Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study
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Electronic cigarettes (e-Cigarette) are battery-operated devices designed to vaporise nicotine that may aid smokers to quit or reduce their cigarette consumption. Research on e-Cigarettes is urgently needed to ensure that the decisions of regulators, healthcare providers and consumers are evidence based. Here we assessed long-term effectiveness and tolerability of e-Cigarette used in a ‘naturalistic’ setting. This prospective observational study evaluated smoking reduction/abstinence in smokers not intending to quit using an e-Cigarette (‘Categoria’; Arbi Group, Italy). After an intervention phase of 6 months, during which e-Cigarette use was provided on a regular basis, cigarettes per day (cig/day) and exhaled carbon monoxide (eCO) levels were followed up in an observation phase at 18 and 24 months. Efficacy measures included: (a) ≥50 % reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥50 %) compared to baseline; (b) ≥80 % reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥80 %) compared to baseline; (c) abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking (together with an eCO concentration of ≤10 ppm). Smoking reduction and abstinence rates were computed, and adverse events reviewed. Of the 40 subjects, 17 were lost to follow-up at 24 months. A >50 % reduction in the number of cig/day at 24 months was shown in 11/40 (27.5 %) participants with a median of 24 cig/day use at baseline decreasing significantly to 4 cig/day (p = 0.003). Smoking abstinence was reported in 5/40 (12.5 %) participants while combined >50 % reduction and smoking abstinence was observed in 16/40 (40 %) participants at 24 months. Five subjects stopped e-Cigarette use (and stayed quit), three relapsed back to tobacco smoking and four upgraded to more performing products by 24 months. Only some mouth irritation, throat irritation, and dry cough were reported. Withdrawal symptoms were uncommon. Long-term e-Cigarette use can substantially decrease cigarette consumption in smokers not willing to quit and is well tolerated. (http://ClinicalTrials.govnumberNCT01195597).
KeywordsSmoking cessation Smoking reduction Quit rate Adverse events Electronic cigarettes Electronic nicotine delivery devices Cigarette substitutes
Electronic nicotine delivery device
Cigarettes smoked per day
Millimetres of mercury
Fagerstrom test of nicotine dependence
Beck’s depression inventory
Exhaled carbon monoxide
Parts per billion
Cartridges used per day
Parts per million
We wish to thank Arbi Group Srl (Milano, Italy) for the free supplies of ‘Categoria’ e-Cigarette kits and nicotine cartridges as well as their support. We would also like to thank the study participants for all their time and effort and LIAF (Lega Italiana AntiFumo) for the collaboration.
Conflict of interest
JBM has received lecture fees from Pfizer. RP has received lecture fees from Pfizer and, from Feb 2011, he has been serving as a consultant for Arbi Group Srl.Arbi Group Srl (Milano, Italy), the manufacturer of the e-Cigarette supplied the product, and unrestricted technical and customer support. They were not involved in the study design, running of the study or analysis and presentation of the data. None of the authors have any competing interests to declare.
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