Randomized withdrawal from nifedipine: Placebo-controlled study in patients with coronary artery spasm

Edgar C. Schick, Chang seng Liang, Frederick A. Heupler, Frederick R. Kahl, Kenneth M. Kent, Nicholas Z. Kerin, R. Roe Noble, Melvyn Rubenfire, Bernard Tabatznik, Richard W. Terry

Research output: Contribution to journalArticlepeer-review

Abstract

A multicenter randomized double-blind withdrawal study was conducted to compare the efficacy of nifedipine to that of placebo in vasospastic angina. Following a 2-week single-blind nifedipine baseline period, during which nifedipine was maintained at prestudy levels, 38 patients, 19 taking placebo and 19 continuing nifedipine therapy, either completed a 4-week randomized phase or were prematurely withdrawn because of therapeutic failure. During the randomized phase, an increase in median anginal frequency (2.8 attacks/wk, p < 0.003) and nitroglycerin usage (0.5 tablets/wk, p < 0.03) occurred only in the placebo group. The randomized phase was prematurely terminated because of anginal exacerbation in 7 of 19 placebo patients (37%) (only 1 patient receiving nifedipine [p = 0.02] experienced anginal exacerbation). Double-blind therapy was judged effective in 16 patients (84%) receiving nifedipine and in 3 patients (16%) receiving placebo (p < 0.001). Nifedipine was well tolerated. This study establishes the efficacy of nifedipine in the treatment of variant angina and validates previous clinical experience.

Original languageEnglish (US)
Pages (from-to)690-697
Number of pages8
JournalAmerican heart journal
Volume104
Issue number3
DOIs
StatePublished - Sep 1982

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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