IQOS® Cross-Sectional and Cohort US Study Documentation

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.