RISK FROM E-VAPOUR PRODUCTS FOR USERS AND BYSTANDERS
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1 RISK FROM E-VAPOUR PRODUCTS FOR USERS AND BYSTANDERS Dr Konstantinos Farsalinos Researcher Onassis Cardiac Surgery Center, Greece University of Patras, Greece
2 COI Past 36 months 1 study funded by non-profit Tennessee Smoke-Free Association (consistency in nicotine delivery to the aerosol of e-cigarettes) 2 studies funded by non-profit AEMSA (nicotine PK studies) Past 48 months 2 unpublished studies on cardiovascular effects of e-cigarettes, hospital reimbursed for the cost of echocardiograms by 2 e-cigarette companies
3 EXPOSURE OF USERS Propylene glycol Glycerol Nicotine Contaminants - Thermal degradation products
4 PG Synthetic compound Approved by the FDA for use in food, tobacco, and pharmaceutical products as an inert ingredient Generally Recognized As Safe (GRAS) for direct addition to foods (1982)
5 PROPYLENE GLYCOL INHALATION
6 PROPYLENE GLYCOL INHALATION Bacteriostatic/bactericidal effects of PG vapors Protective effect against influenza and common cold
7 PROPYLENE GLYCOL INHALATION Continuous exposure to an atmosphere saturated with the vapor for months showed no deleterious effect on any organ, including the lungs, compared to control animals
8 PROPYLENE GLYCOL INHALATION No toxic effect was shown in any organ system or blood component Elevation in the number of goblet cells and elevated mucin production in the nasal turbinates (dehydrating effects)
9 PROPYLENE GLYCOL INHALATION FEV 1 : 103% 102% Small but significant decrease in FEV 1 /FVC Driven by an increase in FVC No lung disease causes an increase in FVC No clinical significance
10 VG Natural compound, essential for living organisms Approved by the FDA for use in food, tobacco, and pharmaceutical products Generally Recognized As Safe (GRAS) for direct addition to foods (1959) Metabolism through citric acid cycle
11 VG
12 CV EFFECTS OF NICOTINE Positive chronotropic and inotropic effects Raises BP, HR, could be arrhythmogenic (ectopic beats) This is a temporary effect Smoking is NOT a risk factor for developing hypertension
13 SMOKING AND CVD Rigotti & Clair, Eur Heart J 2013
14 NICOTINE AND CVD Am J Cardiol 2012
15 NICOTINE AND CVD Woolf et al., Am J Cardiol 2012
16 NICOTINE AND CVD
17 NICOTINE AND CVD NRT, the most widely used pharmacotherapy for smoking cessation was associated with an increase in CVD events that was driven by lower risk events, typically tachycardia, a well-known and largely benign effect of NRT Mills et al., Circulation 2013
18 NICOTINE AND CVD - SNUS
19 NICOTINE AND CVD - SNUS Smoking 3.53 ( ) 8.57 ( ) Huhtasaari et al., JACC 1999
20 NICOTINE AND CVD - SNUS
21 NICOTINE AND CVD - SNUS Hansson et al., Eur J Epidemiol 2012
22 NICOTINE AND CVD - SNUS Hansson et al., Eur J Epidemiol 2012
23 NICOTINE AND CVD - SNUS
24 NICOTINE AND STROKE - SNUS 130,000 participants All were never-smokers
25 NICOTINE AND STROKE - SNUS Hanson et al., j Intern Med 2014
26 NICOTINE AND CVD - SNUS Lee, Harm Red J 2013
27 NICOTINE AND FATAL MI Acute myocardial infarction + Acute sympathetic activation = Arrhythmias Exercise causes acute sympathetic activation Contraindicated in acute MI
28 FLAVORINGS Natural Nature-identical (synthetically produced) Artificial GRAS status for ingestion (FEMA/FDA, EFSA) Not evaluated for safety when inhaled Does not necessarily mean they are harmful (or harmless)
29 DIACETYL ACETYL PROPIONYL Diketones, safe for ingestion but reasons for concern regarding inhalation Bronchiolitis obliterans, non-specific lung dysfunction (reduced FEV 1 )
30 THERMAL DEGRADATION Oxidation of PG and VG to form aldehydes (mainly formaldehyde, acetaldehyde) Gillman et al., Regul Toxicol Pharmacol 2015
31 THERMAL DEGRADATION Oxidation of PG and VG to form aldehydes (mainly formaldehyde, acetaldehyde) Farsalinos et al., Addiction 2015
32 THERMAL DEGRADATION Dry puffs will increase aldehyde formation Flavors? Khlystov et al., Environm Res Technol 2016
33 ug/g liquid THERMAL DEGRADATION Coffee flavor in both cases (different brands) Khlystov (EVOD, 10.7 W, no dry puff) Farsalinos (CE4, 7 W, no dry puff) Farsalinos (CE4, 8 W, dry puff) Farsalinos (CE4, 11.4 W, dry puff) 2339
34 THERMAL DEGRADATION Khlystov-cigalike-tobacco flavor 70 Geiss-3rd gen-15w-tobacco
35 ACROLEIN?
36 ACROLEIN? Hect SS, et al. Nicotine Tob Res 2015 McRobbie et al. Cancer Prev Res 2015
37 PASSIVE EXPOSURE TO NICOTINE Czogala et al., Nicotine Tob Res 2013
38 PASSIVE EXPOSURE TO NICOTINE
39 PASSIVE EXPOSURE TO NICOTINE
40 PASSIVE EXPOSURE TO NICOTINE No biological effect LOAEL (increase in heart rate 260 ug nicotine IV 25 ug nicotine/d Passive vaping (Balbe, 2016) Smoking (Balbe, 2009)
41 PM SIZE AND MASS Particulate matter (PM) associated with cardiovascular and respiratory disease Not all is the same PM of environmental pollution/smoking PM from boiling water (the smallest-size particles) (Ogulei et al., Indoor Air 2006;16: ) PM from e-cigarettes microdroplets of PG, VG, nicotine What matters is composition If composition is harmful, low PM size and high PM mass will cause harm
42 FORMALDEHYDE Schripp et al., Indoor Air 2013
43 METAL EMISSIONS
44 WHAT IS THE VAPER EXHALING? Long, IJERPH 2014
45 CONCLUSIONS E-cigarette users Probably not harmless Level of risk by far lower compared to smoking Perfect harm reduction approach, but not for general use by non-smokers Passive exposure Main exposure to PG,VG and extremely low nicotine No reason for concern No harm ever seen from passive use Abuse of precautionary principle to apply universal restrictions-bans Will expose vapers to harmful effects of passive smoking will provide misleading message to smokers that e-cigarettes are of similar risk to smoking
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