PMI's first online poster session and live Q&A

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 12 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 other 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 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 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 3 months or after 6 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 4 to 5 kiloo.

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 effects 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.

Hello everybody. I am Karina Fischer of the Regulatory Research Team of Philip Morris International, and I represent the study of the impact of perception of reduced harm on [THS] use patterns in Japan.

In the presentation, I will refer to “reduced formation of harmful chemicals” only as “reduced formation,” and to “reduced risk of harm” as “reduced harm.” In our study, we hypothesize that if adult smokers perceive using heated tobacco products as less harmful than smoking conventional cigarettes, then they will be more likely to accept and use heated tobacco products as an alternative to continuing smoking conventional cigarettes, and in the best case, will use heated tobacco products a hundred percent exclusively.

We therefore investigated whether and how reduced formation or reduced harm reasons for using PMI’s heated tobacco product [THS] impact the use-pattern of the [THS] product in Japan.

Method-wise, as part of longitudinal online surveys, Japanese adults [THS] users who used [THS] either exclusively or together with other tobacco products, and who were followed-up over 48, 60, or 72 weeks, had to repeatedly mention the reasons why that they were using [THS].

And out of 22 possible reasons they could select, two reasons were related to reduced formation or reduced harm.

The first reason was "The tobacco vapor of [THS] has significantly less amount of harmful chemicals than the smoke of conventional cigarettes. This does not mean that [THS] is risk-free."

The second reason was, "Because switching completely to [THS] is likely to present less risk of harm than continuing to smoke conventional cigarettes. This does not mean [THS] is risk-free."

The study population included 8,136 adult [THS] users randomly selected from the Japanese [THS] owner database with mean age of 43 years, and a proportion of male [THS] users of 74%. From our study, we derived three major results that were similar for 48, 60, or 72 weeks of follow-up.

The first result as illustrated in the first figure was the more often [THS] users mentioned “reduced formation” or “reduced harm” as a reason for using [THS] during the follow-up, the more likely they were to be exclusive [THS] users at a certain week.

For example, at week 48, the percentage of exclusive [THS] users range from 50-76%, depending on the number of reduced formation and reduced harm mentions as shown by the yellow bars.

The second result as presented in the table was that the positive relationship between the number of reduced formation and reduced harm mentions and the likelihood of [THS] exclusive use, as well as the effect size of this relationship, represented by the odds ratios, were statistically significant.

For example, at week 48, [THS] users who mention reduced formation or reduced harm as a reason for using [THS] six to ten times during the follow-up were about 2.3 times more likely to be exclusive [THS] users than those [THS] users who never mention reduced formation or reduced harm as a reason for using [THS] during the follow-up.

Eventually, the third result as illustrated in the second figure was that [THS] users who mentioned reduced formation and reduced harm as a reason for using [THS] during the follow-up were more likely to be stable exclusive [THS] users during follow-up.

For example, for follow-up of 48 weeks, they were more likely to be exclusive [THS] users for the whole 48 weeks, or from the 12 to the 48 week, and they were less likely to not be [THS] exclusive users at week 48. This all compared to those [THS] users who never mentioned reduced formation or reduced harm as reasons for using [THS] during the follow-up.

From these results, we finally concluded that leveraging reduced formation and reduced harm messages as part of consumer communication may facilitate the acceptance and use of heated tobacco products or in more general, smoke-free tobacco products among adult smokers who otherwise would continue to smoke and therefore may ultimately have positive impact on population health.

Thank you for your time and attention, and have a nice remaining day.

Bye, bye!