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Authors’ Reply: 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;47:e2025054.   Published online September 20, 2025
DOI: https://doi.org/10.4178/epih.e2025054
  • 4,504 View
  • 90 Download
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Abstract
Summary
Original Articles
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;47:e2025029.   Published online May 28, 2025
DOI: https://doi.org/10.4178/epih.e2025029
  • 12,641 View
  • 210 Download
  • 2 Web of Science
  • 2 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
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.
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.

Citations

Citations to this article as recorded by  
  • Letter to the Editor: Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study
    Zhanyi Zhou
    Epidemiology and Health.2025; 47: e2025053.     CrossRef
  • Authors’ Reply: 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
    Epidemiology and Health.2025; 47: e2025054.     CrossRef
Prevalence of cardiovascular-kidney-metabolic syndrome in Korea: Korea National Health and Nutrition Examination Survey 2011-2021
Sung-Bin Hong, Ji-Eun Kim, Seung Seok Han, Joseph J. Shearer, Jungnam Joo, Ji-Yeob Choi, Véronique L. Roger
Epidemiol Health. 2025;47:e2025005.   Published online February 14, 2025
DOI: https://doi.org/10.4178/epih.e2025005
  • 19,589 View
  • 446 Download
  • 9 Web of Science
  • 11 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
The American Heart Association (AHA) recently defined cardiovascular-kidney-metabolic (CKM) syndrome to better characterize the associations among cardiovascular, kidney, and metabolic diseases. Although about 9 in 10 United States adults have at least 1 risk factor for CKM syndrome, its prevalence in other populations is less understood. To fill this gap, we examined the prevalence of CKM syndrome in Korea and its association with demographic and socioeconomic status (SES).
METHODS
Using data from the Korean National Health and Nutrition Examination Survey between 2011 and 2021, we calculated the prevalence of CKM syndrome across the following stages: stage 0 (no risk factors), stage 1 (excess or dysfunctional adiposity), stage 2 (other metabolic risk factors or chronic kidney disease), and stages 3-4 (subclinical/clinical cardiovascular diseases) among adults aged ≥20 years. Weighted analyses were used to estimate prevalence and 95% confidence intervals (CIs) for each CKM syndrome stage, stratified by age, gender, and SES factors.
RESULTS
Among 54,994 Korean adults, the prevalence of CKM syndrome was as follows: stage 0 (25.2%; 95% CI, 24.7 to 25.8), stage 1 (19.3%; 95% CI, 18.9 to 19.7), stage 2 (51.6%; 95% CI, 51.1 to 52.2), and stages 3-4 (3.9%; 95% CI, 3.7 to 4.0). The prevalence of stages 2 and 3-4 was higher in men than in women. In addition, stages 3-4 were more prevalent among rural residents and those with lower education or income.
CONCLUSIONS
About 3 out of 4 Koreans are at risk for CKM syndrome. These findings highlight that CKM syndrome is a global health problem and that interventions are urgently needed to prevent further progression.
Summary
Korean summary
최근, 심장-신장-대사 증후군을 하나로 묶어 관리하는 것의 필요성이 대두되고 있다. 본 연구 결과 20세 이상의 한국 성인들의 74.8%가 심장-신장-대사 증후군의 위험군에 속해 있었다. 또한 그 정도가 증가하는 추세로 나타나 적절한 관리가 필요해 보인다.
Key Message
Recently, the need for an integrated approach to managing cardiovascular-kidney-metabolic (CKM) syndrome has been emphasized. This study found that 74.8% of Korean adults aged 20 and older had a risk for CKM syndrome. Moreover, the prevalence is increasing, highlighting the necessity of proper management.

Citations

Citations to this article as recorded by  
  • Stage-specific risks of mortality and renal outcomes in cardiovascular-kidney-metabolic syndrome: findings from a nationwide Japanese cohort
    Kenta Fujimoto, Masao Kikuchi, Michikazu Nakai, Tsuneo Konta, Kunitoshi Iseki, Kazuhiko Tsuruya, Kunihiro Yamagata, Ichiei Narita, Toshiki Moriyama, Yugo Shibagaki, Masato Kasahara, Masahide Kondo, Koichi Asahi, Tsuyoshi Watanabe, Koichi Kaikita, Shouichi
    Clinical and Experimental Nephrology.2026; 30(3): 434.     CrossRef
  • 2026 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association
    Latha P. Palaniappan, Norrina B. Allen, Zaid I. Almarzooq, Cheryl A.M. Anderson, Pankaj Arora, Christy L. Avery, Carissa M. Baker-Smith, Nisha Bansal, Maria E. Currie, Rebecca S. Earlie, Wenjun Fan, Jessica L. Fetterman, Bethany Barone Gibbs, Debra G. Hea
    Circulation.2026;[Epub]     CrossRef
  • The Prevalence of Cardiovascular–Kidney–Metabolic Syndrome: A Review of Published Estimates and New Findings from BRFSS Surveys
    Steven S. Coughlin, Nikul Parikh, Ashley Oh, Biplab Datta, Marlo Vernon, Jennifer Sullivan
    Cardiovascular Medicine.2026; 29(1): 5.     CrossRef
  • Cardiovascular-kidney-metabolic syndrome stages, stage transitions, and risk of cardiovascular disease and mortality: The Tehran Lipid and Glucose Study
    Soroush Masrouri, Navid Ebrahimi, Amirhossein Hasanpour, Babak Sohrabi, Fereidoun Azizi, Farzad Hadaegh
    Diabetes Research and Clinical Practice.2026; 235: 113223.     CrossRef
  • Epidemiology of cardiovascular–kidney–metabolic syndrome
    Lucas A. Mavromatis, Morgan E. Grams
    Nature Reviews Nephrology.2026;[Epub]     CrossRef
  • Cardiovascular–kidney–metabolic syndrome: a comprehensive review of pathophysiology, epidemiology, diagnosis, and management
    Stanislovas S. Jankauskas, Klara Komici, Fahimeh Varzideh, Luigi Simone Aversa, Urna Kansakar, Maria Luisa D’Onghia, Shivangi Pande, Pasquale Mone, Gaetano Santulli
    Cardiovascular Diabetology.2026;[Epub]     CrossRef
  • Residual cholesterol inflammatory index and its prognostic role in mortality among individuals with cardiovascular–kidney–metabolic syndrome stages 0–3 based on U.S. and Chinese national cohorts
    Shouxin Wei, Sijia Yu, Chuan Qian, Zhengwen Xu, Yindong Jia
    European Journal of Medical Research.2025;[Epub]     CrossRef
  • Relationship between estimated pulse wave velocity trajectories and cardiovascular disease risk in patients with cardiovascular-kidney-metabolic syndrome stages 0–3
    Tingting Chen, Huangyi Yin, Yubo Zhou, Min Liang
    Nutrition, Metabolism and Cardiovascular Diseases.2025; 35(11): 104192.     CrossRef
  • The Reply
    Ji-Eun Kim, Véronique L. Roger, Joseph J. Shearer
    The American Journal of Medicine.2025; 138(8): e163.     CrossRef
  • Prevalence of Cardiovascular–Kidney–Metabolic (CKM) Syndrome in Lithuanian Adults: Insights from a Nationwide Real-World Study Using Electronic Health Records
    Gediminas Urbonas, Indrė Čeponienė, Inga Arūnė Bumblytė, Marius Miglinas, Lina Gatelytė, Živilė Steponkutė, Aušra Degutytė, Ingrida Grabauskytė, Džilda Veličkienė
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  • Data-driven cluster analysis identifies distinct types of cardiovascular-kidney-metabolic syndrome
    Mengge Yang, Chang Su, Xiaona Chang, Guang Wang, Jia Liu
    European Journal of Preventive Cardiology.2025;[Epub]     CrossRef
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