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Challenges to Effective Medication Use. February 19, 2003 Richard D. Hurt, M.D. Professor of Medicine Director, Nicotine Dependence Center Mayo Clinic www.mayoclinic.org/ndc-rst. 46 y/o Neurosurgeon. Began smoking age 11, currently smokes 20-30 cpd

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challenges to effective medication use

Challenges to Effective Medication Use

February 19, 2003

Richard D. Hurt, M.D.Professor of MedicineDirector, Nicotine Dependence CenterMayo Clinic

www.mayoclinic.org/ndc-rst

46 y o neurosurgeon
46 y/o Neurosurgeon
  • Began smoking age 11, currently smokes 20-30 cpd
  • Multiple prior attempts to stop: cold turkey, acupuncture, nicotine patch, hypnosis, bupropion, and aversion therapy
  • Withdrawal symptoms: anxiety, impatient, craving,  appetite, and irritability
  • Longest previous smoking abstinence: 2-3 days
  • Persistent and chronic cough
46 y o neurosurgeon cont
46 y/o Neurosurgeon (cont.)
  • Admitted for residential treatment, CO=25 ppm
  • Bupropion 150 bid begun before admission
  • Nicotine patch dose 35 mg/d
  • Severe cravings and loss of concentrating ability
  • Baseline cotinine 621 mg/mL
46 y o neurosurgeon cont1
46 y/o Neurosurgeon (cont.)
  • Day 3: Nicotine patch dose  to 42 mg/d but still had constant low grade urge to smoke. Add nicotine gum.
  • Day 5: Struggling with withdrawal symptoms and emotional lability.  patch dose to 63 mg/d. Steady state cotinine 259 mg/mL.
46 y o neurosurgeon cont2
46 y/o Neurosurgeon (cont.)
  • Day 6: Improved. Less emotional lability. Appears more relaxed. Still has urges. Doesn’t recall very much of the first 3 days after admission. She critiqued a video on day 2 but had no recall of that.  nicotine patch dose to 77 mg/d.
  • Days 7-8: Comfortable on 77 mg nicotine patch dose + bupropion + 6-10 pieces of nicotine gum/d.
46 y o neurosurgeon cont3
46 y/o Neurosurgeon (cont.)
  • Week 2: Patch dose reduced to 70 mg/d (2 - 21 and 2 - 14 mg patches) + bupropion + nicotine gum. Some emotional lability.
  • Week 8: Symptoms of depression – insomnia, loss of appetite and some suicidal ideation. She had ’d her dose of bupropion to 200 mg/d at week 4. Also had ‘d nicotine patch dose to 35 mg/d + 6 pieces of nicotine gum/d. Returned to work half-time.
46 y o neurosurgeon cont4
46 y/o Neurosurgeon (cont.)
  • Week 13: Her internist had ’d her bupropion dose to 450 mg/d and added mitrazapine 60 mg/d. Off nicotine patch therapy. 6 pieces nicotine gum/d.
  • Week 16: Saw psychiatrist in Rochester. Major depression in partial remission. Obsessive-compulsive personality traits.
  • Weeks 28-40: Begin reducing mitrazapine. Continue bupropion 450 mg/d but begin reducing week 32. Nicotine gum 4-6/d. Therapy visit with psychiatrist every 2 months.
46 y o neurosurgeon cont5
46 y/o Neurosurgeon (cont.)
  • Week 48: Had reduced bupropion to 150 mg/d and mitrazapine to 15 mg/d.  dysphoria and  insomnia –  bupropion to 150 mg/d. “Still vulnerable to reemergence of significant depression.”
  • Week 52: Bupropion 150 mg BID. Nicotine gum 1-3/d. Therapy visit with psychiatrist.
  • Week 64: Final therapy session with psychiatrist. Bupropion 150 mg/d. Mitrazapine 15mg HS. Nicotine gum 6/d. Dismissed back to her internist.
53 y o wm executive
53 y/o WM Executive
  • Smoked cigarettes as early as age 5
  • 20 cpd until 1991 MI  CABG x 3
  • 3 mos post-MI – relapse to smoking cigarettes
  • Switched to pipe – “I knew I couldn’t smoke cigarettes anymore
  • Inhaled the pipe smoke from outset
  • 3-5 bowls of pipe tobacco per day
53 y o wm executive cont
53 y/o WM Executive (cont.)
  • Multiple attempts to stop “cold turkey” never more than a day
  • Abstinence with nicotine patch + bupropion but serious w/d symptoms – decreased mood, inability to concentrate, anxiety, and craving
  • Relapsed during high stress at work
  • Admitted for residential treatment – Rx bupropion + 21 mg nicotine patch
53 y o wm executive cont1
53 y/o WM Executive (cont.)
  • Persistent “anxiety” symptoms   patch dose to 2 - 21 mg patches
  • PFT – COPD
  • Baseline cotinine 516 ng/ml, steady state 265 ng/ml
  •  patch dose to 3 - 21 mg patches + NNS  less anxiety symptoms
  • Dismissed on 3 - 21 mg nicotine patch dose + bupropion + ad lib nicotine gum and NNS for crises
high dose patch therapy conclusions
High Dose Patch TherapyConclusions
  • High dose patch therapy safe for heavy smokers
  • Smoking rate or blood cotinine to estimate initial patch dose
  • Assess adequacy of nicotine replacement by patient response or percent replacement
  • More complete nicotine replacement improves withdrawal symptom relief
  • Higher percent replacement may increase efficacy of nicotine patch therapy
therapeutic drug monitoring
Therapeutic Drug Monitoring
  • Clinicians recognize limitations of empirical dosing (standard or fixed dose regimens)
  • Clinical observations have led to individualizing patient drug doses
  • Allows scientific approach to selecting drug regimen to achieve targeted serum concentration
  • Serum drug analyses are critical adjunct to optimal therapeutic drug utilization
pharmacotherapy for tobacco dependence multifactoral problem
Pharmacotherapy for Tobacco DependenceMultifactoral Problem
  • Relatively few medications
  • Virtually no changes in existing medications since introduction
  • ONE new medication (nicotine lozenge) introduced in past 5 years
  • Multiple barriers to use – clinicians, patients, payers, tobacco industry
pharmacotherapy for tobacco dependence clinicians
Pharmacotherapy for Tobacco DependenceClinicians
  • Lack of familiarity with and understanding of existing medications
  • Concern about safety – overdosing and abuse liability
  • Perceived low efficacy
pharmacotherapy for tobacco dependence patients
Pharmacotherapy for Tobacco DependencePatients
  • Low self-esteem and embarrassment
  • Expense
  • Inadequate relief of withdrawal and craving
  • Concern about safety – underdosing and short duration of use
  • Hard to use products – gum, inhaler, nasal spray
  • Pharmaceutical marketing focus on competition rather than the problem
pharmacotherapy for tobacco dependence payers
Pharmacotherapy for Tobacco DependencePayers
  • Perceived low efficacy
  • Concern about costs – fear of “herd” effect
  • Perception it is the patient’s responsibility – choice and self-quitting
  • Not buying cigarettes should offset cost to patient
pharmacotherapy for tobacco dependence tobacco industry
Pharmacotherapy for Tobacco DependenceTobacco Industry
  • Highly sophisticated products and marketing
  • Underregulated and politically protected
  • Enormous resources and pervasive influence
  • Constantly preempting or adapting to public health environment
  • Morally and ethically bankrupt
pharmacotherapy for tobacco dependence nicotine withdrawal syndrome
Pharmacotherapy for Tobacco DependenceNicotine Withdrawal Syndrome
  • Needs to be revisited with more scientific vigor
  • Spectrum of symptoms is broader than presently defined
  • Better understanding of neurophysiology of withdrawal and craving
  • Pharmacotherapy targeted toward withdrawal and/or craving
pharmacotherapy for tobacco dependence ideal drug
Pharmacotherapy for Tobacco DependenceIdeal Drug
  • High efficacy – withdrawal and craving relief, tobacco abstinence plus relapse prevention
  • Few side effects
  • Easy to administer
  • Long duration of action
  • Positive ancillary effects – no weight gain or weight loss, improved mood, eliminates wrinkles……
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