DIPEPTIDYL PEPTIDASE-4 INHIBITOR-ASSOCIATED HYPERKALEMIA: A DISPROPORTIONALITY ANALYSIS IN THE FAERS DATABASE
Author(s)
Sonal Sekhar, MPharm, PhD1, Ashika Sanil, PharmD2, Elsa Ann George, PharmD3, Chandrashekar U K, MBBS, MD4, Gouri Nair, MPharm, PhD5.
1Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, India, 2Dept. of Pharmacy Practice,, Manipal College of Pharmaceutical Sciences, Manipal, India, 3Dept. of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, India, 4Department of Medicine, Kasturba Medical College, Manipal, India, 5Department of Pharmacology, Faculty of Pharmacy, Bengalore, India.
1Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, India, 2Dept. of Pharmacy Practice,, Manipal College of Pharmaceutical Sciences, Manipal, India, 3Dept. of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, India, 4Department of Medicine, Kasturba Medical College, Manipal, India, 5Department of Pharmacology, Faculty of Pharmacy, Bengalore, India.
OBJECTIVES: To perform disproportionality analysis to investigate the potential risk of hyperkalemia associated with dipeptidyl peptidase-4 inhibitors (DPP-4Is) use.
METHODS: A disproportionality analysis was performed using the FDA Adverse Event Reporting System (FAERS) database. Reports mentioning the preferred term “Hyperkalaemia” were extracted for six DPP-4Is: vildagliptin, sitagliptin, teneligliptin, linagliptin, saxagliptin, and alogliptin. The reporting odds ratio (ROR) was used to detect signals. Adjusted reporting odds ratio (aROR) was calculated after excluding reports involving known hyperkalemia-inducing drugs.
RESULTS: Out of 80232 DPP-4I-related reports, 754 involved hyperkalemia. Sitagliptin had the most reports (n = 546). The overall ROR and aROR for DPP-4Is were 7.198 (95% CI:6.690-7.745) and 2.504 (95% CI:2.172-2.887), respectively. Signal strengths along with aROR were above threshold for all DPP-4Is, with vildagliptin having the highest ROR (17.274 [95% CI:14.675-20.330]) and aROR (7.246[95%CI:5.192-10.111]). Sub-group analysis showed higher signal strength among females (8.446 [95% CI:7.464-9.558]) than males (5.683 [95% CI:5.148-6.273]). Similarly, geriatrics (5.584 [95% CI:5.108-6.104]) had higher signal strength than adults (4.953 [95% CI:4.142-5.921]).
CONCLUSIONS: The study identified a potential hyperkalemia signal associated with all DPP-4Is. Further studies with robust epidemiological designs are warranted to confirm these findings.
METHODS: A disproportionality analysis was performed using the FDA Adverse Event Reporting System (FAERS) database. Reports mentioning the preferred term “Hyperkalaemia” were extracted for six DPP-4Is: vildagliptin, sitagliptin, teneligliptin, linagliptin, saxagliptin, and alogliptin. The reporting odds ratio (ROR) was used to detect signals. Adjusted reporting odds ratio (aROR) was calculated after excluding reports involving known hyperkalemia-inducing drugs.
RESULTS: Out of 80232 DPP-4I-related reports, 754 involved hyperkalemia. Sitagliptin had the most reports (n = 546). The overall ROR and aROR for DPP-4Is were 7.198 (95% CI:6.690-7.745) and 2.504 (95% CI:2.172-2.887), respectively. Signal strengths along with aROR were above threshold for all DPP-4Is, with vildagliptin having the highest ROR (17.274 [95% CI:14.675-20.330]) and aROR (7.246[95%CI:5.192-10.111]). Sub-group analysis showed higher signal strength among females (8.446 [95% CI:7.464-9.558]) than males (5.683 [95% CI:5.148-6.273]). Similarly, geriatrics (5.584 [95% CI:5.108-6.104]) had higher signal strength than adults (4.953 [95% CI:4.142-5.921]).
CONCLUSIONS: The study identified a potential hyperkalemia signal associated with all DPP-4Is. Further studies with robust epidemiological designs are warranted to confirm these findings.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH60
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity), No Additional Disease & Conditions/Specialized Treatment Areas