PMID- 35036003 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220118 IS - 2090-0384 (Print) IS - 2090-0392 (Electronic) VI - 2022 DP - 2022 TI - A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients with Essential Hypertension and Type 2 Diabetes in Asia. PG - 2717291 LID - 10.1155/2022/2717291 [doi] LID - 2717291 AB - 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. CI - Copyright (c) 2022 Chaicharn Deerochanawong et al. FAU - Deerochanawong, Chaicharn AU - Deerochanawong C AUID- ORCID: 0000-0001-9666-7050 AD - Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit Medical School, Bangkok, Thailand. FAU - Chang, Kuan-Cheng AU - Chang KC AD - Division of Cardiovascular Medicine, Department of Medicine, China Medical University Hospital and Graduate Institute of Biomedical Sciences, China Medical University, Taichung, Taiwan. FAU - Woo, Yu Cho AU - Woo YC AD - Department of Medicine, Queen Mary Hospital, Pok Fu Lam, Hong Kong. FAU - Lai, Wen-Ter AU - Lai WT AD - Cardiology, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan. FAU - Chutinet, Aurauma AU - Chutinet A AD - Chulalongkorn Stroke Center, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. LA - eng PT - Journal Article DEP - 20220107 PL - United States TA - Int J Hypertens JT - International journal of hypertension JID - 101538881 PMC - PMC8759883 COIS- The authors declare no conflicts of interest regarding the publication of this paper. EDAT- 2022/01/18 06:00 MHDA- 2022/01/18 06:01 PMCR- 2022/01/07 CRDT- 2022/01/17 06:00 PHST- 2020/01/24 00:00 [received] PHST- 2021/11/10 00:00 [revised] PHST- 2021/12/15 00:00 [accepted] PHST- 2022/01/17 06:00 [entrez] PHST- 2022/01/18 06:00 [pubmed] PHST- 2022/01/18 06:01 [medline] PHST- 2022/01/07 00:00 [pmc-release] AID - 10.1155/2022/2717291 [doi] PST - epublish SO - Int J Hypertens. 2022 Jan 7;2022:2717291. doi: 10.1155/2022/2717291. eCollection 2022.