1. That Patient Who Will Not Quit – A New Treatment Option April 18, 2007 Michael C. Fiore, MD, MPH Professor of Medicine Director, Center for Tobacco Research and Intervention University of Wisconsin School of Medicine and Public Health

2. Over the last year, I have served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer. In 1998, I was appointed to a named Chair made possible by an unrestricted gift to UW from GlaxoWellcome to the University of Wisconsin. Disclosure Statement

3. Case Study Mr. and Mrs. S Both late 60s Both NIDDM Both Hyperlipidemia Both BMIs over 35 Both smoke more than a ppd and have tried to quit many times

4. A New Quit Attempt Varenicline Quit Line

5. Varenicline Approved by FDA in May, 2006 Marketed as Chantix A non-nicotine medication A selective  4  2 Nicotinic Acetylcholine Receptor Partial Agonist

6. Varenicline: A Highly Selective  4  2 Receptor Partial Agonist Chantix Chantix is an  4  2 nicotinic receptor partial agonist, a compound with dual agonist and antagonist activities. This is believed to result in both a lesser amount of dopamine release from the VTA at the nAcc as well as the prevention of nicotine binding at the  4  2 receptors Nicotine Binding of nicotine at the  4  2 nicotinic receptor in the Ventral Tegmental Area (VTA) is believed to cause release of dopamine at the Nucleus Accumbens (nAcc)

7. Varenicline Efficacy Data

8. Varenicline Phase 3 Studies: Efficacy Measurements: CO-Confirmed 4-Wk Continuous Abstinence Rates Wks 9-12

9. Point Prevalence Outcome

10. Varenicline: Most Common Adverse Events From 12-Week Fixed-Dose, Placebo-Controlled Studies

11. Varenicline – Prescribing Information Start varenicline one week before the quit date for maximum effectiveness Recommended treatment is 12 weeks: – Days 1-3………..1 pill (0.5 mg) per day – Days 4-7………..1 pill (0.5 mg) twice a day (am & pm) – Day 8-end………1 pill (1 mg) twice a day (am & pm) An additional course of 12 weeks for maintenance can be considered

12. Treatment Counseling – The Wisconsin Tobacco Quit Line at 1-800-QUIT-NOW. – It’s free, confidential, and non-judgmental. – Callers are 4 times more likely to quit than those who try to quit cold turkey. – Services are available in virtually any language.

13. Designed to help employees at the University of Wisconsin Hospital and Clinics quit. A UWHC Employee Program 608-438-4517

14. UW-CTRI Outreach Specialist Southern Region- Madison Tricia Brein, MS UW-CTRI 1930 Monroe St, Suite 200 Madison, WI 53711 608-265-4860 Fax: 608-265-3102 trb@ctri.medicine.wisc.edu

15. 15 www.ctri.wisc.edu