Abstrakt

Efficacy of Allisartan Isoproxil in the Treatment of Mild-to-Moderate Essential Hypertension

Hongyi Wang, Yang Xi, Yuanyuan Chen, Luyan Wang, Fan Yang, Xining Lu, Ningling Sun*

Objective: This study aimed to assess the clinical efficacy of allisartan isoproxil, a selective nonpeptide Angiotensin II (AT1) receptor blocker developed independently in China for the treatment of mild-to-moderate essential hypertension.

Methods: Patients with Essential Hypertension (EH) aged 18-75 years with 18.5 kg/m² ≤ BMI ≤ 30 kg/m², 140 mmHg ≤ Systolic Blood Pressure (SBP) <180 mmHg, and 90 mmHg ≤ Diastolic Blood Pressure (DBP)<110 mmHg were selected at 44 sites in China from September 9, 2016, to December 7, 2018. The individuals were administered 240 mg allisartan isoproxil tablets daily for 4 weeks, and those with controlled blood pressure continued monotherapy for 8 weeks. Patients with uncontrolled blood pressure were randomly assigned (1:1) to one of two groups: allisartan isoproxil tablet (240 mg)+indapamide sustained-release tablet (1.5 mg) (A+D) or allisartan isoproxil tablet+amlodipine besylate tablet (5 mg) (A+C) and were treated for 8 weeks. The primary efficacy endpoint was the sitting blood pressure control rate at week 12. The secondary efficacy endpoints were the rates of sitting blood pressure control, sitting blood pressure drop from baseline, and ambulatory blood pressure decrease at weeks 4 and 8.

Results: This study included 2126 patients. After 12 weeks of treatment, SBP and DBP decreased by 19.24 ± 12.02 and 10.63 ± 8.89 mmHg, respectively, and the overall rate of blood pressure control was 78.56%. After 4 and 8 weeks of treatment, the control rates were 68.85% and 79.99%, respectively.

Patients with controlled blood pressures after 4 weeks of treatment with allisartan isoproxil continued monotherapy, and Sitting Blood Pressures (SBP/DBP) decreased by 19.12 ± 11.71/10.84 ± 8.73 mmHg after 12 weeks of treatment (both p<0.0001). After 4 and 8 weeks of combination therapy, blood pressure was further reduced, and the reductions and rates of control were comparable between the A+D and A+C groups, with no statistically significant differences. A total of 48 patients with monotherapy-controlled blood pressure underwent ambulatory blood pressure monitoring, with a baseline 24 h ambulatory blood pressure of 133.29 ± 11.56/80.46 ± 10.19 mmHg, a mean decrease in ambulatory blood pressure of 10.04 ± 10.87/5.50 ± 8.07 mmHg after 12 weeks of treatment, and consistent reductions between day and night. SBP and DBP had trough-to-peak ratios of 64.64% and 62.63% and smoothness indices of 3.82 and 2.92, respectively. The overall rate of adverse reactions was 7.26%, with 96.15% mild and no severe or life-threatening adverse reactions.

Conclusion: An allisartan-isoproxil-based antihypertensive regimen that is safe and tolerable can effectively control blood pressure in patients with mild-to-moderate essential hypertension.