Associated Diabetes and Ketoacidosis Were Found in FDA Adverse Event Reporting System: A Real-World Evidence Database Study
Authors' conclusion
The study reveals the risk and characteristics of diabetes and ketoacidosis associated with ICIs, which may provide evidence for postmarketing evaluation. Careful consideration should be given to the possibility of an increased risk of diabetes and ketoacidosis after using ICIs, and careful monitoring for diabetes and ketoacidosis is recommended.
Study context
- Population
- Reports of ICI-associated Diabetes Mellitus (DM) and ketoacidosis in the FDA Adverse Event Reporting System, January 2004–March 2022reports
- Participants
- 2,110 reports
- Outcome
- Risk (signals) of DM and ketoacidosis with immune checkpoint inhibitors (ICIs)
Methodological detailsreal-world evidence database, disproportionality analysis (fourfold table-based proportional imbalance algorithms)
- Real-world evidence database
- Disproportionality analysis (fourfold table-based proportional imbalance algorithms)
Main finding
As reported in the abstract
Drugs with signals of DM and ketoacidosis by 4 proportional imbalance algorithms
7: nivolumab, pembrolizumab, cemiplimab, dostarlimab, atezolizumab, avelumab, durvalumab
Observational data: associations, not effects.
Further findings
Country of reports
- Japan
- 752, 35.64%
- United States
- 624, 29.57%
- France
- 183, 8.67%
Time to event onset
- Median time to onset (IQR 27-199)
- 144.5 days
- Generally occurred early in ICI treatment
Safety
Outcomes of ICI-related diabetes and ketoacidosis events
- Major medical events
- 934 (44.3%)
- Hospitalizations
- 524 (24.8%)
- Life-threatening events
- 60 (2.8%)
- Deaths
- 42 (2.0%)
- Disability events
- 39 (1.8%)
Original publication
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