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

Cancer Epidemiology Biomarkers and Prevention

Volumn 28, Issue 11, 2019, Pages 1934-1943

  Ludicke, Frank ^a   Michael Ansari, S ^a   Lama, Nicola ^a   Blanc, Nicolas ^a   Bosilkovska, Marija ^a   Donelli, Andrea ^a   Picavet, Patrick ^a   Baker, Gizelle ^a   Haziza, Christelle ^a   Peitsch, Manuel ^a   Weitkunat, Rolf ^a  

^a PHILIP MORRIS PRODUCTS S A   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

11 OXOTHROMBOXANE B2; 2 CYANOETHYLMERCAPTURIC ACID; 3 HYDROXYBENZO[A]PYRENE; 3 HYDROXYPROPYLMERCAPTURIC ACID; 4 (METHYLNITROSAMINO) 1 (3 PYRIDYL)ALPHA 1 BUTANOL; 8 ISOPROSTAGLANDIN F2 ALPHA; BIOLOGICAL MARKER; CARBON MONOXIDE; CARBOXYHEMOGLOBIN; CIGARETTE SMOKE; COTININE; CREATININE; GLYCEROL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INTERCELLULAR ADHESION MOLECULE 1; MONOHYDROXYBUTENYLMERCAPTURIC ACID; NICOTINE; NITROSONORNICOTINE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CHOLESTEROL BLOOD LEVEL; CIGARETTE SMOKING; CLINICAL OUTCOME; CONTINUING SMOKER; CONTROLLED STUDY; CREATININE URINE LEVEL; EXHALATION; EXPOSURE; FEMALE; FORCED EXPIRATORY VOLUME; HEALTH CANADA; HEAT NOT BURN TOBACCO PRODUCT; HEATING; HEMOGLOBIN BLOOD LEVEL; HUMAN; LEUKOCYTE COUNT; LUNG FUNCTION; MALE; MULTICENTER STUDY; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FUNCTION; RISK FACTOR; TOBACCO; ADVERSE EVENT; CHEMISTRY;

BIOMARKERS; FEMALE; HUMANS; MALE; TOBACCO PRODUCTS;

EID: 85074445908     PISSN: 10559965     EISSN: None     Source Type: Journal    
DOI: 10.1158/1055-9965.EPI-18-0915     Document Type: Article

References (34)

1. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. The health consequences of smoking – 50 years of progress: a report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014.
2. Jamal A, Phillips E, Gentzke AS, Homa DM, Babb SD, King BA, et al. Current cigarette smoking among adults—United States, 2016. In: Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, CDC, editors. Morbidity and Mortality Weekly Report. Volume 67. Atlanta (GA): CDC (Centers for Disease Control); 2018. p. 53.
3. Russell MA. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. Br Med J 1976;1:1430–3.
4. Huang J, Duan Z, Kwok J, Binns S, Vera LE, Kim Y, et al. Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tob Control 2019;28:146–51.
5. Rodgman A, Perfetti TA. The chemical components of tobacco and tobacco smoke. Boca Raton (FL): CRC Press, Taylor & Francis Group; 2013.
6. U.S. Department of Health and Human Services, Food and Drug Administration. Harmful and potentially harmful constituents in tobacco products and tobacco smoke; established list. Fed Regist 2012;77: 20034–7.
7. Smith MR, Clark B, Ludicke F, Schaller JP, Vanscheeuwijck P, Hoeng J, et al. Evaluation of the Tobacco Heating System 2.2. Part 1: description of the system and the scientific assessment program. Regul Toxicol Pharmacol 2016;81 Suppl 2:S17–26.
8. Li X, Luo Y, Jiang X, Zhang H, Zhu F, Hu S, et al. Chemical analysis and simulated pyrolysis of tobacco heating system 2.2 compared to conventional cigarettes. Nicotine Tob Res 2018;21:111–8.
9. Farsalinos KE, Yannovits N, Sarri T, Voudris V, Poulas K, Leischow S. Carbonyl emissions from a novel heated tobacco product (IQOS): comparison with an e-cigarette and a tobacco cigarette. Addiction 2018;113: 2099–106.
10. Mallock N, Boss L, Burk R, Danziger M, Welsch T, Hahn H, et al. Levels of selected analytes in the emissions of "heat not burn" tobacco products that are relevant to assess human health risks. Arch Toxicol 2018;92:2145–9.
11. Schaller JP, Keller D, Poget L, Pratte P, Kaelin E, McHugh D, et al. Evaluation of the Tobacco Heating System 2.2. Part 2: chemical composition, genotoxicity, cytotoxicity, and physical properties of the aerosol. Regul Toxicol Pharmacol 2016;81 Suppl 2:S27–47.
12. Ludicke F, Picavet P, Baker G, Haziza C, Poux V, Lama N, et al. Effects of switching to the Tobacco Heating System 2.2 menthol, smoking abstinence, or continued cigarette smoking on biomarkers of exposure: a randomized, controlled, open-label, multicenter study in sequential confinement and ambulatory settings (part 1). Nicotine Tob Res 2017;20: 161–72.
13. Haziza C, de La Bourdonnaye G, Donelli A, Poux V, Skiada D, Weitkunat R, et al. Reduction in exposure to selected harmful and potentially harmful constituents approaching those observed upon smoking abstinence in smokers switching to the menthol Tobacco Heating System 2.2 for three months (part 1). Nicotine Tob Res 2019 Feb 5 [Epub ahead of print].
14. Ludicke F, Picavet P, Baker G, Haziza C, Poux V, Lama N, et al. 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). Nicotine Tob Res 2017;20: 173–82.
15. Chang CM, Edwards SH, Arab A, Del Valle-Pinero AY, Yang L, Hatsukami DK. Biomarkers of tobacco exposure: summary of an FDA-sponsored public workshop. Cancer Epidemiol Biomarkers Prev 2017;26:291–302.
16. FDA (Food and Drug Administration). Guidance for industry - reporting harmful and potentially harmful constituents in tobacco products and tobacco smoke under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act - draft guidance; 2012.
17. Peck MJ, Sanders EB, Scherer G, Ludicke F, Weitkunat R. Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products. Biomarkers 2018:1–32.
18. Scherer G. Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: a literature review. Regul Toxicol Pharmacol 2018;94:203–33.
19. Xue J, Yang S, Seng S. Mechanisms of cancer induction by tobacco-specific NNK and NNN. Cancers 2014;6:1138–56.
20. FDA (Food and Drug Administration). Guidance for industry - bioanalytical method validation - draft guidance; 2013.
21. Haziza C, de La Bourdonnaye G, Skiada D, Ancerewicz J, Baker G, Picavet P, et al. Biomarker of exposure level data set in smokers switching from conventional cigarettes to Tobacco Heating System 2.2, continuing smoking or abstaining from smoking for 5 days. Data Brief 2017;10:283–93.
22. Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav 2007;32:912–23.
23. Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom test for cigarette dependence. Nicotine Tob Res 2012;14:75–8.
24. Hailperin R. Best possible inequalities for the probability of a logical function of events. Am Math Mon 1965;72:343–59.
25. 0 ab, wenn k unter n gegebenen Tests zur Ablehnung fuhren"] € German. Metrika 1978; 25:171–8.
26. Philip Morris International, Camilleri LC, Calantzopoulos A. Annual meeting of shareholders; 2018.
27. Ludicke F, Magnette J, Baker G, Weitkunat R. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers. Biomarkers 2015;20:411–21.
28. Joseph AM, Hecht SS, Murphy SE, Lando H, Carmella SG, Gross M, et al. Smoking reduction fails to improve clinical and biological markers of cardiac disease: a randomized controlled trial. Nicotine Tob Res 2008;10: 471–81.
29. Eliasson B, Hjalmarson A, Kruse E, Landfeldt B, Westin A. Effect of smoking reduction and cessation on cardiovascular risk factors. Nicotine Tob Res 2001;3:249–55.
30. Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, Westin A, et al. Influence of long-term smoking reduction on health risk markers and quality of life. Nicotine Tob Res 2002;4:433–9.
31. Leone FT, Carlsen KH, Chooljian D, Crotty Alexander LE, Detterbeck FC, Eakin MN, et al. Recommendations for the appropriate structure, communication, and investigation of tobacco harm reduction claims. An official American Thoracic Society policy statement. Am J Respir Crit Care Med 2018;198:e90–e105.
32. Weitkunat R, Lee PN, Baker G, Sponsiello-Wang Z, Gonzalez-Zuloeta Ladd AM, Ludicke F. A novel approach to assess the population health impact of introducing a Modified Risk Tobacco Product. Regul Toxicol Pharmacol 2015;72:87–93.
33. Lee PN, Fry JS, Hamling J, Sponsiello Wang Z, Baker G, Weitkunat R. Estimating the effect of differing assumptions on the population health impact of introducing a Reduced Risk Tobacco Product in the USA. Regul Toxicol Pharmacol 2017;88:192–213.
34. Martin F, Vuillaume G, Baker G, Sponsiello-Wang Z, Ricci PF, Ludicke F, et al. Quantifying the risk-reduction potential of new Modified Risk Tobacco Products. Regul Toxicol Pharmacol 2018;92:358–69.