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Original article Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study
Hyesung Lee1orcid , Bin Hong2orcid , Chris Tzu-Ting Su3orcid , Sungho Bea4orcid , Han Eol Jeong5orcid , Kyungyeon Jung2orcid , Michael Chun-Yuan Cheng3orcid , Zoe Chi-Jui Chang3orcid , Edward Chia-Cheng Lai3orcid , Jongyoung Lee6orcid
Epidemiol Health 2025;e2025029
DOI: https://doi.org/10.4178/epih.e2025029 [Accepted]
Published online: May 28, 2025
1Kangwon National University College of Medicine, Chuncheon-si, Gangwon State, Korea
2School of Pharmacy, Sungkyunkwan University, Suwon, Korea
3School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan
4Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, United States
5DSC Investment, Seoul, Korea
6Division of Cardiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
Corresponding author:  Hyesung Lee,
Email: hs.lee@kangwon.ac.kr
Received: 10 March 2025   • Revised: 23 April 2025   • Accepted: 29 April 2025
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Abstract

OBJECTIVES
This study investigated the safety of azilsartan and amlodipine combination therapy versus other angiotensin receptor blockers (ARBs) and amlodipine in patients with hypertension.
METHODS
We conducted a cohort study utilizing healthcare databases from South Korea and Taiwan. Patients aged between 18 and 75 years who were newly prescribed both an ARB and amlodipine within 6 months of hypertension diagnosis were included. Safety outcomes assessed were hypotension, angioedema, acute pancreatitis, hyperkalemia, hypokalemia, toxic liver disease, hepatic failure, nausea and vomiting, and fall-related injury. Hazard ratios (HRs) with 95% confidence intervals (CIs) for each safety outcome associated with azilsartan medoxomil and amlodipine versus other ARBs combined with amlodipine were calculated within a 1:1 propensity score (PS)-matched cohort. Summary HRs across databases were computed using random-effects meta-analysis.
RESULTS
We identified 2,472 eligible patients (1,521 from Korea, 951 from Taiwan) initiating treatment with azilsartan medoxomil and amlodipine, and 671,468 patients (312,322 from Korea, 355,409 from Taiwan) initiating other ARBs with amlodipine. After PS matching, baseline characteristics were well-balanced between treatment groups. During the 180-day follow-up, most adverse outcomes did not occur even once in either group, thus precluding the calculation of HRs. The risk of acute pancreatitis was not significantly different between the azilsartan medoxomil and amlodipine group and the other ARB and amlodipine groups (summary HR, 0.86 [95% CI, 0.14–5.37]).
CONCLUSIONS
In this population-based cohort study, azilsartan medoxomil combined with amlodipine was not associated with an increased risk of adverse outcomes compared to other ARBs combined with amlodipine.

Epidemiol Health : Epidemiology and Health
© Korean Society of Epidemiology.
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