Secondary analysis of adverse event data from a randomised placebo-controlled trial of e-cigarettes for smoking reduction

Nicotine e-cigarettes can help people who smoke to quit combustible cigarette use and reduce some cigarette-related toxicant exposures.

This study adds evidence that e-cigarette use in smoking reduction trials may be accompanied by more frequent study-related adverse events (AEs), particularly cough, headache and sore throat, with cough occurring more frequently among users of nicotine-containing e-cigarettes. However, most study-related AEs were mild, none were serious and few participants discontinued because of AEs.

These findings may contribute to e-cigarette safety evaluations by clarifying the differences in AE profiles across products with varying nicotine concentrations. Results may also help clinicians counsel patients who have been unsuccessful with Food and Drug Administration-approved smoking cessation therapies and are considering e-cigarettes as an alternative.