LAUSR

Background: Cigarette smoke (CS) is causally linked to the development of cardiovascular diseases (CVD) Tobacco harm reduction, by virtue of substituting cigarettes with less harmful products, is a complementary approach to current strategies for smokers who would otherwise continue to smoke The Tobacco Heating System (THS) 2 2 is a novel tobacco product that heats tobacco instead of burning it, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from occurring and producing substantially lower levels of toxicants than CS Methods: The program includes in vitro/in vivo toxicology testing methods that follow OECD guidelines and Good Laboratory Practice, a systems toxicology approach, and randomised, controlled clinical studies that follow the principles of Good Clinical Practice Results: The effects of THS aerosol on the adhesion of monocytic cells to human coronary endothelial cells in vitro are significantly reduced Switching to THS halted the progression of CS-induced atherosclerotic changes in ApoE-/- mice in vivo Biomarkers linked to the development of smoking-related diseases were analysed following a 6-month randomised, controlled clinical study with THS, which demonstrated a consistent improvement of biomarkers in different pathophysiologic pathways leading to atherosclerosis Conclusions: The evidence available to date indicates that switching to THS has the potential to reduce the risk of smoking-related diseases such as CVD As a next step, PMI will complement its THS assessment program with cardiovascular outcome studies intended to further support the clinical benefits of switching to THS over continuous smoking