Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk
| Autor: | Catherine Scott-Wilson, Henry Covelli, Courtney Crim, Isabelle Schenkenberger, Amanda Emmett, Bonavuth Pek |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.drug_class International Journal of Chronic Obstructive Pulmonary Disease Chlorobenzenes Fluticasone propionate chemistry.chemical_compound Pulmonary Disease Chronic Obstructive tiotropium cardiovascular disease anticholinergic Internal medicine Forced Expiratory Volume Administration Inhalation medicine Anticholinergic ICS/LABA COPD Humans Tiotropium Bromide Benzyl Alcohols Asthma Original Research Aged fluticasone furoate/vilanterol business.industry General Medicine Tiotropium bromide Middle Aged medicine.disease Fluticasone furoate/vilanterol respiratory tract diseases Bronchodilator Agents Androstadienes Drug Combinations Treatment Outcome chemistry Cardiovascular Diseases Anesthesia Quality of Life Corticosteroid Female Vilanterol Drug Monitoring Symptom Assessment business medicine.drug |
| Zdroj: | International Journal of Chronic Obstructive Pulmonary Disease |
| ISSN: | 1178-2005 1176-9106 |
| Popis: | Henry Covelli,1 Bonavuth Pek,2 Isabelle Schenkenberger,3 Catherine Scott-Wilson,4 Amanda Emmett,5 Courtney Crim4 1Kootenai Health, Coeur d’Alene, ID, USA; 2Clinique de Pneumologie et de Sommeil de Lanaudière, Quebec, Canada; 3Klinische Forschung, Berlin, Germany; 4GlaxoSmithKline Inc., Research Triangle Park, 5PAREXEL International, Durham, NC, USA Background: Fluticasone furoate/vilanterol (FF/VI) is a novel, once-daily, inhaled corticosteroid/long-acting β2-agonist combination approved for the treatment of COPD and asthma. We compared the safety and efficacy of FF/VI and tiotropium (TIO) in subjects with moderate-to-severe COPD with greater risk for comorbid cardiovascular disease (CVD).Methods: This randomized, blinded, double-dummy, parallel-group study compared a once-daily morning dose of FF/VI 100/25mcg delivered via ELLIPTA™ with TIO 18mcg via HandiHaler® for 12weeks in subjects with diagnosed COPD, forced expiratory volume in 1second (FEV1) 30%–70% predicted, and CVD or CVD risk. The primary endpoint was change from baseline in 24-hour weighted mean FEV1 on Day 84. Other efficacy endpoints included time to onset of bronchodilation, trough FEV1, other spirometry measures, rescue medication use, symptoms, quality of life (St George’s Respiratory Questionnaire-COPD [SGRQ-C]), and health status (COPD Assessment Tests [CAT]) measures. Safety endpoints included cardiovascular monitoring, cortisol excretion, COPD exacerbations, and adverse events, including prespecified drug effects.Results: Both FF/VI and TIO improved the 24-hour weighted mean FEV1 from baseline after 12weeks with no significant difference between treatments. Other endpoints favored FF/VI for time to onset of bronchodilation, rescue medication use, dyspnea, SGRQ-C and CAT scores, or favored TIO for change from baseline in forced vital capacity and inspiratory capacity. Pneumonia occurred more frequently in the FF/VI group, and two TIO-treated subjects died following cardiovascular events. Other safety measures were similar between groups, and cardiovascular monitoring did not reveal increased CVD risk.Conclusion: Both FF/VI and TIO were efficacious in improving lung function in subjects with COPD and comorbid CVD or CVD risk factors, with minor differences in efficacy and safety profiles. Keywords: fluticasone furoate/vilanterol, tiotropium, COPD, cardiovascular disease, ICS/LABA, anticholinergic |
| Databáze: | OpenAIRE |
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