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

Abstract

Background: Cigarette smoking increases the risk of chronic diseases; heating instead of burning tobacco can lower these risks, contributing to tobacco harm reduction. This study (with 984 adult American smokers) examined whether favorable changes occur in 8 co-primary endpoints (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL, sICAM-1, 11-DTX-B2, 8-epi-PGF2a) indicative of biological and functional effects when cigarette smokers switch to the heat-not-burn Tobacco Heating System 2.2 (THS). Additionally, these biomarkers of exposure (BoExp) were quantified: MHBMA, 3-HPMA, Total NNN, CEMA, 3-OH-B[a]P, HMPMA, Total 1-OHP, NEQ, and CO exhaled. Methods: Participants were randomized to continued smoking of their preferred cigarette brand (n ¼ 496) or to using THS (IQOS brand; n ¼ 488) for 6 months. THS has a maximum heating temperature of 350 C, delivering 1.21 mg nicotine/stick and 3.94 mg glycerin/ stick under the Health Canada Intense smoking regimen. Results: The main outcome was a favorable change 6 months after baseline, with statistically significant improvements in 5 of 8 biomarkers of effect (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL) when smokers switched to THS compared with those who continued to smoke cigarettes. Likewise, BoExp were markedly reduced. Conclusions: All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups. Impact: Improvements in 5 of 8 biomarkers of effect are supportive of the research hypothesis, suggestive of disease risk reduction potential for smokers switching to THS instead of continuing to smoke cigarettes.

Human Biomarker Exposure From Cigarettes Versus Novel Heat-Not-Burn Devices: A Systematic Review and Meta-Analysis

“…After baseline measurements and allocation, the intervention period ran for 5 days in confinement in six studies, [28][29][30][31][32]34 28 days in a residential setting in one study, 27 5 days in confinement followed by 85 days ambulatory in two studies study, 33,35 and a 6-month ambulatory period in one study. 36 For consistency across the studies, those that collected data both during confinement and in an ambulatory setting only had their confinement data analysed. Confinement involved physical restriction to the clinic for the duration of the intervention period, and supervised smoking only in smoking rooms during approved hours (6:30am to 11:00pm in most studies).…”

Acute Effects of a Heat-Not-Burn Tobacco Product on Pulmonary Function

“…Industry data suggest that IQOS reduces exposure to several harmful or potentially harmful constituents compared with CC. In a recent study by Philip Morris, switching from conventional cigarettes predominantly or completely to HNB products lead to higher FEV1% pred, decreased exhaled CO, and reduced exposure to carcinogens [28]. However, IQOS presented higher cytotoxic effects compared with EC, but lower compared with CC, in in vitro studies on bronchial epithelial cells [29].…”

Comparative Indoor Pollution from Glo, Iqos, and Juul, Using Traditional Combustion Cigarettes as Benchmark: Evidence from the Randomized SUR-VAPES AIR Trial

“…Smoking of traditional combustion cigarettes (TCC) is associated with major burdens of mortality, morbidity, and cost [ 1 , 2 ]. Recently, novel smoking approaches have been introduced, with very favorable market penetration, including electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) [ 3 , 4 ]. The popularity of EVC has considerably increased during the past decades in the United States [ 5 ] and in European countries [ 6 ].…”