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Cancer risk associated with DPP4 inhibitors in type 2 diabetes: A pharmacovigilance analysis of the FDA Adverse Event
Wan Xiong1,2, Yilin Li3, Juanjuan Huang1,2
1Department of Pharmacy, The First Hospital of Changsha, Changsha, China.
Background:
The use of dipeptidyl peptidase 4 (DPP4) inhibitors in treating type 2 diabetes mellitus (T2DM) is increasingly widespread. However, their association with malignancy risk has not been comprehensively evaluated in real-world clinical settings. This study, utilizing the Food and Drug Adverse Event Reporting System (FAERS) database, investigated the potential link between DPP4 inhibitors and malignancies.
Methods:
Data from the FAERS database (January 2019 to December 2024) were analyzed. Descriptive statistics assessed patient demographics for each drug-event combination, while disproportionality analysis based on Reporting Odds Ratio (ROR) and Information Component (IC) metrics valuated cancer-related adverse event (AE) risks. Binary logistic regression was used to minimize potential bias.
Results:
A comprehensive analysis identified 3,764 AE reports linked to malignancies in T2DM individuals treated with DPP4 inhibitors. Signal detection analysis revealed that sitagliptin exhibited the strongest and most extensive positive signals across both the Preferred Terms and Standardized Medical Dictionary for Regulatory Activities Queries. Specifically, significant signals were observed for malignancies (ROR025: 13.80, IC025: 3.48), tumor lysis syndrome (ROR025: 5.79, IC025: 2.32), and site-specific neoplasms (e.g., uterine, fallopian tube, and prostate). Age distribution analysis indicated that the median age of individuals reporting malignancy-related AEs exceeded 70 years in most drug groups. Furthermore, in studies with larger sample sizes, the median time to AE onset for for DPP4 inhibitors ranged from 13 to 15 months.
Conclusions:
This study demonstrates significant associations between all five DPP4 inhibitors and malignancy-related AEs, with sitagliptin showing the highest risk profile. These findings highlight the need for further validation through large-scale prospective studies to verify the observed pharmacovigilance signals and to elucidate their potential clinical significance and underlying biological mechanisms.
Insights
Dipeptidyl peptidase 4 (DPP4) inhibitors, commonly used for type 2 diabetes, show potential links to cancer risk. Sitagliptin, in particular, demonstrated the highest association with malignancy-related adverse events in a real-world data analysis.
Area of Science:
- Pharmacovigilance
- Endocrinology
- Oncology
Background:
- Dipeptidyl peptidase 4 (DPP4) inhibitors are widely prescribed for type 2 diabetes mellitus (T2DM).
- Concerns exist regarding a potential association between DPP4 inhibitors and malignancy risk.
- Real-world data analysis is crucial to evaluate this association comprehensively.
Purpose of the Study:
- To investigate the potential link between DPP4 inhibitors and malignancy risk.
- To analyze adverse event reports in patients with T2DM treated with DPP4 inhibitors.
- To identify specific DPP4 inhibitors associated with increased malignancy risk.
Main Methods:
- Utilized the Food and Drug Adverse Event Reporting System (FAERS) database (January 2019 - December 2024).
- Employed descriptive statistics and disproportionality analysis (ROR, IC) for signal detection.
- Applied binary logistic regression to mitigate potential biases.
Main Results:
- Identified 3,764 malignancy-related adverse event reports associated with DPP4 inhibitors in T2DM patients.
- Sitagliptin showed the strongest positive signals for malignancies, tumor lysis syndrome, and specific neoplasms.
- Median age of affected individuals exceeded 70 years, with median AE onset between 13-15 months.
Conclusions:
- All five DPP4 inhibitors demonstrated significant associations with malignancy-related adverse events.
- Sitagliptin presented the highest risk profile among the evaluated DPP4 inhibitors.
- Further large-scale prospective studies are warranted to validate these pharmacovigilance signals and explore underlying mechanisms.
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