Background: Because nicotine can cause adverse cardiovascular effects, we assessed the safety of transdermal nicotine for smoking cessation in patients with coronary artery disease.
Methods: This 5-week, double-blind, randomized, placebo-controlled, multicenter study enrolled 156 patients with coronary artery disease who smoked at least one pack of cigarettes daily. Patients were randomized to receive either transdermal nicotine (14 mg/d) or transdermal placebo. After 1 week, patients who had smoked more than seven cigarettes were able to have their dose of blinded study medication increased to 21 mg/d of transdermal nicotine or corresponding placebo. All participants then continued to receive their chosen medication dose for an additional 4 weeks and attended weekly group counseling sessions. Adverse effects, cardiac events, electrocardiographic changes, frequency of angina, other cardiac symptoms, vital signs, and weight were monitored. Serial 24-hour ambulatory electrocardiographic monitoring was performed at one center. Smoking cessation rates were determined from diary reports of no smoking during the last 4 weeks of the study, corroborated weekly by expired breath carbon monoxide levels no higher than 8 ppm.
Results: Eight of 79 patients randomized to receive placebo and three of 77 patients randomized to receive transdermal nicotine withdrew during the trial owing to adverse effects (P = .13), most of which were cardiovascular. Transdermal nicotine did not affect angina frequency, overall cardiac symptom status, nocturnal events, arrhythmias, or episodes of ischemic ST segment depression. Smoking cessation was achieved by 36% and 22% of patients receiving transdermal nicotine and placebo, respectively (P < .05).
Conclusion: Transdermal nicotine was well tolerated by patients with stable coronary artery disease in this trial.