Smoking Cessation: A Practical Overview of Pharmacotherapy Joseph Saseen, Pharm.D., FCCP, BCPS...

Smoking Cessation:A Practical Overview of

Pharmacotherapy

Joseph Saseen, Pharm.D., FCCP, BCPSProfessor

University of [email protected]

Learning Outcomes

● Apply recommendations from guidelines to customize clinical interventions to patients who use tobacco

● Compare and contrast advantages and disadvantages of various tobacco cessation pharmacotherapy products to

U.S. Department of Health and Human Services:

Public Health Service (May 2008)

Clinical Practice GuidelineTreating Tobacco Use and Dependence

2008 Update

http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pd f

Potential Health Benefits of Smoking Cessation

Time After Smoking

20 minBP, HR, peripheral circulation improve

24 hrsCO levels drop

48 hrsNicotine eliminated;

taste and smell improve

2-12 wksLung function can

improve 30%

3-9 moSOB and coughing

decrease

1 yrRisk of MI reduced 50%

10 yrsRisk of lung cancer

reduced 50%

15 yrsRisk of MI and

stroke reduce to level of nonsmoker

Nicotine Stimulates Dopamine Release

● High nicotine levels achived in 11 seconds from inhalation

Nicotine and Tobacco Research 1999;1:s121-s125

10 Key Guideline Recommendations

1. Repeated intervention and multiple attempts

2. Identify and document tobacco use status and treat every tobacco user

3. Treatments are effective: counseling and medications

4. Brief treatment is effective

5. Counseling is important: practical and social support


10 Key Guideline Recommendations

6. Medications should be used whenever possible

7. Combination of counseling and medication more effective than either alone

8. Telephone quitline counseling is effective

9. Use motivational treatment if patients unwilling to quit

10. Insurance plans should include counseling and medication coverage


The “5 A’s” Model


Meta Analysis 2008 (n=18 studies)

Treatment Arms (#)

Estimated Odds Ration

(95% CI)

Estimated Abstinence Rates

(95% CI)Medication Alone 8 1.0 21.7

Medication and Counseling

39 1.4(1.2-1.6) 27.6 (25.0-30.3)

0-1 Sessions plus Medication

13 1.0 21.8


6 1.4 (1.1-1.8) 28.0 (23.0-33.6)


19 1.3 (1.1-1.5) 26.9 (24.3-29.7)

> 8 Sessions plus Medication

9 1.7 (1.3-2.2) 32.5 (27.3-38.3)


First Line Medications

Nicotine Replacement● Nicotine gum

● Nicotine inhaler

● Nicotine lozenge

● Nicotine nasal spray

● Nicotine patch

Oral Agents● Bupropion SR

● Varenicline


Nicotine Gum

Advantages

● May satisfy oral cravings● May delay weight gain● Patients can titrate

therapy to manage withdrawal symptoms

Disadvantages

● Gum chewing may not be socially acceptable

● May stick to dental work and dentures

● Proper chewing technique (Chew/Park) needed to minimize adverse effects

● Cannot eat or drink 15 minutes before or while using the nicotine gum

Nicotine Inhaler

Advantages

● Patients can easily titrate therapy to manage withdrawal symptoms

● Mimics the hand-to-mouth ritual of smoking

Disadvantages

● Initial throat or mouth irritation (in first week)

● Cartridges should not be stored in conditions >86oF or <59oF

● Patients with underlying bronchospastic conditions should use with caution

Nicotine Lozenge

Advantages

● May satisfy oral cravings● Easy to use and conceal● Patients can titrate

therapy to manage withdrawal symptoms

Disadvantages

● Gastrointestinal side effects (nausea, hiccups, heartburn) may be bothersome

● Must allow slow dissolution for 20-30 minutes (no chewing)

● Should not eat or drink for 15 minutes before or while using the nicotine lozenge

Nicotine Nasal Spray

Advantages

● Dose can be easily titrated to rapidly manage withdrawal symptoms

Disadvantages

● Initial nasal or throat irritation can be bothersome (may last up to 3 weeks)

● Higher dependence potential relative to other NRT formulations

● Patients with chronic nasal disorders (e.g., rhinitis, polyps, sinusitis) or severe reactive airway disease should not use

Nicotine Patch

Advantages

● Steady-state nicotine levels are achieved throughout the day

● Easy to use and conceal● Fewer compliance

issues are associated with the patch

Disadvantages

● Patients cannot titrate dose

● Allergic reactions to the adhesive may occur

● Patients with underlying dermatologic conditions (e.g., psoriasis, eczema, atopic dermatitis) should not use the patch

Bupropion SR (Zyban)

Advantages

● Oral formulation given BID that is easy to use

● May be beneficial for patients with coexisting depression

● Initiated before quit date● No risk of nicotine

toxicity if patient continues to smoke

Disadvantages

● Increases seizure risk● Several

contraindications and precautions that may preclude use

● Side effects of insomnia and dry mouth

Varenicline (Chantix)

Advantages

● Oral formulation given BID that is easy to use

● Initiate before quit date● New mechanism of

action for persons who previously failed using other medications

Disadvantages

● May induce nausea in up 1/3 of patients (need to titrate)

● Post-marketing surveillance data stimulated FDA warning

Varenicline (Chantix):Package Insert Update

WARNINGS and PRECAUTIONS

Serious neuropsychiatric symptoms have occurred in patients being treated with CHANTIX. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke. All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

Varenicline (Chantix):FDA Alert February 1, 2008

Recommendations and Considerations for Healthcare Professionals

● Monitor all patients taking Chantix for serious neuropsychiatric symptoms

● Serious psychiatric illness (e.g., schizophrenia, bipolar, major depressive disorder) may worsen

● Consider these safety concerns and alert patients about these risks

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm

Varenicline (Chantix):FDA Alert February 1, 2008

Information for the patient● Report any history of psychiatric illness prior to

starting Chantix● Be alert to changes in mood and behavior● Immediately report changes in mood and

behavior● Vivid, unusual, or strange dreams may occur

Medication Guide (5/16/08)● http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088569.pdf

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm

MonotherapyTreatment Arms

(#)Estimated

Odds Ratio (95% CI)


(95% CI)Placebo 80 1.0 13.8

Nicotine Gum • 6-14 wks• > 14 wks

156

1.5 (1.2-1.7)2.2 (1.5-3.2)

19.0 (16.5-21.9)26.1 (19.7-33.6)

Nicotine Inhaler 6 2.1 (1.5-2.9) 24.8 (19.1-31.6)

Nicotine Nasal 4 2.3 (1.7-3.0) 26.7 (21.5-32.7)

Nicotine Patch• 6-14 wks• >14 wks• High-dose (>25mg)

32104

1.9 (1.7-2.2)1.9 (1.7-2.3)2.3 (1.7-3.0)

23.4 (21.3-25.8)23.7 (21.0-26.6)26.5 (21.3-32.5)

Bupropion SR 26 2.0 (1.8-2.2) 24.2 (22.2-26.4)

Varenicline (2 mg/d) 5 3.1 (2.5-3.8) 33.2 (28.9-37.8)


Combination Pharmacotherapy

Treatment Arms (#)

Estimated Odds Ratio

(95% CI)


(95% CI)Nicotine Patch (>14 wk) + ad lib Nicotine Gum/Spray

3 3.6 (2.5-5.2) 36.5 (28.6-45.3)

Nicotine Patch + Nicotine Inhaler

2 2.2 (1.3-3.6) 25.8 (17.4-36.5)

Nicotine Patch + Bupropion SR

3 2.5 (1.9-3.4) 28.9 (23.5-35.1)

● These combinations are considered “effective” according to guidelines


Cost of Pharmacotherapy

http://www.drugstore.com

Bottom Line: Pharmacotherapy for Smoking Cessation

All smokers trying to quit should be offered medication…. except when contraindicated or for specific populations for which there is insufficient evidence of effectiveness:

• Pregnant women• Smokeless tobacco users• Light smokers• Adolescents


Plethora of Resources

● CO Quitline (www.coquitline.org)● Fixnixer (www.fixnixer.com)● Become an Ex (www.becomeanex.com)● My Last Dip (www.mylastdip.com) ● Cigarette is Dead

(www.thecigaretteisdeadtimeline.com)● Quit Doing it Labs (www.quitdoingitlabs.com)● Raise Smoke Free Kids

(www.raisesmokefreekids.com)

Quit Tips● Make a quit plan. Pick a date and make a

list of reasons you want to quit.● Prepare for your quit date. This means

getting rid of all tobacco-related items, such as ashtrays, lighters and matches.

● Ask your family and friends to support you in your quit attempt. Tell them your quit date and ask them to be supportive and understanding.

● Keep a picture of your loved ones. Tape a message to the picture that reminds you that you are quitting for them. Look at the picture and read the message anytime you have an urge to smoke.

● When you feel an urge to reach for a cigarette, try taking a walk, playing with your kids or running up and down the stairs instead of lighting up.

● For the first few days after you quit smoking, spend as much free time as possible in public places where smoking is not allowed.

● Reward yourself when you reach milestones in your quit attempt, such as buying yourself a new book or treating yourself to a nice dinner with a supportive friend.

● Keep healthy snacks, gum, mints and toothpicks around, and drink plenty of water.

● Try to avoid people, places or other trigger habits you typically associate with smoking.

● Take deep, slow breaths and imagine your lungs filling with clean, fresh air.

● Create a smoke-free rule for your home and car. Smoke-free environments can support you in the quitting process.

● Don´t give up. Most people have to try several times to quit smoking. You can do it.

www.myquitpath.com

Smoking Cessation: A Practical Overview of Pharmacotherapy Joseph Saseen, Pharm.D., FCCP, BCPS...

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