Efficacy and Safety of Azilsartan Medoxomil and Telmisartan in Hypertensive Patients: A Randomized, Assessor-Blinded Study.

Background: Few studies have compared the safety and efficacy of azilsartan medoxomil (AZL-M) and telmisartan in hypertensive patients, especially using ambulatory blood pressure monitoring (ABPM).

Objective: The objective of this study was to compare the efficacy and safety profile of AZL-M and telmisartan in hypertensive patients using ABPM and clinic blood pressure (BP) monitoring.

Materials and Methods: This prospective, randomized, open-label, blinded endpoint, parallel-arm study included 700 patients, aged 18-70 years, with clinic and 24-h mean ambulatory systolic BP (SBP) of 150-180 mmHg and 130-170 mmHg, respectively. They were randomized equally into two groups: Group A received AZL-M 40 mg and Group T received telmisartan 40 mg; the dose was force titrated to 80 mg after 2 weeks if the response rate was not achieved. BP (clinical and ambulatory) was measured after 12 weeks and compared with baseline measurements.

Results: AZL-M significantly reduced the 24-h mean ambulatory SBP (Group A: 112.74 ± 7.58 mmHg; Group T: 113.96 ± 8.52 mmHg; P < 0.0001) and diastolic BP (Group A: 71.39 ± 5.89 mmHg; Group T: 67.29 ± 6.79 mmHg; P < 0.0001) compared with telmisartan at week 12. The clinic SBP significantly decreased in Group A at weeks 4 (-30.69± -0.33 mmHg) and 12 (-39.69± -1.09 mmHg) (for both, P = 0.0001). Dose titration was done in 99 and 128 patients from Group A and Group T, respectively ( P = 0.012). Headache was the most common adverse drug reaction (Group A: 21; Group T: 27) and fatigue the least.

Conclusion: This study found that AZL-M has greater antihypertensive efficacy than telmisartan, with comparable side effects. In addition, ABPM was shown to be a feasible method for such studies.