[The treatment of chronic stable angina with isradipine. A cooperative Latin American study].
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)
Román
O
O
Alcocer
L
L
Espinoza
J
J
Arcos
R
R
Gómez
G
G
Mayorga
E
E
Buzzi
A
A
Tavella
N
N
Romero
C
C
Kuster
F
F
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D017275:Isradipine; D007843:Latin America; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method
D002121:Calcium Channel Blockers; D011725:Pyridines; D017275:Isradipine
Tratamiento de la angina crónica estable con isradipina. Estudio cooperativo latinoamericano.