Category: Research

  • Vaping Surges Nearly 600 Percent in Malaysia

    Vaping Surges Nearly 600 Percent in Malaysia

    Photo: fedorovacz

    Vaping prevalence in Malaysia has surged 600 percent in 12 years, reports the New Straits Times, citing a recent study.

    The 2023 Global Adult Tobacco Survey (GATS) found that some 5.8 percent of Malaysian adults are e-cigarette users compared with only 0.8 percent in 2011.

    GATS is a nationally representative household survey conducted in more than 30 countries globally.

    The report also revealed an increase in the percentage of people who used both tobacco and e-cigarettes, from 0.8 percent in 2011 to 3.9 percent last year.

    The 15–24 age group had the highest prevalence (8.6 percent) compared with 7.1 percent for those between 25 and 44.

    The top 3 reasons cited for using e-cigarettes were flavors, the perception of lower risk compared to smoking, and more enjoyment.

    The GATS also found that 41 percent of adult smokers in Malaysia have no plans to quit the habit.

    Another 13 percent said they were thinking about quitting smoking within the next 12 months, and another 37 percent said they planned to stop someday.

    The survey found that around 4.8 million or 19 percent of adults in Malaysia smoke, with 3.7 million or 14.6 percent of adults smoking daily.

    GATS Malaysia 2023 queried 5,780 households across all states, with respondents aged 15 years and above, over two months.

  • Study: Vapers Now More Likely to Quit Cigarettes

    Study: Vapers Now More Likely to Quit Cigarettes

    Photo: Pcess609

    Smokers who switch to e-cigarettes are now more likely to stop smoking regular cigarettes, according to a new paper published by Oxford University Press in Nicotine & Tobacco Research. In the past, smokers who began vaping mostly continued smoking.

    Electronic nicotine delivery systems first emerged on the U.S. market in 2007. The first e-cigarettes resembled conventional cigarettes (in appearance) and used fixed low-voltage batteries. Beginning in 2016, manufacturers introduced e-liquids containing nicotine salt formulations. These new e-cigarettes became widely available. These nicotine salts are lower in pH than freebase formulations, which allow manufacturers to increase nicotine concentration while avoiding harshness and bitterness.

    Past population-level research provided conflicting findings on whether vaping helps people who smoke combustible cigarettes to quit smoking. Some research suggests improved cigarette quitting-related outcomes with e-cigarette use, while other research suggests the opposite. Inconsistent findings may be due to differences in the samples and measures considered, differences in the analytic approaches of researchers used, the rapidly changing product environment, or policy contexts.

    While our study doesn’t give the answers as to why vaping is associated with cigarette quitting in the population today when it wasn’t associated with quitting years ago, design changes leading to e-cigarettes that deliver nicotine more effectively should be investigated.

    Karin Kasza, assistant professor of oncology, Department of Health Behavior at Roswell Park Comprehensive Cancer Center

    The researchers here examined differences in real-world trends in population-level cigarette discontinuation rates from 2013 to 2021, comparing U.S. adults who smoked combustible cigarettes and used e-cigarettes with U.S. adults who smoked combustible cigarettes and did not use e-cigarettes.

    Using data from among adults (ages 21+) in the Population Assessment of Tobacco and Health (PATH) Study, a national longitudinal study of tobacco use from people from all over the United States, the researchers found that between 2013 and 2016, rates of discontinuing cigarette smoking among adults in the U.S. population were statistically indistinguishable between those who used e-cigarettes and those who did not. Cigarette discontinuation rates were 15.5 percent for those who used e-cigarettes and 15.6 percent for those who did not.

    But the quit rates changed in subsequent years; the researchers here found that between 2018 and 2021 only 20 percent of smokers who did not use e-cigarettes stopped smoking combustible cigarettes, but some 30.9 percent of smokers who used e-cigarettes stopped smoking combustible cigarettes.

    The paper notes that the full study period spanned a time in the United States when the e-cigarette marketplace was expanding; salt-based nicotine formulations gained market share in 2016 and vaping products became available with increased nicotine yields over time. This was also a period in which state and federal governments restricted tobacco in various ways, including increasing the tobacco-purchase age to 21 and restricting flavored e-cigarettes.

    “Our findings here suggest that the times have changed when it comes to vaping and smoking cessation for adults in the U.S.,” said study first author, Karin Kasza, an assistant professor of oncology in the Department of Health Behavior at Roswell Park Comprehensive Cancer Center in Buffalo, New York, in a statement.

    “While our study doesn’t give the answers as to why vaping is associated with cigarette quitting in the population today when it wasn’t associated with quitting years ago, design changes leading to e-cigarettes that deliver nicotine more effectively should be investigated. This work underscores the importance of using the most recent data to inform public health decisions.”

  • Study: Similar DNA Changes in Smokers and Vapers

    Study: Similar DNA Changes in Smokers and Vapers

    A new study from University College London (UCL) and the University of Innsbruck shows that e-cigarette users with limited smoking history have similar DNA changes to specific cheek cells as smokers, reports Medical Xpress.

    The study was published in Cancer Research. It analyzed epigenetic effects of tobacco and e-cigarettes on DNA methylation in more than 3,500 samples to determine the impact on cells directly exposed to tobacco (e.g., cells in the mouth) and cells that are not directly exposed to tobacco (e.g., blood cells or cervical cells).

    Data showed that epithelial cells in the mouth had substantial epigenomic changes in smokers. Similar epigenetic changes were seen in epithelial cells in the mouths of e-cigarette users who had smoked fewer than 100 tobacco cigarettes in their lifetime.

    “This is the first study to investigate the impact of smoking and vaping on different kinds of cells—rather than just blood—and we’ve also strived to consider the longer term health implications of using e-cigarettes,” said Chiara Herzog, first author of the study. 

    “We cannot say that e-cigarettes cause cancer based on our study, but we do observe e-cigarette users exhibit some similar epigenetic changes in buccal cells as smokers, and these changes are associated with future lung cancer development in smokers,” Herzog said. “Further studies will be required to investigate whether these features could be used to individually predict cancer in smokers and e-cigarette users.”

    “While the scientific consensus is that e-cigarettes are safer than smoking tobacco, we cannot assume they are completely safe to use, and it is important to explore their potential long-term risks and links to cancer,” said Herzog. “We hope this study may help form part of a wider discussion into e-cigarette usage—especially in people who have never previously smoked tobacco.”

    The study also showed that some smoking-related epigenetic changes remained more stable than others after quitting smoking, including smoking-related epigenetic changes in cervical samples.

    “The epigenome allows us, on one side, to look back,” said Martin Widschwendter, senior author of the study. “It tells us about how our body responded to a previous environmental exposure like smoking. Likewise, exploring the epigenome may also enable us to predict future health and disease. Changes that are observed in lung cancer tissue can also be measured in cheek cells from smokers who have not (yet) developed a cancer.

    “Importantly, our research points to the fact that e-cigarette users exhibit the same changes, and these devices might not be as harmless as originally thought. Long-term studies of e-cigarettes are needed. We are grateful for the support the European Commission has provided to obtain these data.”

    In response to the study, the U.K. Vaping Industry Association (UKVIA) released a statement.

    “While the study data—which one leading academic has described as ‘crude’—implies a link to changes in cheek cells, which could potentially cause cancer, the study authors said their findings did not prove that e-cigarettes caused cancer,” the statement read.

    “The study authors said their findings showed that vapes ‘might not be as harmless as originally thought,’ but it is important to make clear that nobody in the vape industry ever said that vaping was harmless. There are risks from vaping, but they are tiny compared to smoking,” the UKVIA said.

    “This latest study,” the UKVIA statement said, “is also questioned by leading experts such as Peter Shields, an emeritus professor of medical oncology at Ohio State University. He states that critical pieces of information are missing and calls the smoking and vaping data that they are working from as ‘crude.’ He points to the fact that there is no biochemical verification that the vapers are actually not also smokers. He concludes that ‘researchers are still a far distance from being able to show causality, and the data looks like vapers are actually more like never smokers—implying their risk of cancer is not increasing by vaping.”

  • Study Finds States Differ in Harm Reduction Efforts

    Study Finds States Differ in Harm Reduction Efforts

    A new R Street Institute report found that while some states support one type of harm reduction, those same states may actively oppose another type of harm reduction. 

    The report, “Progressive Except for Nicotine: A Discussion of States’ Inconsistent Adoption of Harm Reduction Public Policy, examined the harm reduction policy landscape across tobacco, opioids and cannabis in all 50 U.S. states.

    Researchers identified several important harm reduction-related policies that have varying levels of acceptance/implementation across different states or are currently in legislative flux: tobacco: state and municipal restrictions on electronic nicotine-delivery systems; opioids: states’ authorization of syringe services programs, decriminalization of drug checking equipment, and presence of state-imposed restrictions on methadone that go beyond federal regulations; and cannabis: the legal status of medical and recreational adult-use cannabis markets in each state.

    Researchers then used this information to rank states as “restrictive,” “moderate” or “permissive” on harm reduction with regard to each substance. These rankings were quantitatively compared for all states, and states deemed “restrictive” on at least one substance were qualitatively examined. 

    The report also showed that the five states most restrictive of reduced-risk nicotine products in tobacco harm reduction are California, Massachusetts, New Jersey, New York and Rhode Island, and these states are relatively “permissive” when it comes to opioid harm reduction and cannabis use.

    The researchers have suggested that lawmakers reflect on the inconsistencies between harm reduction policies across substances and put political motivations aside to support harm reduction across all substances.

  • Study: Vapes ‘Twice as Effective’ to Quit Smoking

    Study: Vapes ‘Twice as Effective’ to Quit Smoking

    The American Consumer Institute (ACI) unveiled a study that provides a pivotal analysis of the potential for tobacco harm reduction alternative products, such as vaping and modern oral, to significantly reduce smoking-related deaths across the United States.

    Key findings from the study entitled “Transition from Tobacco to Vaping: The Health Impacts by State” by ACI Senior Policy Analyst Justin Leventhal, include:

    • A potential reduction of nearly 300,000 smoking-related deaths annually if e-cigarettes replace traditional smoking nationwide.
    • An estimated four million lives could have been saved from 2010 to 2024, surpassing deaths from the Coronavirus by a factor of four.
    • State restrictions and regulatory barriers on vaping products have been identified as significant obstacles for smokers seeking to quit, thereby increasing the annual death toll from smoking-related diseases.
    • Removing regulatory barriers on vaping products would enable a smoother transition for smokers toward safer products or kicking the habit entirely, potentially saving hundreds of thousands of lives each year.

    “Evidence suggests that e-cigarettes are nearly twice as effective as traditional nicotine replacement therapies like gums and patches in aiding smoking cessation,” a press release states. “Despite this, recent years have seen an increase in regulations, taxes, and outright bans on vaping products, hindering the progress toward a smoke-free future.”

    ACI calls for policymakers to reconsider these restrictive measures and focus on harm-reduction strategies that offer a pragmatic approach to reducing smoking-related mortality rates. By embracing tobacco harm reduction products as viable alternatives to smoking, states can significantly lower healthcare costs and mortality rates associated with tobacco use.

  • Another Study Finds Vape More Effective Than NRTs

    Another Study Finds Vape More Effective Than NRTs

    Nicotine e-cigarettes are more effective quit-smoking products than conventional nicotine-replacement therapies (NRTs), reports University of Massachusetts Amherst, citing the latest Cochrane review.

    The review found high certainty evidence that e-cigarettes lead to better chances of quitting smoking than using patches, gums, lozenges or other traditional NRTs.

    “In England, quite different from the rest of the world, e-cigarettes have been embraced by public health agencies as a tool to help people reduce the harm from smoking,” said Jamie Hartmann-Boyce, assistant professor of health policy and promotion in the School of Public Health and Health Sciences at the University of Massachusetts Amherst.

    “Most of the adults in the U.S. who smoke want to quit, but many find it really difficult to do so,” said Hartmann-Boyce, who conducted research at the University of Oxford in England before joining the University of Massachusetts Amherst earlier this year and is the senior author of the review and a Cochrane editor. “We need a range of evidence-based options for people to use to quit smoking, as some people will try many different ways of quitting before finding one that works for them.”

    The review included 88 studies and more than 27,235 participants, with most of the studies taking place in the U.S., the U.K. or Italy.

    “We have very clear evidence that, though not risk-free, nicotine e-cigarettes are substantially less harmful than smoking,” Hartmann-Boyce said. “Some people who haven’t had success in the past with other quit aids have found e-cigarettes have helped them.”

    For every 100 people using nicotine e-cigarettes to quit smoking, eight to 10 are expected to successfully quit compared to six of 100 people using traditional NRTs and four of 100 trying to quit without support or with only behavioral support, according to the review.

    “Not everything is either entirely harmful or beneficial,” Hartmann-Boyce said. “Different things can have different impacts on different populations. Evidence shows that nicotine e-cigarettes can help people quit smoking and that people who don’t smoke shouldn’t use e-cigarettes.”

    Hartmann-Boyce compared tobacco smoking versus e-cigarette use to the treatment for substance use disorders involving opioids. “We’re not going to prescribe methadone to people who aren’t addicted to opioids,” she said. “But for people addicted to opioids, we recognize that methadone is a helpful thing.”

    In 2021, a study by Queen Mary University of London, published in Addiction, shows that e-cigarettes are more effective in achieving long-term smoking reduction and cessation than NRTs.

    The U.S. Food and Drug Administration has not approved any e-cigarettes as medications to help adults quit smoking. “While certain e-cigarettes may help adult smokers transition completely away from, or significantly reduce their use of, more harmful combusted cigarettes, the law’s public health standard balances that potential with the known and substantial risk with regard to youth appeal, uptake and use of these highly addictive products,” said Robert Califf, FDA commissioner.

  • Study Finds Cytisine More Effective than NRTs

    Study Finds Cytisine More Effective than NRTs

    Image: molekuul.be

    Cytisine, a low-cost, generic stop-smoking aid that has been used in eastern Europe since the 1960s, increases the chances of successful smoking cessation by more than two-fold compared with placebo and may be more effective than nicotine replacement therapy, according to a new study published in Addiction. The cessation tool reportedly has a benign safety profile, with no evidence of serious safety concerns. 

    Cytisine is a plant-based compound that eases smoking withdrawal symptoms. It was first synthesized in Bulgaria in 1964 as Tabex and later spread to other countries in eastern Europe and Asia, where it is still marketed. In 2017, the Polish pharmaceutical company Aflofarm began selling it as Desmoxan, a prescription-only medicine, and Canada approved it as an over-the-counter natural health product, Cravv.

    This study pooled the results of eight randomized controlled trials comparing cytisine with placebo, with nearly 6,000 patients. The combined results showed that cytisine increases the chances of successful smoking cessation by more than twofold compared with placebo.

    The study also looked at two randomized controlled trials comparing cytisine with nicotine replacement therapy, with modest results in favor of cytisine, and three trials comparing cytisine with varenicline, without a clear benefit for cytisine.

    “Our study adds to the evidence that cytisine is an effective and inexpensive stop-smoking aid,” said lead author Omar De Santi in a statement. “It could be very useful in reducing smoking in low- and middle-income countries where cost-effective smoking cessation drugs are urgently needed.”

    Cytisine is currently not licensed or marketed in most countries outside of central and eastern Europe, making it unavailable in most of the world. At the end of January, cytisine pills are due to become available in the U.K., according to National World.

  • Qnovia Cessation Therapy Validated in Human Study

    Qnovia Cessation Therapy Validated in Human Study

    Image: Qnovia

    Qnovia announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy that is currently being evaluated by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).

    “Today marks a pivotal milestone for Qnovia as we believe this data validates the clinical translation of our platform for the first time in patients,” said Qnovia CEO Brian Quigley.

    “One of the reasons that quitting smoking is so challenging is that cigarettes provide a significant nicotine spike directly into the bloodstream within seconds. The challenge with current nicotine replacement therapies is that they fail to deliver nicotine quickly enough and at concentrations high enough to effectively alleviate a smoker’s withdrawal symptoms. Unfortunately, this leads to smokers relapsing, resulting in a significant unmet need for novel smoking cessation therapies.

     

    We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most

    Brian Quigley, CEO, Qnovia

    “We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most,” said Quigley.

    “We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated. We look forward to submitting our IND and CTA for QN-01 and advancing our clinical development program into Phase 1/2 clinical trials next year.”

    The Phase 1 study was an open-label trial evaluating the delivery of QN-01 for three different nicotine dosing regimens to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who currently smoke combustible cigarettes. Each adult received three different doses of treatment delivered on subsequent days after a washout period.

    The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the Qnovia’s RespiRx device. The mean maximum plasma concentration (Cmax) was higher, and the time to achieve the maximum plasma concentration  (Tmax) was lower for QN-01 across all three dose regimens, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy (NRT). The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

    Highlights of Initial Phase 1 Pharmacokinetic and Safety Data

    “We are pleased to see our platform being utilized for the first time in human clinical trials. We believe these results validate that we have identified an optimal Cmax for QN-01 that is higher than the currently available inhaled NRTs but lower than combustible cigarettes, thus enabling QN-01 to have optimal therapeutic efficacy while mitigating abuse liability potential,” said Mario Danek, Founder and chief technology officer of Qnovia.

    “What makes our platform unique is that the RespiRx device utilizes a vibrating mesh nebulizer aerosol engine with zero heat to create an aerosol that can be inhaled by the smoker. Given our e-liquid drug product is not heated, there is no formation of thermal degradants or other toxicants during the aerosol generation process. As a result, our device platform is uniquely positioned to meet CDER’s safety standards. Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.”

  • Global Vaping Market to Reach $93.9 Billion by 2030

    Global Vaping Market to Reach $93.9 Billion by 2030

    Credit: Jet City Image

    The global vaping and e-cigarette market was valued at $24.19 billion in 2021. That number is projected to reach $93.94 billion by 2030, registering a CAGR of 16.27 percent from 2022 to 2030, according to Straits Research.

    In a recent report for market participants in the vaping industry, the demand for diversely flavored products represents a “lucrative opportunity.” Similarly, technological developments in the industry are anticipated to contribute to the sector’s growth.

    “The vaping industry has established numerous organizations to oppose anti-vaping legislation and to regulate the sector for monitoring and promoting the development of the e-cigarette and vaping markets, which are anticipated to boost the smokeless cigarettes market’s key trends and opportunities during the period 2022-2030,” a release states. “In recent years, regional government bans on the sale of vaping products and e-liquids in countries such as the United States and India have hindered the expansion of the smokeless cigarette sector.”

    The Asia-Pacific market size for e-cigarettes is predicted to expand at a CAGR of 16.2 percent between 2022 and 2030. The report states it is anticipated that the presence of established product manufacturers in China and the rising demographic advantage for retailers would contribute to expanding the vaping industry in the region.

    The European vaping industry is anticipated to expand significantly during the forecast period. “E-cigarettes and vaping products from companies such as BAT’s Vype and Imperial Brands Blu have been certified by European health regulators as a healthier alternative to tobacco smoking, which is expected to promote the growth of the smokeless cigarettes industry in Europe,” the report states.

  • Replica Vape Study Confirms Minimal Carcinogenic Effects

    Replica Vape Study Confirms Minimal Carcinogenic Effects

    Photos: CoEHAR

    The aerosol from e-cigarettes induced slight to no cytotoxic, mutagenic and genotoxic effects during tests conducted by the Replica research team of the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) that compared these effects to those induced by cigarette smoke.

    According to CoEHAR, science has been suffering from a “replicability crisis” in recent years. The use of different research methodologies usually leads to different data, resulting in flawed results that misinform policies and impact on health and social care practices, as well as smokers who are seeking a complete cessation.

    Replica researchers aim to fill this methodological gap by replicating  international in vitro studies on the toxicity of cigarette smoke and e-cigarette aerosol by an independent and multicentric approach, adding experiments or conditions where necessary, in order to verify the robustness and replicability of the data and results.

    The most recent study replicated by the team was published by Rudd and colleagues in 2020. The study aimed to establish the cytotoxicity, mutagenesis and genotoxicity of cigarette smoke or e-cigarette aerosol on cells .

    Replica researchers performed a standard toxicology battery of three assays used for product assessment and regulatory applications. Their results, published by Springer Nature’s Scientific Reports,  indicated that e-cigarette aerosol was low cytotoxic and it did not show any mutagenic or genotoxic activity unlike the cigarette smoke, which showed high cytotoxic, mutagenic and genotoxic activity. Moreover, the Replica study covered some methodological gaps and limitations in the original work, by adding some conditions with the aim of covering all the possible ways of inducing genotoxicity and mutagenesis on cells.

    Our findings not only confirmed the results obtained by our colleagues but also addressed some methodological gaps and limitations in the original work.

    First author Rosalia Emma

    “Our findings not only confirmed the results obtained by our colleagues but also addressed some methodological gaps and limitations in the original work,” said Rosalia Emma, first author of the Replica study, in a statement. “However, it’s important to highlight that, despite using different machinery and the variations in the exposure methodology, in the case of cytotoxicity (NRU assay), the toxicity of the e-cigarette is significantly lower than that of traditional cigarettes”.

    In the Replica study, the team performed the NRU assay to assess cytotoxicity, the bacterial reverse mutation (Ames) assay to evaluate mutagenicity and the in vitro micronucleus assay to measure genotoxicity. Despite some different methodologic aspects, the researchers obtained results similar to those obtained by Rudd and colleagues.

    “Although we have added experimental conditions neglected by the authors of the first paper, the results obtained previously are confirmed and even strengthened, confirming the electronic cigarette as a useful tool for reducing smoking damage in healthy smoking subjects” said Massimo Caruso, co-project leader of the Replica project and corresponding author.