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Tabagismo: tratamento expandido. Prof. Dr. José Miguel Chatkin Faculdade de Medicina PUCRS Progama de Auxílio à Cessação do Tabagismo. Data: 23 novembro 2008 Horário: 16:40 – 17:05. Different determinants for individual smoking and for populatin smoking.
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Tabagismo:tratamento expandido Prof. Dr. José Miguel Chatkin Faculdade de Medicina PUCRS Progama de Auxílio à Cessação do Tabagismo Data: 23 novembro 2008 Horário: 16:40 – 17:05
Different determinants for individual smoking and for populatin smoking
Table 1.1: Topics chosen by the USPHS 2008 Guideline Panel for updated meta-analysis Effectiveness of proactive quitlines Effectiveness of combining counseling and medication relative to either counseling or medication alone Effectiveness of varenicline Effectiveness of various medication combinations Effectiveness of long-term medication use Effectiveness of tobacco use interventions for individuals with low SES/limited formal education Effectiveness of tobacco use interventions for adolescent smokers Effectiveness of tobacco use interventions for pregnant smokers Effectiveness of tobacco use interventions for individuals with psychiatric disorders, including substance use disorders Effectiveness of providing tobacco use interventions as a health benefit Effectiveness of systems interventions, including provider training and the combination of training and systems interventions
Tratamento expandido: terapia cognitivo-comportamental terapia de reposição nicotínica bupropiona nortriptilina vareniclina
Adesivos de nicotina Collaborative European Anti-Smoking Evaluation: ERS 1999 CEASE trial
Extended Use: USPHS 2008 Update • For some patients, it may be appropriate to continue medication treatment for periods longer than is usually recommended. • Results of meta-analysis indicated that long-term patch and gum use are effective. • Evidence indicates that the long-term use of gum may be more effective than a shorter course of gum therapy. • The Lung Health Study reported that 1/3 of long-term quitters still were using nicotine gum at 12 months and some for as long as 5 years, with no serious side effects.
Extended Use: USPHS 2008 Update • Among patients given free access to nicotine gum, 15-20% of successful abstainers continue to use the gum for a year or longer. • Thus, certain groups of smokers may benefit from long-term medication use. • Although weaning should be encouraged for all patients using medications, continued use of such medication clearly is preferable to a return to smoking with respect to health consequences. • Finally, it should be noted that the medication treatment that produced the largest effects on abstinence rates, of those analyzed, involved long-term nicotine patch therapy + ad libitum NRT
Bupropiona • Bupropiona por 7 semanas – fase aberta • 59% abstinentes: eram então randomizados para TCC + BUP ou TCC + PLAC tratamento por 45 sem seguimento 52, 78, 104 semanas
Bupropiona • Resultados: • BUP52: 55,1% Plac52: 42,3% P=0,008 • BUP78: 47,7% Plac78: 37,7% P= 0,034 • BUP104: 41,6% Plac104: 40,0% P>0,05 • não controlado para TCC
BUP/PLA 26 sem BUP/PLA 26 sem 28% Bup 25% Plac 3% Bup 0% Plac P=0.73 P=0.12 Bupropiona J Clin Oncol, 2003 578 fumantes: TRN 8 semanas 31% abstinentes 69% fumantes
Bupropiona J Consult Clin Psychol, 2006
Bupropiona / TRN Croghan, Mayo Clin Proc 2007 1700 smokers: 566 TRN; 567 BUP; 567 BUP+TRN
Bupropiona / TRN Croghan, Mayo Clin Proc 2007
Bupropiona / TRN Croghan, Mayo Clin Proc 2007
Bupropiona / TRN Croghan, Mayo Clin Proc 2007
Bupropiona+ TRN Study Design: Single site 48 week duration 24-wk Rx-free Follow-up 16-wk D/Blind Maintenance 8-week Open Pbo + Pbo Pbo pill + Nicotine gum BUP + Pbo gum BUP + Nicotine Gum Wk 36 Wk 48 BUP Nicotine patch Success Counseling PHASE III PHASE I PHASE II
Bupropiona+ TRN Median days to relapse by treatment through 16-week maintenance and 24 week follow-up
Bupropiona+ TRN Abstinence rate at Week 24/26 Authors Bup N= Pbo N= Bupropion Abstinent N (%) Placebo Abstinent N (%) O.R. 95% C.I. p-value Meta-analysis of 3 maintenance trials of bupropion Hays, 2001 215 214 112 (52.3) 90 (42.3)* 1.50 1.02 - 2.19 0.04 Hurt, 2003 88 88 25 (28) 22 (25) 1.17 0.60 - 2.28 0.65 Covey, 2006 73 71 40 (54.8) 25 (35.2)* 2.23 1.14 - 4.36 0.02 Combined odds ratio 376 373 - - 1.54 1.14 - 2.07 0.01
Bupropiona+ TRN Abstinence rate at Week 24/26 Authors Bup N= Pbo N= Bupropion Abstinent N (%) Placebo Abstinent N (%) O.R. 95% C.I. p-value Meta-analysis of 3 maintenance trials of bupropion Hays, 2001 215 214 112 (52.3) 90 (42.3)* 1.50 1.02 - 2.19 0.04 Hurt, 2003 88 88 25 (28) 22 (25) 1.17 0.60 - 2.28 0.65 Covey, 2006 73 71 40 (54.8) 25 (35.2)* 2.23 1.14 - 4.36 0.02 Combined odds ratio 376 373 - - 1.54 1.14 - 2.07 0.01
Abstinence rate at Week 26/52 Authors Bup N= Pbo N= Bupropion Abstinent N (%) Placebo Abstinent N (%) O.R. 95% Confidence Interval p-value Meta-analysis of 3 maintenance trials of bupropion Hays, 2001 215 214 76 (35.5) 70 (32.1) 1.16 . 0.78-1.74 0.46 Hurt, 2003 88 88 19 (22) 13 (15) 1.60 0.74 - 3.46 0.23 Covey, 2006 73 71 23 (31.5) 13 (18.3) 2.05 0.94 - 4.47 0.07 Combined odds ratio 376 373 - - 1.36 0.98 - 1.88 0.06 Bupropiona+ TRN
Main conclusions • Extended BUP exerted a moderate benefit for reducing relapse (6 mo: OR 1.5 12 mo: OR 1.3) • This effect occurred mainly while using the drug (BUP) • Nicotine gum had limited appeal, but when used reduced relapse among some smokers Predictors of longer time to relapse • Older age • Low nicotine dependence (FTND) • Fewer cigarettes smoked daily • Lower cotinine at baseline • High BMI at screening (or at randomization)
Nortriptilina Hall, Am J Psychiatry, 2004
Nortriptilina Hall, Am J Psychiatry, 2004
Vareniclina Tonstadt, JAMA 2006 Stage 2: Double Blind Stage 1: Open Label 12 weeks - VAR 1 mg bid 12 additional weeks - VAR 1 mg bid vs placebo 70.5% stayed quit 603 subjects who quit randomized to varenicline 35.9% did not quit (n= 692) 61.1% quit (n=1236) 607 subjects who quit randomized to placebo 49.6% stayed quit Week 12 Weeks 13-24 varenicline varenicline varenicline placebo P<0.001 vs placebo
The place of varenicline in smoking cessation treatment Aveyard, Thorax Aug 2008 “While taking longer courses of VAR may prevent some relapse, lifetime VAR is unlikely to be a major solution. Instead, we need to develop cognitive-behavioral interventions together with judicious use of various medications.”
Tempo de tratamento influi na prevenção da recaída? Ineficaz: 1999: ERS– adesivo TRN 2003: Hurt – BUP+TRN 2006: Killen - BUP Eficácia limitada 2001: Hays – BUP Eficácia moderada 2006: Tonstad – VAR 2007: Covey: BUP;TRN Eficácia significativa 2000: Murray: goma TRN 2004: Hall: NOR 2005: Hajek: Cochrane 2006: Convey: vários esquemas 2006: Lancaster: revisão sistemática 2007: Crogham: BUP; TRN, BUP+TRN
Conclusões: Cochrane • Stead, 2006 • Hughes, 2007 • Cahill, 2008 • Não há evidências que suportem o tratamento estendido para cessação do tabagismo
Sims TH, Fiore MC, 2002 CNS Drugs 2002 Pharmacotherapy for treating tobacco dependence: • What is the ideal duration of therapy? • In what populations of smokers is long-term therapy an effective strategy?
Sims TH, Fiore MC, 2002 CNS Drugs 2002 Pharmacotherapy for treating tobacco dependence: • What is the ideal duration of therapy? • In what populations of smokers is long-term therapy an effective strategy? If a smoker is doing very well on nicotine replacement, with no adverse effects and full relief of withdrawal symptoms, yet has reached week 12, but states clearly that if we stop his/her NRT, they will most likely return to smoking, do we stop the treatment because the clock has struck 12 weeks? Steinberg MB 2008
Sims TH, Fiore MC, 2002 CNS Drugs 2002 Pharmacotherapy for treating tobacco dependence: • What is the ideal duration of therapy? • In what populations of smokers is long-term therapy an effective strategy? If a smoker is doing very well on nicotine replacement, with no adverse effects and full relief of withdrawal symptoms, yet has reached week 12, but states clearly that if we stop his/her NRT, they will most likely return to smoking, do we stop the treatment because the clock has struck 12 weeks? Individualized duration of treatment for this and other medical conditions is the best practice and the ethical thing to do for these few smokers. As far as I know, there are no clinical trial data supporting the use of statins for 40 or more years. However, right now, my patients can have their cholesterol lowering medications continued indefinitely. Are smokers less worthy of treatment than non-smokers? Steinberg MB 2008
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