Health Effects of Electronic Nicotine Delivery Systems: A Systematic Review

Transcription

1 Health Effects of Electronic Nicotine Delivery Systems: A Systematic Review ALLISON GLASSER SENIOR PROJECT MANAGER FEBRUARY 21, 2017 RAYMOND NIAURA DIRECTOR, SCIENCE AND TRAINING

2 Disclosures Allison Glasser Senior Project Manager for Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative Subcontractor for Population Assessment of Tobacco and Health Study and the Center for Evaluation & Coordination of Training and Research in Tobacco Regulatory Science (CECTR) - HHSN: C - 1U54CA No support from any industry sources Ray Niaura Director of Science and Training, Schroeder Institute, Truth Initiative Funded in part by Population Assessment of Tobacco and Health Study (PATH) and the Center for Evaluation & Coordination of Training and Research in Tobacco Regulatory Science (CECTR) Expert witness for plaintiff vs. tobacco companies. Received compensation from various pharmaceutical companies for services (consulting, trial site PI, honoraria) but not for the past six years. Opinions expressed are solely our own and do not necessarily reflect those of our employer, Truth Initiative, or any funding agencies.

3 Background Dramatically changing product landscape warrants frequent updates and synthesis of rapidly-growing evidence to inform prudent practice, policy and regulation. Comprehensive systematic review of empirical studies on ENDS across a broad range of topics.

4 Search Strategy Systematic review of all published scientific literature on ENDS conducted via a PubMed search through May 31, 2016**. Search keywords included: "e-cigarette*" OR "electronic cigarette" OR "electronic cigarettes" OR "electronic nicotine delivery" OR vape OR vaping. Eligible literature included experimental, quasi-experimental, observational, mixed methods, and preclinical/animal studies providing empirical data on the health impact of ENDS. **Search update conducted on February 1, 2017 new studies (n=249) have not been synthesized, but some highlighted here

5

6 250 Number of Included Articles by Year Number of Articles Publication Year

7 Search Results 129 peer-reviewed articles related to the health effects of ENDS were included in this review (116 human, 13 animal). Animal studies not discussed in this presentation Studies address: physiologic and cognitive effects of vaping, adverse events associated with vaping, exposure to secondhand vapor, and cytotoxicity of ENDS

8 Biomarkers

9 Health Effects in ENDS Users Studies of vaping indicate no or minimal impact on physiologic biomarkers and some possible acute positive effects on cognition and mood regulation. Cardiovascular Few studies have examined cardiovascular measures associated with ENDS use; findings divided with respect to impact on heart rate. Longitudinal studies show reduction in heart rate and blood pressure over time among smokers. 1,2 Pulmonary All studies measuring lung function either found no impact on or an improvement in lung function (among smokers) as a result of ENDS use. 3,4 Cognitive Studies demonstrate improved memory and mood. 5,6

10 Toxicant Exposure Liquids and exhaled aerosol contain measurable amounts of nicotine, propylene glycol, toxic constituents (tobaccospecific nitrosamines, heavy metals, carbonyls), but at much lower levels (9-450 times lower) 7 than tobacco smoke. Human exposure studies show significantly reduced toxicant exposure in current or former cigarette smokers using e-cigarettes.

11 Vapor vs. Cigarettes vs.? Goniewicz ML, Knysak J, Gawron M, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2014;23(2):

12 Exposure Biomarkers Goniewicz ML, Gawron M, Smith DM, Peng M, Jacob P, 3rd, Benowitz NL. Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study. Nicotine Tob Res. 2017;19(2):

13 Exposure Biomarkers Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis U, Feng J, Wang L, West R. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Annals of Internal Medicine Feb 7. [Epub ahead of print].

14 Dual Use: Concerns Expose users to increased nicotine and toxins compared to single use of either product People may not stop smoking conventional cigarettes or stop using other harmful tobacco products (discourage quitting)

15 Dual Use: Issues Exposure to toxins is highly device- and user-specific Exposure to toxins is driven primarily by combustible products (cigarettes) Dual use behaviors are poorly understood longitudinal patterns and duration

16 Transition Paths Tobacco Use States N N N N = never user C = combustible tobacco CNC = combustible and noncombustible tobacco NC = noncombustible tobacco S = stop (former user) Most harm Less harm? No harm C CN C NC C CN C NC C CN C NC This is the ENTIRE population S S S time

17 Adverse Events Adverse events reported by vapers are generally mild and resolve on their own, although there have been serious adverse events reported. From , there were 92 reported overheating/fire/explosion events in the U.S., and about half resulted in injuries (i.e., thermal burns, lacerations, or smoke inhalation). 8 The most common adverse events associated with vaping are mouth and throat irritation, nausea, headache, and dry cough.

18 Smoking Cessation Smoking Cessation 58 articles related to the impact of ENDS use on cigarette smoking cessation (abstinence or reduction) included in the review. The four studies with the strongest methods suggest that: - ENDS are effective in helping adult smokers to quit or to reduce their cigarette consumption, and that rates of smoking cessation with ENDS are similar to rates of cessation with NRT. 9-12

19 Vulnerable Populations Population Youth Existing research [None] Pregnant Women [None] Medical Co-Morbidities NHIS data reports that ENDS use is common among adults with medical comorbidities. 13,14 Studies show that ENDS use among those with chronic disease (COPD, asthma, diabetes, CAD) is associated with improved disease symptoms. 6,15,16

20 COPD Polosa R, Morjaria JB, Caponnetto P, Prosperini U, Russo C, Pennisi A, Bruno CM. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respir Res 2016, Dec 16;17(1):166.

21 Health Effects in ENDS Non-Users Increased number of poison control center calls related to nicotine exposures from ENDS in recent years, including exposures among children. Calls related to cigarette exposures where smoking is much more prevalent than vaping remain more common. Secondhand vape studies show that non-users may be exposed to nicotine in vapor, but at lower levels than when exposed to smoke.

22 Conclusions Difficult to estimate the precise difference in harmful exposure of vaping compared to smoking, but experts have concluded that ENDS are substantially less harmful than cigarettes. Little is known about health effects in youth, pregnant women (or women of reproductive age), and never smokers. Little is known about health effects of secondhand vapor exposure.

23 Challenges/Lessons Learned Rapid rate of publication Limited resource capacity Heterogeneity of study designs Variability in study quality (e.g., preponderance of cross-sectional behavioral studies)

24 References 1. Farsalinos K, Cibella F, Caponnetto P, Campagna D, Morjaria JB, Battaglia E, Caruso M, Russo C, Polosa R. Effect of continuous smoking reduction and abstinence on blood pressure and heart rate in smokers switching to electronic cigarettes. Intern Emerg Med. 2016;11: Polosa R, Morjaria JB, Caponnetto P, et al. Blood Pressure Control in Smokers with Arterial Hypertension Who Switched to Electronic Cigarettes. Int J Environ Res Public Health. 2016;13(11). 3. Ferrari M, Zanasi A, Nardi E, Norselli Labate AM, Ceriana P, Balestrino A, Pisani L, Corcione N, Nava S. Short-term effects of a nicotine-free e- cigarette compared to a traditional cigarette in smokers and non-smokers. BMC Pulmonary Medicine. 2015;15: Cibella F, Campagna D, Caponnetto P, et al. Lung function and respiratory symptoms in a randomized smoking cessation trial of electronic cigarettes. Clin Sci (Lond). 2016;130(21): Dawkins L, Turner J, Crowe E. Nicotine derived from the electronic cigarette improves time-based prospective memory in abstinent smokers. Psychopharmacology. 2013;227(3): Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. Characteristics, perceived side effects and benefits of electronic cigarette use: a worldwide survey of more than 19,000 consumers. International journal of environmental research and public health. 2014;11(4): Goniewicz ML, Knysak J, Gawron M, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2014;23(2): Rudy SF, Durmowicz EL. Electronic nicotine delivery systems: overheating, fires and explosions. Tob Control Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382(9905): Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, et al. EffiCiency and Safety of an electronic cigarette (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013;8(6):e O'Brien B, Knight-West O, Walker N, Parag V, Bullen C. E-cigarettes versus NRT for smoking reduction or cessation in people with mental illness: secondary analysis of data from the ASCEND trial. Tobacco induced diseases. 2015;13(1): Tseng TY, Ostroff JS, Campo A, Gerard M, Kirchner T, Rotrosen J, et al. A Randomized Trial Comparing the Effect of Nicotine Versus Placebo Electronic Cigarettes on Smoking Reduction Among Young Adult Smokers. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco Kruse GR, Kalkhoran S, Rigotti NA. Use of Electronic Cigarettes Among U.S. Adults With Medical Comorbidities. Am J Prev Med Spears CA, Jones DM, Weaver SR, Pechacek TF, Eriksen MP. Use of Electronic Nicotine Delivery Systems among Adults with Mental Health Conditions, Int J Environ Res Public Health. 2016;14(1). 15. Polosa R, Morjaria J, Caponnetto P, Caruso M, Strano S, Battaglia E, Russo C. Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal. Int J Environ Res Public Health. 2014;11: Polosa R, Morjaria JB, Caponnetto P, et al. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respir Res. 2016;17(1):166.