Randomized placebo-controlled trial of amlodipine in vasospastic angina. Amlodipine Study 160 Group

Détails

ID Serval
serval:BIB_A9E52E38BAF4
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Randomized placebo-controlled trial of amlodipine in vasospastic angina. Amlodipine Study 160 Group
Périodique
Journal of the American College of Cardiology
Auteur(s)
Chahine  R. A., Feldman  R. L., Giles  T. D., Nicod  P., Raizner  A. E., Weiss  R. J., Vanov  S. K.
ISSN
0735-1097 (Print)
Statut éditorial
Publié
Date de publication
05/1993
Volume
21
Numéro
6
Pages
1365-70
Notes
Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: May
Résumé
OBJECTIVES. This study was designed to assess the efficacy and safety of amlodipine, a long-acting calcium channel blocker, in patients with vasospastic angina. BACKGROUND. Previous studies have established the value of short-acting calcium channel blockers in the treatment of coronary spasm. METHODS. Fifty-two patients with well documented vasospastic angina were entered into the present study. After a single-blind placebo run-in period, patients were randomized (in a double-blind protocol) to receive either amlodipine (10 mg) or placebo every morning for 4 weeks. Twenty-four patients received amlodipine and 28 received placebo. All patients were given diaries in which to record both the frequency, severity, duration and circumstances of anginal episodes and their intake of sublingual nitroglycerin tablets. RESULTS. The rate of anginal episodes decreased significantly (p = 0.009) with amlodipine treatment compared with placebo and the intake of nitroglycerin tablets showed a similar trend. Peripheral edema was the only adverse event seen more frequently in amlodipine-treated patients. No patient was withdrawn from the double-blind phase of the study because of an adverse event. Patients who completed the double-blind phase as responders to amlodipine or as nonresponders to placebo were offered the option of receiving amlodipine in a long-term, open label extension phase. During the extension, the daily dose of amlodipine was adjusted to 5 or 15 mg if needed and the rate of both anginal episodes and nitroglycerin tablet consumption showed statistically significant decreases between baseline and final assessment. CONCLUSION. This study suggests that amlodipine given once daily is efficacious and safe in the treatment of vasospastic angina.
Mots-clé
Adult Aged Amlodipine/adverse effects/*therapeutic use Angina Pectoris, Variant/*drug therapy/physiopathology Double-Blind Method Edema/chemically induced Female Humans Male Middle Aged Treatment Outcome
Pubmed
Web of science
Open Access
Oui
Création de la notice
25/01/2008 15:00
Dernière modification de la notice
20/08/2019 16:14
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