Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 7: A one-month, randomized, ambulatory, controlled clinical study in Poland

Abstract

This randomized, open-label, ambulatory, controlled clinical study investigated biomarkers associated with cardiovascular risk and biomarkers of exposure to 10 selected harmful and potentially harmful constituents (HPHC) in cigarette smoke in 316 male and female Polish smokers. Subjects were randomized to continue smoking conventional cigarettes (CC; N=79) or switch to smoking the Electrically Heated Cigarette Smoking System series-K cigarette (EHCSS-K6; N=237). Biomarker assessments were performed at several time points during the study at baseline and during the 1-month investigational period. The primary biomarkers were high-sensitivity C-reactive protein and white blood cell counts. No statistically significant differences in the two primary biomarkers were found between the study groups at the end of the study. End-of-study comparisons of secondary biomarkers between study groups indicated an increase in high-density lipoprotein cholesterol, and reductions in red blood cell count, hemoglobin, and hematocrit levels in the EHCSS-K6 group. All biomarkers of exposure to cigarette smoke HPHC were decreased in the EHCSS-K6 group, despite an increase in cigarette consumption, compared to the CC group. There were no apparent differences in any of the safety assessment parameters between the groups, and the overall incidence of study-related adverse events was low.

Informing iQOS Regulations in the United States: A Synthesis of What We Know

“…A World Health Organization (WHO) report on HTPs highlighted that HTP marketing acknowledges the health risks of traditional cigarettes and indicates that HTPs are “cleaner,” “reduced-risk” products ( WHO, 2018 ). Initially, most published research regarding iQOS were funded by PMI and its affiliates ( Glantz, 2018a ), indicating lower harmful tobacco carcinogen levels ( Brossard et al, 2017 ; Jaccard et al, 2017 ; Ludicke et al, 2017 , 2018 ; Martin Leroy et al, 2012 ; Pratte et al, 2017 ; Roethig et al, 2005 , 2007 ). However, independent analyses of PMI’s research ( Glantz, 2018a ) elucidated that (a) PMI’s list of 58 harmful and potentially harmful constituents was lower in iQOS emissions compared with cigarette smoke ( St. Helen et al, 2018 ); (b) PMI only reported on 40 of 93 constituents on the FDA’s list for iQOS ( St. Helen et al, 2018 ); (c) 56 other constituents not included on either list were higher in iQOS emissions ( St. Helen et al, 2018 ); (d) iQOS and conventional cigarettes showed no difference in most biomarkers of potential harm ( Glantz, 2018b ); and (e) iQOS has possible hepatotoxicity and potential for unexpected organ toxicity not previously associated with cigarettes ( Chun et al, 2018 ).…”

Reduced Exposure to Harmful and Potentially Harmful Smoke Constituents With the Tobacco Heating System 2.1

“…The peak heating temperature of the tobacco was approximately 550°C. 3,4 THS 1.0 was commercialized in limited test markets in Switzerland, Japan, Australia, and Germany between 2006 and 2010, and the product was distributed through a small number of tobacconists. Consumer feedback highlighted a series of product shortcomings including the bulkiness of the device and dissatisfaction with the taste and flavor, both of which contributed to low adoption levels.…”

“…Later, in a 1-month study executed with THS 1.0 (ISO nicotine yield 0.3mg per cigarette), the nicotine uptake decreased by 18% at the end of study as compared to baseline, while the use of THS 1.0 cigarettes increased by more than 50%. 3 These three studies suggest that nicotine delivery may have been too low to satisfy consumers and/or to suppress smoking abstinence symptoms, despite attempts to compensate the nicotine exposure by increasing number of cigarettes per day. Incomplete withdrawal suppression with Accord has also been reported in other publications.…”

Evaluating the effects of switching from cigarette smoking to using a heated tobacco product on health effect indicators in healthy subjects: study protocol for a randomized controlled trial

“…Several studies have investigated the potential for adverse human health effects of THPs, and in some cases, in comparison with combustible cigarettes. The studies performed to date have predominantly measured chemical emissions [15–21], in vitro endpoints [15, 22–25], in vivo endpoints [26–29] and biomarkers of exposure (BoE) of chemical toxicants found in cigarette smoke in individuals who have switched from smoking to using THPs [30, 31]. In summary, significant reductions in emissions, biological activity and human exposure respectively were rapidly attained and were sustained for at least 1 month of continued use [15, 16, 19].…”