Effective Treatments for Tobacco Dependence

Transcription

1 Effective Treatments for Tobacco Dependence Abigail Halperin MD, MPH Director, University of Washington Tobacco Studies Program Ken Wassum Associate Director of Clinical Development and Support Quit for Life Program, Alere Wellbeing April 2012

2 Effective Treatments for Tobacco Dependence: Overview Why does treatment matter? Why do smokers keep smoking? What smoking cessation treatments are effective? Behavioral Pharmacological Role of health care providers

3 WHY TREATMENT MATTERS Tobacco use is the #1 preventable cause of death Stopping tobacco use reduces health risks Tobacco prevention works slowly Tobacco use is an addictive disorder Tobacco treatment synergizes with tobacco control policies

4 WHY DO SMOKERS KEEP SMOKING? Population Perspective Epidemiologic Model of Tobacco Addiction and Its Control Individual Perspective Tobacco Addiction Triangle Tobacco Products AGENT OF ADDICTION & DISEASE VECTOR Tobacco Industry HOST Tobacco User Orleans & Slade, 1993; Giovino 2002

5 WHY DO SMOKERS KEEP SMOKING? Pharmacologic nicotine dependence DOPAMINE Saturation of nicotinic receptors with smoking in smokers vs. non-smokers (Brody et al., Arch Gen Psych 2006)

6 WHY DO SMOKERS KEEP SMOKING? Pharmacologic nicotine dependence Craving (nicotine hunger ) Nicotine withdrawal symptoms l Irritability, anger, impatience l Restlessness l Difficulty concentrating l Insomnia l Anxiety l Depressed mood l Increased appetite

7 WHY DO SMOKERS KEEP SMOKING? Pharmacologic nicotine dependence Psychological factors Cues (meals, alcohol, other smokers) Coping with stress, emotions (anger) Depression, other substance use

8 WHY DO SMOKERS KEEP SMOKING? Pharmacologic nicotine dependence Psychological factors Behavioral habits Hand to mouth action Oral stimulation/satisfaction Daily routines/rituals

9 THE CHALLENGE FOR TREATMENT We have effective treatments, but we still need better ones, AND We need to deliver the treatments we have to more of the smokers who need them 70% of smokers want to quit; 50% try Only 5% succeed unassisted vs % with help Only 25% use any form of help HCPs poorly trained to treat tobacco Health care systems do not prioritize tobacco tx

10 SMOKING CESSATION METHODS 2008 US Public Health Service Guidelines Effective treatments l Counseling l Pharmacotherapy l Combination - better than either one alone More is better, but even brief intervention works Treating tobacco is highly cost-effective Pharmacotherapy reduces withdrawal while smoker learns to live without cigarettes

11 COUNSELING Content Smokers who want to quit Cognitive-behavioral counseling Practical skills Quit plan (STAR) Social support (intra-tx and extra-tx) Encourage medication use and adherence Smokers who are not ready to quit Motivational interviewing Teachable moments

12 COUNSELING Method of Delivery In-person * - one-on-one or group By telephone * - proactive quitlines Self-help materials little efficacy Newer technologies Web-based evidence is growing but not definitive Text-messaging one randomized trial (Lancet 2011) Social media little evidence * Endorsed as effective by 2008 USPHS Guideline Update

13 TELEPHONE QUITLINES Definition Advantages Proactive multi-session counseling by phone Convenience Privacy Effective (pooled OR 1.4, 95% CI )* Quitlines can also provide medication Facilitate access to free or low-cost medications Strategy for promoting calls to a quitline *Stead LF et al. Tobacco Control 2007;16(suppl 1):i3

14 PHARMACOTHERAPY 1 st Line US Public Health Service Guidelines Nicotine replacement OR l Skin patch 1.9 l Gum 1.5 l Oral inhaler 2.1 l Nasal spray 2.3 l Lozenge 2.0 Bupropion SR (Zyban,Wellbutrin SR) 2.0 Varenicline (Chantix/Champix) 3.1

15 PLASMA NICOTINE LEVELS Cigarettes vs. Nicotine Replacement Products Plasma nicotine level (ng/ml) Cigarette (1-2 mg) Nasal spray (1 mg) Gum (4 mg) Patch (21 mg) Time post administration (min)

16 NICOTINE REPLACEMENT Long-acting, slow onset skin patch l l l Constant nicotine level to avoid withdrawal Simplest to use, best compliance User has no control of dose Short-acting Intermediate onset oral (gum, lozenge, inhaler) More rapid onset nasal (spray) l l l User controls dose, can titrate to need Nicotine blood levels fluctuate more Requires more training to use properly

17 New Ways to Use NICOTINE REPLACEMENT (Supported by evidence and USPHS*) * Combine short- and long-acting forms Patch plus regimen * Extend treatment to prevent relapse Start NRT 2 weeks before quit date Reduce to quit strategy

18 BUPROPION SR (Zyban, Wellbutrin SR) Doubles cessation rate; mechanism independent of its antidepressant effect Reduces post-cessation weight gain Quit rates higher if add counseling Reduces seizure threshold (risk: 1/1000)

19 NH VARENICLINE N N Binds selectively to the α4β2 nicotinic receptor, which mediates nicotine dependence Dual mechanism of action Partial agonist Stimulates receptor to treat craving, withdrawal Antagonist Prevents nicotine from binding to the receptor Blocks reward; reduces reinforcement of smoking

20 VARENICLINE SAFETY The Dilemma Smokers have an increased risk of suicide. Stopping smoking produces nicotine withdrawal symptoms (depressed mood, anxiety, and irritability) When these symptoms occur in a smoker who is stopping smoking on varenicline, is it the drug or quitting smoking that causes the symptom? Case reports cannot answer this question. Clinical trials of varenicline detected no excess of depression or suicidal thoughts, but these studies did not include patients with mental illness.

21 FDA Public Health Advisory July 2009 Chantix (varenicline) and Zyban (bupropion) have been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions. FDA is requiring the manufacturers of both products to add a new Boxed Warning: People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away. Friends or family members

22 VARENICLINE SAFETY Cohort study (Gunnell et al, BMJ 2009) UK General Practice Research Database Population based data: 3.6 million patients in 500 practices Data from electronic medical records Sample: Patients starting medication (9/06 5/08) NRT (n=63,265) Bupropion (n=6422) Varenicline (n=10,973) Outcome: Rates of suicide, suicide attempt, suicidal thoughts, and new antidepressant therapy Results: No evidence of increased risk of suicidal outcomes for varenicline vs NRT, bupropion vs NRT

23 VARENICLINE SAFETY The Bottom Line Varenicline may increase risk of psychiatric symptoms in some patients. The potential risk is not yet well defined. Prescribing varenicline, like prescribing any drug, requires balancing risks and benefits. - Varenicline is one of the most effective drugs available to treat tobacco dependence - Continuing to smoke is clearly hazardous In most cases, the benefits of varenicline outweigh the risks

24 Which drug is most effective? Meta-analysis for 2008 USPHS Guideline Drug Estimated OR (95% CI) Nicotine patch Other nicotine products or bupropion 1.0 (reference) Not significantly different from nicotine patch Varenicline 1.6 ( ) Combinations Long-term patch + gum or nasal spray 1.9 ( ) Patch + bupropion SR 1.3 ( )

25 Two head-to-head randomized trials Piper, Arch Gen Psychiat 2009; Smith, Arch Int Med 2010 Tested five drug treatments (vs placebo) l l Monotherapy: Patch, lozenge, bupropion Combos: Patch + lozenge, bupropion + lozenge Tested drugs in two settings l Clinical trial (on-site counseling) l Results l l l Primary care clinics (using state quitline) Each drug was better than placebo Combinations were better than monotherapy No combination was better than the other

26 PHYSICIAN INTERVENTION Routine advice to quit is effective á Odds of quitting by 66% (vs. no advice) * Brief counseling is more effective á Odds of quitting by 37% (vs. advice) * Brief intervention by other clinicians are also effective (slightly less than by MD) * Cochrane reviews

27 5As BRIEF COUNSELING MODEL 2000 U.S. Public Health Service Guidelines l ASK all patients about smoking l ADVISE all smokers to quit l ASSESS smoker s readiness to quit l ASSIST smokers to quit (counsel + meds) l ARRANGE follow-up care

28 5As BRIEF COUNSELING MODEL Team Approach or AA&R l ASK Done by office staff (ie, vital sign) l ADVISE l ASSESS l ASSIST l ARRANGE Core physician role Core physician role In office or community resource Refer for f/u support (ie, quitline )

29 5As BRIEF COUNSELING MODEL ASSIST: Develop a Quit Plan (STARS) l SET Quit date (within 2 weeks) l TELL Family, friends, co-workers l ANTICIPATE Challenges l REMOVE Tobacco products, matches, etc l SUPPLEMENTAL Materials for support (may include medication instructions, IVR, website, etc)

30 5As BRIEF COUNSELING MODEL ARRANGE: Follow up l Discuss medication use questions or problems l Ask about successes and lapses l Use learning and skill building opportunities l Provide support and encouragement l Offer guidance for problem solving l Adjust quit plan as needed

31 Discussion and Q & A with Ken Wassum Acknowledgements: Slides adapted with permission from Nancy Rigotti, MD Follow-up: Interactive training modules for treating tobacco use and dependence available at: