treating tobacco useprimarycareinternalmedicine2018.com/uploads/1/2/2/... · practical strategies...
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Nancy Rigotti, MD
Professor of Medicine, Harvard Medical School Director, Tobacco Research and Treatment Center
Massachusetts General Hospital, Boston, MA [email protected]
Primary Care Internal Medicine 2019
Treating Tobacco Use: Optimizing for the Best Outcomes
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Disclosures - Nancy Rigotti, MD
Royalties - UpToDate, Inc.
Consultant - Achieve Life Sciences
Unpaid consultant, travel expenses - Pfizer, Inc.
Research grants – NIH
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OVERVIEW
Challenges in treating tobacco users
Which treatments work? Clinical Practice Guidelines Optimizing Pharmacotherapy
Practical strategies for office practice
Electronic cigarettes – risks and benefits
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WHY TREATING TOBACCO USE MATTERS
#1 preventable cause of death in the U.S. (and world)
34 million U.S. adults still smoke (14% of adults in 2017)
MMWR 2018;67(44):1225-32
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WHY TREATING TOBACCO USE MATTERS
#1 preventable cause of death in the U.S. (and world)
34 million U.S. adults still smoke (14% of adults in 2017)
We’ve left vulnerable populations behind
MMWR 2018;67(44):1225-32
• Less educated, lower incomes • Other substance use disorders • Psychiatric illness • Homeless or incarcerated • LGBT
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WHY TREATING TOBACCO USE MATTERS
#1 preventable cause of death in the U.S. (and world)
34 million U.S. adults still smoke (14% of adults in 2017)
Stopping smoking improves length and quality of life Even after chronic disease starts1 Even after age 652 Despite post-cessation weight gain3 It’s never too early or too late to quit
1 Critchley. JAMA 2003;290:86; 2 Gellert. Arch Intern Med 2012; 172:837; 3 Nu. NEJM 2018; 379:623.
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WHY TREATING TOBACCO USE MATTERS
#1 preventable cause of death in the U.S. (and world)
34 million U.S. adults still smoke (14% of adults in 2017)
Stopping smoking improves length and quality of life
Delivering tobacco treatment in health care works
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A CASE 55 yo man with HTN, BMI 30, depression (stable SSRI)
Smokes 15 cigarettes/day, started at age 18
“I know I should quit, but I’ve tried everything and nothing works.”
Used nicotine patch for 3 days → “I still wanted a cigarette”
Used bupropion for 1 month → “I didn’t want to smoke as much… I cut down but couldn’t quit”
Chantix? → “I heard that drug is dangerous!”
“What do you think about the electronic cigarette?”
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QUESTIONS for you
• What’s an electronic cigarette? – Should you recommend it?
• Has he really tried everything?
• Is varenicline (Chantix) really risky?
• What’s your next step?
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QUITTING IN PERSPECTIVE National Health Interview Survey - 2015
55% of smokers try to quit each year
Few succeed long-term (quit for 1 year)
~ 7% succeed without help
25-30% succeed long-term with best treatment
Only 31% of those trying to quit seek help
68% of current smokers want to quit
MMWR January 2017;65:1457
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OVERVIEW
Challenges in treating tobacco users
Which treatments work? Clinical Practice Guidelines Optimizing Pharmacotherapy
Practical strategies for implementing in office practice
Electronic cigarettes
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Smoking Cessation Treatment Guideline
2008 US Public Health Service, Endorsed by 2015 US Preventive Services Task Force
• Effective treatments exist
• More intensive treatment has better outcomes but even brief intervention works
• Pharmacotherapy – targets nicotine addiction • Behavioral support – targets behavioral components – delivery: in-person, by phone [SMS, web, apps]
• Combination is better than either one alone
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Pharmacotherapy
1st Line Medications - 2008 US Public Health Service Guideline
• Nicotine replacement Skin patch (OTC)
Gum (OTC)
Lozenge (OTC) Oral inhaler (Rx)
Nasal spray (Rx)
• Bupropion SR (Zyban, Wellbutrin SR)
• Varenicline (Chantix)
All are FDA approved for cessation
All ~ double quit rate vs. placebo
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Nicotine Replacement Products
Goal = ↓ nicotine withdrawal
All products ~ equally effective
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Varenicline • Partial agonist at α4β2 nicotinic receptor
Receptor subtype that mediates nicotine dependence
• Dual mechanism of action
• Partial agonist Stimulates receptor to treat craving, withdrawal
• Antagonist Prevents nicotine from binding to the receptor → Blocks reward, reinforcement of smoking
NH
NN
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Varenicline: Safety Concerns FDA Public Health Advisory - July 2009
• “[Varenicline] or [bupropion] has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.”
• “FDA is requiring the manufacturers of both products to add a new Boxed Warning”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm169988.htm
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EAGLES Trial (Anthenelli, Lancet 2016)
Continuous abstinence rate
• Double-blind placebo controlled RCT
• Nicotine patch vs bupropion vs varenicline vs placebo
• N=8000 smokers 4000 with + 4000 without diagnosis of mild to moderate psychiatric illness L
• Efficacy results provide a rationale for
choosing among medications
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EAGLES Trial: Safety Outcome Composite neuropsychiatric event endpoint
Non-psychiatric cohort
Psychiatric cohort
Anthenelli. Lancet 2016
• No difference among drugs in rates of psychiatric adverse events in either stratum
FDA removed Black Box warning (Dec. 2016)
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Optimizing Pharmacotherapy
• Combine drugs • Short- and long-acting NRT1
1 USPHS 2008. 2 Carpenter MJ et al. Drugs 2013. 3 Lindson-Hawley N et al. JAMA 2013.
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0 2 4 6 8
10 12 14 16 18
0 10 20 30 40 50 60 70 80 90 100 110 120 Plas
ma
nico
tine
leve
l (ng
/mL)
Time post administration (min)
Cigarette (1-2 mg)
Nasal spray (1 mg)
Gum (4 mg)
Patch (21 mg)
Plasma Nicotine Levels Cigarettes vs. Nicotine Replacement Products
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Nicotine Replacement Options Long-acting, slow onset nicotine delivery → skin patch
Short-acting, faster onset → gum, lozenge, inhaler, spray
+ Constant nicotine level to avoid withdrawal + Simplest to use - User has no control of dose
+ User controls dose - Nicotine blood levels fluctuate more - Many smokers do not use enough
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Optimizing Pharmacotherapy
• Combine drugs • Short- and long-acting NRT1
• Drugs from different classes
1 USPHS 2008. 2 Carpenter MJ et al. Drugs 2013. 3 Lindson-Hawley N et al. JAMA 2013.
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55 49
41
33
Week 12 (End of Treatment)
Week 24 Varenicline + NRT Varenicline + Placebo
OR: 1.85 CI: 1.19-
2.89 P=.007
OR: 1.98 CI: 1.25-
3.14 P=.004
53
37 31
43
28 25
0
10
20
30
40
50
60
Week 12 (End of
Treatment)
Week 26 Week 52 Prol
onge
d Sm
okin
g Ab
stin
ence
(%)
Varenicline + Bupropion Varenicline + Placebo
OR: 1.49 CI: 1.05-
2.12 P=.03 OR: 1.52
CI: 1.04-2.22
P=.03
OR: 1.39 CI: 0.93-
2.07 P=.11
Ebbert JO. JAMA. 2014;311(2):193-194. Koegelenberg C. JAMA 2014; 312:155.
Adding Bupropion or NRT to Varenicline: 2 RCTs Add bupropion Add nicotine patch
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Selecting a Smoking Cessation Medication An Evidence-based Protocol
1st line
Varenicline OR combination NRT
2nd line
Bupropion OR single NRT product
If single agent is insufficient
Combine categories of FDA-approved drugs: Varenicline + NRT Varenicline + bupropion Bupropion + NRT
JACC December 25, 2018
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OVERVIEW
Challenges in treating tobacco users
Which treatments work? Clinical Practice Guidelines Optimizing Pharmacotherapy
Practical strategies for office practice
Electronic cigarettes – risks and benefts
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TREATING TOBACCO IN HEALTH CARE 2008 U.S. Public Health Service Guidelines – 5A’s
Routine advice to quit is effective
Brief counseling is more effective than advice only Evidence-based 5 step (5A) Guideline
ASK all patients about smoking ADVISE all smokers to quit ASSESS smoker’s readiness to quit ASSIST smokers to quit ARRANGE follow-up care
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Reconsidering ASSESS:
Moving to an “Opt Out” model of treatment
If tobacco use is a chronic disease Don’t ask a if a smoker is ready to quit Just offer treatment:
“Quitting smoking can be hard, but there is good treatment and I can help you. Shall we give it a try?”
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Treating Tobacco in the Office: A Practical Strategy 3 Step Model – Ask / Advise / Act
• ASK Do you ever smoke tobacco?
Are you exposed to smoke at home or at work?
• ADVISE Stopping smoking is key to stay (or become) healthy.
• ACT Offer treatment to all smokers
Prescribe pharmacotherapy
Connect to internal or community resources for behavioral support
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ACT Free programs that are easy for patients to access
Telephone Quitline 1-800-QUIT NOW • Multi-session counseling by appointment: Convenient, private, free • IL Quitline offers free sample of nicotine patch, gum, lozenge, website • Make an active referral from your office
Smokefree.gov website • Sign up for
• SmokefreeTXT • Mobile app (quitSTART) • Web-based information
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OVERVIEW
Challenges in treating tobacco users
Which treatments work? Clinical Practice Guidelines Optimizing Pharmacotherapy
Practical strategies for office practice
Electronic cigarettes – risks and benefits
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Electronic Cigarettes A nicotine delivery device that looks like a cigarette
Nicotine + propylene glycol
or glycerin + flavoring
No tobacco burned→ Safer than cigarettes?
Not FDA regulated→ Many knowledge gaps
The devices are changing rapidly
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Electronic Cigarettes
Net Public Health Impact Depends on 3 factors
Potential benefit Help more smokers to quit smoking (especially those unable to
quit with FDA-approved medications)
Potential risks Attract nonsmokers to vape→ develop nicotine dependence →
transition to cigarette smoking
Possible health risks of vaping Absolute (vs. nonsmoking) - youth Relative to combustible tobacco – adult smokers
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E-Cigarettes - Summary of the Evidence 2018 National Academy of Science, Engineering and Medicine Report
Exposure: • E-cigarettes contain fewer (and lower levels)
of toxic substances than conventional cigarettes
Health Effects:
• While not without health risks, they are likely to be far less harmful than smoking combustible tobacco cigarettes
• Long-term health effects of e-cigarettes are not yet clear
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E-Cigarettes – Public Health Effects 2018 National Academy of Science, Engineering and Medicine Report
• Using e-cigarettes may help adults quit smoking, but more research is needed
• Among youth, e-cigarette use increases the risk of initiating smoking
• Modelling results indicate that e-cigarettes will likely result in a net public health benefit
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Participants 886 adult smokers (15 cig/d) attending British NHS Stop Smoking clinics No preference for NRT vs. e-cigarette to quit
Interventions Choice of type of NRT (combination recommended) – 3 mo. OR E-cigarette starter pack (refillable device + 1 bottle e-liquid) (All got 4 weekly counseling visits)
Among those who were quit at 1 year: 80% in e-cig group were still using e-cigs 9% in NRT group were still using NRT
Hajek P et al. N Engl J Med. Feb. 14, 2019.
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Electronic Cigarettes What should you say to a smoker?
• Many unanswered questions about safety and efficacy
• They are likely less harmful than smoking combustible cigarettes
• Recommend FDA-approved safe, effective treatments first
• If these treatments are not effective or desired, then what?
• If using e-cigarettes, switch completely and stop smoking
• Urge patients using e-cigarettes to plan to quit e-cigs too because health effects of long-term use are not known.
Consistent with American College of Cardiology and American Cancer Society guidelines
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JUUL Phenomenon
• Sleek high-tech design
• Better nicotine delivery
• Social media marketing
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Monitoring the Future Study NEJM Dec. 2018 Annual cross-sectional school survey of US adolescents in grades 8-12 CAVEAT: Prevalence of smoking did not change and is at a historic low
Used in past 30 days
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Sept. 5, 2019
Aug. 21, 2019
Aug. 16, 2019
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CDC Health Advisory 8/30/19
Most in adolescents and young adults Symptoms Respiratory: cough, dyspnea, chest pain GI: nausea, vomiting, diarrhea Non-specific: fever, fatigue, weight loss
Onset: acute (several days) to subacute (weeks) Exam: fever, tachycardia Lab: ↑WBC; No infectious etiology identified after work-up
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CXR: bilateral infiltrates
Clinical course Many required
supplemental O2
Some needed mechanical ventilation
Antimicrobials do not appear to be helpful
Possible response to corticosteroids
NYTimes 8/30/19 CDC Advisory – 8/30/19
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Exposures All used e-cigarette products
(different devices) a few days to weeks before symptoms started
Most reported using e-cigarettes containing cannabinoids (THC, CBD)
Some used e-liquids not purchased from stores
No single substance or product is associated with the illness
Products found to contain vitamin E acetate
– NY Dept of Health
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NYT 10/3/19
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September 24, 2019 805 cases
in 46 states + USVI
12 deaths
October 11, 2019 1299 cases
49 states + DC + USVI
26 deaths
CDC Updates
Demographics 70% male 80% <35 yo (median = 24 yo)
Exposures 76% reported vaping THC vaping 58% reported vaping nicotine 32% vaped only THC 13% vaped only nicotine
MMWR 10/11/19
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Why is this appearing now? New contaminant in the supply chain of e-cigarettes? Clustering of cases E-cigs have been sold for years, including to youths, without
these cases appearing Strong association with THC, home-made or street-bought
e-liquids that may have new contaminants
My hypothesis: Most likely due to illicit products, not to commercial e-cigarette products…but we don’t know for sure
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Why is this appearing now? New recognition of a complication of vaping? Was this a rare event that was not recognized? Could cases appear now because newer e-cigs are more
addictive and increased daily vaping prevalence by youths?
A combination of factors? Does vaping impair lung immune mechanisms, making lungs
more susceptible to a 2nd insult (infection), increasing risk of ARDS?
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CDC Recommendations for the Public E-cigarettes should not be used by nonsmokers of any age. What about smokers or current e-cigarette users?
“While investigation is ongoing, if you are concerned about these specific health risks, consider refraining from using e-cigarettes.”
Current smokers: use FDA approved cessation aids. Current e-cigarette users:
“If you are an adult who used e-cigarettes containing nicotine to quit cigarette smoking, do not return to smoking cigarettes.”
Don’t use street-acquired products, especially THC Don’t add substances to cartridges or re-use cartridges Monitor yourself for pulmonary symptoms
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MI, NY, RI, WA All flavored e-cigarettes except tobacco and mint/menthol
MA All e-cigarettes (including tobacco flavor) – for 4 months
SF Ban sales and distribution of all e-cigarettes
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Cautions Effects of vaping bans are unclear and controversial Will they ↓ or ↑ risk of acute lung injury? Will they ↓ youth vaping rates? Will they ↓ adult cessation rates?
Let’s not “throw the baby out with the bath water”
1 in 2 smokers still die of tobacco related disease Many smokers repeatedly fail to quit with existing treatments E-cigarettes can help smokers to quit and are less harmful
than continuing to smoke
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NEXT BEST STEPS Treating smoking = chronic disease management
Use combinations of treatments Drugs + counseling Combine drugs
Use the systems being built to help you Quitline (1-800-QUIT NOW) www.Smokefree.gov
Keep an eye on the CDC and FDA websites as the investigation of acute vaping illness proceeds