electronic nicotine delivery systems

Electronic Cigarettes vs Varenicline for Smoking Cessation in Adults: A Randomized Clinical Trial

Author/s: 
Anna Tuisku, Mikko Rahkola, Pentti Nieminen, Tuula Toljamo

Importance: Little is known about the relative effectiveness of nicotine-containing electronic cigarettes (ECs) compared with varenicline as smoking cessation aids.

Objective: To determine the relative effectiveness of ECs in smoking cessation.

Design, setting, and participants: This randomized placebo-controlled single-center trial was conducted in northern Finland. Participants aged 25 to 75 years who smoked daily and had volunteered to quit smoking were recruited from August 1, 2018, to February 20, 2020, via local media. The trial included 52 weeks of follow-up. All data analyses were conducted from September 1, 2022, to January 15, 2024. The participants, study nurses, and researchers were masked to group assignment.

Intervention: The participants were assigned by block randomization to receive 18 mg/mL of nicotine-containing ECs together with placebo tablets, varenicline with standard dosing together with nicotine-free ECs, or placebo tablets together with nicotine-free ECs, all combined with a motivational interview, with the intervention phase lasting for 12 weeks.

Main outcome and measure: The primary outcome was self-reported 7-day conventional cigarette smoking abstinence as confirmed by the exhaled carbon monoxide level on week 26. The analysis followed the intent-to-treat principle.

Results: Of the 561 recruited participants, 458 (81.6%) eligible participants (257 women [56%]; 201 men [44%]; mean [SD] age, 51 [11.6] years) were randomized. The primary outcome occurred in 61 of 152 participants (40.4%) in the EC group, 67 of 153 (43.8%) in the varenicline group, and 30 of 153 (19.7%) in the placebo group (P < .001). In the pairwise comparison, placebo differed statistically significantly from ECs (risk difference [RD], 20.7%; 95% CI, 10.4-30.4; P < .001) and varenicline (RD, 24.1%; 95% CI, 13.7-33.7; P < .001), but the difference was statistically insignificant between ECs and varenicline (RD, 3.4%; 95% CI, -7.6 to 14.3; P = .56). No serious adverse events were reported.

Conclusions: This randomized clinical trial found that varenicline and nicotine-containing ECs were both effective in helping individuals in quitting smoking conventional cigarettes for up to 6 months.

Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons: US Preventive Services Task Force Recommendation Statement

Author/s: 
US Preventative Services task Force

Tobacco use is the leading preventable cause of disease, disability, and death in the US. In 2014, it was estimated that 480 000 deaths annually are attributed to cigarette smoking, including second hand smoke exposure. Smoking during pregnancy can increase the risk of numerous adverse pregnancy outcomes (eg, miscarriage and congenital anomalies) and complications in the offspring (including sudden infant death syndrome and impaired lung function in childhood). In 2019, an estimated 50.6 million US adults (20.8% of the adult population) used tobacco; 14.0% of the US adult population currently smoked cigarettes and 4.5% of the adult population used electronic cigarettes (e-cigarettes). Among pregnant US women who gave birth in 2016, 7.2% reported smoking cigarettes while pregnant

Association Between E-Cigarette Use and Chronic Obstructive Pulmonary Disease by Smoking Status: Behavioral Risk Factor Surveillance System 2016 and 2017

Author/s: 
Osei , A.D., Mirbolouk, M., Orimoloye, O.A., Dzaye, O.

Introduction: The association between e-cigarette use and chronic bronchitis, emphysema, and
chronic obstructive pulmonary disease has not been studied thoroughly, particularly in populations
defined by concomitant combustible smoking status.

Methods: Using pooled 2016 and 2017 data from the Behavioral Risk Factor Surveillance System,
investigators studied 705,159 participants with complete self-reported information on e-cigarette use,
combustible cigarette use, key covariates, and chronic bronchitis, emphysema, or chronic obstructive
pulmonary disease. Current e-cigarette use was the main exposure, with current use further classified
as daily or occasional use. The main outcome was defined as reported ever having a diagnosis of

chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. For all the analyses, multi-
variable adjusted logistic regression was used, with the study population stratified by combustible ciga-
rette use status (never, former, or current). All the analyses were conducted in 2019.

Results: Of 705,159 participants, 25,175 (3.6%) were current e-cigarette users, 64,792 (9.2%) current
combustible cigarette smokers, 207,905 (29.5%) former combustible cigarette smokers, 432,462

(61.3%) never combustible cigarette smokers, and 14,036 (2.0%) dual users of e-cigarettes and combus-
tible cigarettes. A total of 53,702 (7.6%) participants self-reported chronic bronchitis, emphysema, or

chronic obstructive pulmonary disease. Among never combustible cigarette smokers, current e-ciga-
rette use was associated with 75% higher odds of chronic bronchitis, emphysema, or chronic obstruc-
tive pulmonary disease compared with never e-cigarette users (OR=1.75, 95% CI=1.25, 2.45), with

daily users of e-cigarettes having the highest odds (OR=2.64, 95% CI=1.43, 4.89). Similar associations
between e-cigarette use and chronic bronchitis, emphysema, or chronic obstructive pulmonary disease
were noted among both former and current combustible cigarette smokers.
Conclusions: The results suggest possible e-cigarette−related pulmonary toxicity across all thecategories of combustible cigarette smoking status, including those who had never smoked combus-
tible cigarettes.

Keywords 

Association of E-Cigarette Use With Respiratory Disease Among Adults: A Longitudinal Analysis

Author/s: 
Bhatta, DN, Glantz, SA

INTRODUCTION:

E-cigarettes deliver an aerosol of nicotine by heating a liquid and are promoted as an alternative to combustible tobacco. This study determines the longitudinal associations between e-cigarette use and respiratory disease controlling for combustible tobacco use.

METHODS:

This was a longitudinal analysis of the adult Population Assessment of Tobacco and Health Waves 1, 2, and 3. Multivariable logistic regression was performed to determine the associations between e-cigarette use and respiratory disease, controlling for combustible tobacco smoking, demographic, and clinical variables. Data were collected in 2013-2016 and analyzed in 2018-2019.

RESULTS:

Among people who did not report respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, emphysema, or asthma) at Wave 1, the longitudinal analysis revealed statistically significant associations between former e-cigarette use (AOR=1.31, 95% CI=1.07, 1.60) and current e-cigarette use (AOR=1.29, 95% CI=1.03, 1.61) at Wave 1 and having incident respiratory disease at Waves 2 or 3, controlling for combustible tobacco smoking, demographic, and clinical variables. Current combustible tobacco smoking (AOR=2.56, 95% CI=1.92, 3.41) was also significantly associated with having respiratory disease at Waves 2 or 3. Odds of developing respiratory disease for a current dual user (e-cigarette and all combustible tobacco) were 3.30 compared with a never smoker who never used e-cigarettes. Analysis controlling for cigarette smoking alone yielded similar results.

CONCLUSIONS:

Use of e-cigarettes is an independent risk factor for respiratory disease in addition to combustible tobacco smoking. Dual use, the most common use pattern, is riskier than using either product alone.

Severe Pulmonary Disease Associated with Electronic-Cigarette–Product Use — Interim Guidance

Author/s: 
Schier, JG, Meiman, JG, Layden, J, Mikosz, CA, VanFrank, B, King, BA, Salvatore, PP, Weissman, DN, Thomas, J, Melstrom, PC, Baldwin, GT, Parker, EM, Courtney-Long, EA, Krishnasamy, VP, Pickens, CM, Evans, ME, Tsay, SV, Powell, KM, Kiernan, EA, Marynak, KL, Adjemian, J, Holton, K, Armour, BS, England, LJ, Briss, PA, Houry, D, Hacker, KA, Reagan-Steiner, S, Zaki, S, Meaney-Delman, D, CDC 2019 Lung Injury Response Group

On September 6, 2019, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). As of August 27, 2019, 215 possible cases of severe pulmonary disease associated with the use of electronic cigarette (e-cigarette) products (e.g., devices, liquids, refill pods, and cartridges) had been reported to CDC by 25 state health departments. E-cigarettes are devices that produce an aerosol by heating a liquid containing various chemicals, including nicotine, flavorings, and other additives (e.g., propellants, solvents, and oils). Users inhale the aerosol, including any additives, into their lungs. Aerosols produced by e-cigarettes can contain harmful or potentially harmful substances, including heavy metals such as lead, volatile organic compounds, ultrafine particles, cancer-causing chemicals, or other agents such as chemicals used for cleaning the device (1). E-cigarettes also can be used to deliver tetrahydrocannabinol (THC), the principal psychoactive component of cannabis, or other drugs; for example, "dabbing" involves superheating substances that contain high concentrations of THC and other plant compounds (e.g., cannabidiol) with the intent of inhaling the aerosol. E-cigarette users could potentially add other substances to the devices. This report summarizes available information and provides interim case definitions and guidance for reporting possible cases of severe pulmonary disease. The guidance in this report reflects data available as of September 6, 2019; guidance will be updated as additional information becomes available.

Pulmonary Illness Related to E-Cigarette Use in Illinois and Wisconsin - Preliminary Report

Author/s: 
Layden, J.E., Ghinai, I, Pray, I, Kimball, A, Layer, M, Tenforde, M, Navon, L, Hoots, B, Salvatore, PP, Elderbrook, M, Haupt, T, Kanne, J, Patel, MT, Saathoff-Huber, L, King, BA, Schier, JG, Mikosz, CA, Meiman, J

BACKGROUND:

E-cigarettes are battery-operated devices that heat a liquid and deliver an aerosolized product to the user. Pulmonary illnesses related to e-cigarette use have been reported, but no large series has been described. In July 2019, the Wisconsin Department of Health Services and the Illinois Department of Public Health received reports of pulmonary disease associated with the use of e-cigarettes (also called vaping) and launched a coordinated public health investigation.

METHODS:

We defined case patients as persons who reported use of e-cigarette devices and related products in the 90 days before symptom onset and had pulmonary infiltrates on imaging and whose illnesses were not attributed to other causes. Medical record abstraction and case patient interviews were conducted with the use of standardized tools.

RESULTS:

There were 53 case patients, 83% of whom were male; the median age of the patients was 19 years. The majority of patients presented with respiratory symptoms (98%), gastrointestinal symptoms (81%), and constitutional symptoms (100%). All case patients had bilateral infiltrates on chest imaging (which was part of the case definition). A total of 94% of the patients were hospitalized, 32% underwent intubation and mechanical ventilation, and one death was reported. A total of 84% of the patients reported having used tetrahydrocannabinol products in e-cigarette devices, although a wide variety of products and devices was reported. Syndromic surveillance data from Illinois showed that the mean monthly rate of visits related to severe respiratory illness in June through August of 2019 was twice the rate that was observed in the same months in 2018.

CONCLUSIONS:

Case patients presented with similar clinical characteristics. Although the features of e-cigarette use that were responsible for injury have not been identified, this cluster of illnesses represents an emerging clinical syndrome or syndromes. Additional work is needed to characterize the pathophysiology and to identify the definitive causes.

Keywords 

Electronic Nicotine Delivery Systems (ENDS)

Electronic nicotine delivery systems (ENDS), also called electronic cigarettes, e-cigarettes, vaping devices, or vape pens, are battery-powered devices used to smoke or “vape” a flavored solution which usually contains nicotine. The American Academy of Family Physicians (AAFP) recognizes the alarmingly increased use of ENDS, especially among youth and young adults, as well as its use by those attempting to quit smoking tobacco.

The AAFP calls for further research to assess ENDS’ safety, quality, and efficacy as a potential cessation device. The AAFP also recommends that the marketing and advertising of ENDS to children and youth cease immediately. The AAFP encourages members to screen for ENDS use starting with school-age children, to discuss the potential harms of ENDS, and to recommend cessation interventions with e-cigarette users. The AAFP encourages members to inform patients who use ENDS, especially children, that the majority of these products contain nicotine and are addictive.  (2014 COD) (April 2019 BOD)

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy

Author/s: 
Hajek, Peter, Phillips-Waller, Anna, Przulj, Dunja, Pesola, Francesca, Smith, Katie Myers, Bisal, Natalie, Li, Jinshuo, Parrott, Steve, Sasieni, Peter, Dawkins, Lynne, Ross, Louise, Goniewicz, Maciej, Wu, Qi, McRobbie, Hayden J.

BACKGROUND

E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.

METHODS

We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.

RESULTS

A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.

CONCLUSIONS

E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608.)

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