PMID- 29248487
OWN - NLM
STAT- MEDLINE
DCOM- 20180814
LR  - 20231213
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 92
DP  - 2018 Feb
TI  - Evaluation of the safety profile of an electronic vapour product used for two 
      years by smokers in a real-life setting.
PG  - 226-238
LID - S0273-2300(17)30397-5 [pii]
LID - 10.1016/j.yrtph.2017.12.010 [doi]
AB  - 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.
CI  - Copyright (c) 2017 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Walele, Tanvir
AU  - Walele T
AD  - Fontem Ventures, Barbara Strozzilaan 101, 1083 HN Amsterdam, The Netherlands. 
      Electronic address: tanvir.walele@fontemventures.com.
FAU - Bush, Jim
AU  - Bush J
AD  - Covance Clinical Research Unit, Hyde Street, Leeds, LS2 9LH, UK.
FAU - Koch, Annelize
AU  - Koch A
AD  - Simbec Research, Merthyr Tydfil, CF48 4DR, UK.
FAU - Savioz, Rebecca
AU  - Savioz R
AD  - Clinopsis S.A., Jardins 6, 1426 Concise, Switzerland.
FAU - Martin, Claire
AU  - Martin C
AD  - Clinopsis S.A., Jardins 6, 1426 Concise, Switzerland.
FAU - O'Connell, Grant
AU  - O'Connell G
AD  - Fontem Ventures, Barbara Strozzilaan 101, 1083 HN Amsterdam, The Netherlands.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171214
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Smoke)
RN  - 6M3C89ZY6R (Nicotine)
SB  - IM
MH  - Adult
MH  - Electronic Nicotine Delivery Systems/*methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Nicotine/adverse effects
MH  - Smoke/*adverse effects
MH  - Smokers
MH  - Smoking/*adverse effects
MH  - Smoking Cessation/methods
MH  - Smoking Prevention/methods
MH  - Substance Withdrawal Syndrome/*physiopathology
MH  - Nicotiana/adverse effects
MH  - Tobacco Products/adverse effects
MH  - Tobacco Use Disorder/*physiopathology
OTO - NOTNLM
OT  - Adverse events
OT  - Biomarkers of exposure
OT  - Clinical study
OT  - Electronic cigarette
OT  - Electronic vapour product
OT  - Safety
OT  - Subjective effects
EDAT- 2017/12/19 06:00
MHDA- 2018/08/15 06:00
CRDT- 2017/12/18 06:00
PHST- 2017/09/18 00:00 [received]
PHST- 2017/12/12 00:00 [revised]
PHST- 2017/12/14 00:00 [accepted]
PHST- 2017/12/19 06:00 [pubmed]
PHST- 2018/08/15 06:00 [medline]
PHST- 2017/12/18 06:00 [entrez]
AID - S0273-2300(17)30397-5 [pii]
AID - 10.1016/j.yrtph.2017.12.010 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2018 Feb;92:226-238. doi: 10.1016/j.yrtph.2017.12.010. 
      Epub 2017 Dec 14.