A Randomized Controlled Study of Azilsartan Amlodipine Tablets vs. Alisartan Isoproxil Amlodipine Tablets in the Treatment of Essential Hypertension for 8 Weeks:A 4-Week Efficacy Analysis

Corresponding author: WangBaogong, wangbaogong1@126.com

DOI: 10.12201/bmr.202606.00006

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  Abstract: Background Azilsartan amlodipine is a latest-generation ARB/CCB single-pill combination (SPC) product with potent antihypertensive potential.However,it has not been widely used in clinical practice,and evidence of clinical benefit remains insufficient.Therefore,we conducted this 8-week randomized controlled study to compare the efficacy and safety of azilsartan amlodipine tablets and alisartan isoproxil amlodipine tablets in the treatment of essential hypertension. The intended follow-up period of this study was 8 weeks,and this paper reports the 4-week interim data for the first time,aiming to preliminarily evaluate the early efficacy and safety of the drugs and provide a basis for the subsequent complete endpoint analysis. Method A total of 120 patients with essential hypertension were enrolled and randomly assigned into two groups, receiving Azilsartan Amlodipine Tablets and Allisartan Isoproxil Amlodipine Tablets respectively.Follow-up visits were scheduled at Weeks 4 and 8 of treatment.The reductions in clinic seated SBP and DBP from baseline,blood pressure control rate,treatment response rate and adverse events were compared between the two groups.Only the interim(Week 4) outcomes including baseline-adjusted declines in clinic seated SBP/DBP and blood pressure control rate were presented in the current analysis. Result After 4 weeks of treatment,the mean reductions in office sitting SBP and DBP were 18.3±14.2 mmHg and 8.8±9.4 mmHg in the azilsartan amlodipine group, respectively,which were higher than those in the alisartan isoproxil amlodipine group (16.2±11.5 mmHg and 7.0±7.4 mmHg,respectively).The treatment target achievement rate at 4 weeks was 64.41% in the azilsartan amlodipine group and 52.54% in the alisartan isoproxil amlodipine group. Conclusion The 4-week interim data of this study preliminarily indicate that azilsartan amlodipine can improve blood pressure in patients at an early stage.It shows superior antihypertensive efficacy compared with alisartan isoproxil amlodipine and can be a preferred drug for patients with poorly controlled essential hypertension.This is a week 4 interim analysis and full 8-week follow-up data are required to confirm it’s efficacy and safety.

  Key words: Azilsartan Amlodipine、seated clinic systolic blood pressure、seated clinic diastolic blood pressure、BP control rate

  Submit time: 8 June 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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