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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

Treatment Strategies:Special Considerations

Lowell C. Dale, MD

Associate Director

Mayo Clinic Nicotine Dependence Center

Rochester, MN

Dale.lowell@mayo.edu

slide2
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
optimizing pharmacotherapy
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
plasma concentrations smoking vs nrt
Plasma ConcentrationsSmoking vs. NRT

Nicotine Delivered by NRT

smoking produces much higher nicotine levels and much more rapidly than nrt
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.

slide7
Percentage “replacement”

=

venous cotinine on NRT x 100

venous cotinine while smoking

Goal = 100%

slide8

Dose Ranging Study

Dale, et al. JAMA, 1995.

findings from dose ranging study
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.

is higher dose nrt effective
Is Higher Dose NRT Effective?

OR = 1.21 (95% CI 1.03-1.42)

*Silagy et al. Cochrane Database Syst Rev. 2002;(4):

is higher dose patch therapy safe
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
is higher dose patch therapy safe12
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)
higher dose nicotine patch
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

combination medications
Combination Medications

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

combination nrt
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
combination treatments tested
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

medication effects on withdrawal urges
Medication: Effects on Withdrawal & Urges

Stop Date

Intensity

Intensity

TIME

nicotine patch therapy initial dosing guidelines
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
initial dosing guidelines smokeless tobacco
Initial Dosing Guidelines:Smokeless Tobacco

Cans/Pouches/WeekMg NRT/day

> 3 42+

2-3 33-44

1-2 21-33

< 1 11-22

combined pharmacotherapy
Combined Pharmacotherapy
  • Bupropion SR may be combined with any of the NRTs
  • Different Mechanisms of Action
  • Synergistic Effects
apply principles of therapeutics
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
slide22
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
optimizing pharmacotherapy23
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