open non-comparative study of efficacy and toleration of amlodipine in the treatment of mild to moderate essential hypertension in general clinical practice

ABSTRACT

Forty three patients with a mean age of 46.3 years were selected for this open, non-comparative clinical study to evaluate the efficiency and safety of amlodipine as mono-therapy or in combination in the treatment of mild to moderate essential hypertension. Patients with baseline sitting diastolic blood pressure in the range of 95-114 mmHg entered the base-line run-in-period, after which they went on to a 6 week active phase of the study. In this study, patients received open-label amlodipine at a starting dose of 5 mg/day, which could be adjusted after one week to 10 mg/day if necessary to achieve a sitting diastolic blood pressure Amlodipine produced significant [P< 0.001] blood pressure reductions throughout the study without significant changes in heart rate. The overall evaluation of tolerability was excellent or good in 95% of patients and most of the adverse events were mild or moderate. The most frequently reported adverse events were headache [15%], palpitation [12.5%] and constipation [5%]. Thus, amlodipine is a useful and well tolerated drug for the control of blood pressure in mild to moderate hypertension