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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
  • 4,999 View
  • 94 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
  • 13,699 View
  • 217 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
Risk of new-onset seizures following immunization against COVID-19: a self-controlled case-series study
Hwa Yeon Ko, Dongwon Yoon, Ju Hwan Kim, Han Eol Jeong, Seung Bong Hong, Won-Chul Shin, Ju-Young Shin, on behalf of the CoVaSC Investigators
Epidemiol Health. 2025;47:e2025024.   Published online May 2, 2025
DOI: https://doi.org/10.4178/epih.e2025024
  • 14,941 View
  • 130 Download
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
Despite emerging reports of new-onset seizures (NOS) following coronavirus disease 2019 (COVID-19) vaccination, safety evidence regarding the risk of NOS after vaccination remains limited. We aimed to investigate the potential association between NOS and COVID-19 vaccination.
METHODS
We conducted a self-controlled case series study utilizing a nationwide database linking the COVID-19 vaccination registry and the National Health Information Database (from February 2021 to October 2022). We identified adults (≥18 years) who received COVID-19 vaccination (BNT162b2, ChAdOx1 nCoV-19, mRNA-1273, NVX-CoV2373, or Ad26.COV2.S) and had a diagnosis of NOS accompanied by prescriptions of anti-seizure drugs. The observation period was defined as 240 days following vaccination. We evaluated the risk of NOS during a risk window of 28 days after vaccination compared to the control window (the remaining observation period excluding the risk window). Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were estimated using a conditional Poisson regression model.
RESULTS
Among 42,155,198 COVID-19 vaccine recipients, we identified 1,849 and 4,217 patients with NOS in the risk and control windows, respectively. There was no increased risk of NOS within the 28-day period following vaccination (IRR, 0.99; 95% CI, 0.94 to 1.05). Although results from subgroup analyses by vaccine type were largely consistent with the main findings (IRR, 0.95; 95% CI, 0.88 to 1.03 for BNT162b2; IRR, 0.95; 95% CI, 0.77 to 1.16 for ChAdOx1 nCoV-19; IRR, 1.58; 95% CI, 0.52 to 4.83 for Ad26.COV2.S), a marginally elevated risk was observed for mRNA-1273 (IRR, 1.21; 95% CI, 1.04 to 1.42).
CONCLUSIONS
There was no evidence of an increased risk of NOS following COVID-19 vaccination. These findings can be used as safety evidence in clinical decision-making and to bolster public confidence in COVID-19 vaccines.
Summary
Korean summary
· 질병관리청 코로나19백신 접종 등록자료와 국민건강보험공단의 청구 데이터베이스 연계 자료원을 활용하여 코로나19백신 접종과 경련/발작 발생 간의 관련성에 대한 안전성 평가를 수행함. · 자기-대조환자군 연구설계를 적용하여 4,215만 명 이상의 코로나19백신 접종자를 대상으로 분석한 결과, 대부분의 백신 종류에서 접종 후 28일 이내에 경련/발작 발생 위험이 증가하지 않았으며, mRNA-1273 백신에서만 위험이 다소 증가한 것으로 나타남. · 전반적으로, 본 연구는 코로나19백신 접종 후 경련/발작 발생 위험이 증가하지 않음을 보여주었으며, 이는 임상적 의사결정과 백신 안전성에 대한 신뢰를 높이는 근거로 활용될 수 있음.
Key Message
· A nationwide self-controlled case series study investigated whether COVID-19 vaccination increases the risk of new-onset seizures (NOS) in adults by analyzing over 42 million vaccine recipients. · The results showed no increased risk of NOS within 28 days after vaccination for most vaccine types, with the exception of a marginally elevated risk for the mRNA-1273 vaccine. · Overall, the study found no evidence of increased NOS risk following COVID-19 vaccination, supporting the safety of these vaccines for clinical decision-making.
Socioeconomic disparities in Korea by health insurance type during the COVID-19 pandemic: a nationwide study
Han Eol Jeong, Jongseong Lee, Hyun Joon Shin, Ju-Young Shin
Epidemiol Health. 2021;43:e2021007.   Published online January 13, 2021
DOI: https://doi.org/10.4178/epih.e2021007
  • 31,197 View
  • 449 Download
  • 18 Web of Science
  • 16 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
This study explored socioeconomic disparities in Korea using health insurance type as a proxy during the ongoing coronavirus disease 2019 (COVID-19) pandemic.
METHODS
We conducted a retrospective cohort study using Korea’s nationwide healthcare database, which contained all individuals who received a diagnostic test for COVID-19 (n=232,390) as of May 15, 2020. We classified our cohort by health insurance type into beneficiaries of the National Health Insurance (NHI) or Medicaid programs. Our study outcomes were infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19-related outcomes, a composite of all-cause death, intensive care unit admission, and mechanical ventilation use. We estimated age-, sex-, and Charlson comorbidity index score–adjusted odds ratios (aORs) with 95% confidence intervals (CIs) using a multivariable logistic regression analysis.
RESULTS
Of the 218,070 NHI and 14,320 Medicaid beneficiaries who received COVID-19 tests, 7,777 and 738 tested positive, respectively. The Medicaid beneficiaries were older (mean age, 57.5 vs. 47.8 years), more likely to be males (47.2 vs. 40.2%), and had a higher comorbidity burden (mean CCI, 2.0 vs. 1.7) than NHI beneficiaries. Compared to NHI beneficiaries, Medicaid beneficiaries had a 22% increased risk of SARS-CoV-2 infection (aOR, 1.22; 95% CI, 1.09 to 1.38), but had no significantly elevated risk of COVID-19-related outcomes (aOR 1.10, 95% CI 0.77 to 1.57); the individual events of the composite outcome yielded similar findings.
CONCLUSIONS
As socioeconomic factors, with health insurance as a proxy, could serve as determinants during the current pandemic, pre-emptive support is needed for high-risk groups to slow its spread.
Summary
Korean summary
사회경제적 수준과 코로나19 발생률 및 예후 간 연관성 등 코로나19로 인한 건강 불평등 현상은 아직 확인된 바가 없다. 건강보험 가입자 대비 의료급여 수급권자에서 SARS-CoV-2의 감염 위험이 더 높게 나타났다. 코로나19의 확산을 늦추기 위해서는, 의료급여 수급권자를 비롯한 취약계층 대상의 선제적 지원이 제공되어야 한다.
Key Message
Socioeconomic status, with health insurance as a proxy, could explain health inequalities in clinical outcomes, diverse disease incidence and prognosis, during the COVID-19 pandemic.

Citations

Citations to this article as recorded by  
  • Severe COVID-19 in the Republic of Korea: Epidemiology, Risk Factors, Therapeutics, and Prognostic Models From Nationwide Data
    Jun Yong Choi
    Journal of Korean Medical Science.2026;[Epub]     CrossRef
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    Tae Jung Kim, Ji Sung Lee, Jun Yup Kim, Do Yeon Kim, Yong Soo Kim, Dong-Wan Kang, Jihoon Kang, Beom Joon Kim, Seong-Eun Kim, Jong-Moo Park, Kyungbok Lee, Jeong-Yoon Lee, Yong-Jin Cho, Han-Yeong Jeong, Han-Gil Jeong, Byeolnim Ban, Mi Sun Oh, Soo Joo Lee, J
    International Journal of Stroke.2026; 21(7): 1030.     CrossRef
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    Obinna C. Godfrey, Eze A. Adindu, Uwem O. Edet, Elizabeth N. Mbim, Gabriel C. Eze, Fredrick C. Asogwa, Innocent Benjamin, Terkumbur E. Gber, Rawlings A. Timothy, Hitler Louis
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    Annals of Geriatric Medicine and Research.2023; 27(3): 241.     CrossRef
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