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)

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).

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

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

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

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

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

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

BLOOD PRESSURE CONTROL IN E-CIG USERSK. Farsalinos et al. Int. J. Environ. Res. Public Health 2014

(N = 2162)

Dual users Single users

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.

Chronic effect of abstinence/reductionon spirometry in smokers switching to ECs

Chronic effect of abstinence/reductionon spirometry in smokers switching to ECs

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

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

• 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

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

**

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

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

**

***

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

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

**

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

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

***

***

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

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)

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

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

(N = 1173)

(N = 1062)

Dual users Single users

RESPIRATORY SYMPTOMS IN E-CIG USERSK. Farsalinos et al. Int. J. Environ. Res. Public Health 2014

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.

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

Products that are enjoyable

Products that are not enjoyable

Understanding E-cigs Through the Lens of Pharmaceutical Respiratory

Drug Delivery

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

Areas of Exploration: Hedonistic/Wellness

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

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

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

• 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

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).

“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