Journal Article

Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study

Patalano, Francesco, Nunez, Xavier, Fogel, Robert, Kostikas, Konstantinos, Lossi, Nadine S, Clemens, Andreas, Greulich, Timm, Vogelmeier, Claus, Gaga, Mina, Aalamian-Mattheis, Maryam, Pagano, Veronica A.

2018

Overview

COPD is a progressive disease characterized by exacerbations and a decline in health status and lung function. Clinically important deterioration (CID) is a composite endpoint used to evaluate treatment efficacy. This analysis evaluated the impact of a direct switch to once-daily indacaterol/glycopyrronium 110/50 µg (IND/GLY) from previous monotherapy with a long-acting β -agonist (LABA) or long-acting muscarinic antagonist (LAMA) or with an LABA and an inhaled corticosteroid (LABA + ICS) on reducing CID. CRYSTAL was a 12-week, prospective, multicenter, randomized, open-label study conducted in clinical practice settings. Three definitions of CID (D1-D3) were used, including: 1) ≥100 mL decrease in trough forced expiratory volume in 1 second (FEV ), 2) ≥1 point decrease in transition dyspnea index (TDI) and/or ≥0.4 points increase in clinical COPD questionnaire score (CCQ), or 3) an acute moderate/severe exacerbation (AECOPD). In D1 and D2, either TDI or CCQ was evaluated along with FEV and AECOPD, whereas in D3, all 4 parameters were included. ClinicalTrials.gov number: NCT01985334. Of the 2,159 patients analyzed, 1,622 switched to IND/GLY and 537 continued their baseline treatments. The percentage of patients with a CID was significantly lower after a direct switch to IND/GLY versus LABA or LAMA using all 3 CID definitions (D1: odds ratio [OR] 0.41 [95% CI: 0.30-0.55]; D2: OR 0.41 [95% CI: 0.31-0.55]; D3: OR 0.39 [95% CI: 0.29-0.52]). Compared with LABA + ICS, IND/GLY also reduced the risk of CID (D1: OR 0.76 [95% CI: 0.56-1.02]; D2: OR 0.75 [95% CI: 0.56-1.00]; D3: OR 0.67 [95% CI: 0.51-0.89]). In this analysis, IND/GLY reduced the risk of a CID in moderate COPD patients after direct switch from LABA + ICS or LABA or LAMA in real-life clinical practice.

• Publisher: Dove Medical Press Limited,Dove Medical Press Ltd,Dove Press,Dove Medical Press
• Subject: Administration, Inhalation / Adrenal Cortex Hormones - administration & dosage / Adrenergic beta-2 Receptor Agonists - administration & dosage / Adrenergic beta-2 Receptor Agonists - adverse effects / Aged / Bronchodilator Agents - administration & dosage / Bronchodilator Agents - adverse effects / Care and treatment / Chronic obstructive lung disease / Clinical COPD Questionnaire/CCQ / Clinical trials / Clinically Important Deterioration/CID / COPD Risk Reduction / Corticosteroid drugs / Councils / direct-switch / Disease / Disease Progression / Drug Combinations / Drug Substitution / Dyspnea / Europe / Female / Forced Expiratory Volume / Glucocorticoids / Glycopyrrolate - administration & dosage / Glycopyrrolate - adverse effects / Health / Health Status / Humans / indacaterol/glycopyrronium / Indans - administration & dosage / Indans - adverse effects / Lung - drug effects / Lung - physiopathology / Male / Medical research / Middle Aged / Muscarinic Antagonists - administration & dosage / Muscarinic Antagonists - adverse effects / Open-label / Original Research / Patients / Performance evaluation / pragmatic / Prospective Studies / Pulmonary Disease, Chronic Obstructive - diagnosis / Pulmonary Disease, Chronic Obstructive - drug therapy / Pulmonary Disease, Chronic Obstructive - physiopathology / Quality of life / Questionnaires / Quinolones - administration & dosage / Quinolones - adverse effects / Risk Factors / Severity of Illness Index / Statistical analysis / Steroids / Steroids (Organic compounds) / Time Factors / Tiotropium / transition dyspnea index/TDI / Treatment Outcome