E cigarette History. Disclosure. Objectives. Rises in E cigarette Use. A Cloud of Controversy: E Cigarettes for Smoking Cessation

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1 E cigarette History A Cloud of Controversy: E Cigarettes for Smoking Cessation Karen R. Sando, Pharm.D., BCACP, CDE Clinical Assistant Professor UF College of Pharmacy Gainesville, FL Chinese pharmacist, Hon Lik, is generally cited as inventing the e cigarette in 2003 while working for Golden Dragon Holdings Company later changed name to Ruyan which means resembling smoking Marketing in China in 2004 then exported to Europe and U.S. Yamin CK, et al. Ann Intern Med. 2010; 153: Disclosure I do have a vested interest in or affiliation with the following companies or organizations Grant support for tobacco cessation services and education from University of Florida Area Health Education Center (UF AHEC) Declines in cigarette use breeds a new brand Current adult smoking rate=19% Centers for Disease Control. Smoking & Tobacco Use. Data and Statistics. Available at: Accessed 2014 Oct 4 Objectives Describe history of electronic cigarette emergence in the tobacco product marketplace Discuss current statistics on e cigarette use in the U.S. Review primary literature evaluating safety and efficacy of e cigarettes as tobacco cessation aid Define e cigarette place in therapy for tobacco cessation 40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Rises in E cigarette Use Trends in Awareness and Use of Electronic Cigarettes among U. S. Adults, Adults who have ever used an e Cigarette smokers who have ever used Fomer cigarette smokers who have ever cigarette at least once an e cigarette used an e cigarette King BA, et al. Nicotine Tob Res 2014 Sep 19 [Epub ahead of print] 1

2 From Smokers to Vapers Types of E cigarettes Electronic Nicotine Delivery Systems (ENDS) Electronic Nicotine Delivery Device (ENDD) Electronic Cigarette E cigarette E cig Personal Vaporizer Smokers have become vapers Barbeau, A., Burda, J., Siegel, M. (2013). Perceived efficacy of e cigarettes versus nicotine replacement therapy among successful ecigarette users: a qualitative approach. Addiction Science & Clinical Practice, 8(5). Grana R, et al. Circulation. 2014; 129: How E Cigarettes Work Cartridge typically contains mixture of nicotine; propylene glycol (used to make artificial smoke in theatrical productions); and other chemicals, which may include flavorings Battery Electronic Heating Element Cobb N and Abrams DB. NEJM, (3): Emergence in the Marketplace Marketed alternative to cigarette use Sales are currently estimated at $1.5 billion Projections to grow 24.2% per year through 2018 Large scale manufacturers Lorillard (Newport, Kent, True, Old Gold) Reynolds American (Camel, Doral, Eclipse, etc.) Altria (Phillip Morris USA) Phil Wahba. U.S. e-cigarette sales seen rising 24.2% per year through Fortune Magazine (online). Available at: June 10 How E cigarettes Work Media Presence The user inhales on the mouthpiece, which activates the flow trigger (and LED light as applicable) in the device. The battery sends a current to the heating element, which heats and vaporizes the content of the cartridge The user breaths in the vapor mist Yamin CK, et al. Ann Intern Med. 2010; 153:

3 Marketing Tactics Common web site claims Products are healthier (59%) Cheaper (93%) Cleaner (95%) than cigarettes Can be smoked anywhere (88%) Used to circumvent smoke free policies (71%) Do not produce second hand smoke (76%) Modern (73%) Adult Awareness and Use Population studies show dual use is most common Grana RA, Ling PM. Smoking revolution? A content analysis of electronic cigarette retail websites. Am J Prev Med. 2014;46: Zhu S H, Gamst A, Lee M, Cummins S, Yin L, et al. (2013) The Use and Perception of Electronic Cigarettes and Snus among the U.S. Population. PLoS ONE 8(10): e Marketing Tactics U.S. Youth Use Pictoral and video representations of doctors present on 22% of sites Cessation-related claims found on 64% of sites reviewed Grana RA, Ling PM. Smoking revolution? A content analysis of electronic cigarette retail websites. Am J Prev Med. 2014;46: Centers for Disease Control and Prevention. (2013) E cigarette use more than doubles among U.S. middle and high school students from Retrieved from ecigarette use.html. Adult Awareness and Use Florida Youth Use Zhu S H, Gamst A, Lee M, Cummins S, Yin L, et al. (2013) The Use and Perception of Electronic Cigarettes and Snus among the U.S. Population. PLoS ONE 8(10): e King, B. B.,Alam, S., Promoff, G, Arrazola, R., Dube, S. R. (2013) Awareness and Ever Use of Electronic Cigarettes Among U.S. Adults, Nicotine Tobacco Research, 15(9): Florida Youth Tobacco Survey. Available at Accessed 2014 Oct 4 3

4 Florida Youth Use Regulation and E cigarettes 2013 Florida Youth Tobacco Survey. Available at Accessed 2014 Oct 4 Information from Accessed 2014 June 20 Reasons for Initiation FDA Proposed Rule (2014) Reasons for trying e cigarettes are consistent with marketing messages: Use in places where smoking is restricted To cut down on smoking Help with quitting smoking Those who indicate that e cigs can help with quitting smoking or perceive e cigs to be less harmful than cigarettes are more likely to report experimentation Grana R, et al. Circulation. 2014; 129: Cloud of Controversy Regulation Examining the Evidence 2009 FDA attempted to block the import of e cigarettes, claiming that they were adulterated, misbranded, or unapproved drug device combinations Should fall under FDA s regulatory authority as medical devices under Food, Drug, and Cosmetics Act (FDCA) Sottera, a major importer and distributor of e cigarettes filed for an injunction to block the FDA from regulation and prevent importation block, arguing that e cigs are tobacco products End result (Dec 2010) Sottera awarded injunction. FDA only has regulatory authority under the Family Smoking Prevention and Control Act of 2009 (a.k.a. Tobacco Act) 4

5 Are E cigs Safe? Effective for Smoking Cessation? Very few studies have directly investigated health effects Propylene glycol can form pylene oxide when heated and vaporized (class 2B carcinogen) Short term studies evaluating e cigarettes on lung function have found no significant effects vs. conventional cigarettes Limited sample sizes and duration to e cigs Elevated levels of exhaled nitric oxide in nicotine e cigs (may indicate lung inflammation) Grana R, et al. Circulation. 2014; 129: Grana R et al. Circulation. 2014; 129: Other Safety Concerns Clinical Trials 40 Smokers aged yrs not intending to quit in next 30 days Categoriae cigarettes up to 4 cartridges (7.4 mg nicotine) per day to reduce smoking. Self reported log of cigarettes consumed per day, e cig cartridges per day Adverse events 6 month follow up Follow up completed in 68% of participants (n=27) 13 with dual use (e cig plus cigarettes) 5 continued tobacco cigarettes 9 stopped using tobacco cigarettes and continued e cigarettes Cigarette consumption reduced by at least 50% in the 13 dual users (25 cigs/day to 6 cigs/day) (p<0.001) Polosa R, et al. BMC Public Health. 2011; 11:786 Other Uses Anecdotal reports of using e-cigarettes to deliver illicit substances such as marijuana and methamphetamine Polosa et al Continued follow up of this sample at 18 and 24 months (n=23, 58% of original subjects) 18 continued to smoke 11 had reduced cigarette consumption by 50% (mean 24 cigs/day to 4 cigs/day) (p=0.003) 5 participants had quit cigarettes at 24 months Study Limitations Small sample size Lack of control group Lack of behavioral counseling 5

6 Clinical Trial 14 smokers with schizophrenia not intending to quit in the next 30 days Categoria e cigarette provided Carbon monoxide levels Product use and number of cigarettes smoked Positive and negative symptoms of schizophrenia Assessed at 4, 8, 12, 24, and 52 weeks 50% of participants sustained a 50% reduction in # of cigarettes smoked per day at week 52 Median of 30 cigs/day decreased to 15 cigs/day (p=0.018) Sustained abstinence from smoking occurred in 2 participants (14.3%) at week 52 No changes in positive and negative symptoms More Information Needed Effects of e cigarettes on quitting are similar to what is seen in unassisted or low assistance studies of smokers using NRT E cigarettes deliver low levels of nicotine Low to no behavioral counseling No therapeutic instructions for use Dosage tapering Duration of use How to combine them with behavioral strategies Guidance for discontinuation Caponnetto P, et al. Int J Environ Res Public Health. 2013; 10: Grana R et al. Circulation. 2014; 129: Clinical Trial 300 smokers not intending to quit Randomized to 7.2 mg e cigarette cartridges x 12 weeks (n=100) 7.2 mg e cig cartridge x 6 weeks followed by 5.4 mg cartridge x 6 weeks (n=100) no nicotine cartridge x 12 weeks (n=100) Cigarettes used per day Exhaled carbon monoxide levels Smoking reduction and abstinence rates calculated Adverse events Similar reductions in median cigarettes per day was seen in all 3 treatment arms No statistically significant differences in 6 month or 1 year quit rates among 3 treatment arms 4% for placebo e cigarette users 9% for low nicotine e cigarette users 13% for high nicotine e cigarette users 26% of quitters continued e cigarette use at 1 year Caponnetto P, et al. PLoS One. 2013; 8(6):e66317 What Should I Tell My Patients? Without scientific evidence from credible sources, Tobacco Free Florida cannot endorse e cigarettes as a beneficial step for smokers who are attempting to quit. For smokers looking for an effective way to quit, the best plan is to talk to your health care provider or seek help from a qualified Quit Coach. Additionally, there are nicotine replacement therapies (NRTs) and other quit aids that are approved by the FDA to help tobacco users quit and have been scientifically proven effective as part of a quit plan. These include: FDA approved over the counter NRTs like the patch, gum and lozenges; FDA approved prescription non nicotine medications; and FDA approved prescription NRTs such as the nicotine inhaler and nasal spray. Tobacco Free Florida Policy on E-cigarettes. See URL: 13/Electronic-Cigarettes/. Accessed 2014 June 20 Clinical Trials 657 smokers randomized to 16 mg nicotine e cig vs. 21 mg/day nicotine patch vs. placebo e cig Imitated therapy 1 week prior to quit date and continued for 12 weeks Abstinence rate at 6 months Adverse events Nicotine e cigs vs. patches RR=1.51 (95% CI 2.49 to 5.51) Nicotine e cigs vs. placebo RR=3.16 (95% CI 2.29 to 8.61) Lower than anticipated quit rates in both groups (4.1% in e cig group and 7.3% in patch group) No difference adverse effects between groups Bullen C et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet Sep (online) FDA approved smoking cessation therapies Nicotine replacement therapies Patch (OTC) Gum (OTC) Lozenge (OTC) Inhaler (Rx) Nasal Spray (Rx) Non Nicotine Therapies Varenicline (Chantix) Bupropion SR (Zyban) 6

7 Effectiveness of Current Therapies Can I afford NRT? Network meta analysis and review Included 267 studies; 101,804 participants evaluating therapies vs. placebo or against active comparator Benefit=continuous or prolonged abstinence for at least 6 months Harm=serious adverse events NRT and bupropion superior to placebo (OR 1.84; 95% CI and % CI 1.60 to 2.06, respectively) Varenicline superior to placebo (OR 2.88; 95% CI 2.40 to 3.47) Bupropion vs. NRT showed equal efficacy Varenicline more effective than single type NRT and similar to combination NRT Combination NRT superior to single formulations Cahill K, et al. Pharmacological interventions for smoking cessation: an overview and network metaanalysis (Review). Cochrane Database of Systematic Reviews 2013, Issue 5. Medication Costs The Real Costs of Tobacco Use Prices obtained from Accessed 2014 June 20 Graphic available from URL Accessed 2014 June 20 Insurance Coverage and Obtaining NRT Florida Medicaid Bupropion SR, NRT (patch, gum, lozenge) and varenicline Poor coverage on most private or commercial insurance plans Varenicline (Chantix) Pfizer Connection to Care program Must be below income levels and have no insurance coverage Tobacco Free Florida AHEC Tools to Quit or Quit Smoking Now offers free NRT for class participants Free NRT (including combination) for eligible participants Resources to help people quit Florida Medicaid Formulary. Accessed 2014 June

8 Acknowledgements Kathy L. Nichols, MS, CHES, CTTS Associate Director of UF AHEC Program Questions A Cloud of Controversy: E Cigarettes for Smoking Cessation Karen R. Sando, Pharm.D., BCACP, CDE Clinical Assistant Professor UF College of Pharmacy Gainesville, FL 8