A randomised, parallel group study to evaluate the safety profile of an electronic vapour product over 12 weeks

Introduction:
This text presents the results of a clinical study that aimed to evaluate the safety profile of an electronic vapour product (EVP) in smokers who switched from conventional cigarettes (CCs) to the EVP for 12 weeks. The study also assessed exposure to potential toxicants and changes in biomarkers of biological effect.

Key points:

* The study was an open-label, randomised, parallel group, clinical trial conducted in two centers in the UK.
* A total of 420 adult smokers of CCs were enrolled and randomised in a 3:1 ratio to either switching to the EVP or continuing to smoke their own CC brand for 12 weeks.
* The EVP prototype used in this study consisted of a rechargeable battery, an atomiser, and a capsule containing e-liquid.
* The primary outcomes measured in this study were safety parameters, including vital signs, adverse events (AEs), ECGs, lung function tests, and clinical laboratory parameters.
* The secondary outcomes included a determination of the level of selected biomarkers of exposure (BoE) in urine, blood, and exhaled breath.
* A total of 408 subjects used the study product at least once, and 387 subjects completed the study.
* The study found no clinically significant findings or changes from baseline in vital signs, ECG parameters, clinical laboratory parameters, or lung function tests.
* The study also found that EVP use was associated with reduced exposure to selected HPHCs, as measured by BoE in urine, blood, and exhaled breath.

Main message:
The study provides evidence that the use of the EVP prototype for 12 weeks was safe and well-tolerated in smokers who switched from CCs. Additionally, the study suggests that EVP use may offer smokers a means to reduce exposure to harmful and potentially harmful constituents present in CC smoke. However, further research is needed to assess the long-term safety and efficacy of EVPs in smoking cessation or reduction.

Cravo, Ana S., Jim Bush, Girish Sharma, Rebecca Savioz, Claire Martin, Simon Craige, and Tanvir Walele. “A Randomised, Parallel Group Study to Evaluate the Safety Profile of an Electronic Vapour Product over 12 Weeks.” Regulatory Toxicology and Pharmacology 81 (November 2016): S1–14. https://doi.org/10.1016/j.yrtph.2016.10.003.