Reduced-risk* potential of Velo as cigarette alternative reinforced by innovative real-world study

Dr David O’Reilly, Director, Scientific Research at BAT, said: “These results are very important for Velo and the modern oral nicotine product category. They build on the extensive scientific evidence, including epidemiological data, that already exists for oral tobacco and add to the weight of evidence that supports our belief that Velo is a reduced-risk^*† product for smokers who completely switch from cigarettes as compared to continued smoking. We have already generated data that shows Velo has a toxicant profile better than snus and comparable to Nicotine Replacement Therapy (NRT)ⁱⁱⁱ. These results add further evidence that supports the important contribution Velo can make to Tobacco Harm Reduction.

“I’d like to thank everyone who participated and helped deliver this study. It is another important step forward in our journey to building A Better Tomorrow.”

Based on the biomarkers measured, compared to smokers, Velo consumers who had been using the product exclusively showed:

•  Significantly lower levels in biomarkers of exposure to priority tobacco toxicants
•  Significant favourable differences in a biomarker of potential harm relevant to lung cancer risk
•  Significant favourable differences in a number of biomarkers of potential harm relevant to cardiovascular disease
•  Significant favourable differences in a biomarker of potential harm relevant to general inflammation

For the biomarkers that showed no significant difference between the Velo consumers and smokers, similar levels were observed between the Velo and former and never smoker groups.

About the study

The study included participants who had been using Velo exclusively for over six months, as well as current smokers, former smokers and never smokers. For the Velo consumers and current cigarette smokers, usage patterns and overall consumption were not controlled under the study protocol as the aim was to assess the impact among people using the products in their ‘normal’ way rather than in a controlled way. Four different groups were enrolled and studied.

These comprised:

1. Current smokers who had been smoking for at least one year prior to screening
2. Exclusive Velo consumers for at least six months
3. Former smokers who had quit for at least six months
4. Never smokers

Participants were based in Denmark and Sweden, aged between 19-55 years old, and in good general health.

Unlike longitudinal studies where participants attend multiple clinic visits over an extended period of time, participants in this study made a single clinic visit where samples of blood, urine and breath were collected, and other clinical measurements were performed. These samples and measurements were then assessed for biomarkers of exposure (to selected toxicants) and biomarkers of potential harm. Differences in the biomarker levels between the groups were compared and analysed.

In addition, to ensure compliance with reported product usage, the Velo and former smoker groups were tested for the biomarker, CEVal, to indicate whether or not they had smoked cigarettes during the preceding six months.