May 24, 2019
PMI’s Latest Clinical Results: Findings Add to Extensive Evidence Package on Risk Reduction
- Likely the first ever clinical study of this magnitude to directly assess risk-reduction potential of a smoke-free product in people who switch to it.
- Six-month Clinical Study met primary objective: shows improvements in the biological response of people who switch to IQOS compared to continued smoking.
Results submitted to the US FDA on
June 8to add to the extensive body of evidence already presented to the Agency.
PMI’s Scientific Assessment Program has rigorously tested IQOS over more than 7 years and supports that switching to our most advanced smoke-free product is likely to present less risk of harm than continuing to use cigarettes. Numerous aerosol chemistry and physics measurements demonstrate that IQOS aerosol contains an average of 90-95% lower levels of harmful constituents. Our results support that these reduced emissions translate to reduced toxicity in the laboratory and to reduced exposure in clinical studies. The ERS contributes an important new facet to PMI’s research: it begins to explore the impact of these promising results by measuring the biological response of people who switch to IQOS compared with those who continue to smoke.
“These results are very encouraging. We believe this study on IQOS
is the first ever clinical study of this magnitude to directly assess
the risk-reduction potential of a smoke-free product in people who
switch to it. Everything we’ve seen, including these new results,
continues to point in the direction of risk reduction,” said
About the Study
The ERS was a six-month randomized, controlled, two-arm parallel group, multicenter US study in adults who switched from smoking cigarettes to IQOS as compared to continuing to smoke cigarettes. The study followed 984 people who were randomized to either continue smoking cigarettes (n= 488), or switch to IQOS (n=496) for six months. The ERS assessed a set of eight primary and numerous secondary clinical risk endpoints, which were selected because of their association with smoking-related diseases. These endpoints are negatively impacted by smoking and based on literature are expected to improve within six months of smoking cessation.
The study met its primary objective: all eight of the primary clinical risk endpoints moved in the same direction as observed for smoking cessation in the group who switched to IQOS, with statistically significant changes in five of the eight endpoints compared with on-going smoking. These clinical risk endpoints are associated with diseases including heart and lung diseases, covering multiple organ systems, disease pathways, and biological mechanisms such as inflammation and oxidative stress.
The study was designed to address key questions related to the impact of switching to IQOS, as it is actually used. The study included people who had no intention to quit smoking and allowed them to freely use IQOS as well as other tobacco and nicotine containing products. The study met its primary objective and also saw favorable changes in the secondary clinical risk endpoints, even though there was a proportion of the IQOS users in the study who concomitantly used cigarettes. For more information on the ERS go to www.clinicaltrials.gov (Identifier: NCT02396381). The full results will be submitted for publication in a peer-reviewed journal.
About PMI’s Research
These results contribute to the totality of evidence on IQOS and
were produced as part of PMI’s extensive research and assessment
program. This program is inspired by the well-recognized practices of
the pharmaceutical industry and in line with the draft guidance of the
PMI has spent more than
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