TITLE:
Variability and Correlation in Biomarkers of Exposure from Two Randomized Controlled Studies of JUUL Electronic Nicotine Delivery Systems
AUTHORS:
Qiwei Liang, Lonnie Rimmer, Nick Goldenson, Ryan Black
KEYWORDS:
Biomarkers, Variability, Correlation, Electronic Nicotine Delivery System
JOURNAL NAME:
Open Journal of Preventive Medicine,
Vol.13 No.10,
November
15,
2023
ABSTRACT: The data included in this analysis were from two clinical studies (Study A and Study B), which evaluated JUUL electronic nicotine delivery systems (ENDS) against combustible cigarettes. In both studies, biomarkers of exposure including nicotine equivalents, NNAL, 3-HPMA, MHBMA, S-PMA and COHb were measured. Coefficients of variation (CV) of the biomarkers were calculated and compared. Pearson correlation analysis was used to examine the correlation between the biomarkers. Seven out of the nine biomarkers of exposure in Study A were highly variable (CV > 30%). Higher variability was observed in NNAL, MHBMA and S-PMA than in other biomarkers. After adult cigarette smokers switched from combustible cigarettes to JUUL ENDS, the correlation between nicotine equivalents and other biomarkers became weaker. A similar trend was observed between NNAL and other biomarkers. In Study B, the participants in the 5% ENDS group had higher nicotine equivalent levels than those in the 3% ENDS group. The higher nicotine levels did not result in a substantial increase in the levels of other biomarkers (except 1-OHP). The correlations between nicotine equivalents and 3-HPMA, MHBMA, S-PMA, COHb, HMPMA, and 1-OHP were weak in both the 5% and 3% ENDS groups.