Real-world evidence from a prospective longitudinal cohort study assessing changes in smoking behavior among adults...

Switching from cigarettes to electronic nicotine delivery systems (ENDS) has the potential to reduce smoking-related harm among adults who smoke (AS). Actual use behavior under real-world conditions can inform the substitution potential of ENDS products. The objective of this study was to assess the transition patterns from combustible cigarettes to use of NJOY ACE® ENDS products.

We conducted a prospective longitudinal cohort study (LCS) in a national, purposive sample of 8002 US adults, identity- and age-verified 21 + years, who first used NJOY ACE within the 12-month period prior to Baseline. Participants completed online surveys at Baseline and at 1-, 2-, 3- and 6-month follow-ups. Survey items included demographic characteristics, tobacco product use, and other outcome measures. Adjusted logistic regressions (controlling for relevant covariates) were applied to multiple analytic cohorts - per-protocol (PP) and intent-to-treat (ITT) - to comprehensively determine the association between tobacco and menthol-flavored NJOY ACE use and the association between flavor and past 30-day point prevalence smoking abstinence (30dPPA).

Overall PP/ITT switching rates (30dPPA) among participants who used tobacco or menthol flavored product at the 3- and 6-month time points were 22.0%/15.1% and 36.2%/23.6%, respectively. Menthol-flavored product use was associated with significantly higher switching rates than tobacco-flavored use across the different analytic cohorts (1.12-1.55x higher). Covariate-adjusted logistic regressions demonstrated consistently higher odds of 3-month 30dPPA (Odds Ratio = 1.33-1.50) for menthol- compared to tobacco-flavored products.

Real-world data demonstrated that availability of NJOY ACE results in robust switching from cigarettes and therefore can manifest a public health benefit.