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 3 Months (Part 2)

Autor: Guillaume de La Bourdonnaye, Patrick Picavet, Christelle Haziza, Frank Lüdicke, Gizelle Baker, Andrea Donelli, Dimitra Skiada, Valerie Poux, Rolf Weitkunat
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Adult
Male
Hot Temperature
Homocysteine
medicine.medical_treatment
Health Behavior
Physiology
Original Investigations
010501 environmental sciences
Electronic Nicotine Delivery Systems
01 natural sciences
Risk Assessment
law.invention
Heating
03 medical and health sciences
chemistry.chemical_compound
Young Adult
0302 clinical medicine
Randomized controlled trial
Harm Reduction
law
Smoke
medicine
AcademicSubjects/SOC02541
Humans
030212 general & internal medicine
Platelet activation
Endothelial dysfunction
0105 earth and related environmental sciences
Aged
Smokers
biology
business.industry
C-reactive protein
Smoking
Public Health
Environmental and Occupational Health
Antipruritics
Middle Aged
medicine.disease
Menthol
Blood pressure
chemistry
biology.protein
Smoking cessation
Female
Metabolic syndrome
business
AcademicSubjects/MED00010
Biomarkers
Zdroj: Nicotine & Tobacco Research
ISSN: 1469-994X
1462-2203
Popis: 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 found in cigarette smoke. Methods One hundred and sixty healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Subjects were randomized in a 2:1:1 ratio to menthol Tobacco Heating System 2.2 (mTHS), menthol cigarette, or smoking abstinence for 5 days in confinement and 86 subsequent ambulatory days. Endpoints included biomarkers of exposure to harmful and potentially harmful constituents (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 smoking abstinence 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 molecule-1), oxidative stress (8-epi-prostaglandin F2α), and cardiovascular risk factors (eg, 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. Implications Switching to mTHS was associated with favorable changes for some BOPHs indicative of biological pathway alterations (eg, 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. Switching to mTHS for 90 days led to reductions in a number of biomarkers of exposure in smokers, relative to those who continued smoking cigarettes, which were close to those observed when stopping smoking (reported in our co-publication, Part 1). Initial findings suggest reduced levels of 8-epi-prostaglandin F2α and intercellular adhesion molecule 1, when switching to mTHS for 90 days. These changes are comparable to what is observed upon smoking cessation. In normal weight subjects, additional favorable changes were seen in 11-dehydrothromboxane B2, fibrinogen, homocysteine, hs-CRP, percentage of predicted forced expiratory volume in 1 second, systolic blood pressure, diastolic blood pressure, glucose, high-density lipoprotein, apolipoprotein A1, and triglycerides. Trial registration NCT01989156.
Databáze: OpenAIRE
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