Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients with Essential Hypertension: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomised study.

Abstract

This multicenter, double-blind, parallel-group, randomised controlled phase III study evaluated the efficacy and safety of the Allisartan Isoproxil 240 mg /Amlodipine 5 mg (ALI/AML) combination compared with ALI 240 mg monotherapy in patients with mild-to-moderate essential hypertension. Patients aged 18 to 70 years with mean sitting systolic blood pressure (msSBP) between 140 and <180 mmHg and mean sitting diastolic blood pressure (msDBP) between 90 and <110 mmHg were randomised 1:1 to receive ALI/AML or ALI once-daily for 12 weeks after a 4-week treatment with ALI, followed by an open-label extension period with ALI/AML up to week 52. A total of 199 patients were randomised (ALI/AML: n = 99, ALI: n = 100) with 169 completing the study. Baseline characteristics were comparable between groups. After 12 weeks of randomisation, the reduction in msSBP (primary endpoint) was significantly greater in the ALI/AML group vs the ALI group (-18.3 vs. -9.3 mmHg, p < 0.001). Reductions in msDBP (-6.0 vs. -1.9 mmHg, p < 0.001) and 24-hour mean ambulatory systolic/diastolic blood pressure (-19.9/-10.1 vs. -6.9/-4.2 mmHg) were more pronounced in the ALI/AML group. Additionally, a greater proportion of patients achieved the BP response and target office BP in the ALI/AML group compared to the ALI group (53.6% vs. 25.5%, p < 0.001; 40.2% vs. 20.4%, p=0.0026). AML/ALI combination was generally safe and well tolerated, with sustained efficacy up to 52 weeks. The study concluded that ALI/AML offers a convenient, single-pill option for effective BP reduction in hypertensive patients.