Introduction People who both smoke cigarettes and vape are often considered as a homogenous group even though multiple subgroups may exist. We examined biomarkers of exposure (BOE) and biomarkers of potential harm (BOPH) to differentiate between subgroups of people who smoke and vape based on PATH Study Wave 1 (2013–2014) data. Methods We compared people who only smoke cigarettes everyday (Group A, n = 2442) and people who only vape everyday (Group C, n = 169) against people who smoke and vape segmented into subgroups of people who frequently smoke and vape (Group B1, n = 169), frequently smoke and infrequently vape (Group B2, n = 678), frequently vape and infrequently smoke (Group B3, n = 57), and infrequently smoke and vape (Group B4, n = 66). Eighteen BOEs (representing exposure to TSNAs, nicotine, heavy metals, PAHs, and volatile organic compounds) and four BOPHs (representing inflammation and oxidative stress) were compared within the subgroups. Results Levels of many BOEs/BOPHs were higher among Group B2 relative to Groups B1, B3, and B4. Compared to Group A, many BOEs were significantly lower in Groups B3 (15/18) and B4 (17/18), and some BOEs were higher among B2 (4/18). Compared to Group C, significantly lower BOEs were observed for Group B4 (2/18). Conclusions Overall, the levels of BOEs and BOPHs in people who smoke and vape are associated with frequency of cigarette smoking. Our findings indicate that not all people who smoke and vape are the same, and tobacco product use frequency should be considered when categorizing people who smoke and vape.
Background Tobacco use has been identified as a risk factor for oral cancer worldwide. However, oral cancer risk among people who smoke cigarettes, use smokeless tobacco products (ST), have transitioned from cigarettes to ST (“switchers”) or quit both cigarettes and/or ST (“quitters”) has not been well studied. This study compared oral cancer incidence between 2014–2017 relative to never tobacco use.Methods We estimated incidence rates and incidence rate ratios using data from state-wide cancer registries (i.e., Colorado, Florida, North Carolina, and Texas) and population counts derived from national surveys. A random-effect meta-analysis approach was used to summarize estimates among these groups, based on multiple imputation-based incidence rate ratio estimates, by state and age groups while considering potential heterogeneity.Results A total of 19,536 oral cancer cases were identified among adult males 35 years and older in the study geographies and period. People who currently smoked cigarettes were 2.6 (95% CI = 2.0-3.3) times as likely to be diagnosed with oral cancer compared to individuals who currently used ST. The incidence rate ratio among people who currently smoke cigarettes was 3.6 (95% CI = 3.2–4.1) relative to never users, 2.4 (95% CI = 1.8–3.1) relative to switchers and 1.4 (95% CI = 1.0-2.1) among switchers relative to quitters. The incidence rate ratio of current users of ST relative to never-users was 1.4 (95% CI = 1.1–1.9).Conclusions Findings from this population-based study with a large number of oral cancer cases support lower risk of oral cancer among users of ST compared to cigarettes. Compared to those who continue to smoke, oral cancer risks can be reduced by switching to ST products or quitting all tobacco.
BACKGROUND: The FDA’s modified risk authorization for IQOS® is contingent upon approved post-market surveillance studies. The IQOS® Cross-Sectional Post-Market Adult Consumer Study (hereinafter termed IQOS® CS PACS) and the IQOS® Longitudinal Cohort Post-Market Adult Consumer Study (hereinafter termed IQOS® LC PACS) are contiguous surveys designed to fulfill this proviso. OBJECTIVES: IQOS® CS PACS seeks to assess tobacco use patterns in IQOS® users, risk perceptions of IQOS®, and tobacco transition and cessation behaviors related to IQOS®. The IQOS® LC PACS aims to follow over time, and in comparison with cigarette users, these same parameters with additional emphasis on transitions and health outcomes. METHODS AND RESULTS: The IQOS® CS PACS is a repeated cross-sectional study to be conducted annually for four years. The IQOS® LC PACS is a longitudinal study, planned to follow a cohort of new IQOS® users for two years. Potential adult IQOS® consumers aged 21 and older will be recruited from an IQOS® consumer database. Both studies will use self-administered online screening and survey assessment. At least 250 adult ever established IQOS® users (current and former) constitute the target sample size for each administration of the IQOS® CS PACS. The target sample size for the IQOS® LC PACS is 2,100 adult IQOS® users and 1,600 adult cigarette smokers as control. Data analysis includes descriptive statistics for pre-defined outcomes and inferential statistics (e.g., generalized estimating equations and propensity scoring) to compare outcomes among IQOS® and cigarette smokers. The IQOS® CS PACS is designed to commence one year after IQOS® modified risk tobacco product authorization (MRTPA) and will recur annually over the course of four years. The IQOS® LC PACS will begin two years after issuance of the IQOS® modified risk order and has been designed to follow up with participants at 3-, 6-, 12-, 18-, and 24-months from initiation. Final reports will be generated and shared with the FDA when the studies are completed. CONCLUSIONS: Postmarket studies can help inform outcomes related to risk perceptions, tobacco use patterns, and health status related to IQOS® use in a real-world setting.
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