THE SAFETY OF TRANSDERMAL NICOTINE AS AN AID TO SMOKING CESSATION IN PATIENTS WITH CARDIAC DISEASE

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-control led 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 f or 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 f ailure); the secondary end points (admission to the hospital for other reasons and outpatient visits necessitated by increased severity of h eart disease); any side effects of therapy; and abstinence from smokin g. 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 rea ched by 5.4 percent of the subjects in the nicotine group and 7.9 perc ent 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 nico tine group, 11.9 percent of the subjects had at least one of the secon dary end points, as compared with 9.7 percent in the placebo group (di fference, 2.2 percent; 95 percent confidence interval, -2.2 to 7.4 per cent; 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 pl acebo group (P=0.001), but after 24 weeks the abstinence rates were no t significantly different (14 percent vs. 11 percent, P=0.67). Conclus ions Transdermal nicotine does not cause a significant increase in car diovascular events in high-risk outpatients with cardiac disease. Howe ver, the efficacy of transdermal nicotine as an aid to smoking cessati on in such patients is limited and may not be sustained over time. (C) 1996, Massachusetts Medical Society.