Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Hypertension and Cardiovascular Risk Factors,Advances in Therapy

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Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Hypertension and Cardiovascular Risk Factors
Advances in Therapy ( IF 3.4 ) Pub Date : 2023-08-31 , DOI: 10.1007/s12325-023-02632-9
Jaewon Oh ₁ , Wonho Kim ₂ , Gee-Hee Kim ₃ , Hack-Lyoung Kim ₄ , Sang-Don Park ₅ , Kyung Wan Min ₆ , Dongkeun Hyun ₇ , Jun Hwa Hong ₈ , Soo Lim ₉ , Jinho Shin ₁₀ ,

Affiliation

Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
Division of Cardiology, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, College of Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji University School of Medicine, Seoul, Republic of Korea.
Department of Neurosurgery, School of Medicine, Inha University, Incheon, Republic of Korea.
Division of Endocrinology, Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Republic of Korea.
Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.

Introduction

Patients with hypertension and additional cardiovascular risk factors pose a challenge by requiring more intensive blood pressure (BP) control. Single-pill combination (SPC) therapy can benefit these patients by improving medication adherence.

Methods

This prospective, multicenter observational study assessed the real-world safety and effectiveness of an SPC containing olmesartan, amlodipine, and hydrochlorothiazide (O/A/H) in South Korean patients with hypertension and cardiovascular risk factors. BP control rates, defined as the percentage of patients achieving systolic BP (SBP) < 130 mmHg and diastolic BP (DBP) < 80 mmHg for intensive BP control, and < 140 mmHg and < 90 mmHg, respectively, for standard BP control, were investigated across various cardiovascular risk groups, along with changes in SBP and DBP from baseline to week 24.

Results

The most prevalent cardiovascular risk factor was age (≥ 45 years in men, ≥ 55 years in women, 86.1%), followed by cardiovascular diseases (64.4%), dyslipidemia (53.7%), body mass index ≥ 25 kg/m² (53.5%), and diabetes mellitus (DM) (46.3%). Switching to O/A/H showed significant BP reduction, with a mean change of − 17.8 mmHg/− 9.3 mmHg in SBP/DBP within 4 weeks. The intensive BP control rate was 41.4% (95% confidence interval [CI] 39.5, 43.4), and the standard BP control rate was 73.3% (95% CI 71.5, 75.1), with better control rates in the risk age group (43.1% and 74.1%, respectively) and cardiovascular disease group (42.0% and 73.8%, respectively). The DM group had relatively lower control rates (37.5% for intensive control and 69.4% for standard control). Common adverse drug reactions included dizziness (2.91%), hypotension (1.51%), and headaches (0.70%).

Conclusion

The SPC therapy of O/A/H caused a rapid and sustained reduction in SBP/DBP in patients’ hypertension and additional cardiovascular risk factors. The therapy was safe and well tolerated.

Study Registration Number

KCT0003401 (https://cris.nih.go.kr/cris/search/detailSearch.do/20795).

中文翻译：

奥美沙坦/氨氯地平/氢氯噻嗪单药复方对患有高血压和心血管危险因素的韩国患者的真实有效性和安全性

介绍

患有高血压和其他心血管危险因素的患者面临着需要加强血压 (BP) 控制的挑战。单药组合 (SPC) 疗法可以通过提高药物依从性来使这些患者受益。

方法

这项前瞻性、多中心观察性研究评估了含有奥美沙坦、氨氯地平和氢氯噻嗪 (O/A/H) 的 SPC 在患有高血压和心血管危险因素的韩国患者中的真实安全性和有效性。血压控制率，定义为强化血压控制时收缩压 (SBP) < 130 mmHg 和舒张压 (DBP) < 80 mmHg 以及标准血压控制分别 < 140 mmHg 和 < 90 mmHg 的患者百分比，对不同心血管风险组进行了调查，以及从基线到第 24 周的 SBP 和 DBP 变化。

结果

最常见的心血管危险因素是年龄（男性≥45岁，女性≥55岁，86.1%），其次是心血管疾病（64.4%）、血脂异常（53.7%）、体重指数≥25 kg/m ² （ 53.5%）和糖尿病（DM）（46.3%）。改用 O/A/H 后血压显着降低，4 周内 SBP/DBP 平均变化为 − 17.8 mmHg/− 9.3 mmHg。强化血压控制率为41.4%（95%置信区间[CI] 39.5, 43.4），标准血压控制率为73.3%（95% CI 71.5, 75.1），风险年龄组的控制率更好（43.1 %和74.1%）和心血管疾病组（分别为42.0%和73.8%）。 DM组的控制率相对较低（强化控制为37.5%，标准控制为69.4%）。常见的药物不良反应包括头晕（2.91%）、低血压（1.51%）和头痛（0.70%）。