[Isradipine: a Brazilian multicenter study for the evaluation of the efficacy and safety in the treatment of mild and moderate arterial hypertension]. / Isradipina: estudo multicêntrico brasileiro de avaliação de eficácia e tolerabilidade no tratamento da hipertensão arterial leve e moderada.

ABSTRACT

PURPOSE: To evaluate the efficacy and tolerability of isradipine, a new dihydropyridine calcium antagonist, in the treatment of mild-to-moderate hypertension. PATIENTS AND METHODS: One hundred and eighty outpatients with different races, who had supine and orthostatic diastolic blood pressure (DBP) > or = 95 mmHg and < or = 115 mmHg, with a mean age of 52.03 +/- 11.47 years, 70 men, 110 women; underwent the study. After a two-week wash-out period patients received isradipine 2.5 mg b.i.d. for 90 days. Follow-up visits were performed at the 30th, 60th and 90th days of treatment. RESULTS: At the end of treatment (90 days), a statistically significant decrease (p < 0.05) in SBP and DBP in supine position was observed. A mean SBP was reduced from 159.28 +/- 16.99 to 142.51 +/- 15.12, and mean DBP declined from 101.49 +/- 6.82 to 86.63 +/- 7.40. Heart rate, weight, electrocardiograms and laboratory tests did not shows significant changes during treatment when compared to baseline evaluation. The most frequent related side effects (headache and dizziness with nausea) were transient, and at the end of the study 96.7% of the patients did not have any complaint. However, two patients were withdrawn from the trial because of important headache. CONCLUSION: Isradipine 2.5 mg by oral route, b.i.d. has shown to be effective and well tolerated in the treatment of mild-to-moderate hypertension in patients of both sexes and several ages and races.