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a randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers.

Author: O'Connell

Year Published: 2019

Summary

Introduction:
This text is a summary of a clinical study investigating the pharmacokinetic profiles and subjective effects of nicotine from e-cigarette device platforms with varying concentrations of nicotine salt formulations compared to conventional cigarettes. The study was conducted in 15 healthy adult smokers over six days.

Key Points:

* The study found that the rate of nicotine absorption into the bloodstream was comparable from all e-cigarettes tested and was as rapid as that for conventional cigarettes.
* however, in all cases, nicotine delivery did not exceed that of the conventional cigarette.
* The pharmacokinetic profiles of nicotine salt emissions were also dependent upon the properties of the e-cigarette device.
* Subjective scores were numerically highest after smoking a conventional cigarette followed by the my blu 40-mg nicotine salt formulation.
* The rise in nicotine blood levels following use of all the tested e-cigarettes was quantified as ‘a little’ to ‘modestly’ satisfying at relieving the desire to smoke.
* all products were well tolerated with no notable adverse events reported.

Main Message:
The study demonstrates that e-cigarettes containing nicotine salts can deliver cigarette-like pulmonary delivery of nicotine, reducing the desire to smoke, but with less nicotine delivery than conventional cigarettes. The pharmacokinetic profiles of nicotine salt emissions were dependent upon the properties of the e-cigarette device. The study supports the growing consensus that e-cigarettes are substantially less harmful than smoking and have the potential to generate substantial public health benefits at a population level if significant numbers of smokers switch from smoking to e-cigarette use. however, the study also suggests that currently available e-cigarettes do not provide smokers with the sensory experience they require from their conventional cigarettes, highlighting the need for further research and development in this area.

Citation

O’Connell G, Pritchard JD, Prue C, et al. a randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers. Internal and emergency medicine. 2019;14(6):853-861. doi:10.1007/s11739-019-02025-3
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