Efficacy of Combination First Line Agents for Smoking Cessation

Sneha Baxi, Pharm.D.Pharmacy Practice Resident

University of Illinois at Chicago

Session OutlineDiscuss effects of nicotine dependenceReview smoking cessation methodsPresent research project and resultsConclusionQuestions

Statistics 440,000 American lives/year claimed by smoking related diseases$97.2 billion/year spent in health care costs and lost productivity87% of lung cancer cases are directly related to smoking80% of emphysema and chronic bronchitis cases related to smoking

http://www.lungusa.org/

Deaths Attributed to Cigarette Smoking

http://www.lungusa.org/

Addiction Potential

http://www.cdc.gov/tobacco/nicadd.htm

Cessation MethodsColdTurkey/SelfHelpCounseling/Behavioral

NRT

Bupropion

Otherhttp://www.ahrq.gov/clinic/tobacco/

Smoking Cessation Therapy

First Line Behavioral Modification Nicotine Replacement Therapy

Gum Inhaler Nasal spray Patch Lozenge

Bupropion sustained-release (SR)Second Line Nortriptyline, clonidine

Monotherapy

http://www.cdc.gov/search.do?action=search&queryText=smoking+cessation+therapy+and+quit+rate

Combination TherapyCombinations studiedNicotine patch and gumNicotine patch and nasal sprayNicotine patch and bupropion SRNicotine patch and inhaler

Combination Therapy Abstinence Rates (6 months)

Combination Used Combination (%)

Monotherapy(%)

Patch & gum 27.5 15.3

Patch & gum 27.3 20.7Patch & nasal spray

31.4 16

Patch & inhaler 12.5 11.3Patch & bupropion 38.8 21.3 / 34.8

Variables Associated with Abstinence

Variables associated with higher abstinence rates High motivation and confidence Ready to change Strong support system

Variables associated with lower abstinence rates High nicotine dependence History of psychiatric co-morbidity High stress level

http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.table.8634Table

10. Variables associated with higher or lower abstinence rates

University of IllinoisSmoking Cessation ClinicPharmacist managedIndividual appointmentsReferred by other medical practitioners

Initial Visit:Patient Interview

Medical problem listMedication list and allergiesSocial history identifying other current or past addictions, alcohol use, and occupationInsurance

Smoking HistoryReasons why the smoker wants to quitPrevious quit attempts including length of success, time of last attempt, method used, and efficacy of methodBarriers to stopping smokingMotivation and confidence to quit smokingStage of change (pre-contemplation, contemplation, preparation, action, and maintenance)Smoking triggers

Smoking History (cont.)Objective dataFagerstrom score Carbon monoxide readingBlood pressure, PulseWeight

Assessment/PlanBehavioral recommendations Tally sheet to identify triggers Written trigger plan Stress and time management Healthy diet Educational smoking cessation book

Medication recommendations and educationFollow-up scheduled

MedicationAdvantages and disadvantages of each medicationProper use, side effects, expectations, and cost of each medicationDemonstration of each medicationMedication education sheet(s)Prescription

Research Project

ObjectivesPrimary: Assess the efficacy of using combination therapy for smoking cessationSecondary: Identify specific patient populations that may benefit from combination therapy

Study DesignResearch conducted at the University of Illinois Medical CenterIRB approvedRetrospective chart reviewGemini notesAccess data base

MethodsRetrospective chart reviewEvaluate:Demographic dataMedical, medication, and smoking historyMotivation to quitTreatment Outcomes of therapy

CriteriaInclusion Subjects seen at the

UIC Smoking Cessation clinic from January 2000-November 2004

Exclusion Minors (age < 18)

Clinic Demographics: Age (n = 144)

0

10

20

30

40

50

20-29 30-39 40-49 50-59 60-69 > 70

# of

pa

tient

s

Age

Clinic Demographics: Race

AACaucasianHispanicIndianOther

Clinic Demographics: Gender

WomenMen

Patient Characteristics: Smoking History

0

5

10

15

20

25

Number of Subjects

Pack Year History

<10

10-19

20-29

30-39

40-49

50-59

>60

Patient Characteristics: Fagerstrom Score

05

101520253035404550

Fagerstorm Score

0 to 45 to 78 to 10

Patient Characteristics:Co-Morbid Conditions

Medical Condition % Positive (n)

Diabetes Mellitus 20.4 (29)

COPD 10.6 (15)

Psychiatric 25.3 (36)

CAD 10.6 (15)

Seizures 11.3 (16)

Other Addictions 10.6 (15)

Subjects Abstinent > 6 Months: Demographics

Characteristic Monotherapy(n = 12)

Combination(n = 9)

Age (mean)Race (% AA)Sex (% female)

54.866.6 (n = 8)66.6 (n = 8)

47.755.5 (n = 5)77.7 (n = 7)

Co-Morbidities (%) DM COPD Psych CAD Seizures Addictions

2533.325816.60

44.422.233.3022.211.1

Subjects Abstinent > 6 Months: Smoking History

Characteristic Monotherapy(n = 12)

Combination(n = 9)

Pack Year History (mean)

33.7 34.3

Fagerstorm Score (mean)

3.12 4.3

Baseline CO Reading (mean)

13 12.3

MonotherapyMethod # Subjects

(n=120)6 Month Success

Rate % (n=12)

Cold Turkey 90 3.3 (3)

Patch 10 40 (4)

Gum 2 50 (1)

Nasal Inhaler 5 0

Nasal Spray 2 50 (1)Lozenges 3 33.3 (1)

Bupropion 8 25 (2)

Combination TherapyMethod # Subjects

(n= 24)6 Month Success

Rate % (n=9)

Patch + Inhaler 12 33.3 (4)

Patch + Gum 4 25 (1)

Patch + Spray 1 100 (1)

Patch + Bupropion 2 0 (0)

Inhaler + Bupropion 4 50 (2)

Inhaler + Gum 1 100 (1)

ConclusionsHigher percentage of patients were able to quit for at least 6 months in the combination therapy group versus the monotherapy groupSmoking tobacco quit rate similar to national averages

LimitationsLow number of subjects in studyRetrospective studyNo randomization

QUESTIONS?