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

TL;DR

A study found that combining Allisartan Isoproxil and Amlodipine significantly lowers blood pressure more effectively than using Allisartan alone in patients with hypertension.

Contribution

This study provides clinical evidence that the ALI/AML combination is more effective in reducing blood pressure than ALI monotherapy.

Findings

ALI/AML reduced systolic blood pressure significantly more than ALI alone after 12 weeks.

The ALI/AML group had a higher proportion of patients achieving target blood pressure goals.

The combination therapy was well-tolerated and showed sustained efficacy up to 52 weeks.

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.

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