E-Cigarettes: current evidence and · Treatment of tobacco dependence (i.e. Smoking cessation)...
Transcript of E-Cigarettes: current evidence and · Treatment of tobacco dependence (i.e. Smoking cessation)...
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E-Cigarettes: current evidence and future areas of exploration
Prof. Riccardo PolosaProfessor of Internal MedicineUniversità di Catania - ITALY
Scientific Advisor:Lega Italiana AntiFumo (LIAF)
Consumer Advocates for Smoke-free Alternatives Association (CASAA)
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Negative Aspects
The Past
Vaping: Current and Emerging Views
Positive Aspects
The Future
Janus head. Terracotta sculpture, from Vulci, II century BC (Rome, National Etruscan Museum of Villa Giulia).
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Long-term effect of reduced smoking on BP in smokers switching to ECs
Farsalinos K, Cibella F, Caponnetto P, et al. Intern Emerg Med. 2016
Systolic BP changes at Week 52 from baseline
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Long-term effect of reduced smoking on BP in smokers switching to ECs
HarmReversal!
Farsalinos K, Cibella F, Caponnetto P, et al. Intern Emerg Med. 2016
Systolic BP changes at Week 52 from baseline
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BLOOD PRESSURE CONTROL IN SMOKERS WITH ARTERIAL HYPERTENSION WHO SWITCH TO ELECTRONIC CIGARETTES
Polosa et al. (paper under review)
• ECs are effective and safe in RCTs of “healthy” smokers• Smoking abstinence by using ECs may lower elevated
systolic BP• No data about EC use in smokers with pre-existing disease• We investigated changes in BP and BP control in smoking
hypertensive patients who switched to EC
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Visits
Mea
n Co
nven
tiona
l Ciga
rette
s/day
0
5
10
15
20
25
30
Baseline Visit 1 Visit 2
EC usersControls
Changes in daily smoking from baseline
P
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Visits
Mea
n Sy
stol
ic Bl
ood
Pres
sure
(mm
Hg)
120
130
140
150
160
Baseline Visit 1 Visit 2
EC usersControls
Changes in SBP from baseline
P
-
Visits
Mea
n Di
asto
lic B
lood
Pre
ssur
e (m
mHg
)
70
80
90
100
Baseline Visit 1 Visit 2
EC usersControls
Changes in DBP from baseline
P=0.006average decrease of 6 mmHg
Baseline ≈ 6 months ≈ 12 months
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0
10
20
30
40
50
60
70
80
90
BL BL V1 V1 V2 V2
E-Cig Gp Control Gp E-Cig Gp Control Gp E-Cig Gp Control Gp
Go…
Proportion of good and poor BP controlthroughout the study
Good Control
Poor Control
BaselineEC Group
BaselineCtrl Group
≈ 6 monthsEC Group
≈ 12 monthsEC Group
% Good Control criteria:systolic BP
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BLOOD PRESSURE CONTROL IN E-CIG USERSK. Farsalinos et al. Int. J. Environ. Res. Public Health 2014
(N = 2162)
Dual users Single users
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Take Home Message
• Lowered BP and improved BP control in hypertensive patients;
• Improvements also reported in dual users;• An helpful alternative to cigarettes, even in
smokers with hypertension.
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Chronic effect of abstinence/reductionon spirometry in smokers switching to ECs
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Chronic effect of abstinence/reductionon spirometry in smokers switching to ECs
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Effect of abstinence/reduction on coughin smokers switching to ECs
0
10
20
30
40
50
60
70
80
90
100
%
BL W12 W24 W52
Yes
No
Cough
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Shortness of Breath
0
10
20
30
40
50
60
70
80
90
100
%
BL W12 W24 W52
Yes
No
Effect of abstinence/reduction on SOBin smokers switching to ECs
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• ECs are effective and safe in RCTs of “healthy” smokers• Smoking abstinence by using ECs may improve respiratory
function and symptoms• No data about EC use in smokers with pre-existing disease• We investigated changes in subjective and objective asthma
outcomes in smoking asthmatics who switched to EC
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1st F/up Visit
Assessment Timepoints
Baseline Pre-Baseline
For
ced
Exp
irato
ry V
olum
e in
1 s
econ
d (L
)
3.0
3.2
3.4
3.6
3.8
2nd F/up Visit
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FEV1Improvement from baseline to 24 months
p=0.005mean increase of 100mls
HarmReversal!
Regular EC use
3rd F/upVisit
Polosa et al.Discov Med 2016
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FE
F25
-75
(L/s
ec)
2.4
2.6
2.8
3.0
3.2
3.4
1st F/up Visit
Assessment Timepoints
Baseline Pre-Baseline
2nd F/up Visit
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FEF25-75Improvement from baseline to 24 months
p=0.006mean increase of 250mls/sec
p=0.001mean increase of 360mls/sec
HarmReversal!
Regular EC use
3rd F/upVisit
Polosa et al.Discov Med 2016
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Pre-Baseline
Met
hach
olin
e P
C20
(mg/
mL)
1.0
1.5
2.0
2.5
3.0
3.5
Baseline 2nd F/up Visit
1st F/up Visit
Assessment Timepoints
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Methacholine PC20Improvement from baseline to 24 months
p=0.003mean increase of 1.2 DD
HarmReversal!
Regular EC use
3rd F/upVisit
Polosa et al.Discov Med 2016
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AC
Q s
core
s
1.2
1.4
1.6
1.8
2.0
2.2
2.4
1st F/up Visit
Assessment Timepoints
Baseline Pre-Baseline
2nd F/up Visit
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Juniper’s ACQImprovement from baseline to 24 months
p=0.001mean decrease of 0.43
p=0.001mean decrease of 0.56
HarmReversal!
Regular EC use
3rd F/upVisit
Polosa et al.Discov Med 2016
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Vaping and asthma exacerbations
Parameter Baseline
N=18
1st follow-up visit
(6 months)N=18
2nd follow-up visit
(12 months )N=18
3nd follow-up visitw/o relapsers(24 months)
N=16
p value toBaseline
p value toBaseline
p value toBaseline
Cigarettes/day 21.9 (±4.5)
5.0 (±2.6)
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COPD patients - QoL
Time
Baseline 12 Months 24 Months
COPD
Ass
essm
ent T
ool (
CAT)
Sco
re
14
16
18
20
22
24
COPD E-Cig user SubjectsCOPD Control Subjects
p=0.001
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COPD patients - Severe Exacerbations
Time
Baseline 12 Months 24 Months
Seve
re C
OPD
Exa
cerb
atio
ns
1.0
1.5
2.0
2.5
3.0
COPD E-Cig user SubjectsCOPD Control Subjects
p = 0.005
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(N = 1173)
(N = 1062)
Dual users Single users
RESPIRATORY SYMPTOMS IN E-CIG USERSK. Farsalinos et al. Int. J. Environ. Res. Public Health 2014
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Take Home Message
• Improved lung function, respiratory symptoms, subjective/objective asthma outcomes;
• Improvements also reported in dual users;• EC use unlikely to warrant significant respiratory
concerns; • An helpful alternative to cigarettes, even in
smokers with asthma/COPD.
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Treatment of tobacco dependence (i.e. Smoking cessation) Relapse prevention (protracted NRT use as smoking substitution is
now recommended by several health authorities – e.g. MHRA, NICE) Mangement of several medical conditions:
Parkinson’s disease (Thiriez et al., 2011) Ulcerative colitis (Sandborn, 1999) Major depression (McClernon, Hiott, Westman, Rosse, & Levin, 2006) Schizophrenia (Barr et al., 2008) Attention deficit hyperactivity disorder (Gehricke Hong, Whalen, Steinhoff &
Wigal, 2009) Mild cognitive impairment (Newhouse et al., 2012) Others?
Areas of Exploration: Therapeutic Nicotine
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Products that are enjoyable
Products that are not enjoyable
Understanding E-cigs Through the Lens of Pharmaceutical Respiratory
Drug Delivery
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Understanding E-cigs Through the Lens of Pharmaceutical Respiratory
Drug Delivery
Why not making enjoyable,products (i.e. drugs) that are not enjoyable?
• Replacement of syringes and pills (e.g. vaccination, insulin injection)
• Cannabidiols (CBD) for refractory pain control
• Improved medication adherence
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Areas of Exploration: Hedonistic/Wellness
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Russo C, Cibella F, Caponnetto P, et al. Sci Rep. 2016 Jan5;6:18763.
Post Cessation Weight Gain
Effect of smoking abstinence/reduction on weight changes in smokers switching to ECs
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Post Cessation Weight Gain in Quitters: Cochrane vs ECLAT
2.9
4,2
4,7
2.4
2.9
2.5
Week-12 Week-24 Week-52
Wei
ght i
n kg
Quitters’ weight
62 previous studies Our study
Wk-12 Wk-24 Wk-52
Quitters’ weight in Kg
2.9
4.2
4.7
2.4
2.9
2.5
Cochrane reviewof 62 studies
ECLAT study
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score 0 = “not at all present”
score 1 = “slight”
score 2 = “moderate”
score 3 = “quite a bit”
Russo C, Cibella F, Caponnetto P, et al. Sci Rep. 2016 Jan5;6:18763.
Effect of smoking abstinence/reduction on appetite score in smokers switching to ECs
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• Weight loss programs (e.g. VaporDiet)• Improved sleep/anxiety (e.g. NutriCigs)• Energy boost (e.g. VitaCig)• Memory boost• Research programs addressing
consumers hedonic and sensory characteristics
• …….
Future Vaping Trends
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Negative Aspects
Minimize Risk
Vaping: Current and Emerging Views
Positive Aspects
Maximize Benefit
Janus head. Terracotta sculpture, from Vulci, II century BC (Rome, National Etruscan Museum of Villa Giulia).
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“E-cigs greatest health advance since vaccinations”Prof. David NuttBBC Radio 5 live’s Shelagh Fogarty4 February 2014
Professor David Nutt,Former government's chief drug adviser
Slide Number 1Slide Number 2Slide Number 3Slide Number 4Slide Number 5Slide Number 6Slide Number 7Slide Number 8Slide Number 9Slide Number 10Slide Number 11Slide Number 12Slide Number 13Slide Number 14Slide Number 15Slide Number 16Slide Number 17Slide Number 18FEV1� Improvement from baseline to 24 months Slide Number 20Slide Number 21Slide Number 22Vaping and asthma exacerbationsSlide Number 24Slide Number 25Slide Number 26Slide Number 27Slide Number 28Slide Number 29Slide Number 30Slide Number 31Slide Number 32Slide Number 33Slide Number 34Future Vaping TrendsSlide Number 36Slide Number 37