Epidemiology and Health

Original article

Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study: 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; Epidemiol Health. 2025;e2025029. Published online May 28, 2025; DOI: https://doi.org/10.4178/epih.e2025029 [Accepted]

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Abstract PDF: 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.; Summary

COVID-19: Original Article

Clinical outcomes of COVID-19 following the use of angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among patients with hypertension in Korea: a nationwide study: Ju Hwan Kim, Yeon-Hee Baek, Hyesung Lee, Young June Choe, Hyun Joon Shin, Ju-Young Shin; Epidemiol Health. 2021;43:e2021004. Published online December 29, 2020; DOI: https://doi.org/10.4178/epih.e2021004

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Abstract Summary PDF

Abstract

OBJECTIVES
Recent evidence has shown no harm associated with the use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs) in patients with coronavirus disease 2019 (COVID-19). We sought to further clarify the possible association between ACEI/ARB use and the risk of poor clinical outcomes of COVID-19.

METHODS

From the completely enumerated COVID-19 cohort in Korea, we identified 1,290 patients with hypertension, of whom 682 had and 603 did not have records of ACEI/ARB use during the 30-day period before their COVID-19 diagnosis. Our primary endpoint comprised clinical outcomes, including all-cause mortality, use of mechanical ventilation, intensive care unit admission, and sepsis. We used inverse probability of treatment weighting (IPTW) to mitigate selection bias, and a Poisson regression model to estimate the relative risks (RRs) and 95% confidence intervals (CIs) for comparing outcomes between ACEI/ARB users and non-users.

RESULTS

Compared to non-use, ACEI/ARB use was associated with lower clinical outcomes (IPTW-adjusted RR, 0.60; 95% CI, 0.42 to 0.85; p=0.005). For individual outcomes, ACEI/ARB use was not associated with all-cause mortality (IPTW-adjusted RR, 0.62; 95% CI, 0.35 to 1.09; p=0.097) or respiratory events (IPTW-adjusted RR, 0.99; 95% CI, 0.84 to 1.17; p=0.904). Subgroup analysis showed a trend toward a protective role of ACEIs and ARBs against overall outcomes in men (IPTW-adjusted RR, 0.84; 95% CI, 0.69 to 1.03; p<sub>interaction</sub>=0.008) and patients with pre-existing respiratory disease (IPTW-adjusted RR, 0.74; 95% CI, 0.60 to 0.92; p<sub>interaction</sub>=0.002).

CONCLUSIONS

We present clinical evidence to support continuing ACE/ARB use in COVID-19 patients with hypertension based on the completely enumerated Korean cohort.

Summary

Korean summary
– 코로나-19 검사를 받은 69,793명 중에 코로나-19 양성이며 고혈압이 있는 1,290명을 연구대상자로 선정했으며, 이중 코로나-19 진단일로부터 30일이내에 ACEI 또는 ARB를 사용한 환자는 682명이었음. – ACEI 또는 ARB 사용은 비사용 대비 사망 또는 폐 관련 질환의 위험과의 관련성이 없었음. – 하위그룹 분석에서 남성 또는 기저 폐질환 보유 환자에서 ACEI 또는 ARB 사용이 코로나-19 예후 악화를 예방하는 트렌드를 보였음.

Key Message
– Among 69,793 individuals screened for COVID-19, we identified 1,290 patients with hypertension who tested positive, of whom 682 had records of using ACEIs or ARBs in the 30 days before their COVID-19 diagnosis. – ACEI/ARB use (compared with non-use) was not associated with all-cause mortality or respiratory events. – A subgroup analysis showed a trend toward a protective role of ACEIs and ARBs against the overall composite endpoint of poor outcomes in men and those with pre-existing respiratory disease.

Citations

Citations to this article as recorded by

A Meta-Analysis of the Impact of Using Angiotensin-Converting Enzyme Inhibitors (ACEIs) or Angiotensin II Receptor Blockers (ARBs) on Mortality, Severity, and Healthcare Resource Utilization in Patients with COVID-19
Ruijuan Li, Jie Zhang, Liang Ren
Advances in Respiratory Medicine.2025; 93(1): 4. CrossRef
Systematic review and meta-analysis of the clinical outcomes of ACEI/ARB in East-Asian patients with COVID-19
Nancy Xurui Huang, Qi Yuan, Fang Fang, Bryan P. Yan, John E. Sanderson, Masaki Mogi
PLOS ONE.2023; 18(1): e0280280. CrossRef
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Frontiers in Medicine.2022;[Epub] CrossRef
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Journal of the American Heart Association.2022;[Epub] CrossRef
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Journal of Medical Case Reports.2021;[Epub] CrossRef
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Journal of the American Heart Association.2021;[Epub] CrossRef
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Journal of Cardiovascular Pharmacology.2021; 78(5): e648. CrossRef
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