Abstract

EVALUATION OF SAFETY AND EFFICACY OF FIXED DOSE COMBINATION OF TELMISARTAN 20mg AND AMLODIPINE BESYLATE WITH ATENOLOL/AMLODIPINE COBMINATION FOR THE TREATMENT OF ESSENTIAL HYPERTENSION

R. Suthakaran*

Abstract

Objective: To evaluate the efficacy and safety of the telmisartan plus amlodipine (T/A) single-pill combination (SPC) in Asian patients with hypertension whose blood pressure (BP) was not adequately controlled on either monotherapy or on low-dose combination therapy. Patients and Methods: A total of 190 eligible patients (TEST GROUP: 94 subjects; COMPARATOR: 96 subjects) satisfying inclusion/exclusion criteria were enrolled on the study. Nine patients from test group and six patients from reference group were lost to follow-up. 1 patient from test group was withdrawn due to adverse event. A total of 174 patients completed the study (test group: 84; reference group: 90). The 2 treatment groups were similar with respect to demography and baseline disease characteristics. Results: At the end of 4 weeks of therapy, 62 patients from test group and 50 patients from reference group responded to the therapy (SBP < 140 mmHg and DBP < 90 mmHg). Sixty-two non responders (Ne/Am combination therapy: 22; At/Am combination therapy:40) were escalated to respective step-up therapies to receive Nebivolol 5 mg/Amlodipine 2.5 mg and atenolol 50 mg/Amlodipine 2.5 mg for further 8 weeks. At the end of therapy, total 23 patients (Ne/Am combination therapy: 12; At/Am combination therapy group: 11) responded to the step-u p therapies (SBP < 140 mmHg and DBP < 90 mmHg). Step-up therapy of Ne/Am combination group showed significantly better response rate as compared with step-up therapy of atenolol/Amlodipine. Discussion and Conclusion: The primary goal of treating hypertension is to reduce their blood pressure to target level, which eventually leads to a reduction in the long-term total risk of cardiovascular morbidity and mortality.

Keywords: Hypertension; Diabetes; Telmesartan; Amlodipine; Angina; Tachyarrhythmias.