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Primary Care Conference Case Presentation: A New Smoking Cessation Treatment Option. 25 October 2006 Douglas E. Jorenby, Ph.D. Disclosures. Research support from Pfizer, Nabi Biopharmaceuticals, NIDA Consulting and educational honoraria from Nabi Biopharmaceuticals, Veterans’ Administration.
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Primary Care Conference Case Presentation: A New Smoking Cessation Treatment Option 25 October 2006 Douglas E. Jorenby, Ph.D.
Disclosures • Research support from Pfizer, Nabi Biopharmaceuticals, NIDA • Consulting and educational honoraria from Nabi Biopharmaceuticals, Veterans’ Administration
Learning Objectives • Understand the mechanism of action of varenicline for smoking cessation • Be informed regarding the pros and cons of this treatment • Apply evidence-based smoking cessation treatments in a patient with multiple complicating factors
Case History • Caucasian male in his late 40s • Currently smoking 15 cpd • Daily smoker for over 30 years • Longest period of cessation = 6 mos. • Failed “cold turkey” • Not using other forms of tobacco
SCPC Assessments • BP 140/82 • CO = 18 ppm • FVC = 3.91 l (79%) • FEV1 = 3.26 l (82%) • FEF25-75 = 3.75 l/s (96%)
Complicating Factors • Seizure disorder • Sleep apnea • Visual impairment • Caffeine use • Alcohol use
Things Go Better With Dopamine • Nicotine • Bupropion • Cytisine • Varenicline
The α4β2 Receptor Subtype • Key to the rewarding effects of nicotine • Modulates dopamine release • Varenicline has 35-60% of the agonist effect • Affinity is higher than for nicotine
Randomized Controlled Trial • Phase 3 placebo-controlled comparison • 1.0 mg twice daily (n=344) • 150 mg bupropion SR twice daily (n=342) • Placebo (n=341)
Point Prevalence Outcome Jorenby DE, et al. JAMA. 2006;296:56-63.
Rates of Discontinuation Jorenby DE, et al. JAMA. 2006;296:56-63.
Nausea As AE Jorenby DE, et al. JAMA. 2006;296:56-63.
Point Prevalence Outcome Replication Gonzales D, et al. JAMA. 2006;296:47-55.
Dosing Regimen • 0.5 mg in the morning for 3 days, then • 0.5 mg twice a day for 4 days, then • 1 mg twice a day (target quit date) • Continue for 3-6 months
Dose & Titration Effects On Nausea Oncken C, et al. Arch Intern Med. 2006;166:1571-1577.
Bupropion SR Hurt et al. (1997) Jorenby et al. (1999) N = 1,508 Varenicline Gonzales et al. (2006) Jorenby et al. (2006) Tonstad et al. (2006) Nides et al. (2006) Oncken et al. (2006) N = 5,265 A Matter Of Scale
Case Outcome • Medication well-tolerated • Attended SCPC support group for 4 weeks • Reported no withdrawal symptoms (?!) • Smoke-free • Follow-up at 6 months • Repeat PFT at 12 months