Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD.

Autor: Martinez FJ; Joan and Sanford Weill Department of Internal Medicine, Weill Cornell Medicine, New York, NY. Electronic address: fjm2003@med.cornell.edu., Fabbri LM; Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI., Orevillo C; Former employee of Clinical Development, Pearl Therapeutics, Inc, Morristown, NJ., Darken P; Department of Biostatistics, Pearl Therapeutics, Inc, Morristown, NJ., Martin UJ; Respiratory Global Medicines, AstraZeneca, Gaithersburg, MD., Reisner C; Clinical Development and Medical Affairs, Pearl Therapeutics, Inc, Morristown, NJ; and Respiratory Global Medicines, AstraZeneca, Gaithersburg, MD.
Jazyk: angličtina
Zdroj: Chest [Chest] 2017 Dec; Vol. 152 (6), pp. 1169-1178. Date of Electronic Publication: 2017 Jul 16.
DOI: 10.1016/j.chest.2017.07.007
Abstrakt: Background: The clinical severity of COPD is currently categorized by symptom burden and exacerbation risk. Previous 24-week phase III trials (NCT01854645 and NCT01854658) that demonstrated better improvement of lung function with glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) (an MDI fixed-dose of GFF 18/9.6 μg) over individual monocomponent MDIs included a cross-section of patients with moderate to very severe airflow limitation and a broad range of COPD symptoms.
Methods: These post hoc analyses of pooled data investigated whether baseline symptom burden, assessed using the COPD Assessment Test (CAT) score, impacted GFF MDI-associated improvements in lung function, health status, rescue medication use, and exacerbation risk.
Results: In 3,699 patients, improvement in FEV 1 at week 24 between the GFF MDI and monocomponent MDIs and a placebo MDI was similar in magnitude regardless of baseline CAT score. In contrast, the magnitude of mean difference in the St. George's Respiratory Questionnaire total score for GFF MDI vs monocomponent MDIs and the placebo MDI increased with increasing baseline CAT scores. Likewise, reduced rescue medication use and lower exacerbation risk were more pronounced in GFF MDI groups with a higher baseline symptom burden.
Conclusions: Beneficial effects of GFF MDI on health status, rescue medication use, and exacerbation risk in symptomatic patients with COPD increased as a function of baseline symptom burden, whereas lung function benefits were independent. These data suggest a greater clinical benefit from dual bronchodilators in symptomatic patients than in patients without symptoms.
Trial Registry: ClinicalTrials.gov; No.: NCT01854645 and NCT01854658; URL: www.clinicaltrials.gov.
(Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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