Favorable Changes in Biomarkers of Potential Harm to Reduce the Adverse Health Effects of Smoking in Smokers Switching to the Menthol Tobacco Heating System 2.2 for Three Months (Part 2)


Authored by  C Haziza, G de La Bourdonnaye, A Donelli, D Skiada, V Poux, R Weitkunat, G Baker, P Picavet, F L├╝dicke

Published in Nicotine & Tobacco Research    

Abstract

Introduction

Tobacco Heating System (THS) 2.2, a candidate modified-risk tobacco product aims at offering an alternative to cigarettes for smokers while substantially reducing the exposure to harmful and potentially harmful constituents (HPHCs) found in cigarette smoke.

Methods
One hundred and sixty healthy adult U.S. smokers participated in this randomized, three-arm parallel group, controlled clinical study. Subjects were randomized in a 2:1:1 ratio to menthol THS 2.2 (mTHS), menthol cigarette, or smoking abstinence (SA) for five days in confinement and 86 subsequent ambulatory days. Endpoints included biomarkers of exposure to HPHCs (reported in our co-publication, Part 1) and biomarkers of potential harm (BOPH).

Results
Compliance (protocol and allocated product exposure) was 51% and 18% in the mTHS and SA arms, respectively, on Day 90. Nonetheless, favorable changes in BOPHs of lipid metabolism (total cholesterol and high- and low-density cholesterol), endothelial dysfunction (soluble intercellular adhesion molecule1), oxidative stress (8-epi-prostaglandin F2α), and cardiovascular risk factors (e.g., high-sensitivity C-reactive protein) were observed in the mTHS group. Favorable effects in other BOPHs, including ones related to platelet activation (11-dehydrothromboxane B2) and metabolic syndrome (glucose), were more pronounced in normal weight subjects.

Conclusions
The results suggest that the reduced exposure demonstrated when switching to mTHS is associated with overall improvements in BOPHs, which are indicative of pathomechanistic pathways underlying the development of smoking-related diseases, with some stronger effects in normal weight subjects.

Clinical trial registration
NCT01989156 (ClinicalTrials.gov)

Implications
Switching to mTHS was associated with favorable changes for some BOPHs indicative of biological pathway alterations (e.g., oxidative stress and endothelial dysfunction). The results suggest that switching to mTHS has the potential to reduce the adverse health effects of smoking and ultimately the risk of smoking-related diseases.