A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients with Essential Hypertension and Type 2 Diabetes in Asia.

Chaicharn Deerochanawong,Yu Cho Woo,Wen-Ter Lai,Kuan-Cheng Chang,Aurauma Chutinet,Massimo Salvetti

doi:10.1155/2022/2717291

Abstract

This phase 4 study evaluated the efficacy and safety of azilsartan medoxomil (AZL-M) in patients with essential hypertension and type 2 diabetes mellitus (T2DM) in Hong Kong, Taiwan, and Thailand. This was a prospective, multicenter, single-arm, open-label study with patients aged 18–75 years with T2DM and essential hypertension and on stable treatment for T2DM. Patients with uncontrolled hypertension were treated with AZL-M 40 mg daily, with the option to uptitrate to 80 mg at 6 weeks. In all, 380 of the 478 patients screened in Hong Kong, Taiwan, and Thailand were enrolled. At week 6, 97 patients (25.5%) were titrated up to AZL-M 80 mg based on BP readings. At 12 weeks, 54.8% of patients reached the blood pressure (BP) goal of <140/85 mm Hg by trough sitting clinic BP (primary endpoint), and 62.8% and 27.0% achieved a BP of <140/90 mm Hg and <130/80 mm Hg, respectively. The efficacy of AZL-M over 12 weeks was also seen in different age and body mass index groups. The incidence of treatment emergent adverse events (TEAEs) was 12.9% before 6 weeks and 16.1% after 6 weeks, and they were mostly mild in severity. The most frequent TEAE was dizziness (4.7%). The incidence of TEAEs leading to study drug discontinuation (4.5%) and drug-related TEAEs (5.0% before 6 weeks; 3.9% after 6 weeks) was low. In patients with essential hypertension and T2DM in Asia, treatment with AZL-M indicated a favorable efficacy and safety profile in achieving target BP.

Highlights

Hypertension (defined by the World Health Organization (WHO) as systolic blood pressure (SBP) and/or diastolic BP (DBP) ≥140/90 mmHg) is the leading risk factor for cardiovascular disease (CVD)
Recent guidelines published by the American College of Cardiology (ACC) and American Heart Association (AHA) have lowered the definition of high BP to 130/80 mm Hg, suggesting a higher burden of illness associated with hypertension [7]
E primary endpoint, which was the percentage of patients with BP < 140/85 mm Hg at week 12, was determined using a generalized estimated equation (GEE) logistic regression model, including SBP as the covariate, country, baseline hypertension treatment (BHT) status, visit, and BHT and visit interaction as fixed factors

Summary

Introduction

Hypertension (defined by the World Health Organization (WHO) as systolic blood pressure (SBP) and/or diastolic BP (DBP) ≥140/90 mmHg) is the leading risk factor for cardiovascular disease (CVD). Key exclusion criteria included the following: uncontrolled essential hypertension despite concurrent treatment with 3 antihypertensive medications from different classes; type 1 or poorly controlled T2DM (HbA1c ≥ 9.5%); congestive heart failure; clinically relevant cardiac arrhythmias; severe obstructive coronary artery disease; severe renal impairment; and hyperkalemia E primary objective of the study was to determine the percentage of patients reaching a BP goal of

Results

Conclusions

Disclosure