Tractament farmacològic de l MPOC LAMA-LABA

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1 Tractament farmacològic de l MPOC LAMA-LABA Pilar Ausín

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7 SABA-SAMA vs LABA-LAMA

8 EPOC moderado 65 años Exfumador (50 PA) FEV 1 : 58% Camina: 400 m BMI: 23 Disnea grado 1

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10 Estadio II de GOLD Función Pulmonar * * * * * * * * * Peak FEV 1 Tio vs. control = ml * * * * * * * * * Trough FEV 1 Tio vs. control = ml Day 30 (steady state) Month *P< vs. control. Repeated measure ANOVA was used to estimate means. Estimated means are adjusted for baseline measurements. Month 0 values are observed means. Patients with 3 acceptable PFTs after day 30 were included in the analysis. Tiotropium: Month 0 n = 1196, Month 48 n = 923; Control: Month 0 n = 1140, Month 48 n = 853

11 Improvement SGRQ Total Score (Units) Estadío II de GOLD : Calidad de Vida 50 Tiotropium Control 45 Diferencia: units (p<0.001 at all time points) * * * * * * * * Month *P< vs. control. Repeated measure ANOVA was used to estimate means. Estimated means are adjusted for baseline measurements. Month 0 values are observed means. Patients with 2 acceptable SGRQ Total Scores after Month 6 were included in the analysis. Tiotropium: Month 0 n = 1179, Month 48 n = 906; Control: Month 0 n = 1117, Month 48 n = 833

12 Exacerbaciones: Estadio II de GOLD Tiotropium Control Ratio (95% CI) P-value n = 1384 n = 1355 Tiempo hasta 1ª exacerbación 23.1 (21.0, 26.3) 17.5 (15.9, 19.7) 0.82 (0.75, 0.90)* <0.0001* # exacerbaciones/pt yr mean (95% CI) 0.56 (0.52, 0.60) 0.70 (0.65, 0.75) 0.80 (0.72, 0.88) < *Hazard ratio (control vs. tiotropium) and p-value were estimated using Cox regression with treatment, GOLD stage, and treatment by GOLD stage interaction as covariates. Ratio (tiotropium/control) and p-value were estimated using the Poisson with Pearson overdispersion model adjusting for treatment exposure. Randomized patients taking 1 dose of study medication were included in the analysis.

13 EPOC MODERADO Infravaloración de síntomas Poca variabilidad Adherencia al tratamiento

14 SABA ó SAMA vs LABA + LAMA

15 EPOC moderado 70 años Exfumador (50 PA) FEV 1 : 52% Camina: 350 m BMI: 20 Disnea grado 3

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17 Broncodilatadores larga duración Efecto sobre FEV 1 durante 12 h de salmeterol y salmeterol+ ipratropio van Noord et al. ERJ 2000;15:

18 QVA 149: Indacaterol 300 μg/glycopyrronium 50 μg Van Noord et al. Thorax 2010; 65:

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23 EPOC moderado alto nivel de síntomas Mejoría de función pulmonar Mejora de disnea Mejora calidad de vida

24 Corticoides+ LABA vs LABA + LAMA

25 EPOC moderado 65 años Exfumador (50 PA) FEV 1 : 40% DLCO: 50% Camina: 380 m BMI: 21 Disnea grado 2 1 hospitalización por exacerbación

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27 ILLUMINATE study design 26-week, multicentre, randomised, double-blind, parallel-group, double-dummy study Pre-randomisation period Double-blind treatment period 30-day post-safety follow-up Pre-screening washout period Run-in period* QVA /50 µg once daily via Breezhaler device Salmeterol/fluticasone 50/500 µg twice daily via Accuhaler device Day-21 to Day-15 Day-14 to Day-1 Day-1 to Day-184 Visit 1 Visit 2 Visit 3 Randomisation Visit 7 *Salbutamol as needed can be used throughout the study as rescue medication; Accuhaler is a registered trade mark of GSK Group Ltd Vogelmeier CF, et al. Lancet Resp Med. 2012

28 FEV 1 (L) Improvements of FEV 1 from 0-12 h post-dose at Week 26 1,85 SFC QVA149 1,75 1,65 1,55 1,45 1, Time post-dose (hours) Data are LSM (SE); treatment differences: p< for QVA149 versus SFC at each assessed timepoint; FEV 1 =forced expiratory volume in 1 second; SFC=salmeterol/fluticasone; LSM=least squares means; SE=standard error; QVA149 (n= ), SFC (n= ) Vogelmeier CF, et al. Lancet Resp Med. 2012

29 SGRQ-C Improvement of mean SGRQ-C total score 45 QVA149 SFC Improvement n=211 n=216 n=211 n=216 Baseline Week 26 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

30 LANTERN (CQVA149A2331) primary publication summary slides LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD Nanshan Zhong, Changzheng Wang, Xiangdong Zhou, Nuofu Zhang, Michael Humphries, Linda Wang, Chau Thach, Francesco Patalano, Donald Banerji International Journal of Chronic Obstructive Pulmonary Disease 2015

31 Study design 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group, active controlled study Pre-randomization period Treatment Period IND/GLY110/50 μg o.d. via the Breezhaler Device Post-treatment follow-up Pre-screening Run-in period Salmeterol/Futicasone 50/500 μg b.i.d. via the Accuhaler Device Day -21 to Day -15 Day -14 to Day -1 Day 1 to Day Days Randomization (1:1) Before the run-in period, patients discontinued LAMAs and the LABA indacaterol for at least 7 days and all other LABAs and LABA/inhaled corticosteroid combinations for 48 hours. o.d., once-daily Zhong et al. Int J COPD, 2015

32 IND/GLY significantly prolonged the time to first moderate or severe exacerbation by 35% compared with SFC Kaplan-Meier plots of the time to first moderate or severe COPD exacerbation over 26 weeks of treatment (full analysis set) IND/GLY Zhong et al. Int J COPD, 2015

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35 EPOC grave con exacerbaciones corticoides? A todos los EPOC o sólo a HRB?

Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Online Data Supplement

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