Predictors and timing of adverse experiences during transdermal nicotine therapy

Objectives: Difficulty sleeping is a recognised tobacco withdrawal symptom, but sleep problems, like application site reactions, an commonly reported as adverse reactions to transdermal nicotine therapy. However, no studies h ave examined potential predictive factors associated with the occurrence of expected adverse experiences during transdermal nicotine therapy. The subj ect of skin tolerability among patients with a history of eczema, psoriasis or other skin disorders is of particular interest, as are the relationship s between plasma concentrations of nicotine, concurrent smoking, sleep prob lems and nausea. Methods: The cohort study involving 1392 participants was designed to asses s the timing, severity and predictive factors of adverse experiences report ed during 24-hour transdermal nicotine therapy. Data were collected on pati ents aged 18 to 70 years old who were smokers and who had expressed a stron g desire to stop smoking. The intervention consisted of brief behavioural c ounselling, a booklet containing smoking cessation advice and instructions for use of the patches, and a 12-week course of decreasing transdermal nico tine doses. Results: Follow-up was available on 1392 out of 1481 study participants. Th e majority of adverse experiences were mild. Sleep problems occurred in 669 out of 1392 (48%) participants and most often commenced on the day of smok ing cessation. Application site reactions occurred in 378 out of 1392 (34%) participants and most often occurred after 6 days of therapy. No predictor had an adjusted hazard ratio above 2. Statistically significant (p < 0.05) predictors of sleep problems were successfully quitting smoking and female gender. Predictors of application site reactions were psoriasis or eczema, other skin conditions, age <40 years, female gender, place of birth outsid e Australasia, and trade or university education level. Substantially increased nicotine intake during therapy compared with baseli ne smoking occurred in 8% of participants who smoked concurrently, and 4% o f participants who did not (p = 0.1). Increased nicotine intake was associa ted with a modest increase in the overall rate of adverse experiences (89% vs 63%, p = 0.04) and dizziness/lightheadedness (17% Ils 3%, p = 0.03), but not with sleep problems or cardiovascular events. Conclusions: Transdermal nicotine therapy appears to be well tolerated, eve n if the user smokes concurrently. Sleep disturbance during therapy appeare d to be primarily associated with tobacco withdrawal rather than with nicot ine excess from treatment with transdermal nicotine. Study participants wit h pre-existing skin disorders were somewhat more likely to report mild appl ication site reactions than other participants.