Amsterdam, Netherlands, 17th January 2018 – A new peer-reviewed clinical trial to be published in the February edition of Regulatory Toxicology and Pharmacology shows that regular use of e-cigarettes does not have any negative health impact on smokers.
The study, “Evaluation of the Safety Profile of an Electronic Vapour Product Used for Two Years by Smokers in a Real-life Setting”, examined 209 volunteer smokers who used a typical closed-system e-cigarette for 24 months while researchers monitored for adverse events, as well as lung function, electrocardiogram results, and exposure to nicotine and tobacco constituents.
“This study shows that after two years of continual e-cigarette use, there were no signs of serious health complications in smokers.” said Tanvir Walele, Director of Scientific Affairs at Fontem Ventures, the owner of e-cigarette brand blu.
During the trial, no serious safety concerns were recorded among the participants and no clinically relevant findings were observed in all other medically-defined safety criteria. Further, the use of the vaping products was associated with a reduction in nicotine withdrawal symptoms, reduced exposure to cigarette smoke constituents, and no increase in body weight.
“Clinical data over a two-year period gives us a much clearer picture about longer term vaping, and the potential implications for the health of smokers, so they can make an informed decision.” said Walele.
A recently updated Cochrane Review1, whilst acknowledging the small number of published clinical studies currently available, reached a similar conclusion to this study: that e-cigarettes with nicotine can help smokers to reduce or replace smoking with no increased health risks associated with short- to mid-term (up to two years) use.
“Governments and policy-makers should ensure that regulatory frameworks reflect this emerging scientific consensus, as more long term research demonstrates the safety profile of e-cigarettes,” said Walele. “This research suggests we need e-cigarette regulation that is not modelled on tobacco product regulation, but encourages innovation and compliance with robust product quality, manufacturing and safety standards.”
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1 http://www.cochrane.org/CD010216/TOBACCO_can-electronic-cigarettes-help-people-stop-smoking-and-are-they-safe-use-purpose
Abstract
The safety profile of Puritane™, a closed system electronic vapour product (EVP), was evaluated when used by smokers of conventional cigarettes (CCs) for 24 months in a real-life setting.
The study was a two-centre ambulatory clinical study with 209 healthy volunteers. Outcome measures included adverse events (AEs), vital signs, electrocardiogram, lung function tests, exposure to nicotine and selected smoke constituents, nicotine withdrawal effects and smoking desire.
No serious AEs related to EVP use were observed. The most frequently reported AEs were headache, nasopharyngitis, sore throat and cough, reported by 28.7%, 28.7%, 19.6% and 16.7% of subjects, respectively, which dissipated over time. Small decreases in lung function were not considered clinically relevant. No clinically relevant findings were observed in the other safety parameters. From Month 2, nicotine withdrawal symptoms decreased. Smoking desire and CC consumption steadily decreased over time in all subjects. EVP use was associated with reduced exposure to cigarette smoke constituents, whereas urinary nicotine levels remained close to baseline. Body weight did not increase in CC subjects switching to the EVP.
In conclusion, the aerosol of the EVP at study was well tolerated and not associated with any clinically relevant health concerns after usage for up to 24 months.
Study FAQ
Who funded the study?
This work was funded and supported by Fontem Ventures B.V., the manufacturer of the vaping product used in this study. Fontem Ventures is a subsidiary of Imperial Brands Group PLC.
Why do you fund these studies?
There is not enough long-term science on vaping being conducted. The public health community, governments, regulators and the public at large should know the facts about vaping. We at Fontem Ventures passionately believe that e-vapour products can offer a less harmful alternative for smokers. That’s why we support peer-reviewed science on the subject – we believe scientific evidence can help smokers make better decisions.
What product was used in this study?
The study was conducted with Puritane™ e-cigarettes manufactured by Fontem Ventures. The study used pre-filled (closed system) cartomisers with either tobacco flavour or menthol flavour e-liquid containing 1.6% pharmaceutical grade nicotine.
This product is no longer available so is the study still relevant?
The device and liquid ingredients are comparable to similar closed system e-cigarette products available in the market today including those manufactured by Fontem Ventures under its brand blu™.
Does this mean e-cigarettes are harmless?
No you cannot draw that conclusion. The conclusion of the study is that the use of the e-cigarette for up to 2 years appears to be an acceptable alternative for smokers, with the advantage of reducing their exposure to harmful tobacco smoke constituents.
Were the results what you expected?
Yes, given the known toxicological profile of the e-liquids manufactured by Fontem Ventures, and the emerging scientific evidence on the limited health impacts of vaping when used by smokers, we did not expect to find any adverse health impact from two years of regular usage.
What is the significance of the absence of weight gain?
Stopping smoking has been associated with weight gain. There is currently no evidence that smokers that switch to vaping also experience weight gain. In this study mean body weight was stable for the 209 participants over the two years.
Can the conclusion be extrapolated for all e-cigarettes?
No, as this depends on the quality ingredients manufacturers use in the liquid. Studies have found variations in the toxicity of different flavoured e-liquids and their resulting aerosols when assessed in in vitro assays. Our findings extrapolated to other flavours should therefore be treated with caution. However, the device and liquid ingredients used in this study are comparable to similar closed system e-cigarette products manufactured by Fontem Ventures under the blu™ brand.
About Fontem Ventures
Fontem Ventures, a division of Imperial Brands PLC, is the owner of the blu e-cigarette brand. Headquartered in the Amsterdam, Netherlands and with a Research Development centre in Liverpool, UK, Fontem Ventures’ purpose is to drive electronic vaping technology forward, and deliver something better to smokers and vapers around the world.