1. Efficacy of Combination First Line Agents for Smoking Cessation Sneha Baxi, Pharm.D. Pharmacy Practice Resident University of Illinois at Chicago

2. Session Outline Discuss effects of nicotine dependence Review smoking cessation methods Present research project and results Conclusion Questions

3. Statistics 440,000 American lives/year claimed by smoking related diseases $97.2 billion/year spent in health care costs and lost productivity 87% of lung cancer cases are directly related to smoking 80% of emphysema and chronic bronchitis cases related to smoking http://www.lungusa.org/

4. Deaths Attributed to Cigarette Smoking http://www.lungusa.org/

5. Addiction Potential http://www.cdc.gov/tobacco/nicadd.htm

6. Cessation Methods http://www.ahrq.gov/clinic/tobacco/

7. Smoking Cessation Therapy First Line Behavioral Modification Nicotine Replacement Therapy Gum Inhaler Nasal spray Patch Lozenge Bupropion sustained-release (SR) Second Line Nortriptyline, clonidine

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

9. Combination Therapy Combinations studied Nicotine patch and gum Nicotine patch and nasal spray Nicotine patch and bupropion SR Nicotine patch and inhaler

10. Combination Therapy Abstinence Rates (6 months) Combination UsedCombination (%) Monotherapy (%) Patch & gum27.515.3 Patch & gum27.320.7 Patch & nasal spray 31.416 Patch & inhaler12.511.3 Patch & bupropion38.821.3 / 34.8

11. 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

12. University of Illinois Smoking Cessation Clinic Pharmacist managed Individual appointments Referred by other medical practitioners

13. Initial Visit: Patient Interview Medical problem list Medication list and allergies Social history identifying other current or past addictions, alcohol use, and occupation Insurance

14. Smoking History Reasons why the smoker wants to quit Previous quit attempts including length of success, time of last attempt, method used, and efficacy of method Barriers to stopping smoking Motivation and confidence to quit smoking Stage of change (pre-contemplation, contemplation, preparation, action, and maintenance) Smoking triggers

15. Smoking History (cont.) Objective data Fagerstrom score Carbon monoxide reading Blood pressure, Pulse Weight

16. Assessment/Plan Behavioral recommendations Tally sheet to identify triggers Written trigger plan Stress and time management Healthy diet Educational smoking cessation book Medication recommendations and education Follow-up scheduled

17. Medication Advantages and disadvantages of each medication Proper use, side effects, expectations, and cost of each medication Demonstration of each medication Medication education sheet(s) Prescription

18. Research Project

19. Objectives Primary: Assess the efficacy of using combination therapy for smoking cessation Secondary: Identify specific patient populations that may benefit from combination therapy

20. Study Design Research conducted at the University of Illinois Medical Center IRB approved Retrospective chart review Gemini notes Access data base

21. Methods Retrospective chart review Evaluate: Demographic data Medical, medication, and smoking history Motivation to quit Treatment Outcomes of therapy

22. Criteria Inclusion Subjects seen at the UIC Smoking Cessation clinic from January 2000- November 2004 Exclusion Minors (age < 18)

23. Clinic Demographics: Age (n = 144) # of patients Age

24. Clinic Demographics: Race

25. Clinic Demographics: Gender

26. Patient Characteristics: Smoking History <10 10-19 20-29 30-39 40-49 50-59 >60

27. Patient Characteristics: Fagerstrom Score

28. Patient Characteristics: Co-Morbid Conditions Medical Condition% Positive (n) Diabetes Mellitus20.4 (29) COPD10.6 (15) Psychiatric25.3 (36) CAD10.6 (15) Seizures11.3 (16) Other Addictions10.6 (15)

29. Subjects Abstinent > 6 Months: Demographics CharacteristicMonotherapy (n = 12) Combination (n = 9) Age (mean) Race (% AA) Sex (% female) 54.8 66.6 (n = 8) 47.7 55.5 (n = 5) 77.7 (n = 7) Co-Morbidities (%) DM COPD Psych CAD Seizures Addictions 25 33.3 25 8 16.6 0 44.4 22.2 33.3 0 22.2 11.1

30. Subjects Abstinent > 6 Months: Smoking History CharacteristicMonotherapy (n = 12) Combination (n = 9) Pack Year History (mean) 33.734.3 Fagerstorm Score (mean) 3.124.3 Baseline CO Reading (mean) 1312.3

31. Monotherapy Method# Subjects (n=120) 6 Month Success Rate % (n=12) Cold Turkey903.3 (3) Patch1040 (4) Gum250 (1) Nasal Inhaler50 Nasal Spray250 (1) Lozenges333.3 (1) Bupropion825 (2)

32. Combination Therapy Method# Subjects (n= 24) 6 Month Success Rate % (n=9) Patch + Inhaler1233.3 (4) Patch + Gum425 (1) Patch + Spray1100 (1) Patch + Bupropion20 (0) Inhaler + Bupropion450 (2) Inhaler + Gum1100 (1)

33. Conclusions Higher percentage of patients were able to quit for at least 6 months in the combination therapy group versus the monotherapy group Smoking tobacco quit rate similar to national averages

34. Limitations Low number of subjects in study Retrospective study No randomization

35. QUESTIONS?