Journal Article

Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA

Fabbri, Leonardo M, Vezzoli, Stefano, Petruzzelli, Stefano, Papi, Alberto, Singh, Dave

2019

Overview

Current pharmacological therapies for COPD improve quality of life and symptoms and reduce exacerbations. Given the progressive nature of COPD, it is arguably more important to understand whether the available therapies are able to delay clinical deterioration; the concept of \"clinically important deterioration\" (CID) has therefore been developed. We evaluated the efficacy of the single-inhaler triple combination beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G), using data from three large 1-year studies. The studies compared BDP/FF/G to BDP/FF (TRILOGY), tiotropium (TRINITY), and indacaterol/glycopyrronium (IND/GLY; TRIBUTE). All studies recruited patients with symptomatic COPD, FEV <50%, and an exacerbation history. We measured the time to first CID and to sustained CID, an endpoint combining FEV , St George's Respiratory Questionnaire (SGRQ), moderate-to-severe exacerbations, and death. The time to first CID was based on the first occurrence of any of the following: a decrease of ≥100 mL from baseline in FEV , an increase of ≥4 units from baseline in SGRQ total score, the occurrence of a moderate/severe COPD exacerbation, or death. The time to sustained CID was defined as: a CID in FEV and/or SGRQ total score maintained at all subsequent visits, an exacerbation, or death. Extrafine BDP/FF/G significantly extended the time to first CID vs BDP/FF (HR 0.61, <0.001), tiotropium (0.72, <0.001), and IND/GLY (0.82, <0.001), and significantly extended the time to sustained CID vs BDP/FF (HR 0.64, <0.001) and tiotropium (0.80, <0.001), with a numerical extension vs IND/GLY. In patients with symptomatic COPD, FEV <50%, and an exacerbation history, extrafine BDP/FF/G delayed disease deterioration compared with BDP/FF, tiotropium, and IND/GLY. The studies are registered in ClinicalTrials.gov: TRILOGY, NCT01917331; TRINITY, NCT01911364; TRIBUTE, NCT02579850.

• Publisher: Dove Medical Press Limited,Dove Medical Press Ltd,Dove Press,Dove Medical Press
• Subject: Administration, Inhalation / Adrenal Cortex Hormones - administration & dosage / Adrenal Cortex Hormones - adverse effects / Adrenergic beta-2 Receptor Agonists - administration & dosage / Adrenergic beta-2 Receptor Agonists - adverse effects / Aged / anticholinergics / Beclomethasone / Beclomethasone - administration & dosage / Beclomethasone - adverse effects / beta-2 agonists / Bronchodilator Agents - administration & dosage / Bronchodilator Agents - adverse effects / Care and treatment / Chronic obstructive lung disease / Chronic obstructive pulmonary disease / Clinical Trial Report / Corticosteroid drugs / disease activity / Disease Progression / Diseases / double-blind / Drug Combinations / Dyspnea / exacerbation frequency / Female / Forced Expiratory Volume / Formoterol / Formoterol Fumarate - administration & dosage / Formoterol Fumarate - adverse effects / Glucocorticoids / Glycopyrrolate - administration & dosage / Glycopyrrolate - adverse effects / hospitalization / Humans / Indacaterol / indacaterol/glycopyrronium / inhaled / inhaled corticosteroids / Inhalers / Lung - drug effects / Lung - physiopathology / Lung diseases / lung-function decline / Lungmedicin och allergi / Male / Medical research / Middle Aged / Muscarinic Antagonists - administration & dosage / Muscarinic Antagonists - adverse effects / Nebulizers and Vaporizers / obstructive pulmonary-disease / parallel-group / Pharmaceutical industry / pooled analysis / post-hoc analysis / prevention / Pulmonary Disease, Chronic Obstructive - diagnosis / Pulmonary Disease, Chronic Obstructive - drug therapy / Pulmonary Disease, Chronic Obstructive - mortality / Pulmonary Disease, Chronic Obstructive - physiopathology / Questionnaires / Randomized Controlled Trials as Topic / Respiratory Medicine and Allergy / Respiratory system agents / Surveys and Questionnaires / Time / Time Factors / Tiotropium / Treatment Outcome