PubMed1991
In order to study the efficacy and tolerance of isradipine, a new Ca++ antagonist for the treatment of stable chronic angina, a multicentric cooperative study was carried out in eight Latin American countries (Argentine, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay and Venezuela), which included 169 patients (60% men and 40% women), average age 62.6 +/- 9.7. Patients with more than 4 biweekly anginal crisis were accepted, with one or more of the following inclusion criteria: coronariographic evidence of obstruction greater than 60% in one or more vessels, IAM history, positive scintigraphy and positive effort test. The trial was single-blind, with placebo during the admission phase (2 weeks) and active treatment for 12 weeks. isradipine was administered in increasing doses of 2.5, 5, and 7 mg thrice a day, according to the presence or absence of anginal crisis. It was observed that the average frequency of weekly pains decreased from 8.2 +/- 7 under placebo to 6.3 +/- 7.5 under isradipine at low doses, and to 2.0 +/- 2.0 (p less than 0.001) under maximum doses. TNT intake decreased parallel also in a significant way. At the end of the trial, 37% of patients had become asymptomatic, and angina had reduced to less than two crisis a week in 33%. A clear relation doses-effect was observed. There was no alteration in laboratory exams neither in ECG. Seven patients had complications derived from the evolutional course of disease (2 IAM, 5 unstable angina and one sudden death). Adverse events were relatively frequent and the majority derived from vasodilator effect (tibial oedema 37%, flushing 17%, headache 23%).(ABSTRACT TRUNCATED AT 250 WORDS)