Clinical study shows favorable differences in biomarkers of potential harm in smokers who switched from cigarette smoking to THS use for at least 2 years
Positive results from PMI’s latest cross-sectional risk marker study on THS users versus smokers
A cross-sectional risk marker study showed positive results in THS users* compared with smokers. The study met all primary and key secondary objectives.
Conducted in 37 healthcare institutions across six countries in Asia and Europe, the study’s results demonstrated that:
- Switching was associated with favorable differences in BoPH related to biological pathways impacted by cigarette smoke (inflammation, oxidative stress, oxygen transport, genotoxicity, lipid metabolism, endothelial function, and blood clotting potential), as well as better cardiovascular and respiratory function compared with current smokers.
- Subjects who switched to THS had similar results compared to former smokers.
- Exposure to nicotine, measured as part of the additional objectives, was comparable between THS users and current smokers.
* Subjects in the THS group (i) had used ≥10 sticks/day on average over the past 2 years, (ii) had smoked ≥10 cigarettes/day on average for at least 8 years prior to switching to THS, (iii) had smoked <30 cigarettes/month and did not use other tobacco or nicotine products on a daily basis over the past 2 years, and (iv) had verified product use based on urinary cotinine (≥200 ng/mL) and carbon monoxide breath test (<10 ppm).
The results of this cross-sectional risk marker study build on previous findings from our 6-month exposure response study and its 6-month extension, which demonstrated that predominantly switching (up to 30% of cigarettes in addition to THS) from smoking to THS use resulted in trajectory changes in eight BoPH, in the same direction as observed for smoking cessation. Five of them (total NNAL, COHb, WBC, FEV1 %predicted value, HDL-C) reached statistical differences against continuing smoking, but sICAM-1, 11-DTX-B2, and 8-epi-PGF2α did not. The new data now show that these BoPH are significantly different in switchers compared with smokers after at least 2 years of real-life use, and therefore complement the data from our exposure response study.
About the clinical study
This matched, three-group, cross-sectional risk marker study was conducted in healthy subjects to examine if those who had switched from cigarettes to THS for at least 2 years showed differences from smokers in BoPH associated with smoking-related disease. The study was conducted according to Good Clinical Practice (GCP) and registered on clinicaltrials.gov (Identifier: NCT05385055).
In total, 982 subjects were enrolled, and data from 888 was analyzed as triplets of current smokers, THS users, and former smokers (n=296 in each group). They were matched based on the product use history, age, region (Europe/Asia), and sex for evaluation of the study objectives. These latest results add to the existing evidence that substantiates the risk reduction potential of THS use in comparison with cigarette smoking.
Conclusions on PMI’s cross-sectional risk marker study
Our latest results:
- Strengthen findings from previous studies showing reduced exposure and improved BoPH among smokers who switched from cigarettes to THS during an interventional study.
- Provide real-life data on THS users who chose to switch without intervention, showing the importance of replacing smoking with THS use, as the magnitudes of changes were larger than those observed in the exposure response study where concomitant use of cigarettes occurred.
- Add new insight on the impact of THS use on cardiovascular function, indicating for the first time that regular THS use is less detrimental than cigarette smoking for arterial elasticity as measured by AIx.
Quitting tobacco and nicotine altogether is the best choice a smoker can make for their health. While THS is not risk free and contains nicotine, which is addictive, the totality of our clinical program to date has demonstrated that adult smokers who switch to THS are exposed to fewer and lower levels of harmful chemicals and show favorable changes in multiple BoPH associated with smoking-related disease. These conclusions are consistent with the results observed in former smokers. Health outcome studies are still needed to provide conclusive evidence that switching from cigarette smoking to THS use reduces the risk of smoking-related disease.
Analyses of the full study dataset are ongoing, and additional data will be presented at upcoming scientific meetings and submitted to peer-reviewed scientific & medical journals.
