oral presentation on vaping

• Case report
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• Published: 05 March 2021

Vaping-associated esophagitis

• Trisha Satya Pasricha   ORCID: orcid.org/0000-0002-8859-0361 1 &
• Bharati Kochar 1 , 2  

BMC Gastroenterology volume  21 , Article number:  106 ( 2021 ) Cite this article

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Vaping, or e-cigarettes, heat nicotine and other chemicals to create a vapor that is inhaled. The practice has gained rapid popularity with 41 million people globally reporting regular or occasional use. Although tobacco smoking is well-known to increase esophageal acid exposure by augmenting the number of reflux events, the effects of vaping on the gastrointestinal tract have not yet been elucidated. Our objective is to report a case of severe esophagitis associated with vaping, which is the first in the literature to our knowledge.

Case presentation

A 25-year-old male with a history of well-controlled gastro-esophageal reflux disease presented to the emergency room for evaluation of one week of severe odynophagia. He had been treated with a proton-pump inhibitor for several years with good effect. Approximately two months prior to presentation, he started vaping tetrahydrocannabinol and nicotine with recent heavy daily use. He denied any alcohol or non-steroidal anti-inflammatory drug use. We performed esophagogastroduodenoscopy that revealed Los Angeles Grade C esophagitis (involving ≥ 1 mucosal breaks continuous between tops of ≥ 2 mucosal folds, < 75% circumferential). Histopathological analysis of esophageal biopsies demonstrated granulation tissue with acute and chronic inflammation. Periodic acid-Schiff-diastase staining was negative and immunohistochemical stains for herpes simplex virus and cytomegalovirus were negative. There was no evidence of eosinophilic esophagitis. We treated him with intravenous PPI and analgesics until he was able to tolerate oral intake. He was counseled extensively on vaping cessation and reported complete resolution of symptoms after 2 months.

This patient’s presentation illustrates a serious gastrointestinal consequence of vaping, the long-term consequences of which warrant additional studies. Like smoking, the mechanism of injury in vaping may be, at least in part, due to the effects of nicotine. As prevalence of vaping continues to rise, clinicians should be aware of this complication and carefully solicit a patient’s vaping history as a simple denial of “smoking” can be misleading.

Peer Review reports

Vaping, or e-cigarettes, heat nicotine and other chemicals to create a vapor that is inhaled. The practice has gained rapid popularity with 41 million people globally reporting regular or occasional use [ 1 ]. Although tobacco smoking is well-known to increase esophageal acid exposure by augmenting the number of reflux events [ 5 ], the effects of vaping on the gastrointestinal tract have not yet been elucidated. Our objectives are to report a case of severe esophagitis associated with vaping, which is the first in the literature to our knowledge.

A 25-year-old male with a history of well-controlled gastro-esophageal reflux disease (GERD) presented to the emergency room for evaluation of one week of severe odynophagia and inability to tolerate po. He had been treated with a proton-pump inhibitor (PPI) for several years with good effect. Approximately 2 months prior to presentation, he started vaping tetrahydrocannabinol (THC) and nicotine with recent heavy daily use. He denied any alcohol or NSAID intake. On physical exam, the patient was non-toxic appearing with a soft abdomen.

We performed esophagogastroduodenoscopy that revealed Los Angeles Grade C esophagitis (involving ≥ 1 mucosal breaks continuous between tops of ≥ 2 mucosal folds, < 75% circumferential) (Fig.  1 ). Histopathological analysis of esophageal biopsies demonstrated granulation tissue with acute and chronic inflammation (Fig.  2 ). Periodic acid-Schiff-diastase staining was negative and immunohistochemical stains for herpes simplex virus and cytomegalovirus were negative. There was no evidence of eosinophilic esophagitis. He was diagnosed with esophagitis secondary to vaping. We treated him with intravenous 40 mg twice daily PPI and analgesics until he was able to tolerate oral intake. He was counseled extensively on vaping cessation. The patient reported complete resolution of symptoms after 2 months of PPI therapy and vaping cessation.

Images of the esophagus during esophagogastroduodenoscopy. Images of the patient’s esophagus obtained during esophagogastroduodenoscopy demonstrating severe bridging mucosal breaks less than 75% of the circumference, consistent with Grade C esophagitis per the Los Angeles Criteria for erosive esophagitis

Histological image of the distal esophageal biopsy specimen. Hematoxylin and eosin stain of the patient’s distal esophageal mucosal biopsy specimen demonstrating granulation tissue with acute on chronic inflammation. Photograph provided by Dr. Vikram Deshpande (Massachusetts General Hospital)

Discussion and conclusion

The emerging consequences of vaping have garnered significant public health attention in the product’s largest markets, the United States, the United Kingdom and France, which spend a combined $10 billion yearly on vaping products [ 1 ]. In addition to well-publicized lung injury, vaping is also associated with increased cardiovascular disease [ 2 ] and the development of oral ulceration [ 3 ].

The temporality of his commencing vaping with his symptoms strongly suggested a relationship, supported by the endoscopic appearance, histopathologic analysis, and exclusion of other etiologies. Cigarette smoking classically increases the risk of Barrett’s esophagus and malignancy, which it does synergistically with GERD [ 4 ]. Indeed cigarette smoking increases the odds of gastro-esophageal reflux symptoms [ 5 ] and greatly increases acid exposure time on ambulatory pH monitoring [ 6 ]—effects which are largely attributed to nicotine. Similarly, the mechanism of injury in vaping may be, at least in part, due to the effects of nicotine when present in the vaping substrate. Interestingly, like nicotine [ 7 ], THC (and namely, activation of cannabinoid receptors 1 and 2) has also been shown to play in important role in the regulation of transient lower esophageal sphincter relaxations, as well as lower esophageal pressure [ 8 , 9 ], further supporting vaping as the trigger of our patient’s presentation. Vaping poses particular challenges given the risk of unknown chemicals and toxins entering the substrate due to inconsistent regulations. However, independent of the substrate itself, direct mucosal injury as another mechanism of injury has been proposed secondary to the by-products of vaporized additives, which result in oxidative stress and DNA damage [ 10 ].

This patient’s presentation illustrates a serious gastrointestinal consequence of vaping, the long-term consequences of which warrant additional studies. As prevalence of vaping continues to rise, clinicians should be aware of this complication and carefully solicit a patient’s vaping history as a simple denial of “smoking” can be misleading.

Availability of data and materials

Data sharing not applicable to this article as no datasets were generated or analysed during the current study.

Abbreviations

Gastroesophageal reflux disease

Proton-pump inhibitor

Tetrahydrocannabinol

Non-steroidal anti-inflammatory drug

Jones L. Vaping: how popular are e-cigarettes? BBC News , BBC, 14 Sept. 2019, www.bbc.com/news/business-44295336 .

Osei AD, Mirbolouk M, Orimoloye OA, Dzaye O, Uddin SMI, Benjamin EJ, Hall ME, DeFilippis AP, Stokes A, Bhatnagar A, Nasir K, Blaha MJ. Association between e-cigarette use and cardiovascular disease among never and current combustible-cigarette smokers. Am J Med. 2019;132(8):949-954.e2.

Article   CAS   Google Scholar  

Ali NS, Billings ML, Tollefson MM, Davis DMR, Hand JL. Oral erosions associated with surreptitious marijuana vaping in an adolescent boy. Pediatr Dermatol. 2020;37(2):347–9.

Article   Google Scholar  

Cook MB, Shaheen NJ, Anderson LA, Giffen C, Chow WH, Vaughan TL, Whiteman DC, Corley DA. Cigarette smoking increases risk of Barrett’s esophagus: an analysis of the Barrett’s and Esophageal Adenocarcinoma Consortium. Gastroenterology. 2012;142(4):744–53.

Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018;67(3):430–40.

Kadakia SC, Kikendall JW, Maydonovitch C, Johnson LF. Effect of cigarette smoking on gastroesophageal reflux measured by 24-h ambulatory esophageal pH monitoring. Am J Gastroenterol. 1995;90(10):1785–90.

CAS   PubMed   Google Scholar  

Kahrilas PJ, Gupta RR. Mechanisms of acid reflux associated with cigarette smoking. Gut. 1990;31(1):4–10.

Beaumont H, Jensen J, Carlsson A, Ruth M, Lehmann A, Boeckxstaens G. Effect of delta9-tetrahydrocannabinol, a cannabinoid receptor agonist, on the triggering of transient lower oesophageal sphincter relaxations in dogs and humans. Br J Pharmacol. 2009;156(1):153–62.

Izzo AA, Camilleri M. Emerging role of cannabinoids in gastrointestinal and liver diseases: basic and clinical aspects. Gut. 2008;57(8):1140–55.

Sundar IK, Javed F, Romanos GE, Rahman I. E-cigarettes and flavorings induce inflammatory and pro-senescence responses in oral epithelial cells and periodontal fibroblasts. Oncotarget. 2016;7:77196–204.

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Trisha Satya Pasricha & Bharati Kochar

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TP wrote the initial draft of the manuscript and BK provided critical analysis and review of the manuscript. Both authors cared for the patient during his hospitalization. Both authors read and approved the final manuscript.

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Correspondence to Trisha Satya Pasricha .

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Pasricha, T.S., Kochar, B. Vaping-associated esophagitis. BMC Gastroenterol 21 , 106 (2021). https://doi.org/10.1186/s12876-021-01695-8

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The Effects of Vaping on the Oral Cavity

Presenters: Ellie Heidenreich ; Ellie Price Authors: Ellie Price, Alexis Pedersen Faculty Advisor: Brenda Armstrong Institution: Dixie State University

Introduction:Within the last several years, vaping—the inhalation of an aerosolized juice via an electronic cigarette—has been on the rise. The issue that will be reviewed in this research project is how vaping influences an individual’s oral health. Because oral health is so interlinked with systemic health, substances that compromise the oral cavity can impact an individual’s overall wellness and quality of life. Methods:Search parameters include vaping, electronic cigarettes, electronic nicotine delivery systems, and oral health. Because this is a new area of study, the most current publications were used, ranging within the last eight years. Results:The literature indicates that vaping is associated with reduced proliferation of epithelial tissue, increased levels of microbes and inflammatory cytokines in the oral cavity, and overall damage to the oral epithelium. Research also shows that vaping puts the user at risk for caries, periodontitis, and even intraoral burns or fractured teeth if the e-cigarette explodes. Additionally, e-juices expose the user to a variety of carcinogens and promote the growth of opportunistic pathogens in the mouth. Overall, the literature was consistent in demonstrating that vaping compromises the oral tissues, exacerbates infection, and weakens host immunity. Conclusion:Vaping is a new trend that lacks substantial longitudinal research, but the data available demonstrates its pathogenic role in oral and systemic health. Electronic nicotine delivery system producers claim vaping can serve as a less dangerous alternative to smoking, but further research is warranted. Dental hygienists should be equipped with this knowledge so that they can provide this information to their patients and advocate for oral health.

• Find-a-Dentist

Around 8% of people living in the U.S. use e-cigarettes, one major poll shows. Although the Food and Drug Administration (FDA) now has the authority to regulate all forms of nicotine, including the nicotine cartridges used in e-cigarettes, we still don’t have all the facts about vaping and dental health.

Could vaping be dangerous for your mouth?

E-cigarettes (also called vape pens) use a battery to heat up the liquid inside a special cartridge, creating a kind of aerosol “smoke” that users inhale. But as the American Lung Association warns, this isn’t just harmless water vapor.

The liquid (or e-juice) inside vaping cartridges usually contains nicotine made from tobacco, along with flavorings and other chemicals. (Even cartridges that claim to be nicotine-free have been shown to contain some nicotine.)

When the liquid in the cartridge heats up, more chemical compounds are formed. Researchers have found harmful substances in vape cartridges, including carcinogens (chemicals known to cause cancer) and heavy metals such as nickel, tin and lead.

The lithium-ion batteries in vape pens provide enough current to heat the liquid inside vape cartridges to 400° F in seconds, a CDC report shows. News reports have documented cases where people have been hurt when e-cigarettes have exploded or caused fires inside their mouths.

The American Dental Association’s stance on tobacco and nicotine products

Decades of research show that smoking  and smokeless tobacco  products are harmful to dental health. This is true whether people smoke cigarettes, cigars, pipes, hookahs (water pipes) or use chewing tobacco and other smokeless tobacco products. All of these products contain nicotine, which is highly addictive and known to affect brain development in children, teens and young adults.

The American Dental Association (ADA) has adopted policies relating to products that contain nicotine, including e-cigarettes. Our policies call for dentists to be fully aware of the health risks that come with tobacco use, including higher rates of tooth decay, gum disease, bone damage, tooth loss and more. Dentists are encouraged to screen patients for nicotine use — including tobacco and non-tobacco products — and provide counseling to help people quit.

The ADA is also concerned that marketing some nicotine delivery methods (such as vaping) as if they were less harmful than others is not a viable strategy for preventing deaths and disease caused by tobacco use.

View current ADA policies relating to nicotine and tobacco use here .

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​​Vaping, JUUL and E-Cigarettes Presentation Toolkit

This toolkit contains a  powerpoint  presentation and related resources about vaping, JUUL, and e-cigarettes. The resources can be used by AAP members and tobacco control advocates for grand rounds or other educational presentations. To obtain an editable version of the  powerpoint , please Contact Us .  

Toolkit Elements:  

• (For a downloadable version of this powerpoint, contact the Richmond Center )   
• E-Cigarette fact sheet for physicians    (This factsheet is also available in  Spanish  )  
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• JUUL: What pediatricians and families need to know  
• To see a previous version of this presentation in action, please view the video presentation:   "JUUL, Vaping and Electronic Cigarettes: A Public Health Crises"   Plenary Presented by Deepa Camenga MD, FAAP at the 2018 AAP National Conference & Exhibition on November 5, 2018 in Orlando, Florida.  Posted on YouTube.   

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The prevalence of electronic cigarettes vaping globally: a systematic review and meta-analysis

Hadi tehrani.

1 Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

2 Department of Health Education and Health Promotion, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran

Abdolhalim Rajabi

3 Environmental Health Research Center, Department of Biostatistics and Epidemiology, Faculty of Health, Golestan University of Medical Sciences, Gorgan, Iran

Mousa Ghelichi- Ghojogh

4 Metabolic Disorders Research Center, Golestan University of Medical Sciences, Gorgan, Iran

Mahbobeh Nejatian

5 Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran

Alireza Jafari

6 Department of Health Education and Health Promotion, School of Health, Social Development and Health Promotion Research Center, Gonabad University of Medical Sciences, Gonabad, Iran

Associated Data

Not applicable.

The purpose of this systematic review study was to determine the national, regional, and global prevalence of electronic cigarettes (e-cigarettes) vaping.

The articles were searched in July 2020 without a time limit in Web of Science (ISI), Scopus, PubMed, and Ovid-MEDLINE. At first, the titles and abstracts of the articles were reviewed, and if they were appropriate, they entered the second stage of screening. In the second stage, the whole articles were reviewed and articles that met the inclusion criteria were selected. In this study, search, selection of studies, qualitative evaluation, and data extraction were performed by two authors independently, and any disagreement between the two authors was reviewed and corrected by a third author.

In this study, the lifetime and current prevalence of e-cigarettes vaping globally were 23% and 11%, respectively. Lifetime and current prevalence of e-cigarettes vaping in women were 16% and 8%, respectively. Also, lifetime and current prevalence of e-cigarettes vaping in men were 22% and 12%, respectively. In this study, the current prevalence of e-cigarettes vaping in who had lifetime smoked conventional cigarette was 39%, and in current smokers was 43%. The lifetime prevalence of e-cigarettes vaping in the Continents of America, Europe, Asia, and Oceania were 24%, 26%, 16%, and 25%, respectively. The current prevalence of e-cigarettes vaping in the Continents of America, Europe, Asia, and Oceania were 10%, 14%, 11%, and 6%, respectively.

Conclusions

Based on the results of this study, it can be concluded that the popularity of e-cigarettes is increasing globally. Therefore, it is necessary for countries to have more control over the consumption and distribution of e-cigarettes, as well as to formulate the laws prohibiting about the e-cigarettes vaping in public places. There is also a need to design and conduct information campaigns to increase community awareness about e-cigarettes vaping.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13690-022-00998-w.

Electronic cigarettes (e-cigarettes) are another type of tobacco that has become popular in the world in recent years. These cigarettes have batteries and heat the liquid and usually contain nicotine and other toxins [ 1 ]. In recent years, the prevalence of e-cigarettes has increased.

The results of a study by Brożek and et al. in several European countries showed that the overall prevalence of lifetime e-cigarette vaping was 43.7%, with 51.3% in men and 40.5% in women [ 2 ]. According to the results of various studies, the prevalence of e-cigarettes vaping in different countries such as France, Mexico, China, Australia, and in the United States were 25.46%, 42.42%, 24.44%, 12.52%, and 13.47%, respectively [ 3 – 7 ].

A systematic review by Pisinger and Dossing in 2014 showed that e-cigarettes can have an adverse effect on the health of individuals due to materials such as fine/ultrafine particles, volatile organic compounds, carcinogenic carbonyls, carcinogenic tobacco-specific nitrosamines, and cytotoxicity. Additionally, another major concern is the availability of novel compounds, such as propylene glycol, which are not found in conventional cigarettes with unknown impact on health [ 8 ]. The results of studies showed that using e-cigarettes may increase the risk of cardiovascular disease and respiratory disease [ 9 , 10 ].

People usually e-cigarettes vaping to quit conventional cigarettes, while some people using both types of cigarettes and are at higher risk [ 11 ]. The e-cigarettes vaping can also encourage people to initial use of conventional cigarettes and other substances [ 12 , 13 ]. The results of a systematic review study have shown that adolescents whose parents and friends vaping of e-cigarettes are more likely to be inclined towards e-cigarettes vaping in the future [ 14 ]. Therefore, this systematic and meta-analysis review study was conducted with the aims of (1) Investigating an updated estimate of the prevalence of lifetime and current e-cigarettes vaping in around the world based on countries, and (2) also demonstrate a trend of the prevalence of lifetime and current e-cigarettes vaping.

Search strategy and selection of articles

This study was a systematic review and meta-analysis to determine the national, regional and global prevalence of e-cigarettes vaping. In this study, articles were searched in July 2020 without a time limit and only in articles published in English in Web of Science (ISI), Scopus, PubMed, and Ovid-MEDLINE. Contrary to what is mentioned in the protocol, we did not use Google Scholar to search for articles. Also, the reference sections of relevant systematic review articles were checked. In this study, the phrase of “lifetime prevalence” referred to e-cigarette vaping by a person during his/her lifetime, and the phrase of “current prevalence” referred to e-cigarette vaping during the last 12 months. The search strategy was performed with the keywords of “Electronic Cigarette” OR “Electronic Nicotine” OR “E-Cigarette” OR “Vaping” OR “E-Cig” (Additional file 1 ). This study was based on the PRISMA guideline (Fig.  1 ). The protocol of this study has been registered in the PROSPERO system (registration number: CRD42020183032).

Flowchart of the systematic review process using PRISMA checklist

To select articles, first, all search results were entered into Endnote software and then reviewed by two authors separately and any disagreement was reviewed by the third author. At this stage, first, the titles and abstracts of the articles were reviewed, and if they were appropriate, they entered in the second stage of screening. In the second stage, the all articles were reviewed and articles that met the inclusion criteria were selected. The process of reviewing the selection of articles is shown in Fig.  1 .

Inclusion and exclusion criteria

Inclusion criteria included (1) papers published in English language, (2) cross-sectional, cohort, case–control, and intervention articles, (3) papers that reported the prevalence of e-cigarette vaping, and (4) papers that were published in full text. Exclusion criteria included qualitative papers, and papers that were published as review study, editorials comments, presentations or conference abstracts.

Quality assessment

Methodological quality was assessed using the Joanna Briggs Institute’s critical appraisal tool [ 15 ] for prevalence studies. This tool evaluates the extent to which a study has addressed the potential biases in its design, conduct, and analysis. Studies were examined for representativeness, sample size, recruitment, description of study participants and setting, data coverage of the identified sample, reliability of the measured condition, statistical analysis, and confounding factors. Scores ranged from 0–9 with ≤ 5 as “low/moderate quality” and > 5 as “fair quality.” All studies selected for this meta-analysis were independently assessed by two authors (A.R. and A.J), and any disagreements between the two authors were reviewed and corrected by a third author.

Data extraction

All final papers entered into the study process were extracted from a pre-prepared checklist. The checklist included the surname of the first author, year of data collection, year of paper publication, target group, age of target group, place of study, type of study, the data gathering instrument, sample size, current and lifetime prevalence of e-cigarettes vaping, the prevalence of current e-cigarettes vaping in who had lifetime smoked conventional cigarettes, or currently smoking conventional cigarettes (Table S 1 ). In this study, search, study selection, qualitative evaluation, and data extraction were conducted independently by two authors, and any disagreements between the two authors were reviewed and corrected by a third author.

Data analysis

The pooled prevalence of e-cigarettes and a 95% confidence interval (CI) was calculated with raw data in STATA version 16 (Stata Corp LP, College Station, TX, USA). A random effects models (Der-Simonian Laird method) were used to combine data from individual studies. Q test and I2 statistic were used to calculate the heterogeneity between studies. I2 describes the percentage of total variation because of between-study heterogeneity [ 16 ]. Subgroup analysis was conducted according to the continent, study design, population study, and tools of assessment of e-cigarettes. Meta-regression was performed to explore the possible sources of heterogeneity. A p -value less than 0.05 was considered to be statistically significant.

In brief, a total of 146 eligible studies were identified and included in in the final analysis from 4026 potentially relevant articles with 5,495,495 participants. A flowchart of the inclusion and exclusion criteria of articles are shown in Fig.  1 . The included studies were published between 2010 and 2020. The studies were conducted on four continents, with 67 studies in North America, 28 studies in Asia, 43 studies in Europe, and 8 studies in Australia/Oceania. Of the total studies included in this systematic review, 137 studies were cross-sectional and 9 studies were cohort studies (Table S 1 ) [ 3 – 7 , 12 , 17 – 156 ].

The prevalence of lifetime and current e-cigarettes vaping

The results of this study showed that the lifetime and current prevalence of e-cigarettes vaping were 23% (with a confidence interval (CI) of 95%: 21–25%) and 11% (95% CI: 10–11%), respectively (Fig.  2 ). The lifetime and current prevalence of e-cigarettes vaping among women were 16% (95% CI: 15–18%) and 8% (95% CI: 0.07–0.08%), respectively (Fig.  3 ). Also, the lifetime and current prevalence of e-cigarettes vaping among men were 22% (95% CI: 20–25%) and 12% (95% CI: 11–13%), respectively (Fig.  4 ).

Pooled lifetime and current prevalence of e-cigarettes vaping in all subjects

Pooled lifetime and current prevalence of e-cigarettes vaping in women

Pooled lifetime and current prevalence of e-cigarettes vaping in men

In this study, the lifetime prevalence of e-cigarettes vaping among adolescents and school students, adults, college students, and patients were 25% (95% CI: 21–30%), 19% (95% CI: 17–21%), 26% (95% CI: 15–37%), and 29% (95% CI: 16–43%), respectively (Fig.  5 ). Also, the current prevalence of e-cigarettes vaping in adolescent and school students, adults, college students, and patients were 11% (95% CI: 10–12%), 11% (95% CI: 10–12%), 14% (95% CI: 7–22%), and 10% (95% CI: 8–11%), respectively (Fig.  5 ). The lifetime and current prevalence of e-cigarettes by subgroups in women and men can be seen in Fig S 1 and Fig S 2 .

Pooled lifetime and current prevalence of e-cigarettes vaping in all subjects by study population, continent, type of study, and tools assessment

The lifetime prevalence of e-cigarettes vaping in the continents of America, Europe, Asia, and Oceania were 24% (95% CI: 21–27%), 26% (95% CI: 21–31%), 16% (95% CI: 11–20%), and 25% (95% CI: 18–33%), respectively (Fig.  5 ). The current prevalence of e-cigarettes vaping in the continents of America, Europe, Asia, and Oceania were 10% (95% CI: 9–10%), 14% (95% CI: 10–17%), 11% (95% CI: 10–11%), and 6% (95% CI: 4–8%), respectively (Fig.  5 ).

According to the type of study, the lifetime prevalence of e-cigarettes vaping in cohort studies and cross-sectional studies were 28% (95% CI: 11–45%) and 23% (95% CI: 21–25%), respectively (Fig.  5 ). Also, based on the type of study, the current prevalence of e-cigarettes vaping in cohort studies and cross-sectional studies were 13% (95% CI: 11–16%) and 11% (95% CI: 10–11%), respectively (Fig.  5 ).

In terms of assessment tools, the lifetime prevalence of e-cigarettes vaping in studies conducted by self-report and standard questionnaire were 23% (95% CI: 21–26%) and 20% (95% CI: 15–25%), respectively (Fig.  5 ). Also, in terms of assessment tools, the current prevalence of e-cigarettes vaping in studies conducted by self-report and the standard questionnaire were 12% (95% CI: 11–12%) and 5% (95% CI: 4–6%), respectively (Fig.  5 ). In this study, the current prevalence of e-cigarettes vaping in people who had lifetime used conventional cigarettes, and in current smokers (conventional cigarettes) were 39% (95% CI: 36–42%) and 43% (95% CI: 39–47%), respectively (Fig.  6 ).

Pooled current prevalence of e-cigarettes vaping in ex-smokers and current smokers

The trend of current e-cigarettes vaping

The cumulative meta-analysis examined current e-cigarette vaping trends, which showed an upward trend from 2011 to 2014 and then a constant trend from 2014 to 2019 (Figure S 3 , Part A). The current prevalence of e-cigarettes among women first showed an upward and then a downward trends (Figure S 4 , part A). However, the current prevalence of e-cigarettes among men first showed an upward trend and then showed a constant trend (Fig S 5 , part A). The current prevalence of e-cigarettes vaping among adolescents and school students showed an upward trend. However, results of current e-cigarettes vaping among adolescents and school students showed an upward trend and among adults showed a downward trend (Fig S 6 , part A). The current prevalence of e-cigarettes vaping in continents of Americas and Asia first showed an upward trend and then showed an almost constant trend. The current prevalence of e-cigarettes vaping in Europe continent showed an upward trend (Fig S 7 , part A). The current prevalence of e-cigarettes vaping among people who had lifetime used conventional cigarettes and among current smokers (conventional cigarettes) first showed an upward trend and then showed an almost constant trend (Fig S 8 ). The current prevalence of e-cigarettes vaping by subgroups among women and men can be seen in Fig S 9 (part A) and Fig S 10 (part A). The lifetime prevalence of e-cigarettes vaping by subgroups among women and men in each continent can be seen in Fig S 11 (part A) and Fig S 12 (part A).

The trend of lifetime e-cigarettes vaping

The cumulative meta-analysis examined the lifetime e-cigarettes vaping, which showed an upward trend from 2011 to 2019 (Fig S 3 , part B). The trend of lifetime e-cigarettes vaping among women first showed an upward trend and then showed a constant trend (Fig S 4 , part B). Also, the trend of lifetime e-cigarettes vaping among men showed an upward trend and then showed a constant trend (Fig S 5 , part B). According to the results, the lifetime e-cigarettes vaping among adolescents and school students showed an upward trend (Fig S 6 , part B). The lifetime e-cigarettes vaping in the continents of the Americas, Asia, Europe, and Oceania showed an upward trend (Fig S 7 , part B). The lifetime prevalence of e-cigarettes vaping by subgroups among women and men can be seen in Fig S 9 (part B) and Fig S 10 (part B). The lifetime prevalence of e-cigarettes vaping by subgroups among women and men in every continent can be seen in Fig S 11 (part B) and Fig S 12 (part B).

Quality of included studies

The risk of bias and the quality of the included articles is illustrated in Table S 2 . All studies used an adequate sample size (100%) to determine the prevalence of e-cigarettes vaping. All studies (100%) used appropriate statistical analysis to measure the prevalence of e-cigarettes vaping. According to the Joanna Briggs Institute's Quality Assessment Checklist; the included articles had a score ranging from five to nine (Total nine-scored scale). Four studies scored nine out of nine (2.74%), fifty-seven studies scored seven to eight out of nine (39.04%) and the remaining eighty-five studies scored five to six out of nine score (58.22%) (Table S 2 ) [ 3 – 7 , 12 , 17 – 156 ].

Meta-regression analyses

Exploratory univariate meta-regression was conducted with the introduction of sample size, year of publication, tools of assessment, study design, continent, and population study for lifetime vaping and current vaping prevalence. The meta-regression coefficients for lifetime e-cigarettes vaping, 95% CI and P -value for these variables were, year of publication: β = 0.013, (95% CI: 0.0024, 0.0254, p  = 0.01), sample size: β = -1.42e −6 (95% CI: -2.05e −6 , -7.82e −7 , p  < 0.001), tools of assessment: β = -0.029, (95% CI: -0.098, 0.039, p  = 0.39), continent: β = 0.010, (95% CI: -0.011, 0.032, p  = 0.34), study design: β = -0.049, (95% CI: -0.170, 0.072, p  = 0.42), study population: β = -0.0012, (95% CI: -0.028, 0.025, p  = 0.92). The meta-regression coefficients for current e-cigarettes vaping showed that th95% CI and P -value for follow variables were, year of publication: β = 0.0065, (95% CI: 0.0037, 0.0092, p  < 0.001), sample size: β = -1.88e −6 (95% CI: -2.30e −6 , -1.46e −7 , p  < 0.001), tools of assessment: β = -0.059, (95% CI: -0.076, -0.043, p  < 0.001), continent: β = 0.005, (95% CI: -0.0013, 0.010, p  = 0.05), study design: β = -0.025, (95% CI: -0.042, -0.0075, p  = 0.005), study population: β = 0.0037, (95% CI: -0.0022, 0.0097, p  = 0.22).

This systematic review and meta-analysis study was conducted to determine the global prevalence of e-cigarettes vaping. In this study, the lifetime and current prevalence of e-cigarettes vaping in both sexes were 23% and 11%, respectively. The Europe continent had the high prevalence of e-cigarettes vaping and the lifetime and current of e-cigarettes vaping were 26 and 14 respectively. According to the results of this study, the overall trend of e-cigarettes vaping from 2011 to 2019 showed an upward trend. The current e-cigarettes vaping trend has been increasing from 2011 to 2014, and then there is a steady trend from 2014 to 2019.

Prevalence in men and women

The lifetime prevalence of e-cigarettes vaping among men and women were 22% and 16%, respectively. Also, the current prevalence of e-cigarettes vaping among men and women were 12% and 8%. In a study conducted in South Korea, the lifetime and current prevalence of e-cigarettes were 11.2% and 2% in men and 2.1% and 0.4% in women, respectively [ 117 ]. In a study conducted in Spain, the lifetime prevalence of e-cigarettes vaping among men and women were 8% and 5.3%, respectively [ 121 ]. The current prevalence of e-cigarettes vaping among Japanese men and women were 6.7% and 3.1%, respectively [ 136 ]. The lifetime prevalence of e-cigarettes vaping among Germany men and women were 9.2% and 6.7%, respectively, and the current prevalence of e-cigarettes vaping were 2.6% and 1.3%, respectively [ 115 ]. Among American men and women, the lifetime prevalence of e-cigarettes vaping were 9.6% and 7.4%, respectively, and current prevalence of e-cigarettes vaping were reported 2.6% and 2.1%, respectively [ 133 ]. Men and women use e-cigarettes for a variety of reasons. Men will start using e-cigarettes for reasons such as quitting smoking, health concerns related to conventional cigarette, and curiosity about e-cigarettes. In women, the recommendation to use e-cigarettes by family or friends is one of the important reasons for e-cigarettes vaping [ 157 ].

According to the results, the current prevalence of e-cigarettes among men first showed an upward trend and then showed a constant trend. Also, the current prevalence of e-cigarettes among women first showed an upward and then a downward trends. One of the reasons for the increasing trend of the current prevalence is the positive expectations of e-cigarettes including good taste, good social performance, and increased energy in men compared to women, while the only positive expectation of women to use e-cigarettes is weight loss due to e-cigarettes vaping [ 157 ]. The findings suggest that young women are more likely to use e-cigarettes, while pregnant women are less likely to use e-cigarettes due to the adverse effects of e-cigarettes [ 158 ]. The reason for the decrease of e-cigarettes vaping among women may be the failure of smoking consumption to help with weight loss and fitness. Also, women are generally more concerned about their health than men, and the reason for the reduced consumption may be due to greater awareness of the complications of e-cigarettes vaping.

Prevalence in adolescent’s and school students

In this study, the lifetime and current prevalence of e-cigarettes vaping among adolescents and school students were 25% and 11%, respectively. In a study conducted in Russia, the lifetime and current prevalence of e-cigarettes vaping were 28.6% and 2.2%, respectively [ 114 ]. The current prevalence of e-cigarettes vaping among adolescents and school students is very wide in different countries, such as 1% in Mexico [ 159 ] and 9.9% in the United States [ 122 ]. In other countries such as China, the United Kingdom, Canada, and Poland, the current prevalence of e-cigarettes vaping were reported 1.2%, 2.2%, 3.6% and 3.5%, respectively [ 148 , 150 , 160 ]. According to the results, the trend of lifetime and current prevalence of e-cigarettes vaping in adolescents has been increasing, for example, the lifetime prevalence rate in the UK has increased from 22% in 2014 to 25% in 2016 [ 161 ], also the current prevalence rate in the United States has increased rapidly from 1.5% in 2011 to 20.8% in 2018 [ 162 ]. In various studies, a positive relationship has been found between the amounts of monthly allowance given by parents to their adolescent children, so as much as the amount of money is higher, the probability of e-cigarettes vaping is also higher by children [ 144 , 163 – 165 ] and this factor could have been a reason to increase e-cigarettes vaping. Another reason for increasing the prevalence of e-cigarettes vaping could be the use of e-cigarettes to quitting conventional cigarette by adolescents. Therefore, this results indicate that families should pay more attention to their adolescent and children about e-cigarettes vaping. Also, as an important channel for e-cigarettes vaping education, health professionals could play an important role, especially for adolescents and school students. Additionally, banning the sale of e-cigarettes to people under 18 years may help reduce e-cigarettes vaping rates among adolescents and school students.

Prevalence in adults

In this study, the lifetime and current prevalence of e-cigarettes vaping among adults were 19% and 11%, respectively. In a study in South Korea, the lifetime and current prevalence of e-cigarettes were 6.6% and 1.1%, respectively [ 117 ]. In a study conducted in Spain, the lifetime prevalence of e-cigarettes vaping among adult men was 6.5% [ 121 ]. The current prevalence of e-cigarettes vaping in Japan has been reported to be 4.3% [ 136 ]. The current prevalence of e-cigarettes among adults varies from country to country, which can be influenced by various factors such as availability of these products and regulatory rules. For example, in China, the current prevalence of e-cigarettes vaping was 1.2%, while in the United States has been reported to be 5.5% [ 148 , 159 , 166 ]. However, the lack of laws on the sale of e-cigarettes and widespread access to tobacco in Chinese stores is a cause for concern about the increasing use of e-cigarettes, as in other countries [ 148 ]. In various studies conducted in different countries around the world, including Mexico, Australia, New Zealand, and Canada, the current prevalence of e-cigarettes has been reported to be 1.1%, 1.2%, 2.1%, and 2.9%, respectively [ 37 , 167 , 168 ]. Based on the results of this study, current prevalence of e-cigarettes vaping among adults showed decreasing trend. The downward trend in current prevalence may be due to increased awareness among adults about the harms and dangers of e-cigarettes, and the creation of regulatory laws that prohibit e-cigarette use.

Prevalence in college students

In this study, the lifetime and current prevalence of e-cigarettes in college students were 26% and 14%. In a study conducted in five European countries including Slovakia, Belarus, Poland, Russia and Lithuania, the lifetime prevalence of e-cigarettes among college students were 34.4%, 42.7%, 45%, 33.4%, and 42.7%, respectively, and the current prevalence of e-cigarettes in these five countries were 2.3%, 2.7%, 2.8%, 4%, and 3.5%, respectively [ 2 ]. In a study conducted in the United States, the lifetime and current prevalence of e-cigarettes vaping among college students were 9% and 30%, respectively [ 130 ]. In another study among health science students in Saudi Arabia, the lifetime prevalence of e-cigarettes vaping has been reported to be 27.7% [ 137 ]. In a study conducted in Pakistan on medical students, the prevalence of e-cigarettes vaping was 13.9% [ 139 ], while in another study, the current prevalence of e-cigarettes vaping was 4.4% on medical students and 12.4% on non-medical students [ 2 ]. It has been reported that the reason for the low prevalence among medical students maybe their high awareness of the dangers of e-cigarettes vaping during the period of their education course [ 2 ]. The lifetime prevalence of e-cigarettes in Malaysian college students has been reported to be 20.4% [ 143 ]. Differences prevalence of e-cigarettes vaping in studies can be due to the different target groups, differences in age groups, and method of conducted the studies. According to the results of this study, the lifetime prevalence of e-cigarettes among college students showed increasing trend and the current prevalence of consumption has been decreasing. The reasons for the declining trend of the current prevalence of e-cigarettes can be cultural differences and the creation of laws to monitor and prohibit the use of e-cigarettes. Also, the prohibition of e-cigarettes vaping in the college can be effective in reducing e-cigarettes vaping.

Prevalence by continent

In this study, the lifetime prevalence of e-cigarettes vaping was 24% in the Americas, 26% in Europe, 16% in Asia and 25% in Oceania. Also, in this study the current prevalence of e-cigarettes vaping was 10% in the Americas, 14% in Europe, 11% in Asia, and 6% in Oceania. In a study conducted in 27 European countries, the lifetime prevalence of e-cigarettes increased from 7.2% in 2012 to 11.6% in 2016 [ 169 ]. One of the reasons for the increase in consumption in this continent may be because people usually use e-cigarettes to reduce or quit conventional cigarettes, but after a period of time, they start to use e-cigarettes continuously.

In this study, the lifetime prevalence of e-cigarettes vaping in the continents of Americas, Asia, Europe, and Oceania showed an upward trend. Also, the current e-cigarettes vaping in the continents of Americas and Asia first showed an upward trend and then showed an almost constant trend, but in Europe continent, it was showed an upward trend. In general, the use of e-cigarettes is increasing across different continents, possibly due to insufficient taxation of e-cigarettes. Also, given the increase in e-cigarettes in recent years, the law may not have been enacted yet. The reason for the differences in the prevalence of e-cigarettes in different continents may be due to the enactment of laws to reduce publicity, ban sales, increase taxes and conduct information campaigns in the field.

Prevalence of e-cigarettes vaping among ex-smokers and current smokers

In this study, the current prevalence of e-cigarettes vaping in people who had lifetime used conventional cigarettes, and among current smokers were 39% and 43%, respectively. In a study conducted in Malaysia, the current prevalence of e-cigarettes vaping in who had lifetime smoked conventional cigarettes, and in current smokers conventional cigarettes were 4.3% and 8%, respectively [ 146 ]. In a study in the USA, the current prevalence of e-cigarettes vaping among current smokers has been reported to be 24.1% [ 128 ]. One of the reasons for e-cigarettes vaping among current smoker’s conventional cigarettes is the curiosity to try it, helping to quit and reduce conventional cigarette smoking. In a study conducted in Serbia, 12.8% of respondents reported that e-cigarettes vaping helped reduce their conventional cigarette smoking [ 153 ].

The current prevalence of e-cigarettes among people who had lifetime smoked conventional cigarettes or among current smokers first showed an upward trend and then t showed an almost constant trend. The reason for the increasing trend of e-cigarettes vaping may be the tendency of more smokers to quit or reduce conventional cigarettes, which can also be seen as both a threat and an opportunity. The threat aspect of this approach may be that a greater tendency to use e-cigarettes can lead to addiction to e-cigarettes. The opportunity aspect of this approach is that since most people have a tendency to quit smoking, e-cigarette can be a good option for quit or reducing conventional cigarettes.

According to the results of this study, it can be concluded that the prevalence of e-cigarettes is increasing worldwide. Therefore, it is necessary for countries to have more control over the consumption and distribution of e-cigarettes, as well as to formulate laws prohibiting the consumption of e-cigarettes in public places. Due to the increase in the prevalence of e-cigarettes among adolescents and school students, it is necessary that parents pay more attention to their children and also schools should also design and implement various educational programs to increase the awareness of adolescents and school students in this field. A broad program of behavioral, communications, and educational research is crucial to assess how youth perceive e-cigarettes and associated marketing messages, and to determine what kinds of tobacco control communication strategies and channels are most effective.

Besides, due to the high prevalence of e-cigarettes among current smokers, to quit or reduce their conventional cigarette smoking, more evidence is require in this regard and Clinical trial studies are also recommended to evaluate the benefits and harms of e-cigarettes vaping. The increase in e-cigarettes consumption in continental Europe compared to other continents indicates more detailed studies to identify the use of e-cigarettes, survey, and enact laws to ban e-cigarettes in this continent.

Limitations and strengths

This study also had its limitations. Due to the use of studies whose data are collected through self-reporting data, the results of the study may be distorted due to measurement errors such as reporting bias and reminder bias. This self-reporting can lead to the misclassification of people that applies to smoke behavior in women, who are often underreported. Another limitation of this study was that due to the smaller number of studies that reported the lifetime prevalence of e-cigarettes vaping in pregnant women (2 studies) than the studies that reported the current prevalence of e-cigarettes vaping in this group (3 studies), the lifetime prevalence rate was lower than the current prevalence rate. One of the strengths of the study is that it includes cross-sectional, cohort, case–control, and intervention studies, and examines the prevalence of e-cigarettes in worldwide, and examines both the lifetime and current prevalence of e-cigarettes. It has also examined the prevalence of e-cigarettes in different subgroups including men, women, adults, adolescents, university students, by continents, and conventional cigarette users.

Acknowledgements

Abbreviation, authors’ contributions.

AJ and HT conceptualized the study and led the project and writing. All authors contributed to the development of the coding scheme. AJ, MGh and AR conducted the coding and analyses and drafted the methods. AR, MN, AJ and HT reviewed the codes and results. All authors contributed to the writing and revision and approved the final version of the manuscript.

Social Development and Health Promotion Research Center funded this project.

Availability of data and materials

Declarations.

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Hadi Tehrani and Abdolhalim Rajabi contributed equally as first author.

Contributor Information

Hadi Tehrani, Email: ri.ca.smum@hinarheT .

Abdolhalim Rajabi, Email: [email protected] .

Mousa Ghelichi- Ghojogh, Email: [email protected] .

Mahbobeh Nejatian, Email: [email protected] .

Alireza Jafari, Email: [email protected] .

News Details

Achv: 2023 results.

By John Vandermosten, CFA

NASDAQ:ACHV

READ THE FULL ACHV RESEARCH REPORT

Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported full year 2023 results in a March 28th press release . The company subsequently held a conference call discussing recent events and what to expect over the next year. A Form 10-K was filed with the SEC providing additional disclosures. Highlights since the third quarter earnings call include attendance at investor conferences and presentation of results at scientific conferences including results from the three most recent ORCA trials at SRNT Europe. Most importantly, following October’s pre-NDA meeting, the FDA voiced its desire to see long term safety data. As a result, Achieve has designed a safety trial designated ORCA-OL which will begin enrolling in 2Q:24. Based on the safety trial design and anticipated availability of data, NDA submission is expected in 1H:25 with a target action date expected one year later in 1H:26.

Milestones:

➢ Pre-NDA meeting with the FDA – October 2023

➢ Clarification regarding FDA request for additional safety data – December 2023

➢ Capital raise of $60 million – February 2024

➢ Agreement regarding long-term safety study with FDA – February 2024

➢ Three presentations at SRNT Annual Meeting (Edinburgh, Scotland) – March 2024

➢ Launch of ORCA-OL trial – 2Q:24

➢ End of Phase II meeting with FDA to determine Phase III vaping cessation trial design – 2H:24

➢ Data from 300 patients with six months exposure to cytisinicline – year-end 2024

➢ Submission of new drug application (NDA) – 1H:25

➢ Data from 100 patients with twelve months exposure to cytisinicline – mid-year 2025

➢ FDA target action date for cytisinicline NDA – 1H:26

Financial Results

No revenues were reported for 2023. Operating expense was $27.3 million producing a net loss of ($29.8) million or ($1.50) per share. For the year ending December 31, 2023 and versus the same comparable period in the prior year:

➢ Research & development expense totaled $15.8 million, down 47% from $30.1 million, as expenses in the prior year related to ORCA-3 and ORCA-V1 fell substantially and spending shifted towards the three ancillary support studies required for cytisinicline NDA submission and FDA preparatory efforts;

➢ General & administrative expense was $11.4 million, up 7% from $10.7 million on higher employee expenses associated with stock-based compensation, legal expenses as a result of general corporate activities, investor relation activities and commercial market planning activities. The increased expenses were partially offset by a decrease in costs associated with clinical trial media and awareness as both the ORCA-3 trial and ORCA-V1 trial were fully enrolled in the third and fourth quarter of 2022, respectively, and lower patent filing expenses as a result of a decrease in patent associated activities in 2023;

➢ Net interest expense was ($2.0) million vs. $0.2 million as higher debt balance and higher floating interest rates offset interest income;

➢ Net loss was ($29.8) million vs. ($42.4) million or ($1.50) and ($4.00) per share, respectively.

As of December 31, 2023, cash and equivalents totaled $15.5 million. This amount compares to a $24.8 million balance in cash and equivalents held at the end of 2022. Achieve has assumed $15 million of convertible debt related to its loan facility originally with SVB and now with First Citizens Bank & Trust Company. It is carried at $16.7 million on the balance sheet and includes accrued interest. The term loan was modified last May and now matures in December 2024. Achieve is in the process of negotiating the loan further and may pay the amount in cash using equity raise proceeds. In 2024, Achieve closed a capital raise that provided $60 million in upfront financing and a warrant component that may raise an additional $64 million. The warrants have a 42-month life, but can be called following acceptance of a new drug application (NDA) by the FDA which is expected in 1H:25. 2023 cash used in operations was ($24.5) million versus ($37.5) million in the prior year.

Poster Presentations at SRNT 2024

Achieve and its representatives participated in the 2024 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting which was held in Edinburgh, Scotland from March 20 to 23. The oral presentations featured data from both of the Phase III ORCA trials and from the Phase II ORCA-V1 vaping trial. Below we summarize the presentations and include a link to related materials.

➢ Post-Trial Surveys from two Phase 3 Trials (ORCA-2 and ORCA-3) of Cytisinicline in Adult Smokers

o Presented by Achieve’s Director of Clinical Operations, Roxann Becco on March 21st

o Discusses patient-reported outcomes from the Phase 3 ORCA-2 and ORCA-3 clinical trials. Data collected include trial participants’ experiences, such as cravings and withdrawal symptoms, personal impact on overall health, and opinions on future use.

➢ Efficacy and Safety of Cytisinicline for Smoking Cessation: Confirmation with a Second Randomized Phase 3 Trial (ORCA-3)

o Presented by Achieve’s Chief Medical Officer Dr. Cindy Jacobs on March 22nd

o Reviewed data from the second, completed Phase 3 ORCA-3 trial that evaluated the efficacy and safety of cytisinicline in 792 adult smokers in the United States. Findings confirmed results from the previous Phase 3 ORCA-2 trial demonstrating that cytisinicline, when dosed at the 3 mg, three times daily schedule for either 6 or 12 weeks, increased smoking abstinence when compared with placebo and was very well-tolerated with no treatment-related serious adverse events reported.

➢ Cytisinicline for Vaping Cessation Among Adult Nicotine E-Cigarette Users

o Presented by Dr. Nancy Rigotti, ORCA-V1 Principal Investigator and Professor of Medicine at Harvard Medical School on March 23rd

o Discussed data from the Phase 2 ORCA-V1 trial. ORCA-V1 evaluated the effectiveness and safety of cytisinicline in users of nicotine e-cigarettes who wanted to quit vaping. Similar to the efficacy and tolerability findings observed in the combustible cigarette cessation Phase 3 trials, ORCA-V1 participants who received cytisinicline had increased successful vaping cessation rates, compared with placebo, and reported minimal rates of adverse events.

Virtual Life Sciences Conference Participation

On March 7th, 2023, Achieve Life Sciences’ CEO John Bencich participated in the OTC Markets’ Life Sciences Virtual Investor Forum. He was joined by Zacks Small Cap Research’s Senior Life Sciences Analyst John Vandermosten. The 30-minute CEO Chat updated investors on the new open label safety trial, ORCA-OL, and its recent capital raise. Other topics address work on the vaping indication, M&A trends and competing products for nicotine addiction. Follow the link here for the replay.

ORCA-OL Trial

Achieve provided an update to its December 11th announcement regarding the FDA’s desire for additional long-term cytisinicline exposure data to adequately assess safety risk. Despite an initial anticipated treatment duration of six to twelve weeks, cytisinicline could be used for chronic, repeat or intermittent use if a patient relapses. With this possibility guiding its interactions with drug sponsors, the FDA and Achieve have reached an agreement that a single, open-label study evaluating long-term safety exposure of cytisinicline will meet the safety requirement. Details of the arrangement were provided in a February 29th press release and are described further below.

The study will include safety data on at least 300 subjects that have received cumulative cytisinicline treatment for six months. This data will be included with the new drug application (NDA), which we expect in the first half of 2025. Additionally, one year of exposure safety data from at least 100 subjects treated with cytisinicline will be submitted prior to approval. Subjects for the trial will be drawn from the pool of individuals that participated in the ORCA-1, ORCA-2 and ORCA-V1 trials with a preference for subjects who received 12 weeks of treatment. The desired exposure data is cumulative rather than continuous, giving credit to the duration of therapy already received. We anticipate that the minimum 300 subjects could require an additional 14 weeks of treatment to satisfy the 6-month threshold.

To satisfy the safety requirement, Achieve will launch an Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial that will recruit from the more than 1,700 subjects who have already participated in Achieve’s previous studies. 1,100 of these subjects have been treated with six or twelve weeks of cytisinicline. The company may target recruitment of up to 650 subjects to account for an anticipated dropout rate.

Achieve has already activated 30 sites that were involved with previous cytisinicline trials and the sites are actively contacting previous participants. Exit data from the ORCA studies have shown that patients are largely satisfied with cytisinicline and the drug is well tolerated. See the link to “Post Trial Surveys” under the Poster Presentations section for more detail on patient satisfaction. Drug product is in the process of being packaged and should be available in the next few weeks.

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