The Effect of Metabolic Syndrome Status on Lung Function and Patient-reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.

Autor:	Carlin B; Sleep Medicine and Lung Health Consultants, LLC, Pittsburgh, Pennsylvania., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan., Ozol-Godfrey A; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts., Goodin T; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts., Sanjar S; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.
Jazyk:	angličtina
Zdroj:	Chronic obstructive pulmonary diseases (Miami, Fla.) [Chronic Obstr Pulm Dis] 2020 Oct; Vol. 7 (4), pp. 315-326.
DOI:	10.15326/jcopdf.7.4.2020.0145
Abstrakt:	Background: Concurrent chronic obstructive pulmonary disease (COPD) and metabolic syndrome (MetS) represent an important clinical phenotype with overlapping symptomology. The effect of MetS in COPD patients was assessed following treatment with nebulized glycopyrrolate (GLY; administered via eFlow® Closed System Nebulizer). Methods: Posthoc analyses were performed on pooled lung function, patient-reported outcome (PRO) and safety data by MetS status from patients treated with placebo, GLY 25 and 50 mcg twice daily in two 12-week studies (GOLDEN 3 and 4; N=1293). Patients with MetS were characterized as having ≥ 3 of hypertension, hyperlipidemia, diabetes, body mass index (BMI) > 30 kg/m 2 risk factors. The results are presented for the Food and Drug Administration-approved GLY 25 mcg dose. Results: A total of25% of patients met MetS criteria.At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second. In the non-MetS group, significant improvements occurred in the St George's Respiratory Questionnaire (MetS: -2.28, p =0.157; non-MetS: -3.71) and Evaluating Respiratory Symptoms in COPD tool (MetS: 0.42, p =0.574; non-MetS: -1.61) total scores. Incidence of adverse events was similar with GLY versus placebo regardless of MetS status. Conclusion: GLY was well-tolerated and significantly improved lung function regardless of MetS status, while significant PRO improvements occurred in non-MetS patients. These results highlight the importance of comorbidities on bronchodilator responses and patient symptoms in COPD patients. Competing Interests: Dr. Brian Carlin has served on speakers’ bureaus for Sunovion Pharmaceuticals Inc., and GlaxoSmithKline and is an advisory board member for Sunovion Pharmaceuticals Inc., GlaxoSmithKline, and Theravance. Dr. Gary T. Ferguson reports grants, personal fees, and non-financial support from Sunovion Pharmaceuticals Inc., during the conduct of the study; Dr Ferguson has also received grants, personal fees and non-financial support from AstraZeneca, Boehringer Ingelheim, Novartis, Pearl Therapeutics, Sunovion, Theravance, and GlaxoSmithKline; grants and personal fees from Verona and Sanofi; grants from Altavant; and personal fees from Mylan, Innoviva and Circassia. Dr. Ayca Ozol-Godfrey, Dr. Thomas Goodin, and Dr. Shahin Sanjar are employees of Sunovion Pharmaceuticals, Inc. (JCOPDF © 2020.)
Databáze:	MEDLINE
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