Efficacy and safety of azilsartan medoxomil and telmisartan in hypertensive patients: A randomized, assessor-blinded study

• Main Authors: Megha Garg, Geetesh Manik, Alok Singhal, V K Singh, Rohit K Varshney, Aseem Sethi
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2020-01-01
• Series: Saudi Journal of Medicine and Medical Sciences
• Subjects: adverse drug reaction; ambulatory blood pressure monitoring; azilsartan medoxomil; hypertension; telmisartan
• Online Access: http://www.sjmms.net/article.asp?issn=1658-631X;year=2020;volume=8;issue=2;spage=87;epage=94;aulast=Garg

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.