ASSESSMENT OF THE TOLERABILITY AND EFFICACY OF AMLODIPINE IN 9295 PATIENTS WITH MILD OR MODERATE ESSENTIAL-HYPERTENSION

An open multicentre study was conducted to evaluate the long term effi cacy and tolerability of once-daily amlodipine (5 or 10mg for up to 24 weeks) in 9295 patients with mild or moderate essential hypertension. After a 2-week washout period, patients began treatment with amlodipi ne 5 mg/day, and this could be increased to 10 mg/day in patients show ing inadequate blood pressure control after 2 weeks. If acceptable con trol was not achieved after 6 weeks of treatment with amlodipine alone , a second antihypertensive agent could be added (diuretic, ACE inhibi tor or beta-blocker). Data were analysed for the population as a whole , as well as for 2 subgroups based on age (group I: less than or equal to 65 years; group II: > 65 years). 9295 patients were evaluable for tolerability and 8031 for efficacy. Significant reductions were achiev ed in both sitting and standing systolic and diastolic blood pressure after antihypertensive therapy (sitting position from 171/102mm Hg to 143/84mm Hg; standing position from 170/102mm Hg to 143/84mm Hg; p < 0 .001), and successful blood pressure control was achieved in 83% of th e patients treated with amlodipine alone. None of the patients experie nced significant changes in heart rate, ECG parameters or bodyweight. The only statistically significant changes in laboratory findings were a reduction in total cholesterol (-3%) and low density lipid (-4.4%) levels (p < 0.001). Amlodipine was well tolerated in most patients; th e most common adverse events were oedema and headache. Only 3.6% of pa tients discontinued treatment because of adverse events. Thus, these f indings indicate that amlodipine (alone or in combination with another antihypertensive agent)is an effective and well tolerated treatment o ption for mild to moderate hypertension. In addition, the once-daily d osage regimen appears to have a positive influence on patient complian ce, which is reflected in the high percentage of patients (86.4%) comp leting this trial.