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Treatment Strategies: Special Considerations

Treatment Strategies: Special Considerations. Lowell C. Dale, MD Associate Director Mayo Clinic Nicotine Dependence Center Rochester, MN Dale.lowell@mayo.edu. Diabetes Mellitus (HbA1c=11.6), Hypertension (BP:146/94), Osteoporosis, Non-healing lower extremity ulcerations.

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Treatment Strategies: Special Considerations

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  1. Treatment Strategies:Special Considerations Lowell C. Dale, MD Associate Director Mayo Clinic Nicotine Dependence Center Rochester, MN Dale.lowell@mayo.edu

  2. Diabetes Mellitus (HbA1c=11.6), Hypertension (BP:146/94), Osteoporosis, Non-healing lower extremity ulcerations. 30 CPD for 43 years Previous Stop Attempt 6 months ago: 21 mg patch. “They didn’t work!” Irritable, restless and intense cravings. Abstinent for only 4 days. Unsure now that she can quit—or that she wants to! MEDICATIONS? JOAN

  3. Optimizing Pharmacotherapy • Targets can be established • Withdrawal symptom relief • Control of cravings and urges • Abstinence • Modification of medication doses may be necessary to achieve these targets • Higher doses • Multi-drug regimens • Longer course of treatment

  4. Nicotine Delivered by Inhalation

  5. Plasma ConcentrationsSmoking vs. NRT Nicotine Delivered by NRT

  6. Smoking produces much higher nicotine levels and much more rapidly than NRT 14 12 10 8 Increase in nicotine concentration ( ng/ml ) Cigarette Gum 4 mg Gum 2 mg 6 4 Patch 42 mg Inhaler 2 Patch 21 mg 0 5 10 15 20 25 30 Minutes Adapted from Balfour DJ & Fagerström KO. Pharmacol Ther 1996 72:51-81.

  7. Percentage “replacement” = venous cotinine on NRT x 100 venous cotinine while smoking Goal = 100%

  8. Dose Ranging Study Dale, et al. JAMA, 1995.

  9. Findings from Dose Ranging Study: Dose associated with cessation @ 8 weeks (P = .007; OR 2.5; 95% CI:1.3-4.9) 8 weeks6 months1 year 11 mg59% 59% 41% 22 mg 62% 54% 35% 44 mg 100% 78% 67% Dale, et al. JAMA, 1995.

  10. Is Higher Dose NRT Effective? OR = 1.21 (95% CI 1.03-1.42) *Silagy et al. Cochrane Database Syst Rev. 2002;(4):

  11. Is Higher Dose Patch Therapy Safe? • Hughes et al, 1999, N&TR • 1039 smokers • 0, 21, 35, and 42 mg/d • 6 weeks/10 week taper • No difference in adverse events • Fredrickson et al., 1995, Psychopharm • 40 smokers • > 20 cpd • 22 mg/d & 44 mg/d for 4 weeks • Safe, tolerable, no adverse effects

  12. Is Higher Dose Patch Therapy Safe? • Jorenby et al., 1995, JAMA • 504 smokers • 22 mg/d or 44 mg/dfor 8 weeks (4/4) • Adverse effects • Nausea (28% vs. 10%, P < .001) • Vomiting (10% vs. 2%, P < .001) • Erythema (30% vs. 13%, P < .01)

  13. Higher Dose Nicotine Patch • There is a dose-response effect • Long-term abstinence improved; OR=1.21 (95% CI 1.03-1.42)* • Treatment-related adverse events are uncommon • Withdrawal symptoms less with higher dose NRT *Cochrane Database of Systematic Reviews 2005

  14. Combination Medications Combine long-acting patch and/or Bupropion with “as needed” short-acting medication (gum, inhaler, spray or lozenge)

  15. Combination NRT Combine long-acting patch with “as needed” short-acting medication (gum, lozenge, inhaler, nasal spray) • Encourages patient to be in control of cravings and withdrawal symptoms • Improves compliance with treatment plan • Achieves higher drug concentrations • Allows further dose adjustments • Provides an alternative to tobacco

  16. Combination treatments tested • NP plus NG, NNS, NI compared to • Placebos (NG, NNS, NI, NP) • Active NG, NNS, NI alone • Active NP alone • Withdrawal may be improved • Overall abstinence rates at 6 mos. • OR 1.42 (95% CI 1.14-1.76)* *Cochrane Database of Systematic Reviews 2005

  17. Medication: Effects on Withdrawal & Urges Stop Date Intensity Intensity TIME

  18. Nicotine Patch TherapyInitial Dosing Guidelines Based on Baseline Cigarettes/Day • <10 CPD 7-14 mg/d • 10-20 CPD 14-21 mg/d • 21-40 CPD 22-42 mg/d • >40 CPD 42+ mg/d

  19. Initial Dosing Guidelines:Smokeless Tobacco Cans/Pouches/WeekMg NRT/day > 3 42+ 2-3 33-44 1-2 21-33 < 1 11-22

  20. Combined Pharmacotherapy • Bupropion SR may be combined with any of the NRTs • Different Mechanisms of Action • Synergistic Effects

  21. Apply Principles of Therapeutics • Assess Risks • From Continuing to Smoke • From High Dose therapy • Define Benefits • Determine Dose • Assess Response • Adjust medication dose to achieve target

  22. Diabetes Mellitus (HbA1c=11.6), Hypertension (BP:146/94), Osteoporosis, Non-healing lower extremity ulcerations. 30 CPD for 43 years MEDICATIONS Patch 35mg/day 4-6 weeks then taper by 7-14 mg every 2-4 weeks until off Lozenge 2 mg As needed for withdrawal symptoms or cravings Bupropion SR One tablet twice a day for at least 3 months, then reassess Follow-up: Adjust doses based on symptoms and abstinence Monitor for nicotine toxicity Monitor blood pressure JOAN

  23. Optimizing Pharmacotherapy • Establish Targets • Withdrawal symptom relief • Control of cravings and urges • Abstinence • Modify medication as necessary to achieve these targets • Higher doses • Combination of Medications • Longer course of treatment

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