Challenges to effective medication use
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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

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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


Challenges to effective medication use

Hurt RD, et al. Clin Pharmacol Ther 54:98-106, 1993


Challenges to effective medication use

Lawson GM, et al. J Clin Pharmacol 38:502-509, 1998


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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