Estudo multicêntrico brasileiro de avaliaçäo da eficácia e tolerabilidade de trandolapril na hipertensäo arterial essencial leve a moderada: EMBATHE subestudo com monitorizaçäo arterial de pressäo arterial / Brazilian multicenter study on efficacy and tolerability of trandolapril in mild-to-moderate essential arterial hypertension: EMBATHE substudy with ambulatory blood pressure monitoring

ABSTRACT

Objective - A double-blind, placebo-controlled multi-center study involving 34 centers from different Brazilian regions was performed to evaluate the antihypertensive efficacy and tolerability of trandolapril, an angiotensil I converting enzyme inhibitor, in the treatment of mild-tomoderate systemic arterial hypertension. Methods - Of 262 patients enrolled in this study, 127 were treated with trandolapril 2 mg/day for 8 consecutive weeks, and the remaining 135 patients received placebo for the same period of time. Reduction in blood pressure (BP) and the occurrence of adverse events during this period were evaluated in both groups. Results - Significant reductions in both systolic and diastolic pressures were observed in patients treated with trandolapril when compared with those on placebo. Antihypertensive efficacy was achieved in 57.5 per cent of the patients on trandolapril and in 42 per cent of these normal values of BP were obtained. The efficancy of trandolapril was similar in all centers, regardless of the area of the country. In a subset of 30 patients who underwent ABPM, responders showed a significant hypotensive effect to trandolapril throughout the 24 hour day. The adverse event profile was similar in both trandolapril and placebo groups.