la sigaretta elettronica 2019 pdf/23... · 2019-08-03 · sur-vapes2: rctof hnbcvs evc •methods:...
TRANSCRIPT
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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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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