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.

Author Details

Authors

• Riku Matsushima¹
• Masayuki Hashiguchi²
• Tsuyoshi Shiga²

Departments

• ¹ The Jikei University School of Medicine, and
• ² Department of Clinical Pharmacology and Therapeutics, The Jikei University School of Medicine, Tokyo, Japan

Address

Tsuyoshi Shiga, MD, PhD
Department of Clinical Pharmacology and Therapeutics
The Jikei University School of Medicine
3-25-8 Nishi-shinbashi, Minato-ku
Tokyo 105-8461, Japan
Email: [email protected]

Citation