Abstract
Electronic nicotine delivery systems (ENDS) offer adult combustible cigarette smokers an alternative, potentially reduced harm, mode of nicotine delivery, attributed to fewer and reduced levels of harmful and potentially harmful constituents (HPHCs) in their aerosols compared to cigarette smoke. These two identical, randomised, open label, two-part studies aimed to compare levels of 15 biomarkers of exposure (BoE) to selected HPHCs associated with tobacco smoking in healthy US adult smoker subjects (n = 72). Following 9 days of exclusive use of a range of allocated myblu™ ENDS variants, subjects’ levels of 14 non-nicotine BoE were substantially reduced compared to baseline values (combustible cigarette use), in the range of 46–97%. BoE reductions were sustained in subjects who continued myblu use exclusively (n = 25) for a further 5 days, and returned to near baseline levels in subjects who returned to exclusive combustible cigarette use (n = 21). Dual users (n = 24) demonstrated reductions in BoE to a lesser extent than with exclusive myblu use. Measured nicotine equivalents did not significantly change throughout the study. These data suggest exclusive use of ENDS provides adult smokers seeking an alternative to combustible cigarettes with substantial reductions in HPHC exposures whilst achieving satisfying levels of nicotine delivery. Dual use involving substitution of cigarettes may also provide some of this advantage, but to lesser extent. Overall, the data contribute to the weight of evidence that ENDS are an important tool in tobacco harm reduction for adult smokers unwilling to or uninterested in quitting smoking. Study 1: NCT 04430634, study 2: NCT 04429932, clinicaltrials.gov (10-06-2020).
Highlights
Tobacco harm reduction (THR) involves providing a means by which adult combustible cigarette smokers, who are uninterested or unwilling to quit smoking, can achieve satisfactory nicotine consumption but with exposure to fewer, and substantially reduced levels of, toxicants associated with burning tobacco [1, 2]
Clinical data suggest that adult smokers who transition to use of electronic nicotine delivery systems (ENDS) generally experience improvements in their pulmonary and cardiovascular health [6, 7] and there is increasing evidence that the reduced harm potential of ENDS is linked to fewer and/or reduced levels of harmful and potentially harmful constituents (HPHCs) present in their aerosols, compared to smoke generated from cigarette combustion [8,9,10,11,12]
The first part of this study demonstrated substantial reductions in 14 non-nicotine tobacco smoking-related biomarkers of exposure (BoE) in adult smokers following 9 days of exclusive use of myblu ENDS products across two identical, open label, randomised Studies (1 and 2)
Summary
Tobacco harm reduction (THR) involves providing a means by which adult combustible cigarette smokers, who are uninterested or unwilling to quit smoking, can achieve satisfactory nicotine consumption but with exposure to fewer, and substantially reduced levels of, toxicants associated with burning tobacco [1, 2]. This is an increasingly important concept and electronic nicotine delivery systems (ENDS) are one such category which may contribute to THR; a growing body of evidence within the scientific literature supports this, along with a number of regulators and public health bodies [1,2,3,4]. Similar reductions in toxicity of ENDS aerosols when compared to cigarette smoke samples have been recorded in a number of other studies, for example: [13,14,15,16]
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