Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect

Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Morgan, W. T. J.; Stiles, Mitchell F.

doi:10.3109/1354750x.2015.1094135

Cited by 22 publications

(21 citation statements)

References 31 publications

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“…In the present study, there was no significant difference in the levels of hs-CRP, FIB, sICAM-1, LDL-C, HDL-C, HbA1c and T-bil in SM and NS at baseline and significant differences in hs-CRP, FIB, LDL-C, sICAM-1 and HDL-C have been reported in some studies including our previous comparison study (Calapai et al 2009, Bito et al 2011, Frost-Pineda et al 2011, Ludicke et al 2015, Ogden et al 2015, the reason for the poor reproducibility of these BoPH when SM and NS are compared is currently not clear. However, from the results obtained, the levels of many BoPH in the present study are consistent with the findings of our previous study and other reports.…”

Section: Differences In Boph Between Sm and Ns At Baselinesupporting

confidence: 45%

“…The level of HDL-C was not significantly different between the NCIT group and the CC1 group (p ¼ 0.4293). Although, three previous-reported clinical studies showed that there was a statistically significant increase of HDL-C in the NVP (Electrically Heated Cigarette Smoking System (EHCSS/ EHCSS-K6/electric cigarette) group compared with the CC group (Roethig et al 2008, Cravo et al 2016, Ludicke et al 2018, other studies did not show this (Ogden et al 2015, Walele et al 2018. Therefore, the changes in HDL-C levels after switching to NVPs were not consistent.…”

Section: Differences In Boph At Day 28/29mentioning

confidence: 94%

“…In the present study, there was no significant difference in the sICAM-1 level between SM and NS at baseline nor between the NCIT group and CC1 group at Day 28/29. In the previous studies comparing SM and NS, the levels of sICAM-1 were significantly different between SM and NS (Bito et al 2011, Ludicke et al 2015, Ogden et al 2015. In an ambulatory clinical study in which SM switched to NVPs (Eclipse/ menthol Tobacco Heating System [mTHS]), a significant reduction in sICAM-1 was observed within three month in two studies (Ogden et al 2015, Ludicke et al 2018.…”

Section: Differences In Boph At Day 28/29mentioning

confidence: 96%

“…In order to assess health outcomes, studies to identify biomarkers of potential harm (BoPH) associated with oxidative stress, inflammation, lipid metabolism, glucose metabolism and pulmonary functions have been conducted using smokers (SM) and nonsmokers (NS) (Burchfiel et al 1995, Prieme et al 1998, Eliasson et al 2001, Minami et al 2002, Polidori et al 2003, Flores et al 2004, Wannamethee et al 2005, Halvorsen et al 2007, Ludicke et al 2015, Ogden et al 2015. Although, there are many clinical studies on BoE using NVPs, there are few studies on BoPH associated with smoking using NVPs (Roethig et al 2008, Ogden et al 2015, Ludicke et al 2018. In addition, although, some studies have found that exposure to cigarette smoke toxicants (CSTs) with NVPs were significantly reduced compared to conventional cigarettes (CC), the changes in BoPH varied among the studies.…”

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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Section: Differences In Boph Between Sm and Ns At Baselinesupporting

confidence: 45%

Section: Differences In Boph At Day 28/29mentioning

confidence: 94%

Section: Differences In Boph At Day 28/29mentioning

confidence: 96%

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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“…Subjects’ disposition, characteristics, compliance and safety results are presented herein. Results from changes in exposure measures (Ogden et al, 2015a) and biomarkers of biological effect (Ogden et al, 2015b) are reported elsewhere.…”

Section: Introductionmentioning

confidence: 99%

Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology

et al. 2015

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A randomized, multi-center study was conducted to assess potential improvement in health status measures, as well as changes in biomarkers of tobacco exposure and biomarkers of biological effect, in current adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) evaluated over 24 weeks. Study design, conduct and methodology are presented here along with subjects’ disposition, characteristics, compliance and safety results. This design and methodology, evaluating generally healthy adult smokers over a relatively short duration, proved feasible. Findings from this randomized study provide generalized knowledge of the risk continuum among various tobacco products (ClinicalTrials.gov Identifier: NCT02061917).

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Heated tobacco products for smoking cessation and reducing smoking prevalence

Tattan‐Birch

Hartmann‐Boyce

Kock

et al. 2022

Cochrane Database of Systematic Reviews

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Background Heated tobacco products (HTPs) are designed to heat tobacco to a high enough temperature to release aerosol, without burning it or producing smoke. They differ from e‐cigarettes because they heat tobacco leaf/sheet rather than a liquid. Companies who make HTPs claim they produce fewer harmful chemicals than conventional cigarettes. Some people report stopping smoking cigarettes entirely by switching to using HTPs, so clinicians need to know whether they are effective for this purpose and relatively safe. Also, to regulate HTPs appropriately, policymakers should understand their impact on health and on cigarette smoking prevalence. Objectives To evaluate the effectiveness and safety of HTPs for smoking cessation and the impact of HTPs on smoking prevalence. Search methods We searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, and six other databases for relevant records to January 2021, together with reference‐checking and contact with study authors and relevant groups. Selection criteria We included randomised controlled trials (RCTs) in which people who smoked cigarettes were randomised to switch to exclusive HTP use or a control condition. Eligible outcomes were smoking cessation, adverse events, and selected biomarkers. RCTs conducted in clinic or in an ambulatory setting were deemed eligible when assessing safety, including those randomising participants to exclusively use HTPs, smoke cigarettes, or attempt abstinence from all tobacco. Time‐series studies were also eligible for inclusion if they examined the population‐level impact of heated tobacco on smoking prevalence or cigarette sales as an indirect measure. Data collection and analysis We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking at the longest follow‐up point available, adverse events, serious adverse events, and changes in smoking prevalence or cigarette sales. Other outcomes included biomarkers of harm and exposure to toxicants/carcinogens (e.g. NNAL and carboxyhaemoglobin (COHb)). We used a random‐effects Mantel‐Haenszel model to calculate risk ratios (RR) with 95% confidence intervals (CIs) for dichotomous outcomes. For continuous outcomes, we calculated mean differences on the log‐transformed scale (LMD) with 95% CIs. We pooled data across studies using meta‐analysis where possible. Main results We included 13 completed studies, of which 11 were RCTs assessing safety (2666 participants) and two were time‐series studies. We judged eight RCTs to be at unclear risk of bias and three at high risk. All RCTs were funded by tobacco companies. Median length of follow‐up was 13 weeks. No studies reported smoking cessation outcomes. There was insufficient evidence for a difference in risk of adverse events between smokers ...

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Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect

Cited by 22 publications

References 31 publications

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

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

Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology

Heated tobacco products for smoking cessation and reducing smoking prevalence

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