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LA SIGARETTA ELETTRONICA 2019 PDF/23... · 2019-08-03 · SUR-VAPES2: RCTof HNBCvs EVC •Methods:...

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LA SIGARETTA ELETTRONICA Giuseppe Biondi Zoccai Dipartimento di Scienze e Biotecnologie Medico-Chirurgiche Università degli Studi “La Sapienza” di Roma, Latina
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Page 1: LA SIGARETTA ELETTRONICA 2019 PDF/23... · 2019-08-03 · SUR-VAPES2: RCTof HNBCvs EVC •Methods: Independent cross-over randomized trial in 20 TCsmokers, to HNBC, EVC, and TC. Endpoints

LA SIGARETTA ELETTRONICA

Giuseppe Biondi Zoccai

Dipartimento di Scienze e Biotecnologie Medico-ChirurgicheUniversità degli Studi “La Sapienza” di Roma, Latina

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Disclosure

• I have consulted for Abbott Vascular and Bayer.

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The smoking epidemic

World Health Organization. The Tobacco Atlas. http://www.who.int/tobacco/statistics/tobacco_atlas/en

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The smoking epidemic

• 1 billion smokers• 5 million deaths every year due to smoking• These figures will double by 2030

World Health Organization. The Tobacco Atlas. http://www.who.int/tobacco/statistics/tobacco_atlas/en

75% want to quit

<2% succeed

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Pathophysiology of addiction

Benowitz, New Engl J Med 2010

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Cigarettes as suicide weapons

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Cardiovascular effects of smoking

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Quitting is best

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Potential scenarios

Cigarette Abstinence

Cigarette

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Potential scenarios

Cigarette Abstinence

Cigarette

Cigarette AbstinenceIntervention

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Pharmacotherapy

Barboza et al, Exp Opin Pharmacother 2016

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Pharmacotherapy

Suissa et al, Circ Cardiovasc Qual Outcomes 2017

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Behavioral therapy

Suissa et al, Circ Cardiovasc Qual Outcomes 2017

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Network meta-analysis

Suissa et al, Circ Cardiovasc Qual Outcomes 2017

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Alternative to quitting

RRP=reduced risk product

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Modified risk product

• A modified risk product (MRP) is a tobacco or tobacco-like product which can modify(hopefully reduce) the global burden of disease associated with smoking

• An MRP claim is a complex one and notsynonym of a reduced risk product (RRP) claim

• Typical MRPs are electronic vaping cigarettes(EVC) such as JUUL, and heat not burncigarettes (HNBC) such as IQOS or GLO

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Harm minimization

Abrams et al, Ann Rev Pub Health 2018

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Electronic vaping cigarette

Key mechanism: heating (not combustion) up to 250° of nicotine-filled liquid

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Heat not burn cigarette

Key mechanism: heating (not combustion) up to 350° of processed tobacco leaves

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RCT of EVC for smoking cessation

Bullen et al, Lancet 2013

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RCT of rewards for smoking cessation

Halpern et al, New Engl J Med 2018

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HNBC and endothelial dysfunction

Nabavizadeh et al, Tob Control 2018

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Risk of AMI in EVC users

Alzahrani et al, Am J Prev Med 2018

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Sapienza University of Rome-Vascular Assessment of ProatheroscleroticEffects of Smoking (SUR-VAPES)

Study Program

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Effects of EVC on oxidative stress and endothelial dysfunction: SUR-VAPES 1

Carnevale et al, Chest 2016

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Effects of EVC on platelet function: SUR-VAPES 1 substudy

Nocella et al, Am J Cardiol 2018

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Predictors of EVC effects: SUR-VAPES 1 substudy

Mastrangeli et al, Tob Induc Dis 2018

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SUR-VAPES 2: RCT of IQOS vs EVC

Biondi-Zoccai et al, J Am Heart Assoc 2019

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Upcoming studies

• SUR-VAPES 3: RCT of mentoring to EVC and HNBC in primary prevention (primaryendpoint: abstinence)

• SUR-VAPES 4: RCT of EVC vs HNBC in the catheterization laboratory (primary endpoint: coronary flow reserve)

• SUR-VAPES 5: RCT of EVC vs HNBC in secondary prevention (primary endpoint: major adverse cardiac events)

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Pros and cons of different strategies

Biondi-Zoccai et al, J Cardiovasc Med 2019

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Time and interventions

Biondi-Zoccai et al, J Cardiovasc Med 2019

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Conclusions

• Smoking represents the most impactful yetactionable risk factor for cardiovascular diseaseand cancer

• Whenever abstinence is not immediatelyachievable, pharmacologic and behavioraltherapy may provide useful incremental support

• Modified risk products may prove beneficial in selected subjects, but caution is paramount giventhe limited data on safety and the risk of eventually discouraging abstinence

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Many thanks for your attention

For any query:[email protected]

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Quitting TC vs EVC

Hughes et al, Add Behav 2018

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EVC and cannabis

Trivers et al, JAMA Pediatrics 2018

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Misuse of pod mod EVC

Barrington-Trimis et al, N Engl J Med 2018

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SUR-VAPES 2: RCT of HNBC vs EVC• Methods: Independent cross-over randomized trial in 20 TC smokers,

to HNBC, EVC, and TC. Endpoints were oxidative stress, antioxidant reserve, PLT activation, flow-mediated dilation (FMD), blood pressure (BP), and satisfaction scores.

• Results: Any product led to an adverse impact on oxidative stress, antioxidant reserve, PLT function, FMD, and blood pressure. – HNBC had less impact than EVC and TC on soluble Nox2-derived peptide

(respectively p=0.004, p=0.001), 8-iso-prostaglandin F2α-III (p=0.004, p<0.001), and vitamin E (p=0.018, p=0.044).

– HNBC and EVC were equally less impactful than TC on FMD (p=0.872 for HNBC vs EVC), hydrogen peroxide (p=0.522), H2O2 breakdown activity (p=0.091), soluble CD40 ligand (p=0.849), and soluble P-selectin(p=0.821).

– The effect of HNBC and, to a lesser extent EVC, on BP was less evident than that of TC, whereas HNBC appeared more satisfying than EVC (all p<0.05).

• Trial registration: https://clinicaltrials.gov/ct2/show/NCT03301129.

Biondi-Zoccai et al, J Am Heart Assoc 2019

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SUR-VAPES 2: RCT of IQOS vs EVC

Biondi-Zoccai et al, J Am Heart Assoc 2019

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Pragmatism taking into account appeal

Abrams et al, Ann Rev Pub Health 2018


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