Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology.
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SUBMITTER: Ogden MW
PROVIDER: S-EPMC4720039 | biostudies-literature | 2015
REPOSITORIES: biostudies-literature
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Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology.
Ogden Michael W MW Marano Kristin M KM Jones Bobbette A BA Stiles Mitchell F MF
Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals 20151102 6-7
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 resu ...[more]
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Project description:A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) was conducted, and subjects' experience with the products was followed for 24 weeks. Differences in biomarkers of tobacco exposure between smokers and never smokers at baseline and among groups relative to each other and over time were assessed. Results indicated reduced exposure to many potentially harmful constituents found in cigarette smoke following product switching. Findings support differences in exposure from the use of various tobacco products and are relevant to the understanding of a risk continuum among tobacco products (ClinicalTrials.gov Identifier: NCT02061917).
| S-EPMC4720046 | biostudies-literature
Project description:A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) for 24 weeks was conducted. Evaluation of biomarkers of biological effect (e.g. inflammation, lipids, hypercoaguable state) indicated that the majority of consistent and statistically significant improvements over time within each group were observed in markers of inflammation. Consistent and statistically significant differences in pairwise comparisons between product groups were not observed. These findings are relevant to the understanding of biomarkers of biological effect related to cigarette smoking as well as the risk continuum across various tobacco products (ClinicalTrials.gov Identifier: NCT02061917).
| S-EPMC4720037 | biostudies-literature
Project description:BACKGROUND:E-cigarette (EC) use is increasing exponentially worldwide. The early cardiovascular effects of switching from tobacco cigarettes (TC) to EC in chronic smokers is unknown. Meta-analysis of flow-mediated dilation (FMD) studies indicate 13% lower pooled, adjusted relative risks of cardiovascular events with every 1% improvement in FMD. OBJECTIVES:This study sought to determine the early vascular impact of switching from TC to EC in chronic smokers. METHODS:The authors conducted a prospective, randomized control trial with a parallel nonrandomized preference cohort and blinded endpoint of smokers ?18 years of age who had smoked ?15 cigarettes/day for ?2 years and were free from established cardiovascular disease. Participants were randomized to EC with nicotine or EC without nicotine for 1 month. Those unwilling to quit continued with TC in a parallel preference arm. A propensity score analysis was done to adjust for differences between the randomized and preference arms. Vascular function was assessed by FMD and pulse wave velocity. Compliance with EC was measured by carbon monoxide levels. RESULTS:Within 1 month of switching from TC to EC, there was a significant improvement in endothelial function (linear trend ? = 0.73%; 95% confidence interval [CI]: 0.41 to 1.05; p < 0.0001; TC vs. EC combined: 1.49%; 95% CI: 0.93 to 2.04; p < 0.0001) and vascular stiffness (-0.529 m/s; 95% CI: -0.946 to -0.112; p = 0.014). Females benefited from switching more than males did in every between-group comparison. Those who complied best with EC switch demonstrated the largest improvement. There was no difference in vascular effects between EC with and without nicotine within the study timeframe. CONCLUSIONS:TC smokers, particularly females, demonstrate significant improvement in vascular health within 1 month of switching from TC to EC. Switching from TC to EC may be considered a harms reduction measure. (Vascular Effects of Regular Cigarettes Versus Electronic Cigarette Use [VESUVIUS]; NCT02878421; ISRCTN59133298).
| S-EPMC6928567 | biostudies-literature
Project description:IntroductionUS law requires disclosure of quantities of toxic chemicals (constituents) in cigarette smoke by brand and sub-brand. This information may drive smokers to switch to cigarettes with lower chemical quantities, under the misperception that doing so can reduce health risk. We sought to understand past brand-switching behavior and whether learning about specific chemicals in cigarette smoke increases susceptibility to brand switching.MethodsParticipants were US adult smokers surveyed by phone (n = 1,151, probability sample) and online (n = 1,561, convenience sample). Surveys assessed whether smokers had ever switched cigarette brands or styles to reduce health risk and about likelihood of switching if the smoker learned their brand had more of a specific chemical than other cigarettes. Chemicals presented were nicotine, carbon monoxide, lead, formaldehyde, arsenic, and ammonia.ResultsPast brand switching to reduce health risk was common among smokers (43% in phone survey, 28% in online survey). Smokers who were female, over 25, and current "light" cigarette users were more likely to have switched brands to reduce health risks (all p < .05). Overall, 61-92% of smokers were susceptible to brand switching based on information about particular chemicals. In both samples, lead, formaldehyde, arsenic, and ammonia led to more susceptibility to switch than nicotine (all p < .05).ConclusionsMany US smokers have switched brands or styles to reduce health risks. The majority said they might or would definitely switch brands if they learned their cigarettes had more of a toxic chemical than other brands. Brand switching is a probable unintended consequence of communications that show differences in smoke chemicals between brands.
| S-EPMC5764241 | biostudies-literature
Project description:IntroductionMost pregnant smokers report abruptly reducing their cigarettes per day (CPD) by ~50% after learning of pregnancy and making further smaller reductions over the remainder of their pregnancy. Laboratory and naturalistic studies with non-pregnant smokers have found that these types of reductions often lead to changes in smoking topography (i.e., changes in smoking intensity to maintain a desired blood-nicotine level). If pregnant women smoke more intensely, they may expose themselves and their offspring to similar levels of toxicants despite reporting reductions in CPD.MethodsPregnant and non-pregnant female smokers (n = 20 and 89, respectively) participated. At the experimental session, after biochemical confirmation of acute abstinence, participants smoked one usual brand cigarette ad lib through a Borgwaldt CReSS Desktop Smoking Topography device. Carbon monoxide (CO) and measures of nicotine withdrawal, craving, and reinforcement derived from smoking were also collected.ResultsThe two groups did not differ on demographic or smoking characteristics at screening, except nicotine metabolism rate, which as expected, was faster in pregnant smokers. Analyses suggest that none of the smoking topography parameters differed between pregnant and non-pregnant smokers, although pregnant smokers had a significantly smaller CO boost. Both groups reported similar levels of relief of withdrawal and craving after smoking, but other subjective effects suggest that pregnant smokers find smoking less reinforcing than non-pregnant smokers.ConclusionsPregnant smokers do not smoke cigarettes differently than non-pregnant women, but appear to find smoking comparatively less pleasurable.ImplicationsThis is the first study to assess smoking topography in pregnant women. Pregnant women appear to be at increased risk for smoking cigarettes with more intensity because of (1) their tendency to make significant abrupt reductions in the number of cigarettes they smoke each day after learning of pregnancy and (2) an increase in nicotine metabolism induced by pregnancy. Despite these changes, the present results suggest that pregnant women do not smoke cigarettes more intensely or in a way that causes more toxicant exposure, perhaps due to a reportedly less pleasurable smoking experience.
| S-EPMC6121910 | biostudies-literature
Project description:BackgroundThere is considerable debate about the benefits and risks of electronic cigarettes (ECs). To better understand the risk-benefit ratio of ECs, more information is needed about net nicotine consumption and toxicant exposure of cigarette smokers switching to ECs.MethodsForty cigarette smokers (?1 year of smoking) interested in switching to ECs but not necessarily quitting smoking were enrolled in a 4-week observational study and provided an e-Go C non-variable battery and refillable atomizers and choice of eight flavors in 12 or 24 mg nicotine dosage. Measurement of urinary cotinine (metabolite of nicotine), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL; a pulmonary carcinogen), and eight volatile organic compounds (VOCs) that are toxic tobacco smoke constituents was conducted at baseline and week 4.ResultsAll participants with follow-up data (92.5%) reported using the study EC. Of the 40 smokers, 16 reported no cigarettes at week 2 (40%) and six continued to report no cigarettes at week 4 (15%). Change in nicotine intake over the 4 weeks was non-significant (p = .90). Carbon monoxide (p < .001), NNAL (p < .01) and metabolites of benzene (p < .01) and acrylonitrile (p = .001) were significantly decreased in the study sample. Smokers switching exclusively to ECs for at least half of the study period demonstrated significant reductions in metabolites of ethylene oxide (p = .03) and acrylamide (p < .01).ConclusionSmokers using ECs over 4 weeks maintained cotinine levels and experienced significant reductions in carbon monoxide, NNAL, and two out of eight measured VOC metabolites. Those who switched exclusively to ECs for at least half of the study period significantly reduced two additional VOCs.ImplicationsThis study extends current literature by measuring change in smoking dependence and disease-associated biomarkers, NNAL and a panel of eight common VOCs that are toxic tobacco smoke constituents in smokers who switch to ECs. The findings support the idea of harm reduction, however some levels of toxicant exposure are still of clinical concern, particularly for dual users. Extrapolation of these results must be careful to separate the different toxic exposure results for exclusive switchers versus dual cigarette + EC users, and not to equate harm reduction with the idea that using ECs is harmless.
| S-EPMC6251645 | biostudies-literature
Project description:IntroductionTobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes.Aims and methodsThis randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90.ResultsIn continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers.Conclusionglo is a reduced-exposure tobacco product.ImplicationsThis clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely.Clinical trial registrationISRCTN81075760.
| S-EPMC7885769 | biostudies-literature
Project description:IntroductionBased on arguments for harm reduction and health benefits, tobacco companies in the United States can apply for regulatory authorization to make "modified risk tobacco product" (MRTP) marketing claims. The impact of future MRTP claims may depend on whether they are noticed, believed, and lead to smokers switching products. This study provides baseline data about smokers' exposure to perceived MRTP claims ahead of any MRTP authorizations.Aims and methodsWe analyzed measures from Wave 3 of the US-based Population Assessment of Tobacco and Health (PATH) study which asked smokers to indicate if they had seen any e-cigarettes, snus, or other smokeless tobacco (SLT) products that claim to be "less harmful" in the past 12 months, and their likelihood of using products with these claims in the next 30 days.ResultsSignificantly fewer smokers noted having seen snus (5.1%) or other SLT (5.6%) with "less harmful" claims compared with e-cigarettes (29.1%). For each product, the prevalence of MRTP claim exposure was higher among smokers who perceived the product to be less harmful than smoking, who currently used the product, and who had higher rates of tobacco advertising exposure at the point of sale. Among smokers who noticed products with "less harmful" claims, about one-quarter said they would use them in the future (24%-27%).ConclusionsAhead of any Food & Drug Administration (FDA) authorization for MRTP claims, some smokers already perceive exposure to "less harmful" claims for e-cigarettes, but few do for SLT. MRTP claims may motivate some smokers to use these products.ImplicationsThis study provides new baseline data about smokers' perceived exposure to MRTP claims in the United States ahead of any regulatory claim authorization. Using data from Wave 3 of the US PATH study, we found that some smokers already perceive exposure to "less harmful" claims for e-cigarettes (29%), but few do for SLT (5%-6%). Among smokers who noticed products with "less harmful" claims, about one-quarter said they would use them in the future (24%-27%), suggesting MRTP claims may motivate some smokers to use products described as "less harmful."
| S-EPMC7885787 | biostudies-literature
Project description:BackgroundSmoking is a leading cause of numerous human disorders including pulmonary disease, cardiovascular disease, and cancer. Disease development is primarily caused by exposure to cigarette smoke constituents, many of which are known toxicants. Switching smokers to modified risk tobacco products (MRTPs) has been suggested as a potential means to reduce the risks of tobacco use, by reducing such exposure.MethodsThis randomized, controlled study investigated whether biomarkers of toxicant exposure (BoE) were reduced when smokers switched from smoking combustible cigarettes to using a novel (glo™/THP1.0) or in-market comparator (iQOS/THS) tobacco heating product (THP). One hundred eighty Japanese smokers smoked combustible cigarettes during a 2-day baseline period, followed by randomization to either continue smoking cigarettes, switch to using mentholated or non-mentholated variants of glo™, switch to using a non-mentholated variant of iQOS, or quit nicotine and tobacco product use completely for 5 days. Baseline and post-randomization 24-h urine samples were collected for BoE analysis. Carbon monoxide was measured daily in exhaled breath (eCO).ResultsOn day 5 after switching, urinary BoE (excluding for nicotine) and eCO levels were significantly (p < .05) reduced by medians between 20.9% and 92.1% compared with baseline in all groups either using glo™ or iQOS or quitting tobacco use. Between-group comparisons revealed that the reductions in the glo™ groups were similar (p > .05) to quitting in many cases.Conclusionsglo™ or iQOS use for 5 days reduced exposure to smoke toxicants in a manner comparable to quitting tobacco use. THPs are reduced exposure tobacco products with the potential to be MRTPs.ImplicationsThis clinical study demonstrates that when smokers switched from smoking combustible cigarettes to using tobacco heating products their exposure to smoke toxicants was significantly decreased. In many cases, this was to the same extent as that seen when they quit smoking completely. This may indicate that these products have the potential to be reduced exposure and/or reduced risk tobacco products when used by smokers whose cigarette consumption is displaced completely.Clinical trial registrationsISRCTN14301360 and UMIN000024988.
| S-EPMC6698948 | biostudies-literature
Project description:Snus is an oral smokeless tobacco product which is usually placed behind the upper lip, either in a loose form or in portioned sachets, and is primarily used in Sweden and Norway. The purpose of this review is to examine the reported effects of snus use in relation to specified health effects, namely lung cancer, cardiovascular disease, pancreatic cancer, diabetes, oral cancer and non-neoplastic oral disease. The review also examines the harm reduction potential of snus as an alternative to cigarettes by comparing the prevalence of snus use and cigarette smoking, and the reported incidence of tobacco-related diseases across European Union countries. The scientific literature generally indicates that the use of snus is not a significant risk factor for developing lung cancer, cardiovascular disease, pancreatic cancer or oral cancer. Studies investigating snus use and diabetes have reported that high consumption of snus (estimated as being four or more cans per week) may be associated with a higher risk of developing diabetes or components of metabolic syndrome; however, overall results are not conclusive. Snus use is associated with the presence of non-neoplastic oral mucosal lesions which are reported to heal rapidly once use has stopped. The most recent Eurobarometer data from 2017 reported that Sweden had the lowest prevalence of daily cigarette use in the European Union at 5% whilst daily "oral tobacco" use was reported to be 20%. European data published by the World Health Organisation in 2018 indicated that Sweden had the lowest rate of tobacco-related mortality and the lowest incidence of male lung cancer. Overall, prevalence statistics and epidemiological data indicate that the use of snus confers a significant harm reduction benefit which is reflected in the comparatively low levels of tobacco-related disease in Sweden when compared with the rest of Europe. The available scientific data, including long-term population studies conducted by independent bodies, demonstrates that the health risks associated with snus are considerably lower than those associated with cigarette smoking.
| S-EPMC6882181 | biostudies-literature