Evaluation of the safety profile of an electronic vapour product used for two years by smokers in a real-life setting
Autor: | Claire Martin, Jim Bush, Rebecca Savioz, Grant O'Connell, Annelize Koch, Tanvir Walele |
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Rok vydání: | 2018 |
Předmět: |
Adult
Male Nicotine medicine.medical_specialty Vital signs Smoking Prevention Electronic Nicotine Delivery Systems 030204 cardiovascular system & hematology Toxicology Pulmonary function testing law.invention 03 medical and health sciences 0302 clinical medicine law Smoke Internal medicine Tobacco medicine Sore throat Humans 030212 general & internal medicine Adverse effect Smokers business.industry Smoking Tobacco Products Tobacco Use Disorder General Medicine medicine.disease Substance Withdrawal Syndrome Nicotine withdrawal Ambulatory Female Smoking Cessation medicine.symptom business Electronic cigarette medicine.drug |
Zdroj: | Regulatory Toxicology and Pharmacology. 92:226-238 |
ISSN: | 0273-2300 |
Popis: | 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. |
Databáze: | OpenAIRE |
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