NEW YORK (Reuters) -- The nicotine patch is safe for people with heart disease who want to quit smoking, say researchers.
Results of their new study indicate that it is unlikely that these smokers will suffer potentially fatal cardiac complications from using transdermal nicotine patches.
"Concerns about the nicotine patch's effects on the heart came from isolated case reports of people with heart disease that put on patches and went on to have a heart attack or irregular heart beat, but the issue hadn't been carefully studied before," says lead author of the study, Dr. Anne M. Joseph, associate professor of medicine at the University of Minnesota, Minneapolis.
Joseph says smokers with heart disease are patients for whom smoking cessation is critically important, "so we would like to be able to do everything we can to help them quit, and nicotine replacement (with the patch) is one of the things we would use."
The study, which appears in this week's issue of The New England Journal of Medicine, involved nearly 600 smokers diagnosed with coronary heart disease, including some who had survived a heart attack.
Half of the participants were randomly assigned to use the nicotine patch for 10 weeks, and the others were given an inactive (placebo) patch.
After 14 weeks, Joseph and her colleagues evaluated the patch's effect on smoking cessation, "but the main purpose of the study was to look at adverse events -- complications from the nicotine. We looked at complications such as sudden death, heart attack, admission to the hospital, heart rhythm disturbances, and chest pain," she says.
"Even though those events were common, they were equally common in both groups. So if you took active nicotine or placebo, you had the same chance of ending up with a bad thing happening," Joseph explains.
"What we conclude from this study is that it establishes the safety of using nicotine replacement products in this high-risk population," she says.
In terms of smoking cessation, this study also demonstrated that using transdermal nicotine patches alone can help, if only temporarily.
"After 14 weeks, the rate of abstinence from smoking was 21% in the nicotine group, as compared with 9% in the placebo group," the authors state. "But after 24 weeks, the abstinence rates were not significantly different (14% vs. 11%)."
The researchers recommend that doctors caution all patients not to smoke while using patches because even occasional smoking during nicotine replacement therapy has been linked to long-term failure to quit.
"Provided there is still a reasonable chance that patients can manage to abstain from tobacco, however, our data do not demonstrate a need for instructing them to stop patch use immediately if they "slip" and smoke during treatment," the authors conclude.
SOURCE: The New England Journal of Medicine (1996;335:1792-1798)