Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 2. Biomarkers of exposure

Abstract

A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) was conducted, and subjects’ experience with the products was followed for 24 weeks. Differences in biomarkers of tobacco exposure between smokers and never smokers at baseline and among groups relative to each other and over time were assessed. Results indicated reduced exposure to many potentially harmful constituents found in cigarette smoke following product switching. Findings support differences in exposure from the use of various tobacco products and are relevant to the understanding of a risk continuum among tobacco products (ClinicalTrials.gov Identifier: NCT02061917).

Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology

“…improved study design, optimized outcome measures) for the assessment of human exposure and health effects from the use of tobacco products. Additionally, biomarker findings from this randomized study (Ogden et al, 2015a,b) provide generalized knowledge of the risk continuum among various tobacco products.…”

“…These data also indicate that some caution may be required when interpreting observed effects (or lack of observed effects) – for example, any changes in biomarkers (Ogden et al, 2015a,b) – especially for the snus per-protocol subset. For snus, observed effects are likely only partially attributable to the actual use of snus, and correspondingly, failure to observe effects for snus may be due to the continued use of other tobacco products.…”

“…Biomarker changes in the snus group were generally positive (e.g. indications of reductions in exposure) or not different (Ogden et al, 2015a,b); thus it would be expected that with complete switching to snus, additional positive responses would be observed.…”

“…There was evidence of increased daily cigarette consumption at Week 24 in the ultra-low machine yield tobacco-burning cigarette (29.2 assigned study product plus other cigarettes) and tobacco-heating cigarette groups (26.4 assigned study product plus other cigarettes); however, many tobacco-related biomarkers of exposure decreased in both groups (Ogden et al, 2015a). That the study products were provided at no expense to the subjects over the course of study might have affected this behavioral pattern of increased cigarette usage.…”

“…Subjects’ disposition, characteristics, compliance and safety results are presented herein. Results from changes in exposure measures (Ogden et al, 2015a) and biomarkers of biological effect (Ogden et al, 2015b) are reported elsewhere.…”