A Randomized, Comparative, Multicentric Evaluation of Atenolol/Amlodipine Combination with Atenolol Alone in Essential Hypertensive Patients

Abstract

As there is a strong, positive, and continuous correlation between blood pressure and risk of cardiovascular diseases; improved control of blood pressure is necessary to produce maximum reduction in clinical cardiovascular endpoints. The primary objective was to demonstrate that atenolol/amlodipine combination therapy is superior to atenolol monotherapy with respect to mean fall in systolic blood pressure and diastolic blood pressure. The secondary objective was to compare the response rate and to evaluate the tolerability of study medications. This randomized, comparative, multicentric, 12-week study consisted of screening visit followed by baseline visit 48-hours postscreening. All enrolled patients received 7-day placebo washout. Eligible patients were randomized to receive either atenolol 25 mg/amlodipine 2.5 mg or atenolol 25 mg alone. Nonresponders after 4 weeks of therapy were escalated to atenolol 50 mg/amlodipine 5 mg or atenolol 50 mg, respectively. Out of 190 enrolled patients (94: combination group; 96: monotherapy group), 174 patients (84: combination therapy, 90: monotherapy) completed the study. After 4 weeks of therapy, low-dose combination group was superior to low-dose monotherapy with respect to mean fall in SBP (P = 0.008) and DBP (P = 0.021) and response rate (P = 0.012). Also high-dose combination therapy was superior to high-dose monotherapy with respect to mean SBP (P = 0.001), DBP (P = 0.011), and response rate (P = 0.035) at the end of 12 weeks of therapy. At the end of therapy, significantly more number of patients from combination group achieved normalization of BP (SBP < 120 mmHg and DBP < 80 mmHg) (P = 0.009). Thus, once daily treatment with atenolol/amlodipine fixed-dose combination offers superior antihypertensive efficacy over atenolol monotherapy in patients with mild-to-moderate essential hypertension.