Summary
Introduction:
This text provides an in-depth analysis of a clinical study examining the effects of switching from combustible cigarettes (CCs) to electronic cigarettes (ECs) or nicotine gum (NG) on nicotine delivery and biomarkers of tobacco exposure. The study was conducted in a controlled environment over a short-term period of five days. This summary will highlight the key aspects of the study design, major findings, and the overall message conveyed in the text.
Key Points:
* a randomized, controlled, open-label, parallel group study was conducted with 153 subjects who were generally healthy smokers.
* Subjects were divided into four cohorts: non-menthol smokers using VS Original, non-menthol smokers using nicotine gum, menthol smokers using VS Menthol, and menthol smokers using nicotine gum.
* The study consisted of a 9-day in-clinic residence, with baseline assessments during smoking of subjects' usual brand cigarettes for the first three days. On Day 1, smokers were randomized to one of the four cohorts.
* Biological sample collection included whole blood samples for carboxyhemoglobin percent saturation, plasma for nicotine and cotinine, and 24-hour urine samples for biomarker analysis.
* Urinary biomarker analysis was performed by aBF Gmbh, and plasma nicotine and cotinine analysis was performed by Celerion, Inc.
* Nicotine biomarkers, such as total nicotine equivalents, decreased significantly in all groups, but the decrease was less pronounced in the EC groups compared to the nicotine gum groups.
* Biomarkers of tobacco smoke exposure in 24-hour urine and whole blood decreased significantly in all groups, with similar reductions in EC and nicotine gum groups.
* Product use amounts were relatively constant throughout the study, with e-liquid use increasing from Day 1 to Day 3 and then stabilizing, and gum use remaining consistent.
Main Message:
This study demonstrates that switching from CCs to ECs or nicotine gum results in significant reductions in nicotine delivery and biomarkers of tobacco exposure. although the reductions in nicotine and biomarkers were less pronounced in the EC groups compared to the nicotine gum groups, the study suggests that ECs, as represented by the Vuse Solo (VS) product, can expose consumers to fewer and lower levels of smoke toxicants than CCs. These findings provide valuable insights for regulatory matters, as they showcase the potential benefits of ECs as harm reduction tools compared to CCs.
Citation
Round EK, Chen P, Taylor aK, Schmidt E. Biomarkers of Tobacco Exposure Decrease after Smokers Switch to an E-Cigarette or Nicotine Gum. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2019;21(9):1239-1247. doi:10.1093/ntr/nty140
