A study to investigate changes in the levels of biomarkers of exposure to selected cigarette smoke constituents in Japanese adult male smokers who switched to a non-combustion inhaler type of tobacco product

Miura, Naoki; Yuki, Dai; Minami, Naoki; Kakehi, Aoi; Futamura, Yasuyuki

doi:10.1016/j.yrtph.2015.02.007

Cited by 18 publications

(10 citation statements)

References 16 publications

(20 reference statements)

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“…As noted by Stephens, these models only consider toxicants levels and neglect particle effects (50). In addition, there is growing consensus that a complete switch to HTP can reduce toxicant exposure, as confirmed in recent investigations on biomarkers of exposure in smokers (53–57). Haziza et al reported reductions of 51 to 96% for selected HPHC-related biomarkers over a 90-days ambulatory study.…”

Section: Risk Assessment Approachesmentioning

confidence: 89%

Heated Tobacco Products: A Review of Current Knowledge and Initial Assessments

Mallock

Pieper

Hutzler

et al. 2019

Front. Public Health

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The health risks of tobacco smoking have been documented in numerous studies and smoking rates have declined in developed countries over the last 50 years. Today, we know that cigarette smoking is the major cause of preventable deaths due to tobacco smoke induced diseases. As a consequence of an increased awareness of smoking-related health risks, heated tobacco products (HTPs) are marketed as reduced toxicant alternatives to conventional tobacco products. Manufacturers claim that levels of toxicants and hazardous compounds are significantly reduced, implying that inhalation of the modified aerosol is less harmful compared to conventional cigarettes. In this manuscript, previous assessments of HTPs are briefly summarized, including a short discussion on challenges with the adaption of standard analytical methods used for tobacco smoke. The reliability of analytical data is important for risk assessment approaches that are based on reduced toxicant exposure. In order to assess a putative reduction of health risks, an integrated study design is required that should include clinical studies and epidemiology data. One manufacturer applied for a classification as a Modified Risk Tobacco Product (MRTP) in the United States, based on extensive toxicological studies that have also been published. However, data are not yet sufficient for a reliable assessment or recognition of putatively reduced health risks. Challenges regarding a classification in Europe are also discussed briefly in this review.

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Section: Risk Assessment Approachesmentioning

confidence: 89%

Heated Tobacco Products: A Review of Current Knowledge and Initial Assessments

Mallock

Pieper

Hutzler

et al. 2019

Front. Public Health

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show abstract

“…Several studies, including those by Miura et al 16 and Sakaguchi et al, 17 have evaluated the effects of MRTPs on biomarkers of exposure, but they did not examine the effects on clinical risk markers.…”

Section: Discussionmentioning

confidence: 99%

Effects of Switching to the Menthol Tobacco Heating System 2.2, Smoking Abstinence, or Continued Cigarette Smoking on Clinically Relevant Risk Markers: A Randomized, Controlled, Open-Label, Multicenter Study in Sequential Confinement and Ambulatory Settings (Part 2)

Lüdicke

Picavet

Baker

et al. 2017

Nicotine &Amp; Tobacco Research

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IntroductionModified-risk tobacco products are expected to reduce exposure to harmful and potentially harmful constituents of cigarette smoke, and ultimately reduce the health burden of smoking-related diseases. Clinically relevant risk markers of smoking-related diseases inform about the risk profile of new tobacco products in the absence of in-market epidemiological data. The menthol Tobacco Heating System 2.2 (mTHS) is a modified-risk tobacco product in development as an alternative to cigarettes (conventional cigarettes [CCs]).MethodsIn this parallel-group study, Japanese adult smokers (23–65 years; ≥10 mCCs/day) were randomized to mTHS, menthol CCs (mCC), or smoking abstinence (SA) for 5 days in confinement and 85 days in ambulatory settings. Endpoints included biomarkers of exposure to harmful and potentially harmful constituents and clinically relevant risk markers of smoking-related diseases.ResultsOne-hundred and sixty participants were randomized to the mTHS (n = 78), mCC (n = 42), and SA (n = 40) groups. Switching to the mTHS was associated with reductions in biomarkers of exposure compared with continuing mCCs. Reductions in 8-epi-prostaglandin F2α (biomarker of oxidative stress), 11-dehydro-thromboxane B2 (biomarker of platelet activation), soluble intracellular adhesion molecule-1 (biomarker of endothelial function), and an increase in high-density lipoprotein cholesterol (biomarker of lipid metabolism) and forced expiratory volume in 1 second (biomarker of lung function) occurred in the mTHS group compared with the mCC group. The changes in the mTHS group approached those in the SA group.ConclusionsSwitching from mCCs to mTHS was associated with improvements in clinically relevant risk markers linked to mechanistic pathways involved in smoking-related diseases.ImplicationsIn this three-way randomized study, switching from menthol cigarettes to mTHS for 5 days in confinement and 85 days in ambulatory settings was associated with reductions in biomarkers of exposure to cigarette smoke, and changes were observed in clinically relevant biomarkers of oxidative stress (8-epi-prostaglandin F2α), platelet activity (11-dehydro-thromboxane B2), endothelial function (soluble intracellular adhesion molecule-1), lipid metabolism (high-density lipoprotein cholesterol) and lung function (forced expiratory volume in 1 second), similar to the SA group. The results suggest that switching to the mTHS has the potential to reduce the adverse health effects of conventional cigarettes.

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“…2014, Miura et al 2015). In other words, the exposure level to cigarette smoke constituents by NCIT use is considered to be close to the level of smoking cessation compared with that of other NVPs that need to heat tobacco leaves.…”

Section: Discussionmentioning

confidence: 99%

“…Tar was not detected under this condition. Detailed results of the chemical measurement were provided in the previous report (Ohara et al 2014, Miura et al 2015.…”

Section: Test Tobacco Productsmentioning

confidence: 99%

“…We previously conducted two confinement clinical studies (Study 1: UMIN000004334 and Study 2: UMIN000006215) in which healthy adult Japanese smokers switched from smoking 1 mg tar CC (CC1) to NCIT use during the study. The results showed that switching to NCIT use significantly reduced some BoEs selected as harmful and potentially harmful constituents (HPHCs) in CC smoke (FDA 2012b), and mutagens detected by the urine mutagenicity testing in the NCIT group were similar to those in the NS group (Kakehi et al 2012, Ohara et al 2014, Miura et al 2015. Although, the exposure level other than nicotine in NCIT use is similar to that of NS, switching from smoking CC1 to NCIT use did not show marked effects on BoPH levels in either study.…”

Section: Introductionmentioning

confidence: 99%

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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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A study to investigate changes in the levels of biomarkers of exposure to selected cigarette smoke constituents in Japanese adult male smokers who switched to a non-combustion inhaler type of tobacco product

Cited by 18 publications

References 16 publications

Heated Tobacco Products: A Review of Current Knowledge and Initial Assessments

Heated Tobacco Products: A Review of Current Knowledge and Initial Assessments

Effects of Switching to the Menthol Tobacco Heating System 2.2, Smoking Abstinence, or Continued Cigarette Smoking on Clinically Relevant Risk Markers: A Randomized, Controlled, Open-Label, Multicenter Study in Sequential Confinement and Ambulatory Settings (Part 2)

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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