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

Abstract

A randomised, parallel group clinical study was performed to evaluate the safety profile of an e-vapour product (EVP; 2.0% nicotine) in smokers of conventional cigarettes (CCs) switching to use the EVP for 12 weeks. During the study, no clinically significant product-related findings were observed in terms of vital signs, electrocardiogram, lung function tests and standard clinical laboratory parameters. Adverse events (AEs) reported by EVP subjects were more frequent during the first week after switching to the EVP. The frequency of AEs reduced thereafter and out of a total of 1515 reported AEs, 495 were judged as being related to nicotine withdrawal symptoms. The most frequently stated AEs were headache, sore throat, desire to smoke and cough reported by 47.4, 27.8, 27.5 and 17.0% of subjects, respectively. Only 6% of AEs were judged as probably or definitely related to the EVP. Additional observations in EVP subjects included a decrease in the level of urine nicotine equivalents by up to 33.8%, and decreases in the level of three biomarkers of exposure to toxicants known to be present in CC smoke (benzene, acrolein and 4-[methylnitrosamino]-1-[3-pyridyl]-1-butanone). The decrease in nicotine equivalents coincided with an increase in nicotine withdrawal symptoms, measured by a questionnaire, which subsided after two weeks. The data presented here shows the potential EVPs may offer smokers looking for an alternative to CCs.

A Review of Pulmonary Toxicity of Electronic Cigarettes in the Context of Smoking: A Focus on Inflammation

“…In a 2016 trial of 419 smokers randomized to an e-cig or continued smoking over 12 weeks, Cravo et al (209), reported that assignment to e-cigs was associated with statistically significant decreases in urinary metabolites of acrolein (3-HPMA), benzene (S-PMA) and NNAL (a pulmonary carcinogen) compared to controls. Another important measure in that study was urinary PG, which almost doubled after one month of e-cig use, indicating that this could be a biomarker for exposure generally to e-cigs.…”

Electronic cigarettes—A review of the physiological health effects

“…To draw meaningful broad conclusions, there is, therefore, a need for better standardization of protocols (e.g., Azzopardi et al 2016;Farsalinos et al 2016c;Iskandar et al 2016). In addition, future researchers need to take advantage of other tools and methodologies such as randomized controlled trials (Cravo et al 2016), and develop mathematical models and new frameworks (Kalkhoran and Glantz 2015;Levy et al 2017). Finally, ECs also introduce a new suite of toxicants not found in CCs.…”

“…Further studies, therefore, not only need to focus on EC aerosol composition but also on the power of the devices along with the modes of delivery by users. Overall, a large majority of the experiments mentioned above showed that the amounts of aldehydes and other toxicants produced by the ECs were lower than the amounts produced by CCs (Cravo et al 2016). In addition, some EC users experience an unpleasant taste under dry puff conditions and avoid these conditions, thus limiting the likelihood of exposure to high levels of aldehydes (Farsalinos et al 2015d).…”

e‐Cigarettes for smoking cessation: Do they deliver?

“…In two randomized open‐label clinical trials designed to study the AEs experienced by conventional cigarette (CC) smokers who switched to e‐cigarettes in a 12‐week trial, and in a 2‐year extension trial, results from the 12 week study (Table ) showed that the frequency of AEs was greater in the smokers who switched to e‐cigarettes (n = 306) compared to those who remained on CC (n = 102). In the e‐cigarette group, 271 subjects (88.6%) reported a total of 1515 AEs, whereas in the CC group, 80 subjects (78.4%) reported a total of 225 AEs.…”