Showing posts with label e-cigarettes. Show all posts
Showing posts with label e-cigarettes. Show all posts

Saturday, June 22, 2019

HR/June 19/7: Safer nicotine products




·           E-cigarettes are estimated to be 95% safer than smoking cigarettes
·           Snus is not inhaled, so there is no risk of respiratory disease which accounts for nearly half of all smoking-related deaths; and no risk to bystanders. There is no significant association with premature deaths, diabetes, pancreatic and oral cancers, heart disease or strokes
·           It is estimated that by 2021, over 55 million people will be using e-cigarettes or heat-not-burn tobacco products and that the global market will be worth USD $35 billion
·           Use of heat-not-burn products in Japan has seen cigarette sales fall by 27% in two years, an unprecedented national decrease in smoking
·           In Sweden snus has been instrumental in reducing smoking related mortality to the lowest in the EU
·           If the EU ban on snus is lifted, then around 320,000 premature deaths a year could be prevented in the EU
·           As Norwegian smokers switch to snus, the smoking rate among young Norwegian women has dropped to a world record of 1%
·           Over 50% of the UK’s 3 million e-cigarette users are ex-smokers
·           39 countries have inappropriately banned SNP including countries whose smoking prevalence is predicted to rise
·           62 countries regulate e-cigarettes under tobacco legislation.

(Source: No Fire, No Smoke Global State of Tobacco Harm Reduction, 2018 (2018). London: Knowledge-Action-Change)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Friday, February 1, 2019

E-cigarettes to assist with smoking cessation




Excerpts from an editorial published January 30, 2019 (Belinda Borrelli and George T. O’Connor; DOI: 10.1056/NEJMe1816406)

·         The prevalence of tobacco smoking in the United States has declined to 14.0% but still exceeds 25% among high-risk subgroups (1,2).

·         Electronic cigarettes (e-cigarettes) are not approved by FDA for smoking cessation, but Americans trying to quit smoking use these products more frequently than FDA-approved cessation aids (3).

·         Hajek et al (4) now report in the NEJM the results of a multi-center, pragmatic, randomized trial of e-cigarettes, as compared with nicotine-replacement therapy, as a smoking-cessation treatment within the U.K. National Health Service smoking-cessation program. In addition to behavioral support, participants received either a second-generation refillable e-cigarette or a 3-month supply of whichever nicotine-replacement products they preferred. After 1 year, the rate of abstinence from smoking tobacco, validated by exhaled carbon monoxide concentration, was higher in the e-cigarette group (18.0%) than in the nicotine-replacement group (9.9%).

o   Trial limitations: possibility that smoking-cessation counsellors who were aware of the treatment assignments may have influenced patient expectations.

·         These findings must be considered in the context of FDA-approved medications for smoking cessation that have acceptable safety profiles.  Treatment with nicotine-replacement therapy and bupropion achieves abstinence rates of approximately 25 to 26% at 6 months and 20% at 1 year, (5) with slightly higher abstinence rates for combination therapy than for monotherapy (6). Varenicline has been shown to outperform bupropion, all forms of nicotine-replacement therapy, and placebo, with a 26% abstinence rate through 24 weeks of follow-up among participants without psychiatric diagnoses (7). The 1-year abstinence rate of 18% reported by Hajek et al. for the e-cigarette group is similar to these outcomes.

·         This evidence of effectiveness must be balanced against the short-term and long-term safety of e-cigarettes. The data from Hajek et al. are reassuring: the e-cigarette group had greater declines in the incidence of cough and phlegm than the nicotine-replacement group, no excess wheezing or dyspnea, and only a small incidence of oropharyngeal irritation. More frequent respiratory serious adverse events in the e-cigarette group than in the nicotine-replacement group (5 vs. 1) did not appear to be related to e-cigarette use.

·         Previous reports have suggested short-term clinical benefit among patients with these conditions who switch from tobacco smoking to e-cigarette use (8). 

·         The use of e-cigarettes by pregnant women, who were excluded from the trial by Hajek et al., raises special safety concerns.

·         Nicotine-patch use during pregnancy is associated with a higher rate of smoking cessation and better child-development outcomes than placebo, (9) there are no such reassuring data for e-cigarettes.

·         A key finding of Hajek et al. is that among participants with sustained abstinence at 1 year, 63 of 79 (80%) in the e-cigarette group were still using e-cigarettes, whereas only 4 of 44 (9%) in the nicotine-replacement group were still using nicotine replacement.

·         E-cigarette vapor contains many toxins and exerts potentially adverse biologic effects on human cells in vitro or in animal models, although toxin levels and biologic effects are generally lower than those of tobacco smoke (10). 

·         A study involving humans showed an altered bronchial epithelial proteome in association with e-cigarette use, including some protein alterations also seen among tobacco smokers (11). In a mouse model, inhalational exposure to nebulized e-cigarette liquid containing nicotine resulted in distal airspace enlargement that was consistent with pulmonary emphysema (12). These findings argue against complacency in accepting the transition from tobacco smoking to indefinite e-cigarette use as a completely successful smoking-cessation outcome.

·         An additional societal consideration is the effect of adult e-cigarette use on children and young adults.

·         There is substantial evidence that e-cigarette use by youth increases the risk of smoking combustible tobacco cigarettes, (10) and the U.S. Surgeon General has recently declared e-cigarette use among youth “an epidemic.” (13)

·         A consensus has emerged that e-cigarettes are safer than traditional combustible cigarettes, (10) but it remains controversial whether e-cigarettes should be recommended as a first-line treatment to assist smoking cessation, alongside FDA-approved treatments.

·         The appropriate duration of e-cigarette “treatment” for smokers trying to quit is also uncertain.

·         e-cigarettes be used only when FDA-approved treatments (combined with behavioral counseling) fail, that patients be advised to use the lowest dose needed to manage their cravings, and that there be a clear timeline and “off ramp” for use.

·         Use of e-cigarettes should be monitored by health care providers

·         The efficacy and safety of e-cigarettes need to be evaluated in high-risk subgroups

·         Further research on the health consequences of long-term e-cigarette use is needed.

(Source: This editorial was published on January 30, 2019, at NEJM.org)

References

1.     Wang TW, Asman K, Gentzke AS, et al. Tobacco product use among adults — United States, 2017. MMWR Morb Mortal Wkly Rep. 2018;67:1225-1232.
2.     Borrelli B, Busch A, Dunsiger S. Cigarette smoking among adults with mobility impairments: a US population-based survey. Am J Public Health 2014;104:1943-9.
3.     Benmarhnia T, Pierce JP, Leas E, et al. Can e-cigarettes and pharmaceutical aids increase smoking cessation and reduce cigarette consumption? Findings from a nationally representative cohort of American smokers. Am J Epidemiol 2018;187:2397-2404.
4.     Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. DOI: 10.1056/NEJMoa1808779.
5.     Rosen LJ, Galili T, Kott J, et al. Diminishing benefit of smoking cessation medications during the first year: a meta-analysis of randomized controlled trials. Addiction 2018;113:805-16.
6.     Windle SB, Filion KB, Mancini JG, et al. Combination therapies for smoking cessation: a hierarchical Bayesian meta-analysis. Am J Prev Med 2016;51:1060-71.
7.     Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016;387:2507-20.
8.     Polosa R, Morjaria JB, Caponnetto P, et al. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respir Res 2016;17:166.
9.     Cooper S, Taggar J, Lewis S, et al. Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial. Lancet Respir Med 2014;2:728-37.
10.  Stratton K, Kwan LY, Eaton DL, eds. Public health consequences of e-cigarettes. Washington, DC: National Academies Press, January 2018.
11.  Ghosh A, Coakley RC, Mascenik T, et al. Chronic e-cigarette exposure alters the human bronchial epithelial proteome. Am J Respir Crit Care Med 2018;198:67-76.
12.  Garcia-Arcos I, Geraghty P, Baumlin N, et al. Chronic electronic cigarette exposure in mice induces features of COPD in a nicotine-dependent manner. Thorax 2016;71:1119-29.
13.  Stein R. Surgeon General warns youth vaping is now an “epidemic.” NPR. December 18, 2018(https://www.npr.org/sections/health-shots/2018/12/18/677755266/surgeon-general-warns-youth-vaping-is-now-an-epidemic).

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

NEJM study provides evidence of greater efficacy of e-cigarettes vis-à-vis conventional NRTs



One of the most pressing unanswered questions in public health has been "Do e-cigarettes actually help smokers quit?"

The first, large rigorous assessment now answers this question.

A study, published Wednesday in the New England Journal of Medicine, found that e-cigarettes were nearly twice as effective as conventional nicotine replacement products, like patches and gum, for quitting smoking, reports New York Times. The success rate was 18% among the e-cigarette group, compared to 9.9% among those using traditional nicotine replacement therapy.

The study was conducted in Britain and funded by the National Institute for Health Research and Cancer Research UK. For a year, it followed 886 smokers assigned randomly to use either e-cigarettes or traditional nicotine replacement therapies. Both groups also participated in at least four weekly counseling sessions, an element regarded as critical for success.

E-cigarettes provide the nicotine smokers crave without the toxic tar and carcinogens that come from inhaling burning tobacco. But, it is still not approved as smoking cessation tools. 

Doctors up till now were reluctant to recommend their use because of the lack of clear evidence from randomized controlled trials. This is now likely to change.

The New England Journal devoted much of its current issue to e-cigarettes, publishing two editorials and a letter, and the collection embodies the tangled public health debate over the devices.  One editorial — written by Belinda Borrelli, a behavioral health expert and Dr. George T. O’Connor, a pulmonologist — pumped the brakes on inclinations to embrace e-cigarettes.

The editorial recommended that e-cigarettes be taken up when other cessation approaches, including behavioral counselling have failed; that patients use the lowest dose of nicotine possible and that health care providers establish a clear timeline for
e-cigarette use.

The clinical trial took place from May 2015 to February 2018. Because the smokers were recruited at the clinics, they were already predisposed to quitting, a feather on the scale that could slightly have affected results. The participants were typically middle-aged, smoked between half a pack and a pack a day and had already tried quitting.

Because self-reports of smoking abstinence are not considered reliable, researchers measured the quantities of carbon monoxide in the participants’ breath, a more precise validation. Higher quit rates and compliance among e-cigarette users could be additionally explained because those subjects expressed more satisfaction with the devices than did the other group with their products.
Some researchers hypothesize that because a body takes in only the amount of nicotine it needs to maintain a certain level, high-nicotine products could have the advantage of delivering that power punch with fewer puffs, decreasing the amount of harmful aerosol a vaper would inhale.

(Source: New York Times)




NEJM Abstract

A randomized trial of e-cigarettes vs nicotine-replacement therapy

Hajek P, Phillips-Waller A, Przulj D, et al. N Engl J Med. 2019 Jan 3. Epub ahead of print

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, ISRCTN6047760) 


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA