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Terapia della fase stabile della BPCO: farmacoterapia

Terapia della fase stabile della BPCO: farmacoterapia. Dr. Claudio Micheletto – Legnago (VR). …. GOALS FOR TREATMENT OF STABLE COPD Reduce symptoms Relieve symptoms Improve exercise tolerance Improve health status Reduce risk Prevent disease progression Prevent exacerbations

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Terapia della fase stabile della BPCO: farmacoterapia

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  1. Terapia della fase stabile della BPCO: farmacoterapia Dr. Claudio Micheletto – Legnago (VR)

  2. …..

  3. GOALS FOR TREATMENT OF STABLE COPD • Reduce symptoms • Relieve symptoms • Improve exercise tolerance • Improve health status • Reduce risk • Prevent disease progression • Prevent exacerbations • Reduce mortality Am J Resp Crit Care 2013

  4. La scelta terapeutica deve essere adeguata per la singola persona e guidata dalle caratteristiche e dalla gravità del quadro clinico considerato nel suo insieme di sintomi, funzione respiratoria, complicanze, comorbilità e delle peculiarità individuali (fenotipo) della persona che ne è affetta.

  5. Am J RespCrit Care Med 1995

  6. The COPD dilemma COPD is defined by the presence of airflow limitation that is not fully reversible, and its treatment is mostly guided by the severity of this limitation. Han AJRCC 2010

  7. The COPD dilemma it is now widely recognized that COPD is a complex syndrome with pulmonary and extrapulmonary components. Importantly, significant heterogeneity exists with respect to clinical presentation, physiology, imaging, response to therapy, decline in lung function, and survival. Han AJRCC 2010

  8. The COPD dilemma There is consensus that FEV1 by itself does not adequately describe the complexity of the disease and that FEV1 cannot be used in isolation for the optimal diagnosis, assessment, and management of the disease. 4 3 2 1 (C) (D) (A) (B) ≥2 RISK Exacerbation history RISK GOLD classification of Airflow Limitation 1 0 mMRC 0-1 mMRC ≥ 2 CAT < 10 CAT ≥ 10 Symptoms Vestbo J, et al. AJRCCM 2013

  9. Vestbo J, et al. AJRCCM 2013

  10. GOLD 2013Manage Stable COPD: PharmacologicTherapy SAMA: antimuscarinici a breve durata d’azione; SABA: β2-agonisti a breve durata d’azione; p.r.n.: all’occorrenza (pro re nata); LAMA: antimuscarinici a lunga durata d’azione; LABA: β2-agonisti a lunga durata d’azione; ICS: corticosteroidi per via inalatoria; PDE-4: fosfodiesterasi-4 Summary handout, Revised GOLD 2011 www.goldcopd.org/guidelines-gold-summary-2011.html

  11. The identification and subsequent grouping of key elements of the COPD syndrome into clinically meaningful and useful subgroups (phenotypes) that can guide therapy more effectively is a potential solution of the dilemma Han KM, et al. Am J RespirCrit Care Med 2010; 182, 598-564

  12. Phenotypes – an operational definition ‘‘a single or combination of disease attributes that describe differences between individuals with COPD as they relate to clinically meaningful outcomes (symptoms, exacerbations, response to therapy, rate of disease progression, or death).’’ Han KM, et al. Am J Respir Crit Care Med 2010; 182, 598-564

  13. GOLD 2013

  14. Efficacy of Tiotropium in COPD Patients with FEV1 ≥ 60% participating in the UPLIFT® Trial - SGRQ~40 Tashkin DP, et al J COPD 2012

  15. Efficacy of Tiotropium in COPD Patients with FEV1 ≥ 60% participating in the UPLIFT® Trial Tashkin DP, et al J COPD 2012

  16. GOLD Stage II: Exacerbations *Hazard ratio (control vs. tiotropium) and P-value were estimated using Cox regression. †Rate ratio (tiotropium/control) and P-value were estimated using the Poisson with Pearson overdispersion model adjusting for treatment exposure. Decramer et al. Lancet 2009; 374: 1171-78

  17. Indacaterolo 300 µg Indacaterolo µg 150 Tiotropio • ††† • *** • ††† • *** • 220 • 190 • ††† • *** • 180 • ††† • *** • *** • 200 • 160 • 160 • ††† • *** • *** • 180 • 150 • ††† • *** • 140 • *** • 160 • 130 • *** • 120 • 120 • 140 • 110 • *** • 120 • MCID • FEV1 (ml) • 90 • 100 • ** • 80 • 50 • 60 • 40 • 20 • 0 • 5 • 15 • 30 • 60 • Tempo dopo la dose (min) **p<0,01; ***p<0,001 vs placebo. †††p<0,05 vs tiotropio Aumenti rispetto al basale a 5 min post-dose: 60 ml (4,4%) con tiotropio, 130 ml (9,7%) con indacaterolo 150 µg e 140 ml (10,2%) con indacaterolo 300 µg. Vogelmeier et al. Respiratory Research 2010

  18. 3.0 2.0 1.0 0 *** † *** *** *** *** *** 1 punto 1 punto TDI focal score Settimana 12 Settimana 26 • Media dei minimi quadrati (LSM).. ***p<0.001 vs placebo; +p<0.05 vs tiotropio BRACCIO IN APERTO • Differenza ≥1 = miglioramento clinicamente significativo del TDI score Donohue et al. Am J RespirCrit Care Med 2010

  19. Pazienti (%) con variazione clinicamente importante del punteggio totale SGRQ Punteggio totale SGRQ Differenza -2,1 (p<0,001) 51,0 47,0 43,0 39,0 35,0 Oddsratio 1,43 (p<0,001) MIGLIORAMENTO SGRQ = St. George’s RespiratoryQuestionnaire (questionario respiratorio St. George) L.J Dunn , R Buhl et al. Studio Intensity

  20. Aclidinium improves trough FEV1: 150 Placebo BID Aclidinium 400 µg BID *** 100 *** *** *** *** *** 50 128 mL Change from baselinein trough FEV1 (mL) 0 -50 -100 0 4 8 12 16 20 24 Treatment week ***p0.001 vs placebo Jones et al, Eur Respir J 2012

  21. Aclidinium reduces COPD exacerbation(any severity) rates (24 weeks) 1.6 Placebo BID 1.39 Aclidinium 400 µg BID 29% 1.2 0.98* COPD exacerbations(/pt/year) 0.8 0.60 33% 0.40* 0.4 0.0 Healthcare ResourceUtilization criteria EXACTcriteria *p<0.05 vs placebo Jones et al, CHEST 2012

  22. Nelle persone in regolare trattamento farmacologico, valutare ad ogni visita programmata: • la corretta e regolare assunzione della terapia • la valutazione dei sintomi ed in particolare, la tolleranza all’esercizio fisico e la dispnea da sforzo

  23. le modificazioni della funzione polmonare non solo in termini di FEV1 ma anche di altri parametri come i volumi polmonari e la DLCO • la frequenza con la quale la persona ricorre a broncodilatatori a breve durata d’azione come supporto occasionale

  24. la frequenza e gravità degli episodi di riacutizzazione • la frequenza e la durata degli episodi di ospedalizzazione • la frequenza e la gravità di eventuali eventi collaterali e/o avversi

  25. GOLD 2013

  26. Kaplan–Meier Curves for the Primary and Selected Secondary Outcomes. • These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. Vogelmeier C et al. N Engl J Med 2011;364:1093-1103

  27. GOLD 2013

  28. JA van Noord, et al . Eur Resp J 2005; 26: 214-22.

  29. Dual bronchodilation with QVA149:the SHINE study2/3 moderati; quasi 80% no riac. Sintomatici per entry. SGRQ >40 Bateman et al Eur Respir J. 2013

  30. Pre-dose trough FEV1 was significantly higher with QVA149 vs glycopyrronium and tiotropium at all assessments 0 Differences between QVA149 and glycopyrronium and tiotropium were statistically significant (p<0.0001) at each assessment during the treatment period. Data are least squares means ±SE Wedzicha JA, et al. Lancet Resp Med 2013 1 (3): 199-209

  31. Rate reduction of COPD exacerbations 0.86** (0.78, 0.94) 0.84* (0.75, 0.95) 0.85†† (0.77, 0.94) 0.85† (0.75, 0.96) 0.90‡ (0.79, 1.02 1.16¶ (0.84, 1.61) 0.88§ (0.77, 0.99) 0.81|| (0.60, 1.10) Values are rate reduction (95% CI); n numbers per treatment group: QVA149 n=729; glycopyrronium n=739; tiotropium n=737. *p=0.0052,†p=0.0072,‡p=0.096,§p=0.038,¶p=0.36,||p=0.18,**p=0.0017,††p=0.0012. Wedzicha JA, et al. Lancet Resp Med 2013 1 (3): 199-209

  32. FEV1AUC0–12hat Week 26No riac per inclusione ; >80% moderati.. ∆=138 mL, p<0.0001 FEV1 AUC 0–12h ( L) Fluticasone/salmeterol500/50 μg QVA149110/50 μg Values are least-squares mean ± standard error Vogelmeier CF, et al. Lancet Resp Med. 2012

  33. Mean SGRQ-C total score Improvement Data are LSM (SE); Mean difference in SGRQ-C total score for QVA149 versus SFC at Week 26 was –1·24 (p=0·245); SGRQ=St George’s Respiratory Questionnaire; LSM=least squares mean; SE=standard error; SFC=salmeterol/fluticasone Vogelmeier CF, et al. Lancet Resp Med. 2012

  34. GOLD 2013

  35. 1.30 1.5 1.04 1.05 0.97 ** ** * number/patient/year 1 0.5 0 PLA SAL50 FP500 SFC50/500 In the TRISTAN study, FP/Salm combination reduced the number of severe exacerbations * p< 0.001 vs PLA ** p = 0.003 vs PLA Calverly et al, Lancet 2003

  36. TORCH Study: additional effect of salmeterol/fluticasone vs both monotherapies FEV1≤60% Calverley MD, et al. New Eng J Med 2007, Vol.356 (8): 775-210

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