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Assisting a Quitter – The Medications Used in Smoking Cessation

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1 Assisting a Quitter – The Medications Used in Smoking Cessation
Jim Thigpen, PharmD, BCPS ETSU Bill Gatton College of Pharmacy Assisting a Quitter – The Medications Used in Smoking Cessation

2 Learning Outcomes Describe the pharmacotherapy used in smoking cessation Determine the appropriate therapy to recommend for a specific patient Describe patient expectations when using smoking cessation products

3 A Pediatric Disease1…. Extent of harms to children caused by tobacco use and secondhand smoke exposure Relationship of pediatric tobacco use and exposure to adult tobacco use Existence of effective interventions to reduce the use Documented underuse of those interventions Policy Statement – Tobacco Use: A Pediatric Disease, Pediatrics 124(5), Nov 2009

4 The role of Pediatricians….
Provide counseling to expectant parents to quit using tobacco products and avoid SHS exposure during and after pregnancy Assist new parents in their efforts to continue their tobacco use-abstinence or –cessation efforts after delivery Counsel parents to reduce or eliminate children’s exposure to SHS Counsel preadolescents and adolescents to prevent initiation Counsel adolescents and parents to quit using tobacco

5 The role of Pediatricians….
85% of parents who smoke consider it acceptable for their child’s pediatrician to prescribe a smoking-cessation medication for them1 In 2005, the American Medical Association adopted a policy statement supporting the practice of pediatricians addressing parental smoking2 American Medical Association H Physician Responsibilities for Tobacco Cessation. Adopted June 2005, Chicago IL

6 What should you expect? 18.4% will quit if you do nothing
23.1% will quit if you intervene Families with children ages 4-17 more likely Interventions whose primary goal was cessation Interventions that offered medications Interventions with high follow-up rates Rosen LJ, Noach MB et al. Parental smoking cessation to protect young children: a systematic review and meta-analysis. Pediatrics 129(1) Jan 2012

7 Strategies and Evidence
Cessation rates are ↑ when smokers attended two or more sessions of ≥ 20 minutes Motivating the unwilling patient The five Rs Relevant reasons to quit Risks associated with continued smoking Rewards for quitting Roadblocks to successful quitting Repetition of the counseling of subsequent visits

8 Counseling There is a consistent relationship between more intensive counseling and abstinence from smoking No counseling (11%) 1 – 3 minutes (14%) 4 – 30 minutes (19%) 31 – 90 minutes (27%) Counseling should be sympathetic and supportive, not confrontational 1-800-QUIT-NOW (

9 Nonpharmacologic Cold turkey Unassisted tapering Assisted tapering
5% success Unassisted tapering Assisted tapering QuitKey® Computer-assisted behavior modification 19-24% abstinence rate 1 year after quitting Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS

10 Some basic pharmacology3….
Nicotine is carried by tar particles to the lung alveoli and then to the brain Nicotine binds with to nicotinic cholinergic receptors in the brain, leading to neurotransmitter release Tolerance develops with chronic smoking, resulting in the proliferation of nicotine receptors and permitting higher levels of self-administration of nicotine A lack of binding to these receptors due to decreased smoking results in withdrawal symptoms About half of phenotypic variance in tobacco dependence is attributable to genetic influence Fiore MC, Baker TB. Treating smokers in the health care setting NEJM 2011;365:

11 Pharmacologic Methods
Three general classes of FDA-approved drugs for smoking cessation: Nicotine Replacement Therapy (NRT) Gum, patch, lozenge, nasal spray, inhaler Psychotropics Sustained-release bupropion (Zyban®) Partial nicotinic receptor agonist Varenicline (Chantix®)

12 Pharmacotherapy - Pregnancy
The clinical practice guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns NRT products are category D Bupropion is category C Varenicline is category C

13 Pharmacotherapy Not recommended for…..
Smokeless tobacco users No FDA indication Individuals smoking < 10 cigarettes per day Adolescents OTC sales are restricted to ≥ 18 NRT use in minors requires a prescription

14 NRT: Rationale for Use Reduces physical withdrawal from nicotine
Eliminates the immediate, reinforcing effects of nicotine that is rapidly absorbed via tobacco smoke Allows patient to focus on behavioral and psychological aspects of tobacco cessation Use of NRT approximately doubles long-term quit rates relative to placebo Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS

15 NRT Products Polacrilex gum Lozenge Transdermal Patch Nasal Spray
Nicorette®, generics Lozenge Nicorette® Lozenge Nicorette ® Mini Lozenge Generics Transdermal Patch Nicoderm CQ ® Nasal Spray Nicotrol ® NS Inhaler Nicotrol ® Patients should stop using all forms of tobacco upon initiation of NRT

16 NRT Precautions Patients with underlying cardiovascular disease
Recent myocardial infarction Serious arrhythmias Serious or worsening angina NRT products may be appropriate for these patients if they are under medical supervision

17 Nicotine Gum Nicorette® (GSK); generics
Resin complex Nicotine Polacrilin Sugar-free chewing gum base Contains buffering agents to enhance buccal absorption of nicotine Available in 2mg, 4mg; original, cinnamon, fruit, mint (various), and orange flavors

18 Nicotine Gum Dosage based on current smoking patterns:
If patient smokes Recommended strength ≥ 25 cigarettes (1 pack)/day 4 mg < 25 cigarettes/day 2 mg Recommended Usage Schedule for Nicotine Gum Weeks 1 - 6 Weeks 7-9 Weeks 1 piece q 1 – 2 h 1 piece q 2 – 4 h 1 piece q 4 – 8 h Do not use more than 24 pieces per day Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS

19 Nicotine Gum – Directions
Chew each piece slowly several times Stop chewing at first sign of peppery taste “park” gum between cheek and gum Resume chewing when taste or tingle fades Return to “park” when taste or tingle resumes Repeat chew/park until most of the nicotine is gone (≈ 30 minutes) Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS

20 Nicotine Gum Use at least nine pieces per day
Do not eat or drink anything for 15 minutes before or while using nicotine gum Nicotine polacrilex is buffered to pH 8.5 Acidic beverages may reduce the pH of the saliva, reducing the buccal absorption of nicotine Coffee, wine, juices, soft drinks Chewing gum too rapidly can cause excessive nicotine release Lightheadedness, N/V, irritation, hiccups, reflux Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS

21 Nicotine Gum Advantages Disadvantages Satisfy oral cravings
Might delay weight gain (4 mg) Therapy can be titrated to manage withdrawal symptoms Flavors Disadvantages Need for frequent dosing Dental work Must use proper technique Gum might not be socially acceptable

22 Nicotine Lozenge Dosage is based on “time to first cigarette” as an indicator of nicotine dependence Use the 2 mg strength if you smoke the first cigarette more than 30 minutes after waking Use the 4 mg strength if you smoke the first cigarette less than 30 minutes after waking Use is essentially identical to gum Dosing intervals, titration, use, etc

23 Transdermal nicotine patch Nicoderm® CQ, generics
Nicotine is well absorbed across the skin Delivery to systemic circulation avoids hepatic first pass effect Plasma nicotine levels are lower and fluctuate less than with smoking Treatment Estimated abstinence rate Placebo 13.8% Nicotine patch (6-14 weeks) 23.4% Nicotine patch (> 14 weeks) 23.7%

24 Transdermal nicotine patch
Product Light Smoker Heavy Smoker Nicoderm® CQ ≤ 10 cigarettes/day Step 2 (14 mg X 6 weeks) Step 3 (7 mg X 2 weeks) 10 cigarettes/day Step 1 (21 mg X 6 weeks) Step 2 (14 mg X 2 weeks) Generic Step 1 (21 mg X 4 weeks)

25 Transdermal nicotine patch
Choose an area of skin on the upper body or upper outer part of the arm Make sure the skin is clean, dry, hairless, and not irritated Apply patch to different area each day Do not use same area again for at least 1 week

26 Transdermal nicotine patch
Side effects to expect in first hour: Mild itching Burning Tingling Additional possible side effects: Vivid dreams or sleep disturbances Headache Up to 50% will have local skin reactions

27 Nicotine nasal spray Nicotrol® NS (Pfizer)
Aqueous solution of nicotine (10 ml) Each metered dose delivers 50 mcl spray 0.5 mg nicotine ≈ 100 doses/bottle Rapid absorption across nasal mucosa More rapid onset compared to gum, patch, or inhaler 26.7% 6-month abstinence rate

28 Nicotine nasal spray One dose = 1 mg nicotine
(2 sprays, one 0.5 mg spray in each nostril) Start with 1-2 doses per hour Increase prn to maximum dosage of 5 doses per hour or 40 mg (80 sprays; ½ bottle) daily For best results, patients should use at least 8 doses daily for the first 6-8 weeks Gradual tapering over an additional 4-6 weeks

29 Nicotine inhaler Start with at least 6 cartridges/day during the first 3-6 weeks of treatment Increase to a maximum of 16 cartridges per day In general, use 1 cartridge every 1-2 hours Recommended duration of therapy is 3 months Gradually reduce daily dosage over the following 6-12 weeks

30 Nicotine inhaler During inhalation, nicotine is vaporized and absorbed across oropharyngeal mucosa Inhale into back of throat or puff in short breaths Nicotine in cartridges is depleted after about 20 minutes of active puffing Cartridge does not have to be used all at once Open cartridge retains potency for 24 hours Mouthpiece is reusable; clean regularly

31 Nicotine inhaler Side effects associated with the nicotine inhaler include: Mild irritation of mouth or throat Cough Headache Rhinitis Dyspepsia Severity generally rated as mild, and frequency of symptoms declined with use

32 Bupropion SR Zyban®, generics
Non-nicotine Sustained release antidepressant Oral only Estimated abstinence rate is 24.2%

33 Bupropion Atypical antidepressant thought to affect levels of dopamine and norepinephrine Clinical effects ↓ craving for cigarettes ↓ symptoms of nicotine withdrawal Fiore MC, Jaen CR, Baker TB, et al. (2008) Treating tobacco use and dependence, 2008 Update. Clinical Practice Guideline. Rockville, MD: US DHHS

34 Bupropion Contraindications/Precautions History of epilepsy
Other sources of bupropion (Wellbutrin®) MAO inhibitors in preceding 14 days Prior diagnosis of anorexia, bulemia, other psychiatric disorders (suicide risk) Abrupt discontinuation of benzodiazepines, sedatives, or alcohol (↑ seizure risk) Hepatic disease

35 Bupropion Patients should begin therapy 1 – 2 weeks prior to their quit date to ensure target plasma levels 150 mg once daily for 3 days, then BID Duration is 7-12 weeks Common side effects include: Insomnia, dry mouth Less common Tremor, skin rash

36 Varenicline (Chantix®)
Binds with high affinity and selectivity to α4β2 neuronal nicotinic acetylcholine receptors Stimulates low-level agonist activity Competitively inhibits binding of nicotine Clinical effects ↓ symptoms of nicotine withdrawal Blocks dopaminergic stimulation responsible for reinforcement & reward associated with smoking

37 Varenicline Neurophychiatric symptoms and suicidality Changes in mood
Psychosis/hallucinations/paranoia/delusions Homicial ideation/hostility Agitation/anxiety/panic Suicidal ideation or attempts Completed suicide

38 Varenicline Patients should begin therapy 1 week prior to their quit date Treatment Day Dose Day 1 to day 3 0.5 mg daily Day 4 to day 7 0.5 mg BID Day 8 to end of treatment 1 mg BID

39 Verenicline Adverse Effects (> 5% and x2 higher than placebo)
Nausea Sleep disturbances Constipation Flatulance Vomiting Vivid dreams (< 5%)

40 Second-line therapies
Clonidine α2-adrenergic agonist that reduces sympathetic outflow that reduces the autonomic symptoms of withdrawal May be beneficial Nortriptyline TCA

41 Long-term (> 6 month) quit rates
Nasal Spray Bupropion Patch

42 Combination Pharmacotherapy
Combination NRT Patch + gum/inhaler/nasal spray Bupropion + Nicotine patch

43 Comparative Daily Costs
Gum Lozenge Patch Inhaler Nasal Spray Bupropion Verencline $4.68 $4.95 $3.89 $7.02 $3.92 $7.78 $4.70 $2.16 $3.24 $1.90 $3.62

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