A study of the efficacy and safety of amlodipine for the treatment of hypertension in general practice.

Three hundred and twenty hypertensive out-patients were recruited to this multicentre general practice study of the efficacy and safety of amlodipine. Patients with baseline sitting diastolic blood pressure in the range 95-115 mmHg at two consecutive visits went on to a 12-week active treatment 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 4 weeks to 10 mg/day if necessary to achieve a sitting diastolic blood pressure of less than or equal to 90 mmHg. Amlodipine produced significant (P less than 0.05) blood pressure reductions throughout the study without significant changes in heart rate. The exposure to amlodipine in this study was 873 patient months. Most adverse events were mild or moderate and the investigators' overall evaluation of tolerability was excellent or good for 91% of patients. The most frequently reported adverse events were oedema (13.8%), headache (7.8%) and rashes (3.8%). Analysis of data for subgroups of patients confirmed that there were no important differences in the efficacy and tolerability of amlodipine in elderly or young patients and in patients taking amlodipine as monotherapy or in combination with other antihypertensive agents. This uniformity of response is clearly an important factor in consideration of antihypertensive therapy use in general practice.

RCT Entities:   Population Interventions Outcomes