The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease
Open accessAbstract
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.
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Nicotine replacement has shown no adverse effect on outcomes in patients with cardiac disease.
“and nicotine replacement has shown no adverse effect on outcomes in patients with cardiac disease.246,247”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [246]
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- Authors
- Joseph, A. M., Norman, S. M., Ferry, L. H., Prochazka, A. V., Westman, E. C., Steele, B. G., Sherman, S. E., Cleveland, M., Antonuccio, D. O., Hartman, N., & McGovern, P. G.
- Affiliations
- University of Minnesota (US)
- Kansas City VA Medical Center (US)
- VA Loma Linda Healthcare System (US)
- United States Department of Veterans Affairs (US)
- Durham VA Medical Center (US)
- VA Sepulveda Ambulatory Care Center (US)
- Portland VA Medical Center (US)
- VA West Los Angeles Medical Center (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1996-12-12
- Volume
- 335
- Issue
- 24
- Pages
- 1792-1798
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2320130521
- Cited by
- 492
- References
- 32
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 4 · 2023: 7 · 2022: 6 · 2021: 12 · 2020: 13 · 2019: 8 · 2018: 12 · 2017: 11 · 2016: 14 · 2015: 9 · 2014: 14 · 2013: 14 · 2012: 24
- FWCI
- 11.91
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- transdermal nicotine, smoking cessation, heart disease, cardiovascular safety, myocardial infarction, congestive heart failure, cardiac arrhythmias, smoking abstinence, veterans, nicotine therapy
- MeSH terms
- Administration, Cutaneous, Aged, Aged, 80 and over, Analysis of Variance, Cardiovascular Diseases, Double-Blind Method, Female, Humans, Male, Middle Aged, Nicotine, Smoking Cessation, Treatment Outcome
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