Beneficial Impact of Switching from Cigarette Smoking to Tobacco Heating System Use on Biomarkers of Potential Harm in a Randomized Trial

Background: Smoking cessation reduces the risk of developing smoking-related diseases. Although smoking prevalence has declined, many smokers continue smoking cigarettes. Switching to less harmful smoke-free alternatives such as the Tobacco Heating System (THS), a non-combustible tobacco-based product, is an approach to reduce the harm caused by cigarettes. Methods: We conducted a 12-month clinical study with 984 adult smokers randomized to either continue smoking or to use THS. We assessed the trajectories of biomarkers of potential harm (BoPH) known to be reversible upon smoking cessation, as one measure of different pathways involved in the pathogenesis of cardiovascular or respiratory diseases, and carcinogenicity. Beneficial impact on 8 key BoPHs was used as a proxy to evaluate harm reduction. Results: At 12 months, comparison of the 8 BoPH levels between the predominant THS use and cigarette smoking groups showed differences in favor of THS switching when contextualized to the changes reported for smoking cessation. Conclusions: Our results likely indicate a further decrease in carcinogenicity and relative risk of developing cardiovascular or respiratory diseases for smokers switching to THS compared to those who would continue smoking. These results provide additional evidence of the harm reduction potential of predominant THS use. Trial Registration clinicaltrials.gov Identifier: NCT02649556 Date of registration: 07/01/2016 (dd/mm/yyyy)(https://clinicaltrials.gov/ct2/show/NCT02649556)