Antihypertensive drug-induced adverse events in patients aged 80 years and older: A retrospective analysis using the Japanese Adverse Drug Event Report Database.

Abstract

Background: This study aimed to evaluate major antihypertensive drugs associated with adverse events (AEs) in patients aged ≥ 80 years using the Japanese Adverse Drug Event Report (JADER) database.

Materials and methods: We utilized the JADER database (April 2004 - September 2023). Patients aged ≥ 80 years who were taking angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), dihydropyridine calcium channel blockers (CCBs), β-blockers, and thiazide/thiazide-like diuretics as "suspected agents" were included. Eight AEs were extracted for analysis. Adjusted reporting odds ratios (aRORs) and 95% confidence intervals (CIs) were calculated using sex as a covariate.

Results: The highest aROR for syncope/loss of consciousness was associated with β-blockers (2.57 (95% CI 1.84 - 3.58)), followed by CCBs (2.56 (95% CI 1.95 - 3.36)). Only CCBs showed a significant associated with falls (1.58 (95% CI 1.10 - 2.27)). The highest aROR for bradycardia was associated with β-blockers (18.20 (95% CI 15.64 - 21.18)). The highest aROR for renal failure was for diuretics (2.71 (95% CI 1.83 - 4.02)), followed by ACEIs/ARBs (2.26 (95% CI 1.97 - 2.58)). Electrolyte abnormalities had the greatest aROR for hyperkalemia with ACEIs/ARBs (15.34 (95% CI 13.70 - 17.18)) and for hypokalemia and hyponatremia with diuretics (15.72 (95% CI 11.30 - 21.87), 27.40 (20.27 - 37.0)). Only CCBs showed a significant associated with edema (4.00 (95% CI 2.32 - 6.91)).

Conclusion: This study, which employed the JADER database, identified specific AEs associated with drug use in patients aged ≥ 80 years. These AEs included syncope/loss of consciousness associated with β-blockers or CCBs as well as falls and edema associated with CCBs.