Zotti Maria Gioconda. Dalla BPCO all'Insufficienza respiratoria: gestione terapeutica degli stadi di gravità. ASMaD 2010
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Zotti Maria Gioconda. Dalla BPCO all'Insufficienza respiratoria: gestione terapeutica degli stadi di gravità. ASMaD 2010
- 1. Dalla BPCO all’ Insufficienza Respiratoria: gestione Terapeutica degli Stadi di Gravità Dott.ssa Mariagioconda Zotti Dir. Medico U.O.C. Med. D’Urgenza - Pneumologia P.O. Nord Azienda USL di Latina
- 3. PROGETTO MONDIALE BPCO 2010 Livelli di evidenza CATEGORIA FONTE A Studi randomizzati controllati, elevato numero di studi B Studi randomizzati controllati, scarso numero di studi C Studi non randomizzati e studi osservazionali D Opinione di un gruppo di esperti
- 14. GOLD 2010 - Classificazione spirometrica (post-broncodilatatore) di gravità della BPCO STADIO CARATTERISTICHE I LIEVE VEMS/CVF < 0.7; VEMS ≥ 80% del teorico II MODERATA VEMS/CVF < 0.7; 50% ≤ VEMS < 80% III GRAVE VEMS/CVF < 0.7; 30% ≤ VEMS < 50% IV MOLTO GRAVE VEMS/CVF < 0.7; VEMS < 30% del teorico o VEMS < 50% del teorico in presenza di insufficienza respiratoria (PaO 2 < 60 mmHg)
- 16. Deterioramento funzione respiratoria/sintomi Sutherland ER and Cherniack N Engl J Med 2004;350: 2689-2687 I sintomi della BPCO compaiono quando il Fev1 è già in prossimità del 50%
- 18. BPCO: Terapia
- 27. Stadio I Lieve © 2010 PROGETTO LIBRA • www.goldcopd.it VEMS/CVF < 0.7 VEMS ≥ 80% Con o senza s intomi cronici Caratteristiche Trattamento raccomandato Broncodilatatori a breve durata d’azione solo al bisogno
- 32. Studio TORCH
- 33. Celli et al: analisi post-hoc studio TORCH (2009)
- 35. TORCH: disegno dello studio SALM/FP 50/500 µ g bd (n=1533) SALM 50 µg bd (n=1521) Placebo (terapie convenzionali) (n= 1524) Durata dello studio di 3 anni 2 settimane run-in FP 500 µg bd (n=1534) Vestbo et al. Eur Respir J 2004
- 37. Tasso di esacerbazioni moderate-gravi in 3 anni *p < 0.001 vs placebo; † p = 0.002 vs SALM; ‡ p = 0.024 vs FP Numero medio di esacerbazioni/anno 1.13 0.97 * 0.93 * 0.85 * †‡ 25% riduzione 0 0.2 0.4 0.6 0.8 1 1.2 Placebo SALM FP SALM/FP Trattamenti -43% gravi con aggiunta di OCs
- 40. SGRQ Punteggio totale – 5 – 4 – 3 – 2 – 1 0 1 2 3 0 24 48 72 96 120 156 Variazione media corretta del punteggio totale del SGRQ Tempo (settimane) Risultati Qualita’ vita Placebo SALM * FP † *p = 0.057 vs placebo; † p < 0.001 vs placebo; †† p < 0.001 vs placebo, SALM and FP; v ertical bars are standard errors Numero di soggetti 1149 1148 1155 1133 854 906 942 941 781 844 848 873 726 807 807 814 675 723 751 773 635 701 686 731 569 634 629 681 SALM/FP ††
- 42. UPLIFT (5993 pz): Declino del FEV 1 Declino del FEV1: nessuna differenza tra tiotropio e placebo Il declino annuo era di 30 ml (tiotropio) vs 30 ml (placebo) per il FEV1 pre-broncodilatatore (p=0.95) e di 40 ml vs 42 ml per il FEV1 post-broncodilatatore (p=0.21)
- 43. Studio UPLIFT Vi è tuttavia una significativa riduzione delle riacutizzazioni p<0,001 L’impatto sulla mortalita’ non è significativo p<0,09
- 46. Sospendere il trattamento con gli ICS determina peggioramento della funzionalità respiratoria Wouters E.F.M. Thorax 2005;60; 480-487 Studio COSMIC: risultati dello studio
- 47. Sospendere il trattamento con gli ICS determina peggioramento della dispnea e dei sintomi diurni e notturni e un maggiore utilizzo di farmaci al bisogno Wouters E.F.M. Thorax 2005;60; 480-487 Studio COSMIC: risultati dello studio
- 69. Algoritmo per la gestione della riacutizzazione della BPCO a domicilio © 2010 PROGETTO LIBRA • www.goldcopd.it Inizio o aumento dei broncodilatatori Rivalutare entro poche ore Risoluzione o miglioramento dei segni e dei sintomi Nessun miglioramento Continuare il trattamento riducendolo quando è possibile Rivalutare entro poche ore Rivalutare il trattamento a lungo termine Peggioramento dei sintomi Ospedalizzazione Corticosteroidi per via orale eventuale antibioticoterapia 146
- 70. Riacutizzazioni Terapia antibiotica Stratificazione dei pazienti con BPCO riacutizzata per il trattamento antibiotico ed il microrganismo potenzialmente coinvolto in ciascun gruppo © 2010 PROGETTO LIBRA • www.goldcopd.it Gruppo B più P. aeruginosa Riacutizzazione grave con fattori di rischio per infezione da P. aeruginosa Gruppo C (fluorchinolonici o beta-lattamici con effetto su P. Aeruginosa) Gruppo A più microrganismi resistenti (produttori di -lattamasi, S . pneumoniae penicillina resistenti), Enterobacteriaceae ( K. pneumoniae, E. coli, Proteus, Enterobacter, ecc.) Riacutizzazione moderata con uno o più fattori di rischio per esito infausto Gruppo B ( b-lattamici/inibitori delle b-lattamasi, fluorchinolonici, cefalosporine di 2^-3^) H. influenzae S. pneumoniae M. catarrhalis Chlamydia pneumoniae Virus Riacutizzazione lieve: nessun fattore di rischio per esito infausto Gruppo A (Beta-lattamici, tetracicline, Trimetoprim/ Sulfametossazolo) Microrganismi Definizione a Gruppo a Fattori di rischio per esito infausto in pazienti con riacutizzazione di BPCO: presenza di comorbidità, BPCO grave, frequenti riacutizzazioni (>3/anno) e terapia antibiotica negli ultimi tre mesi 149
- 78. NIMV: Indicazioni sulla sede di applicazione © 2010 PROGETTO LIBRA • www.goldcopd.it Gravità Degenza ordinaria UMR UTIIR UTIR se non MOF UTI se MOF pH > 7.36 pH 7.36 -7.30 pH <7.30; Paz. Vigile Farmaci+Ossigeno NIMV + Terapia Medica NIMV IOT o NPPV o NPV pH < 7.25 e/o Alterazione dello stato neurologico, Fatica muscolare, Indicazione alla IOT, MOF Luogo di cura IOT: Intubazione Oro-Tracheale MOF: Multi Organ Failure UMR : Unità di Monitoraggio Respiratorio UTIIR : Unità di Terapia Intensiva Intermedia Respiratoria UTIR : Unità di Terapia Intensiva Respiratoria UTI: Unità di Terapia Intensiva Trattamento
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- QUESTI SONO I PRINCIPALI STUDI CHE NELL’ARCO DI UN DECENNIO HANNO DETERMINATO L’ATTUALE ATTEGGIAMENTO TERAPEUTICO NELLA BPCO. IN PARTICOLARE LO STUDIO TORCH RAPPRESENTA UNA PIETRA MILIARE IN QUANTO DISEGNATO SPECIFICAMENTE PER INDAGARE L’EFFETTO SULLA MORTALITA’ DELLE TERAPIE CONVENZIONALI FINO ALL’INIZIO DEL 2000 E QUELLO DELL’ASSOCIAZIONE SALMETEROLO/FLUTICASONE 04/04/11 17:03
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- NELL’ANALISI POST HOC CONDOTTA DAL PROF. CELLI SI PERVIENE ALLO STESSO RISULTATO 04/04/11 17:03
- 04/04/11 17:03 The primary endpoint of the TORCH trial 1 was the effect of SALM/FP 50/500 µ g combination versus placebo on all-cause mortality over 3 years in patients with moderate-to-severe COPD. All-cause mortality was chosen as the primary endpoint as COPD because it is important to ensure that treatment is not reducing mortality from one cause, while increasing mortality from another. This makes all-cause mortality a more robust endpoint than looking for one single cause of death. COPD is a multicomponent disease and patients die from causes other than COPD, including lung cancer, heart disease and stroke. 2 Additionally, all-cause mortality is not dependent on coding practice, which can differ between countries, and it can be very difficult to reliably differentiate between death due to COPD specifically and that where COPD was a contributing factor. Patients who withdrew prematurely from the study were also followed-up with regular contact for 3 years from the date of randomisation in order to determine survival status. Secondary endpoints of the TORCH trial were: COPD morbidity as measured by the rate of exacerbations Health-related quality of life (HRQoL) as measured by the St. George’s Respiratory Questionnaire (SGRQ) at 24-weekly intervals. References 1. Vestbo J, TORCH Study Group. The TORCH (TOwards a Revolution in COPD Health) survival study protocol. Eur Respir J 2004;24:206–10. 2. Sin DD, Anthonisen NR, Soriano JB, Agusti AG. Mortality in COPD: role of comorbidities . Eur Respir J 2006; accepted.
- 04/04/11 17:03 TOwards a Revolution in COPD Health (TORCH) is a 3-year, international, multicentre, placebo-controlled, double-blind, randomised, parallel group trial. 1 Patients with moderate-to-severe COPD were recruited. The inclusion criteria for patients in TORCH were: Age 40–80 years An established clinical history of COPD A smoking history of 10 pack years Baseline forced expiratory volume in one second (FEV 1 ) < 60% predicted (pre-bronchodilator) < 10% reversibility in predicted FEV 1 and a FEV 1 /forced vital capacity (FVC) ratio 70%. The study design included a 2-week run-in period, a 3-year treatment phase and a 2-week follow-up phase. Patients were randomised to one of the following four treatment groups, all administered twice daily via the Diskus dry powder inhaler device Placebo SALM 50 µg – a long-acting 2-agonist FP 500 µg – an inhaled corticosteroid SALM/FP 50/500 µg. All medications for conditions other than COPD were permitted during the study. Treatment for smoking cessation was permitted. Permitted COPD medications included theophyllines (long and short-acting), short-acting anticholinergics agents and short-acting β2-agonists Salbutamol was provided for use as relief medication throughout the study. Inhaled corticosteroids and long-acting bronchodilators (including both long-acting β2-agonists and long acting anticholinergic agents) were stopped at Visit 1 (prior to run-in). Subjects were told not to start treatment with these medications (other than the blinded study medication) during the treatment period. Long-term use of systemic corticosteroids (defined as chronic, continuous use for greater than 6 weeks) was prohibited. Subjects could take short courses of systemic corticosteroids, where necessary, for the treatment of an exacerbation. Courses of systemic corticosteroids separated by a period of less than 7 days were considered as continuous use. During the study (including run-in and follow-up periods), changes in COPD medication were permitted (e.g., for the treatment of exacerbations). Reference 1. Vestbo J, TORCH Study Group. The TORCH (TOwards a Revolution in COPD Health) survival study protocol. Eur Respir J 2004;24:206–10. N=
- 04/04/11 17:03 Moderate exacerbations are defined as those which require treatment with systemic corticosteroids and/or antibiotics; severe exacerbations are defined as those which require hospitalisation. The exacerbation rate was calculated as the total number of moderate and/or severe exacerbations experienced by a patient during the treatment period. The number of exacerbations was analysed using a generalised linear model, assuming the Negative Binomial distribution, with time on treatment as an offset variable. The model included adjustments for the effects of smoking status, age, gender, baseline FEV 1 , number of exacerbations reported in the 12 months prior to screening, and region. SALM/FP significantly lowered the rate of moderate/severe exacerbations compared with placebo (25% reduction, p < 0.001), SALM (12% reduction, p = 0.002) and FP (9% reduction, p = 0.024). SALM and FP also had significantly lower exacerbation rates than placebo (15%, p < 0.001 and 18%, p < 0.001, respectively). SALM/FP reduced the rate of moderate-to-severe exacerbations to a much greater extent than placebo or either of the component monotherapies. Exacerbations and hospitalisations predict the risk of dying from COPD over 5 years. 1 Reference Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005;60:925–31.
- 04/04/11 17:03 The St George’s Respiratory Questionnaire (SGRQ) was used to record patient health status. The Health Outcomes population comprised 4,951 patients from 28 countries in which a validated SGRQ exists. A transformed score was calculated for each of the SGRQ’s three domains (symptoms, impacts and activity) as well as the overall total score. SGRQ was analysed as change from baseline using repeated measures analysis of covariance (ANCOVA). This model included treatment, smoking status, age, gender, baseline FEV 1 , BMI, region, visit (as a categorical variable) and treatment by visit. Baseline SGRQ and visit by baseline SGRQ were included in the model. Estimated treatment differences at each visit were averaged with equal weights to obtain the overall treatment effect over the study period. Total SGRQ score improved initially from baseline in all groups, the greatest changes occurring with SALM/FP treatment (a decrease in SGRQ score indicates improvement). The improvement in SGRQ total score at 6 months in patients taking SALM/FP was already statistically significant compared with placebo (p = 0.001). The adjusted mean change in SGRQ total score at 3 years was –1.2 for patients taking SALM/FP, –0.2 for patients taking FP, 1.0 for patients taking SALM and 2.1 for patients taking placebo. At 3 years, patients taking SALM/FP had still not returned to baseline SGRQ and these patients were more likely to maintain health status or achieve a 4 unit improvement than those patients taking placebo, SALM or FP. From these results, patients taking steroid-containing medications had the greatest improvement in total SGRQ score at 3 years. Although a clinically relevant 4 unit difference from baseline SGRQ total score was not achieved over 3 years, at 1 year, a 4 unit improvement (raw change) in SGRQ total score was observed in patients taking SALM/FP (the only group to show this). It is important to remember that the fitter patients on placebo remain in the study for longer, which biases against the treatment effect of SALM/FP (see backup slides) COPD is a progressive disease in which health status declines over time, so these results for patients taking SALM/FP (in whom SGRQ score had still not returned to baseline at 3 years and in which SGRQ score was significantly greater than placebo and components) is very important.
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