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Previous Volume 335:1792-1798 December 12, 1996 Number 24 Next

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ABSTRACT

Background Transdermal nicotine therapy is widely used to aid smoking cessation, but there is uncertainty about its safety in patients with cardiac disease.

Methods In a randomized, double-blind, placebo-controlled trial at 10 Veterans Affairs medical centers, we randomly assigned 584 outpatients (of whom 576 were men) with at least one diagnosis of cardiovascular disease to a 10-week course of transdermal nicotine or placebo as an aid to smoking cessation. The subjects were monitored for a total of 14 weeks for the primary end points of the study (death, myocardial infarction, cardiac arrest, and admission to the hospital due to increased severity of angina, arrhythmia, or congestive heart failure); the secondary end points (admission to the hospital for other reasons and outpatient visits necessitated by increased severity of heart disease); any side effects of therapy; and abstinence from smoking.

Results There were 48 primary and 78 secondary end points noted in a total of 95 subjects. At least one of the primary end points was reached by 5.4 percent of the subjects in the nicotine group and 7.9 percent of the subjects in the placebo group (difference, 2.5 percent; 95 percent confidence interval, -1.6 to 6.5 percent; P = 0.23). In the nicotine group, 11.9 percent of the subjects had at least one of the secondary end points, as compared with 9.7 percent in the placebo group (difference, 2.2 percent; 95 percent confidence interval, -2.2 to 7.4 percent; P = 0.37). After 14 weeks the rate of abstinence from smoking was 21 percent in the nicotine group, as compared with 9 percent in the placebo group (P = 0.001), but after 24 weeks the abstinence rates were not significantly different (14 percent vs. 11 percent, P = 0.67).

Conclusions Transdermal nicotine does not cause a significant increase in cardiovascular events in high-risk outpatients with cardiac disease. However, the efficacy of transdermal nicotine as an aid to smoking cessation in such patients is limited and may not be sustained over time.

Source Information

From the Department of Medicine, Veterans Affairs (VA) Medical Center and University of Minnesota, Minneapolis (A.M.J.); the Department of Psychology, VA Medical Center, Kansas City, Mo. (S.M.N.); the Department of Medicine, VA Medical Center, Loma Linda, Calif. (L.H.F.); the Department of Medicine, VA Medical Center, Denver (A.V.P.); the Department of Medicine, VA Medical Center, Durham, N.C. (E.C.W.); the Nursing Service, VA Medical Center, Seattle (B.G.S.); the Primary Ambulatory Care and Education Center, VA Medical Center, Sepulveda, Calif. (S.E.S.); the Department of Medicine, VA Medical Center, Portland, Oreg. (M.C.); the Psychology Service, VA Medical Center, Reno, Nev. (D.O.A.); the Department of Psychiatry, VA Medical Center, Los Angeles (N.H.); and the Division of Epidemiology, School of Public Health, University of Minnesota, Minneapolis (P.G.M.).

Address reprint requests to Dr. Joseph at the Section of General Internal Medicine (111-0), Veterans Affairs Medical Center, 1 Veterans Dr., Minneapolis, MN 55417.

Full Text of this Article

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Lack of Efficacy of Transdermal Nicotine in Smoking Cessation
Joseph A. M., Antonuccio D. O.
Extract | Full Text | PDF  
N Engl J Med 1999; 341:1157-1158, Oct 7, 1999. Correspondence

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