A phase III, open-label, multicenter study to evaluate the safety and efficacy of long-term triple combination therapy with azilsartan, amlodipine, and hydrochlorothiazide in patients with essential hypertension. (4th May 2018)

• Record Type: Journal Article
• Authors: Rakugi, Hiromi; Shimizu, Kohei; Nishiyama, Yuya; Sano, Yuhei; Umeda, Yuusuke
• Is Part Of: Blood pressure. Volume 27:Number 3(2018)
• Page Start: 125
• Page End: 133
• Publication Date: 2018-05-04
• Subjects: Hypertension -- Azilsartan -- angiotensin II receptor blocker (ARB) -- calcium channel blocker (CCB) -- diuretic -- triple combination therapy -- amlodipine -- hydrochlorothiazide; Blood pressure -- Periodicals; Hypertension -- Periodicals; Hypertension -- Periodicals; Blood Pressure -- Periodicals; 612.14
• DOI: 10.1080/08037051.2017.1412797
• Languages: English
• ISSNs: 0803-7051

Abstract

Abstract: Purpose: Patients with essential hypertension who are receiving treatment with an angiotensin II receptor blocker and a calcium channel blocker often develop inadequate blood pressure (BP) control and require the addition of a diuretic. This study aimed to evaluate the long-term safety and efficacy of a triple combination therapy with 20 mg azilsartan (AZL), 5 mg amlodipine (AML) and 12.5 mg hydrochlorothiazide (HCTZ). Materials and methods: The phase III, open-label, multicenter study (NCT02277691) comprised a 4-week run-in period and 52-week treatment period. Patients with inadequate BP control despite AZL/AML therapy ( n = 341) received 4 weeks' treatment with AZL/AML (combination tablet) + HCTZ (tablet) and 4 weeks' treatment with AZL/AML/HCTZ (combination tablet) in a crossover manner, followed by AZL/AML/HCTZ (combination tablet) from Week 8 of the treatment period up to Week 52. The primary and secondary endpoints were long-term safety and BP (office and home), respectively. Results: Most adverse events (AEs) were mild or moderate in intensity, and no deaths or treatment-related serious AEs were reported. The triple therapy provided consistent BP-lowering effects in both office and home measurements. Conclusions: The triple combination therapy with AZL/AML/HCTZ was well tolerated and effective for 52 weeks in Japanese patients with essential hypertension.