1. E-cigarette use in England: Latest trends from the Smoking Toolkit Study Dr Jamie Brown University College London Dr Emma Beard, Dr Daniel Kotz, Prof Susan Michie & Prof Robert West SSA, York, November 2014

2. Financial disclosure 1.Funding sources for presented work ‒ Cancer Research UK, English Department of Health & Pfizer funded data collection for this study, and at outset data collection for the Smoking Toolkit Study was supported by GlaxoSmithKline & Johnson and Johnson ‒ Funders had no final role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication 2.Industry funding to the investigators ‒ JB, DK & EB have all received unrestricted research grants from Pfizer; RW undertakes research, consultancy & receives fees for speaking from companies that manufacture smoking cessation medications (Pfizer, J&J, McNeil, GSK, Nabi, Novartis, and Sanofi-Aventis); there are no other financial relationships with any organisations that might have an interest in the work, particularly e-cigarette companies

3. Outline I.Real-world effectiveness of e-cigarettes when used to aid smoking cessation II.Trends in e-cigarette use and other tobacco control indicators in England 3

4. Outline I.Real-world effectiveness of e-cigarettes when used to aid smoking cessation II.Trends in e-cigarette use and other tobacco control indicators in England 4

5. E-cigarettes and smoking cessation E-cigarettes have rapidly become popular –10% of US smokers in 2013 (King et al 2014) & 20% of English smokers in 2014 (West & Brown 2014) Majority use to try and quit or cut down –Hajek et al 2014 Reduce craving and withdrawal –Bullen et al 2010; Vansickel et al 2010; Dawkins et al 2012; Goniewicz et al 2013; Vansickel & Eissenberg 2013 Two RCTs suggested e-cigarettes may aid smoking cessation –Bullen et al 2013; Caponnetto et al 2013 5

6. Why complement randomised trials? 1.Can only test limited range of products which may be obsolete by the end of the trial 2.Take a long time to report and regulatory decisions are urgent −Borland 2011; Cobb et al. 2011, 2013; Etter, 2013; Flouris et al 2010; Hajek et al 2013; The Lancet, 2013 3.Will exclude all smokers who are not willing to volunteer or to receive another product 4.Cannot tell what happens when no health professionals are involved 6

7. Objective To assess the real-world effectiveness of e- cigarettes when used in a quit attempt, compared with using nothing or licensed nicotine products bought over the counter among the general population, after adjusting for important confounders –Existing studies have produced mixed results –Etter 2010; Etter & Bullen 2011; Foulds et al 2011; Siegel et al 2011; Dawkins et al 2013; Farsalinos et al 2013; Goniewicz et al 2013; Etter & Bullen 2014; Etter & Bullen 2014; Vickerman et al 2013; Adkison et al 2013; Borderud et al 2014 7

8. Objective To assess the real-world effectiveness of e- cigarettes when used in a quit attempt, compared with using nothing or licensed nicotine products bought over the counter among the general population, after adjusting for important confounders –Existing studies have produced mixed results –Etter 2010; Etter & Bullen 2011; Foulds et al 2011; Siegel et al 2011; Dawkins et al 2013; Farsalinos et al 2013; Goniewicz et al 2013; Etter & Bullen 2014; Etter & Bullen 2014; Vickerman et al 2013; Adkison et al 2013; Borderud et al 2014 8

9. Objective To assess the real-world effectiveness of e- cigarettes when used in a quit attempt, compared with using nothing or licensed nicotine products bought over the counter among the general population, after adjusting for important confounders –Existing studies have produced mixed results –Etter 2010; Etter & Bullen 2011; Foulds et al 2011; Siegel et al 2011; Dawkins et al 2013; Farsalinos et al 2013; Goniewicz et al 2013; Etter & Bullen 2014; Etter & Bullen 2014; Vickerman et al 2013; Adkison et al 2013; Borderud et al 2014 9

10. Objective To assess the real-world effectiveness of e- cigarettes when used in a quit attempt, compared with using nothing or licensed nicotine products bought over the counter among the general population, after adjusting for important confounders –Existing studies have produced mixed results –Etter 2010; Etter & Bullen 2011; Foulds et al 2011; Siegel et al 2011; Dawkins et al 2013; Farsalinos et al 2013; Goniewicz et al 2013; Etter & Bullen 2014; Etter & Bullen 2014; Vickerman et al 2013; Adkison et al 2013; Borderud et al 2014 10

11. Study design and sampling Cross-sectional household surveys of representative samples of adults in England (www.smokinginengland.info)www.smokinginengland.info Each month new sample of ~ 1800 adults (16+) selected by random location sampling ‒ Fidler et al., 2011

12. Study population and measures 12 6,134 smokers who had tried to stop in the past 12 months using no aid, NRT-OTC or e- cigarettes Between July 2009 and Feb 2014 3,477 used no aid 1,922 used NRT-OTC 464 used e- cigarette Excluded using both (n=73), and prescription medication or beh support with NRT-OTC (n=173) or e-cigarettes (n=25)

13. Study population and measures 13 6,134 smokers who had tried to stop in the past 12 months using no aid, NRT-OTC or e- cigarettes Between July 2009 and Feb 2014 3,477 used no aid 1,922 used NRT-OTC 464 used e- cigarette How many still not smoking? Is there a difference after adjusting for range of factors? e.g. dependence and time since quit attempt Excluded using both (n=73), and prescription medication or beh support with NRT-OTC (n=173) or e-cigarettes (n=25)

14. Results: unadjusted analysis 14 E-cigarette users were more likely not to be smoking than those using NRT bought over the counter and those using nothing ** ** Significantly different from both other groups

15. Characteristics by quitting method 15 Compared with smokers using e-cigarettes: NRT-OTC: were older had lower SES less likely to have quit recently were more dependent No aid: had lower SES less likely to have quit recently or to have begun attempt gradually were less dependent

16. After adjusting for confounders 16 The odds of e-cigarette users still being abstinent were 61% greater than those using nothing and 63% greater than those using NRT bought over- the-counter

17. Limitations Cannot rule out unmeasured confounding factor –However, external validity greater than RCTs –Longitudinal studies in general population adjusting for baseline characteristics would be valuable No biochemical verification –Misreporting low in population surveys (Wong et al 2012)

18. Limitations Cannot rule out unmeasured confounding factor –However, external validity greater than RCTs –Longitudinal studies in general population adjusting for baseline characteristics would be valuable No biochemical verification –Misreporting low in population surveys (Wong et al 2012) NRT-OTC & e-cigarettes treated homogenously

19. Conclusion 19 Among English adult smokers in the ‘real world’ stopping without professional support, those who use e-cigarettes appear more likely to remain abstinent than those who use a licensed NRT product bought over-the-counter or no aid to cessation –This difference persists after adjusting for a wide range of smoker characteristics such as nicotine dependence

20. Outline I.Real-world effectiveness of e-cigarettes when used to aid smoking cessation II.Trends in e-cigarette use and other tobacco control indicators in England 20

21. Trends in e-cigarette use and other tobacco control indicators in England To monitor e-cigarette prevalence and characterise use over time To assess how far any changes in use are accompanied by changes in: key performance indicators for tobacco control –smoking prevalence –uptake in young adults –smoking cessation rates –attempts to stop smoking –success of attempts to stop smoking –use of other aids to cessation or smoking reduction 21

22. Methods 22 Monthly household surveys Each month involves a new representative sample of ~1800 respondents; smokers ~450 Data collected on electronic cigarettes since second quarter 2011 Fidler, et al., 2011. 'The smoking toolkit study': a national study of smoking and smoking cessation in England. BMC Public Health 11:479 For more info see www.smokinginengland.info

23. Prevalence of electronic cigarette use: smokers and recent ex-smokers 23 N=14490 adults who smoke or who stopped in the past year; increase p<0.001 Growth in prevalence of e-cigarette use has stalled in England

24. Electronic cigarette use 24 N=1323 e-cigarette users not using NRT Frequency of use among users is greater in ex-smokers

25. Age profile of electronic cigarette users 25 N=14490 adults who smoke or who stopped in the past year E-cigarette use is distributed across the age range and representative of smokers

26. Proportion of e-cigarette users who are smokers 26 N=1745 e-cigarette users of adults who smoke or stopped in past year The majority of e-cigarette users also smoke

27. Prevalence of nicotine products while smoking 27 N=13531 smokers, increase p<0.001 e-cigs and all nicotine; decrease p=0.001 for NRT Increase in use of e-cigarettes while smoking has more than offset a decrease in NRT use

28. Prevalence of nicotine products in recent ex-smokers 28 N=959 adults who stopped in the past year; increase p<0.001 for e-cigs and all nicotine; decrease p=0.002 for NRT Increase in use of e-cigarettes has more than offset a reduction in NRT use

29. Nicotine use by never smokers and long-term ex-smokers 29 N=14619 never and long-term ex-smokers from Nov 2013 Current e-cigarette use by never smokers is negligible

30. Prevalence of nicotine use 30 N=63950 adults, decrease p<0.001 for cigarettes and overall nicotine use Cigarette and nicotine show an overall decline

31. Uptake of smoking 31 N=11338 people aged 16-24 Proportion of adults under 25 years who have ever smoked regularly has remained constant

32. Quitting 32 N=17045 adults who smoked in the past year; increase p<0.001 There has been an increase in the rate of quitting smoking

33. Quit attempts 33 N=17045 adults who smoke or who stopped in the past 3 months; increase p=0.002 There has been a small increase in quit attempts

34. Aids used in most recent quit attempt 34 N=9438 adults who smoke and tried to stop or who stopped in the past year Increase in use of e-cigarettes for quitting has been accompanied by a small reduction in use of other aids except behavioural support which has been static

35. Aids used in most recent quit attempt 35 The use of either e-cigs or prescription medication has increased while use of NRT- OTC or nothing has decreased and NHS support has remained static N=9438 adults who smoke and tried to stop or who stopped in the past year; 2009 is Jul to Dec, 2014 is Jan to Sept Approx odds of success relative to nothing and NRT-OTC: 1.5 3.0

36. Cigarette smoking prevalence 36 Graph shows prevalence estimate and upper and lower 95% confidence intervals Base: All adults Cigarette smoking prevalence continues to decline

37. Tried to stop smoking in past year 37 Graph shows prevalence estimate and upper and lower 95% confidence intervals Base: Adults who smoked in the past year The rate at which smokers have tried to stop in the past year has remained relatively stable (excluding the year of smoke-free legislation)

38. Success rate for stopping in those who tried 38 Graph shows prevalence estimate and upper and lower 95% confidence intervals Base: Smokers who tried to stop n the past year The success rate in those who have tried to stop smoking is the highest for at least 7 years

39. Conclusions In England, prevalence of e-cigarette use has remained stable for the past year at around 20% of smokers and recent ex-smokers, with very low rates in never smokers and long-term ex-smokers There has been a substantial increase in the use of e-cigarettes as an aid to cessation which has coincided with a decline in use of less effective methods (NRT-OTC or nothing) Smoking cessation rates have increased over the time period when e-cigarette use has increased Smoking prevalence is continuing to fall Population trends conflict with the view that e-cigarettes are undermining tobacco control and instead provide reason to be cautiously optimistic about the impact of e-cigarettes in England …but need to monitor closely!

40. Acknowledgments Society for the Study of Addiction –JB is funded by a SSA fellowship Co-authors: Susan Michie, Emma Beard, Daniel Kotz & Robert West CRUK, Dept of Health, Pfizer, GSK & Johnson & Johnson have all supported data collection Research team is part of the UK Centre for Tobacco and Alcohol Studies

41. Decrease in smoking prevalence 41 Base: All adults The rate of decline in cigarette smoking prevalence has been relatively stable

42. Stopped smoking in past 12 months 42 Graph shows prevalence estimate and upper and lower 95% confidence intervals Base: Adults who smoked in the past year The smoking cessation rate in 2014 is higher at any time since 2007

43. The nicotine/cigarette market 43 N=63842 adults Nicotine data only from last year smokers nondaily nicotine: <1 pw=0.1, 1+ pw=0.5 The cigarette and nicotine market are both declining