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Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study
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Hyesung Lee, Bin Hong, Chris Tzu-Ting Su, Sungho Bea, Han Eol Jeong, Kyungyeon Jung, Michael Chun-Yuan Cheng, Zoe Chi-Jui Chang, Edward Chia-Cheng Lai, Jongyoung Lee
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Epidemiol Health. 2025;47:e2025029. Published online May 28, 2025
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DOI: https://doi.org/10.4178/epih.e2025029
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 Abstract
Summary
 PDF Supplementary Material
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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 Korea and Taiwan. Patients aged between 18 years 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 to 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.
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Summary
Korean summary
Azilsartan medoxomil과 amlodipine 병용요법의 장기적인 안전성을 평가한 연구는 제한적임. 본 코호트 연구에서는 azilsartan과 amlodipine 병용요법이 다른 ARB-amlodipine 병용요법에 비해 중대한 이상반응 발생 위험을 증가시키지 않는 것으로 나타났음. 이러한 결과는 고혈압 환자에서 azilsartan-amlodipine 병용요법의 실제 진료 환경에서의 안전성을 뒷받침함.
Key Message
Limited studies have evaluated the long-term safety of combined azilsartan medoxomil and amlodipine therapy. This cohort study found the azilsartan and amlodipine combination therapy was not associated with increased risk of serious adverse events compared to other ARB-amlodipine combinations. These results support the real-world safety of azilsartan-amlodipine caombination therapy in patients with hypertension.
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