Atti del XXIV Convegno Nazionale Tabagismo e Servizio Sanitario Nazionale
Pubblicato: 2022-09-21

Update on electronic cigarettes and heated tobacco products

Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO), Firenze

Using electronic cigarettes in a clinical setting or as a consumer product?

When used in a clinical setting with behavioural support, such as in a smoking cessation service, electronic cigarettes (e-cigs) are effective for quitting smoking [1,2]. If we look at nicotine abstinence, instead of smoking cessation, e-cigs record half successes in comparison with nicotine replacement therapy (NRT), because the risk of keeping on e-cigs after quitting is about 9 times compared to NRT [3]. Finally, e-cig use after quitting increases relapse in traditional smoking [4].

As a consumer product, instead, e-cig is not associated with smoking cessation, even among people with some motivation to quit [1,5,6].

Cardiovascular risk of e-cigs

The cardiovascular (CV) risk in dual use of e-cigs and traditional cigarettes is similar to that in exclusive tobacco smokers [7-10]. Nicotine & Particulate Matter (PM) from e-cigs determine increases of heart rate, systolic & diastolic blood pressure; reactive oxygen species; decrease of antioxidant activity; increase of endothelial dysfunction and platelet activation. Moreover, PM from ambient air pollution and tobacco smoking studies determine higher risk of CV mortality (acute myocardial infarction) [7-10]. Thus, e-cigs should not be regarded as a CV safe product. Given the non-linear dose-response relationship between smoking and CV mortality, increasing e-cig use & decreasing smoking may not result in proportional reduction of CV mortality.

Youths and e-cigs

Youth and young adult e-cigarette users had a 3-time risk of subsequent cigarette initiation and a 4-time risk of past 30-day cigarette smoking [11]. The question is: have e-cigs renormalized youth smoking (i.e., e-cigs determine an increase of tobacco users), or e-cigs may be displacing smoking, diverting adolescents from tobacco cigarettes? Three studies from New Zealand, USA, and UK did not support the renormalization hypothesis [12-14]. There are no studies for EU countries on renormalization vs displacement of smoking. Anyway, current smokers in Italy did not increase in last years. In fact, among students aged 13-15 years from Global Youth Tobacco Survey (GYTS) [15], smoking prevalence decreased from 23% in 2014 to 20% in 2018; among students aged 15-19 from ESPAD® Italia [16], smoking prevalence decreased from 34% in 2018 to 27% in 2021, even though current e-cig or heated tobacco products (HTP) users increased in both surveys in last years.

Consumption of HTPs and e-cigs in Italy

In Italy HTP consumption has increased by 6 times since 2018, reaching 9.2 tons in 2021, against 61 of traditional cigarettes, which decreased by 30% since 2010. Despite the fact that from PASSI surveillance system [17] in 2020 the prevalence of HTPs is 1.6% and of e-cig 2.0%, the majority of traditional cigarette smokers (91%) exclusively keep on smoking traditional cigarettes. Thus, Italians seems to be still loyal to traditional cigarettes, despite the introduction of novel tobacco products.

Australia vs UK on e-cig regulation

Even if Australia and UK, both with an excellent level of implementation of tobacco control policies, have chosen a very restrictive regulation and promotion of e-cig to quit, respectively, in 2021 they are both moving towards a medical prescription of e-cigs [18].

Australia developed a very successful anti-tobacco mass media campaign since 1996, was the first Country to implement the Plain Package since 2012, and increased tobacco taxation, so much that in 2021 a 20-cigarette package costed around 23 euro.

In Australia from October 2021, e-cigs with nicotine cannot be sold, unless the user has a prescription from a medical doctor. Even though in Australia nicotine vaping products are not recognised as an effective and safe support to quit, some doctors may recommend use of e-cigs for long-term smokers who have tried to quit using approved medications but failed, and who still want to quit, and have discussed e-cig use with their physicians [19].

In April 2022, the Australian Report: E-cigs and Health outcomes was released, highlighting that for many health outcomes there are still too few studies to conclude that e-cigs are not dangerous [20]. For smoking & nicotine cessation: this report concludes that:

  1. there is limited evidence that, in the clinical context, freebase nicotine e-cigs may be more efficacious than existing NRT, and that nicotine e-cigs may be more efficacious than no intervention or usual care;
  2. trials demonstrating efficacy were limited to products with freebase nicotine concentrations ≤ 20mg/mL;
  3. there is no evidence that nicotine salt products are efficacious for smoking cessation;
  4. there is insufficient evidence that freebase nicotine e-cigs are efficacious outside the clinical setting;

Even UK developed a very powerful tobacco control strategy: the reimbursement of smoking cessation treatments entered into force in 1999; a 20-cigarette package in 2021 costed around 13 euro; each year since 2012 the anti-tobacco mass media campaign «Stoptober» tries to convince smokers to make a quit attempt; plain package was introduced in 2018. The only important difference in comparison to Australia is that since 2015 Public Health England endorsed e-cigs for smoking cessation. In October 2021, UK announced that e-cigs could be prescribed on the National Health System in England to help people stop smoking. An updated guidance to go through the regulatory approvals process for medicinally licensed e-cig products was released for manufacturers [21].

It’s not a new story in England: even though in 2016 one e-cig device (e-Voke) was licensed for medical use by the UK medicines regulator, it was never marketed since this product was already out of date. A license for medical use is very difficult to achieve for e-cigarettes, and manufacturers are more interested in extending consumer choice and delivering ever better next-generation e-cigs.

Why prescription in England? Approved e-cigs can be promoted as smoking cessation aids; the approval may determine further reassurance to health professionals, and may improve confidence among smokers.

A Delphi survey on e-cigs

A Delphi survey among some international experts on e-cigs & HTPs was conducted [22]. Main conclusions for implementing restrictive regulations worldwide are reported here:

e-cigs

  1. components of e-liquids should be provided on the product;
  2. an upper limit of nicotine concentration should be defined;
  3. a warning on the lack of evidence in long term safety and the e-cig addiction potential should be stated;
  4. e-cigs should not be regulated as consumer products but as a new category of products;
  5. e-cigs should be sold in specialised shops (shops selling tobacco or in pharmacies), with sale restriction for minors.

HTPs

  1. they have the same addictive potential than conventional cigarettes;
  2. they should be regulated as a tobacco product with similar warning messages than cigarettes; advertisement should not be allowed.

Both e-cigs

  1. their use should not be allowed in indoor public places;
  2. a specific tax should be implemented for e-cigs, and taxes on HTPs should not be lower than those for conventional cigarettes.

References

  1. Wang RJ, Bhadriraju S, Glantz SA. E-cigarette use and adult cigarette smoking cessation: a meta-analysis. Am J Public Health. 2021; 111:230-46. DOI
  2. Hartmann-Boyce J, McRobbie H, Butler AR, Lindson N, Bullen C, Begh R. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2021; 9:CD010216. DOI
  3. Barufaldi LA, Guerra RL, de Albuquerque RCR, Nascimento A, Chança RD, de Souza MC. Risk of smoking relapse with the use of electronic cigarettes: a systematic review with meta-analysis of longitudinal studies. Tob Prev Cessat. 2021; 29:29. DOI
  4. Hanewinkel R, Niederberger K, Pedersen A, Unger JB, Galimov A. E-cigarettes and nicotine abstinence: a meta-analysis of randomised controlled trials. Eur Respir Rev. 2022; 31:210215. DOI
  5. Chen R, Pierce JP, Leas EC, Benmarhnia T, Strong DR, White MM. Effectiveness of e-cigarettes as aids for smoking cessation: evidence from the PATH Study cohort, 2017-2019. Tob Control 2022:tobaccocontrol-2021-056901.DOI
  6. Gorini G, Ferrante G, Quarchioni E, Minardi V, Masocco M, Fateh-Moghadam P, PASSI coordinating group. Electronic cigarette use as an aid to quit smoking in the representative Italian population PASSI survey. Prev Med. 2017; 102:1-5. DOI
  7. Kennedy CD, van Schalkwyk MCI, McKee M, Pisinger C. The cardiovascular effects of electronic cigarettes: a systematic review of experimental studies. Prev Med. 2019; 127:105770. DOI
  8. Kavousi M, Pisinger C, Barthelemy JC, Smedt D, Koskinas K, Marques-Vidal P. Electronic cigarettes and health with special focus on cardiovascular effects: position paper of the European Association of Preventive Cardiology (EAPC). Eur J Prev Cardiol. 2020;2047487320941993. DOI
  9. Skotsimara G, Antonopoulos AS, Oikonomou E, Siasos G, Ioakeimidis N, Tsalamandris S. Cardiovascular effects of electronic cigarettes: a systematic review and meta-analysis. Eur J Prev Cardiol. 2019; 26:1219-28. DOI
  10. Berlowitz JB, Xie W, Harlow AF, Hamburg NM, Blaha MJ, Bhatnagar A. E-cigarette use and risk of cardiovascular disease: a longitudinal analysis of the PATH study (2013-2019). Circulation. 2022; 145:1557-9. DOI
  11. Soneji S, Barrington-Trimis JL, Wills TA, Leventhal AM, Unger JB, Gibson LA. Association between initial use of e-cigarettes and subsequent cigarette smoking among adolescents and young adults: a systematic review and meta-analysis. JAMA Pediatr. 2017; 171:788-97. DOI
  12. Walker N, Parag V, Wong SF, Youdan B, Broughton B, Bullen C. Use of e-cigarettes and smoked tobacco in youth aged 14-15 years in New Zealand: findings from repeated cross-sectional studies (2014-19). Lancet Public Health. 2020; 5:e204-12. DOI
  13. Foxon F, Selya AS. Electronic cigarettes, nicotine use trends and use initiation ages among US adolescents from 1999 to 2018. Addiction. 2020; 115:2369-78. DOI
  14. Hallingberg B, Maynard OM, Bauld L, Brown R, Gray L, Lowthian E. Have e-cigarettes renormalised or displaced youth smoking? Results of a segmented regression analysis of repeated cross sectional survey data in England, Scotland and Wales. Tob Control. 2020; 29:207-16. DOI
  15. Gorini G, Gallus S, Carreras G, De Mei B, Masocco M, Faggiano F, MADES Working Group. Prevalence of tobacco smoking and electronic cigarette use among adolescents in Italy: Global Youth Tobacco Surveys (GYTS), 2010, 2014, 2018. Prev Med. 2020; 131:105903. DOI
  16. Cerrai S, Potente R, Gorini G, Gallus S, Molinaro S. What is the face of new nicotine users? 2012-2018 e-cigarettes and tobacco use among young students in Italy. Int J Drug Policy. 2020; 86:102941. DOI
  17. EpiCentro - Istituto Superiore di Sanità (ISS). Progressi delle Aziende Sanitarie per la Salute in Italia: la sorveglianza Passi.Publisher Full Text
  18. Gorini G. Review of: “Effectiveness of e-cigarettes as aids for smoking cessation: evidence from the PATH Study cohort, 2017– 2019”. Qeios. 2022. DOI
  19. Australian Government. Department of Health and Aged Care. Therapeutic Goods Administration. Nicotine vaping products: Information for prescribers. 2022. Publisher Full Text
  20. Banks E, Yazidjoglou A, Brown S, Nguyen M, Martin M, Beckwith K. Electronic cigarettes and health outcomes: systematic review of global evidence. Report for the Australian Department of Health. National Centre for Epidemiology and Population Health: Canberra; 2022.
  21. GOV.UK. Government Digital Service. Department of Health and Social Care, Office for Health Improvement and Disparities. E-cigarettes could be prescribed on the NHS in world first. 2021. Publisher Full Text
  22. Berlin I, Jacot-Sadowski I, Humair JP, Cornuz J. International expert consensus on electronic nicotine delivery systems and heated tobacco products: a Delphi survey. BMJ Open. 2021; 11:e045724. DOI

Affiliazioni

Giuseppe Gorini

Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO), Firenze

Copyright

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