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PRESENTAZIONE E DISCUSSIONE DEGLI ELABORATI DEI GRUPPI DI LAVORO

PRESENTAZIONE E DISCUSSIONE DEGLI ELABORATI DEI GRUPPI DI LAVORO. Nuovi trattamenti della BPCO F. Luppi, B. Beghè, L. Corbetta . Nuovi trattamenti per la BPCO Indacaterolo.

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PRESENTAZIONE E DISCUSSIONE DEGLI ELABORATI DEI GRUPPI DI LAVORO

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  1. PRESENTAZIONE E DISCUSSIONE DEGLI ELABORATI DEI GRUPPI DI LAVORO Nuovi trattamenti della BPCO F. Luppi, B. Beghè, L. Corbetta

  2. Nuovi trattamenti per la BPCOIndacaterolo Indacaterolo è il primo Ultra-LABA approvato dall’Agenzia Regolatoria Europea (EMEA) nel dicembre 2009 indicato come terapia broncodilatatrice di mantenimento nell’ostruzione del flusso aereo in pazienti adulti con broncopneumopatia cronica ostruttiva (BPCO). Indacaterolo, somministrato una volta al giorno alle dosi di 150 e 300 microgrammi, ha costantemente prodotto un miglioramento significativo della funzione polmonare nelle 24 ore con un rapido inizio d’azione, entro 5 minuti dall’inalazione. Tale miglioramento è risultato superiore a quello del salmeterolo e del formoterolo. Barnes PJ, Pocock SJ et al. Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. Pulm Pharmacol Ther. 2010 Jan 18 2

  3. This study discriminated between the effects on IC and FEV1 of once daily indacaterol and twice daily formoterol. The greater effect of indacaterol on IC may translate into improved long-term clinical outcomes. Pulm Pharmacol. Ther. 2009; 22: 492-496

  4. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomized clinical trials 1.2 1.1 Mean FEV1 [L] 1 1536 1473 1336 1262 1210 1152 1100 1061 1024 roflumilast* 1554 1506 1419 1375 1306 1241 1167 1102 1072 placebo* 0 4 8 12 20 28 36 44 52 Weeks placebo (pre) roflumilast 500µg (pre) placebo (post) roflumilast 500µg (post) *N patients are given for pre-FEV1 measurements Data on file

  5. Roflumilast as Add-On Therapy in COPD Pre-bronchodilator FEV1 1.6 Salmeterol+ Roflumilast 1.5 Pre bd FEV1 [L] 1.4 Salmeterol + Placebo 466 467 455 463 410 437 389 419 374 403 359 384 Roflumilast Placebo 1.3 0 4 8 12 18 24 Weeks Fabbri LM, Calverley PMA et al. Lancet 2009;374:695–703

  6. Roflumilast as Add-On Therapy in COPD Pre-bronchodilator FEV1 1.7 Tiotropium+ Roflumilast 1.6 Pre bd FEV1 [L] 1.5 Tiotropium + Placebo 371 372 364 363 343 352 325 350 318 347 310 333 Roflumilast Placebo 1.4 0 4 8 12 18 24 Weeks Fabbri LM, Calverley PMA et al. Lancet 2009;374:695–703

  7. Anti-TNF treatment in COPD • Van der Vaart et al. First Study of Infliximab Treatment in Patients with Chronic Obstructive Pulmonary Disease. AJRCCM. 2005 In this short-term study, no clinically beneficial effects of infliximab were observed, and there were no significant safety issues. • Rennard SI et al. The Safety and Efficacy of Infliximab in Moderate to Severe Chronic Obstructive Pulmonary Disease. AJRCCM. 2007 Subjects with moderate to severe COPD did not benefit from treatment with infliximab. Although not statistically significant, more cases of cancer and pneumonia were observed in the infliximab-treated subjects.

  8. Targets for new COPD therapies Barnes PJ. Chest. 2008. 134:1278-1286

  9. Recently approved medication and investigational drugs • Nebulized formoterol (twice a day)* • LAMA (aclidinium) • Once a day LABA (indacaterol, carmoterol and others) • Once a day combination therapies • ICS-LABA • LABA-LAMA • PDE-4 inhibitors * Recently approved LABAs = long-acting β2-agonists

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