Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products

Peck, Michael J.; Sanders, Edward B.; Scherer, Gerhard; Lüdicke, Frank; Weitkunat, Rolf

doi:10.1080/1354750x.2017.1419284

Cited by 20 publications

(14 citation statements)

References 559 publications

(557 reference statements)

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“…As with the BoExp, the dose-response seen in the primary endpoints in the present study, in particular when exposure reduction is further improved by predominant THS users abstaining from cigarette smoking, are consistent with effects seen in smoking cessation (17,18,27) but also in smokers who reduced their daily cigarette consumption (28)(29)(30).…”

Section: Discussionsupporting

confidence: 81%

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Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial

Lüdicke

Ansari

Lama

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: Cigarette smoking increases the risk of chronic diseases; heating instead of burning tobacco can lower these risks, contributing to tobacco harm reduction. This study (with 984 adult American smokers) examined whether favorable changes occur in 8 co-primary endpoints (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL, sICAM-1, 11-DTX-B2, 8-epi-PGF2a) indicative of biological and functional effects when cigarette smokers switch to the heat-not-burn Tobacco Heating System 2.2 (THS). Additionally, these biomarkers of exposure (BoExp) were quantified: MHBMA, 3-HPMA, Total NNN, CEMA, 3-OH-B[a]P, HMPMA, Total 1-OHP, NEQ, and CO exhaled. Methods: Participants were randomized to continued smoking of their preferred cigarette brand (n ¼ 496) or to using THS (IQOS brand; n ¼ 488) for 6 months. THS has a maximum heating temperature of 350 C, delivering 1.21 mg nicotine/stick and 3.94 mg glycerin/ stick under the Health Canada Intense smoking regimen. Results: The main outcome was a favorable change 6 months after baseline, with statistically significant improvements in 5 of 8 biomarkers of effect (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL) when smokers switched to THS compared with those who continued to smoke cigarettes. Likewise, BoExp were markedly reduced. Conclusions: All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups. Impact: Improvements in 5 of 8 biomarkers of effect are supportive of the research hypothesis, suggestive of disease risk reduction potential for smokers switching to THS instead of continuing to smoke cigarettes.

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Section: Discussionsupporting

confidence: 81%

“…They also reflect the adverse health effects of HPHCs that affect multiple organ systems, disease pathways, and mechanisms (15,16). Each primary endpoint was identified through a review of the existing science (17,18).…”

Section: Rationale For Biomarker Selectionmentioning

confidence: 99%

Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial

Lüdicke

Ansari

Lama

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

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“…These biomarkers provide information to policymakers during the assessment of health risks associated with new and modified tobacco products 28. Several biomarkers exist for conventional tobacco products; however, biomarkers specific for WP, smokeless tobacco products or other modified-risk tobacco products have not been well established 29 30. We report, for the first time, the differential expression of immediate-early genes (IEG) upregulated in the lung after acute exposure to WP and dry smoke (with no water in the bowl).…”

Section: Introductionmentioning

confidence: 93%

Immune modulation by chronic exposure to waterpipe smoke and immediate-early gene regulation in murine lungs

et al. 2019

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ObjectiveWe investigated the effects of chronic waterpipe (WP) smoke on pulmonary function and immune response in a murine model using a research-grade WP and the effects of acute exposure on the regulation of immediate-early genes (IEGs).MethodsWP smoke was generated using three WP smoke puffing regimens based on the Beirut regimen. WP smoke samples generated under these puffing regimens were quantified for nicotine concentration. Mice were chronically exposed for 6 months followed by assessment of pulmonary function and airway inflammation. Transcriptomic analysis using RNAseq was conducted after acute exposure to characterise the IEG response. These biomarkers were then compared with those generated after exposure to dry smoke (without water added to the WP bowl).ResultsWe determined that nicotine composition in WP smoke ranged from 0.4 to 2.5 mg per puffing session. The lung immune response was sensitive to the incremental severity of chronic exposure, with modest decreases in airway inflammatory cells and chemokine levels compared with air-exposed controls. Pulmonary function was unmodified by chronic WP exposure. Acute WP exposure was found to activate the immune response and identified known and novel IEG as potential biomarkers of WP exposure.ConclusionChronic exposure to WP smoke leads to immune suppression without significant changes to pulmonary function. Transcriptomic analysis of the lung after acute exposure to WP smoke showed activation of the immune response and revealed IEGs that are common to WP and dry smoke, as well as pools of IEGs unique to each exposure, identifying potential biomarkers specific to WP exposure.

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“…In a literature review, Scherer (2018) stated that there was uncertainty regarding the recovery time of 8-epi-PGF2a after quitting smoking. Moreover, another literature search by Peck et al (2018) indicated that there was no substantial evidence of a strong direct link between 8-iso-PGF2a and smoking cessation except where a long period of time had elapsed. Our results and the other reports suggest that a reduction in cigarette smoke exposure affects the level of 8-epi-PGF2a, but the recovery time to NS levels has still not been clarified.…”

Section: Differences In Boph At Day 28/29mentioning

confidence: 99%

Effects of reduced exposure to cigarette smoking on changes in biomarkers of potential harm in adult smokers: results of combined analysis of two clinical studies

et al. 2019

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Purpose: Nonconventional vapor products (NVP), designed to reduce exposure to cigarette smoke toxicants (CSTs), could cause changes in biomarkers of potential harm (BoPH). Although, NVPs reduced CSTs exposure compared to conventional cigarettes (CC), the changes in the BoPH values varied among the studies. Hence, further information on BoPH using NVPs is needed. Material and methods: The data of two similarly designed studies using a kind of NVP, a noncombustion and nonheating inhaler type of smokeless tobacco product (NCIT) used under 31-day confinement, were pooled, and the differences in 15 BoPH between smokers and nonsmokers at baseline and between the 1 mg tar CC (CC1) group and NCIT group at Day 28/29 were analyzed. Results: At baseline, the levels of eight BoPH (red blood cells, white blood cells, 8-epi-prostaglandin F2a, 8-hydroxy-2 0-deoxyguanosine, malondialdehyde, 11-dehydrothromboxane B2, total cholesterol and glucose) were significantly different between smokers and nonsmokers. At Day 28/29, the levels of six BoPH were significantly different between NCIT and CC1 (8-epi-prostaglandin F2a, malondialdehyde, 11-dehydrothromboxane B2: CC1 > NCIT, total bilirubin, low-density lipoprotein cholesterol and total cholesterol: CC1 < NCIT). Conclusions: Reduced exposure to CSTs has favorable effects on BoPH associated with oxidative stress, antioxidant capacity and platelet activation/coagulation but not in lipid metabolism.

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Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products

Abstract: In clinical studies, it is important to choose biomarkers that show the biological effect of cessation within the duration of the study.

Cited by 20 publications

References 559 publications

Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial

Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial

Immune modulation by chronic exposure to waterpipe smoke and immediate-early gene regulation in murine lungs

Effects of reduced exposure to cigarette smoking on changes in biomarkers of potential harm in adult smokers: results of combined analysis of two clinical studies

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