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<p>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 &lt;180 mmHg and mean sitting diastolic blood pressure (msDBP) between 90 and &lt;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, <i>p</i> &lt; 0.001). Reductions in msDBP (−6.0 vs. −1.9 mmHg, <i>p</i> &lt; 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%, <i>p</i> &lt; 0.001; 40.2% vs. 20.4%, <i>p</i>=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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月17日

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  • Hongjie Chi,
  • Xin Zhang,
  • Shumei Ma,
  • Gang Pan,
  • Xiaojuan Lian,
  • Yuanyuan Chen,
  • Yan Chen,
  • Hao Tang,
  • Zichen Liu,
  • Peng Mi,
  • Xiangmin Lin

摘要

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.