Tobacco harm reduction: The potential to reduce the risk from smoking: a six-month exposure response study on switching from cigarettes to tobacco heating system (THS)

Medical Word 2020; 1(1): 45–48

Guillaume de La Bourdonaye, Roberta Costanzo, Christelle Haziza

Abstract

The primary goal of the Exposure Response Study (ERS) was to generate direct evidence that actual use of Philip Morris International’s smoke-free alternative to cigarettes, Tobacco Heating System (THS), can reduce smokers’ risk of harm compared to continuing to smoke cigarettes. In the study eight biomarkers of potential harm (BoPH) were measured, to provide further evidence on effects of current adult smokers switching to THS. Each of the BoPH were selected because they are associated with smoking-related diseases, are negatively impacted by smoking and are reversible following smoking cessation. Given the study hypothesis, that the eight BoPH which cover eight different pathways of disease would change favorably, similarly to what is reported in the literature following smoking cessation. Therefore all eight BoPH were included and tested as co-primary endpoints.

In total 984 smokers were randomized to either switch to THS use, or continue to smoke cigarettes. The eight BoPH were assessed over a period of six months in an ambulatory setting. The results showed that when smokers switched to THS, all eight BoPH showed a changes similar to what is seen following smoking cessation, and five of the eight BoPH were statistically significant better in smokers who switched to THS than smokers who continued to smoke cigarettes. This led to the conclusion that switching from cigarettes to THS-use likely reduces a smoker’s risk of tobacco-related disease and may present less risk of harm compared to continued smoking.

Key words: tobacco heating system (THS), biomarkers of potential harm (BoPH), smoke-free products, tobacco harm reduction

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References

  • Commar A, Prasad V, Tursan d’Espaignet E. WHO global report on trends in prevalence of tobacco use 2000-2025, third edition, 2019. https://www.who.int/publications-detail/who-global-report-on-trends-in-prevalence-of-tobacco-use-2000-2025-third-edition.
  • Commissioner Oot. FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway (serial online) 2019 Apr “cited 2020 May 5”. Available from: https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway.
  • Schaller J-P, 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: S27–S47. DOI: 10.1016/j.yrtph.2016.10.001.
  • Scientific standards for studies on modified risk tobacco products. Washington, DC: National Academies Press; 2012. 350 p. DOI: 10.17226/13294.
  • Smith MR, Clark B, Lüdicke F, Schaller J-P, 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: S17–S26. DOI: 10.1016/j.yrtph.2016.07.006.
  • U.S. Department of Health and Human Services. Smoking Cessation: A Report of the Surgeon General Available from: https://www.hhs.gov/sites/default/files/2020-cessation-sgr-full-report.pdf
  • Peck MJ, Sanders EB, Scherer G, Lüdicke F, Weitkunat R. Review of biomarkers to assess the effects of switching from cigarettes to modified risk tobacco products. Biomarkers 2018; 23(3): 213–44. DOI: 10.1080/1354750X.2017.1419284.
  • 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. DOI: 10.1016/j.yrtph.
    2018.02.002.
  • Lüdicke 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(6-7): 411–21. DOI: 10.3109/1354750X.2015.1096303.
  • Lüdicke F, Ansari SM, Lama N, Blanc N, Bosilkovska M, Donelli A, et al. 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 Epidemiol Biomarkers Prev 2019; 28(11): 1934–43. DOI: 1055-9965.EPI-18-0915.