Tanvir Walelea, Girish Sharmac, Rebecca Saviozd, Claire Martind, Josie Williams
ScienceDirect / Regulatory Toxicology and Pharmacology Dec, 2015
This is a two part study published in the Journal of Regulatory Toxicology and Pharmacology which found that e-cigarettes share a similar short-term safety profile as Nicorette® products and are comparable in reducing tobacco withdrawal symptoms.
Part A: Pharmacokinetics Dec 13, 2015
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Highlights
- The EVP was shown to deliver as much nicotine to blood as an NRT product in smokers.
- Adding flavours to e-liquids did not influence nicotine pharmacokinetics.
- A dose-dependent increase in blood nicotine was observed.
- The blood nicotine increase was however not directly proportional to the dose.
Abstract
The pharmacokinetic (PK) profile of nicotine delivered by an Electronic Vapour Product (EVP) was characterised in a 2-part study in smokers. The study was designed as a randomised, controlled, four-way crossover trial. Part 1 compared an unflavoured e-liquid (UF2.0%) and a flavoured e-liquid (FL2.0%) to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette®; 15 mg). Part 2 compared e-liquids with increasing nicotine concentrations (0%, 0.4%, 0.9%, 2.0%). Subjects used each different product for a daily use session. In Part 1, maximum plasma nicotine concentration (Cmax) for UF2.0%, FL2.0%, Nicorette® and CC was 3.6, 2.5, 2.5 and 21.2 ng/mL, respectively. The time to maximum plasma nicotine concentration (Tmax) was longer for the EVP (UF2.0%, 9.0 min; FL2.0%, 10.0 min) and the nicotine inhalator (13.0 min) compared to CC (3.0 min). In Part 2, EVP with 0%, 0.4%, 0.9% and 2.0% nicotine produced Cmax values of 0.6, 1.0, 1.9 and 3.6 ng/mL, respectively. At the maximum nicotine concentration of 2% as prescribed by the European Tobacco Directive, the EVP achieved nicotine delivery that was comparable to the inhalator. EVPs thus offer a potential alternative to nicotine inhalator devices for those finding it difficult to quit smoking.
Part B: Safety and subjective effects Dec 15, 2015
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Highlights
- The EVP had a similar short-term safety profile to a licensed NRT product.
- The two different flavour e-liquids had a similar short-term safety profile.
- The EVP was shown to reduce smoking urges at 0% nicotine.
- The EVP was shown to reduce nicotine withdrawal symptoms at 0% nicotine.
Abstract
An Electronic Vapour Product (EVP) has been evaluated for short-term safety parameters and subjective effects in a 2-part study, in smokers. Part 1 compared the EVP with unflavoured (UF) and flavoured (FL) e-liquid at 2.0% nicotine to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette®, 15 mg). Part 2 assessed the effect of increasing concentrations of nicotine in the e-liquid used with the EVP (0%, 0.4%, 0.9%, 2.0%). The study was designed as a randomised, controlled, crossover trial. Outcomes included adverse events (AEs), vital signs, exhaled carbon monoxide (CO), clinical laboratory parameters, smoking urges and withdrawal symptoms. In both study parts, only mild non-serious AEs were reported. No major differences were observed in AEs between the EVPs and Nicorette®. Exhaled CO levels only increased for CC. All products appeared to decrease smoking urges and nicotine withdrawal symptom scores to a similar extent. The EVP had a similar short-term safety profile to Nicorette® and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette® and CC. Unlike nicotine replacement therapies, the EVP may offer an alternative for those finding it difficult to quit the behavioural and sensorial aspects of smoking.
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