The Efficacy and Safety of Amlodipine in the Treatment of Mild and Moderate Essential Hypertension in General Practice

Abstract

The antihypertensive efficacy and safety of amlodipine was evaluated in an open, multicenter general practice study. Hypertensive patients with sitting diastolic blood pressure in the range 95-115 mm Hg entered an initial 2-week baseline period during which they received placebo in a single-blind fashion. The dose of any concomitant antihypertensive treatment was kept constant for 4 weeks prior to baseline evaluations and throughout the study. Patients with an average sitting diastolic blood pressure > or = 95 mm Hg and < or = 115 mm Hg at two consecutive visits during the baseline period continued to the 8-week dose adjustment phase of the study. Patients were started on 5 mg of amlodipine once daily adjusted after 4 weeks to 10 mg once daily to achieve a target sitting diastolic blood pressure < or = 90 mm Hg. Amlodipine treatment produced significant falls in blood pressure (-23.7/-17.3 mm Hg; p < 0.05) with no effect on heart rate. Amlodipine was well tolerated, with most adverse events being mild or moderate. Investigators' global evaluation of toleration was excellent or good in 92% of patients. Subgroup analysis showed amlodipine to be equally efficacious and well tolerated in elderly or young patients, and in patients taking amlodipine as monotherapy or combination therapy.