A Multicentric Observational Study on Azilsartan to Assess the Efficacy, Safety and Tolerability in the Management of Hypertension in Indian Population: ZEAL Study

Abstract

Background: Azilsartan is a recently approved angiotensin receptor blocker (ARB) available for the treatment of hypertension in India. Azilsartan has demonstrated unique properties which are different from the previous ARBs. The study objective was to assess the efficacy, safety of azilsartan in Indian subjects with hypertension. Methodology: The ZEAL study (AZilsartan Efficacy, SAfety and ToLerability Study) was an open label, non-comparative, multi-centric, observational study in Indian adult hypertensive patients. 152 centres were included in this study from across India by convenience sampling. Informed consent was taken from all participating subjects. Azilsartan 80 mg once daily was administered for 12 weeks. The primary outcome measure was decrease in mean seated systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the end of 12 weeks from the baseline value.  The secondary outcome measure included Global assessment of efficacy as evaluated by physician using a 4-point scale. Results: A total of 4560 subjects were recruited in the study, 30 subjects each from 152 centres. 4416 subjects completed the 12-weeks study. Among them 2881 (65.3 %) were men and 1535 (34.7%) women. Mean age of the subjects during the recruitment was 53.6 ± 10.79 years. In our study, at the baseline, the mean SBP and mean DBP was 152.33 ± 16.39 mm Hg and 94.06±8.74 mm Hg respectively.  At 6 weeks, the mean SBP was 143.9±13.6 mm Hg (∆8.43 ± 4.1 mm Hg) and 133.7±9.2 mm Hg (∆18.63±7.2 mm Hg) at the end of 12-weeks study which was clinically and statistically significant (P<0.05). Azilsartan was well tolerated. Global assessment of efficacy as evaluated by physician using a 4-point scale was very good or excellent for 77.8% of the study subjects. Conclusion: Azilsartan effectively reduced SBP and DBP in the study subjects and was well tolerated. Azilsartan is a valuable option for achieving BP targets.