AUTHOR=Zhu Ling , Wei Guo-Cui , Xiao Qing , Chen Qian-Lan , Zhao Qian , Li Xiu-xia , Pan Ling-ai , Xiong Xuan 

TITLE=Efficacy and safety of azilsartan medoxomil in the treatment of hypertension: a systematic review and meta-analysis

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1383217

DOI=10.3389/fcvm.2024.1383217

ISSN=2297-055X

ABSTRACT=Background: ARBs are utilized for the management of hypertension and diabetes. Previous metaanalyses suggested that AZL-M had improved BP reduction, but there were no safety findings or suggestions in patients with hypertension or diabetes. Methods: We performed an efficacy and safety meta-analysis of RCTs of AZL-M therapy for reducing blood pressure (BP) in patients with hypertension. Patients with hypertension complicated by diabetes were analyzed. The relevant literature was searched in English and Chinese databases for RCTs involving AZL-M in hypertension. Efficacy variables included the change from baseline in the 24-hour mean systolic/diastolic BP measured by ambulatory BP monitoring, the change from baseline in clinic systolic/diastolic BP, and responder rates. Safety variables included total adverse events (AEs), serious AEs, AEs leading to discontinuation, and AE related to the study drug. The raw data from the included studies were utilized to calculate the odds ratio (OR) for dichotomous data and the mean difference (MD) for continuous data, accompanied by 95% confidence intervals (CIs). Statistical analysis was performed using R software. Results: A total of 11 RCTs met the inclusion criteria, representing a total of 7608 patients, 5 of whom had diabetes. Pooled analysis suggested a reduction in BP among patients randomized to 40 mg of AZL-M versus control therapy: 24-hour ABPM mean SBP (MD: -2.85 mmHg), clinic SBP (MD: -3.48 mmHg), clinic DBP (MD: -1.96 mmHg), and for 80 mg of AZL-M versus control therapy: 24-hour ABPM mean SBP (MD: -3.59 mmHg), 24-hour ABPM mean DBP (MD: -2.62 mmHg), clinic SBP (MD: -4.42 mmHg), clinic DBP (MD: -3.09 mmHg), and responder rate (OR: 1.46). There was no difference in the reduction of risks other than dizziness (OR: 1.56) in the 80 mg AZL-M group or urinary tract infection (OR: 1.82) in the 40 mg AZL-M group. Analysis of patients with diabetes revealed that AZL-M can provide superior management, while safety and tolerability were similar to that of the control therapy. Conclusions: AZL-M appears to reduce BP to a greater extent than dose-control therapy, and AZL-M does not increase the risk of adverse events in patients with hypertension and diabetes compared with placebo.