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

doi:10.4178/epih.e2025054

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Correspondence Authors’ Reply: Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study: Hyesung Lee¹, Bin Hong², Chris Tzu-Ting Su³, Sungho Bea⁴, Han Eol Jeong⁵, Kyungyeon Jung², Michael Chun-Yuan Cheng³, Zoe Chi-Jui Chang³, Edward Chia-Cheng Lai³, Jongyoung Lee⁶; Epidemiol Health 2025;47:e2025054.
DOI: https://doi.org/10.4178/epih.e2025054
Published online: September 20, 2025

¹Department of Medical Informatics, Kangwon National University College of Medicine, Chuncheon, 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, MA, USA

⁵DSC Investment, Seoul, Korea

⁶Division of Cardiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea

Correspondence: Hyesung Lee Department of Medical Informatics, Kangwon National University College of Medicine, 1 Kangwondaehak-gil, Chuncheon 24341, Korea E-mail: hs.lee@kangwon.ac.kr

• Received: August 18, 2025 • Accepted: August 22, 2025

This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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REFERENCES

See the article "Letter to the Editor: Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study" on page e2025053.

Dear Editor,

We appreciate the thoughtful letter from Dr. Zhanyi Zhou regarding our recent study [1] on the safety of azilsartan medoxomil and amlodipine combination therapy in patients with hypertension. We thank the author for emphasizing the clinical importance of evaluating safety, specifically in patients with hypertension and concomitant heart failure.

While our study rigorously adjusted for multiple comorbidities, including chronic liver disease, chronic obstructive pulmonary disease, diabetes, and cerebrovascular and coronary artery disease, we acknowledge that heart failure was not included as a baseline covariate. This limitation was due to the lack of information on key clinical variables, such as New York Heart Association functional class and ejection fraction. However, given the new-user, active-comparator design and the robust adjustment for numerous relevant confounders, we expect that the prevalence and impact of heart failure would have been comparable between the treatment groups [2]. Furthermore, the relatively small sample size in the azilsartan medoxomil group and the anticipated low proportion of patients with heart failure limited our ability to perform a meaningful subgroup analysis by heart failure status in this study.

Considering the central role of angiotensin II receptor blockers in the management of both hypertension and guideline-directed heart failure, explicitly evaluating safety outcomes in patients with hypertension and concomitant heart failure would indeed provide valuable clinical guidance [3]. We fully support the recommendation that future studies incorporate such subgroup analyses to enhance the generalizability and clinical relevance of safety data across both general and high-risk populations.

NOTES

Ethics statement

This article does not contain any studies with human participants or animals performed by any of the authors.

Conflict of interest

The authors have no conflicts of interest to declare for this study.

Funding

None.

Acknowledgements

None.

Author contributions

Conceptualization: Lee H, Hong B, Su CTT, Bea S, Jeong HE, Jung K, Cheng MCY, Chang ZCJ, Lai ECC, Lee J. Data curation: Lee H. Formal analysis: Hong B. Funding acquisition: Lee H. Methodology: Lee H, Hong B, Su CTT, Bea S, Jeong HE, Jung K, Cheng MCY, Chang ZCJ, Lai ECC, Lee J. Project administration: Lee H. Visualization: Hong B. Writing – original draft: Lee H, Hong B. Writing – review & editing: Lee H, Hong B, Su CTT, Bea S, Jeong HE, Jung K, Cheng MCY, Chang ZCJ, Lai ECC, Lee J.

REFERENCES

1. Lee H, Hong B, Su CT, Bea S, Jeong HE, Jung K, et al. Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study. Epidemiol Health 2025;47:e2025029. https://doi.org/10.4178/epih.e2025029Article PubMed PMC
2. Patorno E, Gopalakrishnan C, Franklin JM, Brodovicz KG, Masso-Gonzalez E, Bartels DB, et al. Claims-based studies of oral glucose-lowering medications can achieve balance in critical clinical variables only observed in electronic health records. Diabetes Obes Metab 2018;20:974-984. https://doi.org/10.1111/dom.13184Article PubMed PMC
3. Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation 2022;145:e895-e1032. https://doi.org/10.1161/CIR.0000000000001063Article PubMed

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