LAUSR

ABSTRACT The safety profile of Puritane™, a closed system electronic vapour product (EVP), was evaluated when used by smokers of conventional cigarettes (CCs) for 24 months in a real‐life setting. The study was a two‐centre ambulatory clinical study with 209 healthy volunteers. Outcome measures included adverse events (AEs), vital signs, electrocardiogram, lung function tests, exposure to nicotine and selected smoke constituents, nicotine withdrawal effects and smoking desire. No serious AEs related to EVP use were observed. The most frequently reported AEs were headache, nasopharyngitis, sore throat and cough, reported by 28.7%, 28.7%, 19.6% and 16.7% of subjects, respectively, which dissipated over time. Small decreases in lung function were not considered clinically relevant. No clinically relevant findings were observed in the other safety parameters. From Month 2, nicotine withdrawal symptoms decreased. Smoking desire and CC consumption steadily decreased over time in all subjects. EVP use was associated with reduced exposure to cigarette smoke constituents, whereas urinary nicotine levels remained close to baseline. Body weight did not increase in CC subjects switching to the EVP. In conclusion, the aerosol of the EVP at study was well tolerated and not associated with any clinically relevant health concerns after usage for up to 24 months. HighlightsThere were no safety concerns in smokers using an EVP for 2 years.Headache, nasopharyngitis and sore throat were the most common adverse events in smokers using an EVP, declining over time.The frequency of adverse events steadily decreased over time after switching to an EVP.EVP use was associated with a reduction in cigarette consumption and a reduced exposure to cigarette smoke constituents.Use of the EVP did not lead to clinically significant adverse changes in biomarkers of haematology or lipid metabolism.