In this 12-month study, risk factors for cardiovascular disease were measured, including cholesterol and weight gain, and compared with data for continuing to smoke.
Without question, quitting smoking completely is the best choice to reduce the risk of developing smoking-related diseases and to increase life expectancy in smokers. Even so, not everyone quits.
As part of our Exposure Response Study, which included a 6-month study period followed by a 6-month extension for a total of 1 year, risk factors for cardiovascular diseases were measured in addition to the eight core biomarkers of potential harm. For those who switched to Platform 1, after 12 months of use, participants experienced on average a slight increase in weight of 0.7 kg, a slight increase in low density lipoprotein cholesterol (1.15 mg/dL), and a slight reduction in high-sensitivity C-reactive protein levels in comparison to smokers who continued smoking. No particular change in waist circumference, blood pressure, hemoglobin A1c, or fibrinogen levels was observed during the 1-year period among Platform 1 users.
Because severe weight gain is known to increase the risk of cardiovascular diseases, the limited weight gain and absence of increase in cardiovascular risk factors when switching to Platform 1 add to the body of evidence on the potential of Platform 1 to reduce the risk of smoking-related diseases compared to subjects who continue to smoke.
See Dr. Haziza present this topic:
Hello everybody, my name is Christelle Haziza. I am Director of a group responsible for designing clinical study from a scientific point of view but also about their execution. I will show you one of the studies today, which has been conducted as part of a clinical program on this product.
The study was a two-arm, randomized study, which was conducted on healthy smokers – adults. These smokers were asked to switch from their own cigarettes to a product, the tobacco heating system, for a period of twelve months or continue smoking their own cigarettes for the same period of time.
In order to show some reduced risk of the product, we have measured well-established cardiovascular marker in this study, and we have measured also over parameters, such as weight gain, as an example or waist circumference. We have also measured some very well-established cardiovascular risk factors, such as C-reactive protein.
To be able to compare how the product can reduce the risk, we need to use what is the usual benchmark. The best way for a smoker to reduce the risk of smoking-related disease is to stop smoking.
This is the reason we have conducted in parallel to this study, a smoking cessation study for a 12-month period, where smokers were asked to remain abstinent from smoking cigarettes for the period of time. We had a look still, at the demographic of the population, because it was quite important to have a look at the gender and age of this population because we compare two studies. In terms of these parameters, they were quite balanced, it has however to be noted, that the baseline weight was slightly lower in the smoking cessation study than in the exposure response study.
When we look at the result of the study, we clearly show in with the table that we had some improvement in cardiovascular marker. These markers indicate clearly that the oxygen delivery to the body was increased when switching to the tobacco heating system. We showed also an improvement in endothelial function, as well as a reduction in inflammation and an improvement on lipid metabolism.
Looking at over well-established cardiovascular risk factors, like blood pressure or C-reactive protein, we didn’t see an increase in this cardiovascular factor, indicating again, the potential of a product to reduce cardiovascular disease in the future. The favorable changes were really following the same trajectory as observed in the smoking cessation study.
We were very much interested in following the evolution of weight gain. Severe weight gain in some people can be also be a factor to increase the risk of cardiovascular risk. When you look at the graph when we show the evolution of weight gain over time, and you see here the end-point at baseline, after three months or after six months and finally after 12 months, you clearly see that we have obtained an increase of weight gain post-smoking cessation, as observed in the literature which was around four to five kilo.
However, there was a limited increase in weight gain when switching to the tobacco heating system. This limited increase in weight gain is probably an additional factor to say that there is no increase or probably even a decrease in cardiovascular risk.
So altogether I am happy to have presented you these results, because it shows how favorable it could be for a smoker to switch from cigarettes to tobacco heating system. And the effect that we have observed post-switching to the product were quite similar to when stopping smoking, which is the best way to minimize the risk of disease.
Thank you for your attention.