Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients
| Autor: | Pritam Gupta, Pascal Pfister, Donald Banerji, Konstantinos Kostikas, Claus Vogelmeier, Stefan-Marian Frent, Jadwiga A. Wedzicha, Francesco Patalano, Alexander J. Mackay |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
COPD Exacerbation business.industry Minimal clinically important difference General Medicine Odds ratio medicine.disease Clinical trial 03 medical and health sciences 0302 clinical medicine 030228 respiratory system Internal medicine medicine Indacaterol 030212 general & internal medicine Salmeterol business Fluticasone medicine.drug |
| Zdroj: | International Journal of Chronic Obstructive Pulmonary Disease. 15:1831-1838 |
| ISSN: | 1178-2005 |
| Popis: | Background Chronic obstructive pulmonary disease (COPD) exacerbations are difficult outcomes to measure in clinical trials. It would be valuable to be able to predict which patients are likely to benefit in terms of exacerbation prevention based on their early response in lung function and symptoms. Methods This was a post-hoc analysis from the 52-week, randomized, double-blind, double-dummy, non-inferiority FLAME trial. Early clinically important improvement (ECII) was defined as achievement of minimal clinically important difference in trough forced expiratory volume in 1 second (FEV1; ≥100 mL increase) and one patient-reported outcome (PRO): either St. George's Respiratory Questionnaire for COPD (≥4-unit reduction; D1), or COPD assessment test (≥2-point reduction; D2) at Week 4 or 12. Results Approximately 18-20% of patients achieved ECII at Week 4 or 12 post-randomization according to any of the two definitions. The rate of subsequent exacerbations was lower in patients who achieved ECII at Week 4 (D1: ratio of rates [95% CI], 0.85 [0.74 to 0.98]; D2, 0.88 [0.77 to 1.00]) or at Week 12 (D1, 0.85 [0.74 to 0.98]; D2, 0.86 [0.75 to 1.00]) versus patients not achieving ECII. Patients who achieved ECII experienced longer time-to-first exacerbation between Week 4 or 12 to end of study. More patients achieved ECII with indacaterol/glycopyrronium versus salmeterol/fluticasone according to both definitions at Week 4 (D1, odds ratio [95% CI], 1.69 [1.40 to 2.04]; D2, 1.61 [1.34 to 1.93]), and 12 (D1, 2.01 [1.66 to 2.44]; D2, 1.80 [1.48 to 2.18]). Conclusion ECII is a novel composite endpoint, based on clinically relevant improvement in lung function and PROs in the early phase of treatment intervention that may predict subsequent exacerbation risk and may be used in clinical trials. |
| Databáze: | OpenAIRE |
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