Obstructive Lung Diseases |

Relationship Between Change in Trough FEV1 and COPD Patient Outcomes: Exploring the Pharmacological Class Effect of Bronchodilators FREE TO VIEW

James F Donohue, MD; Christian Bartels; Francesco Patalano, MD; Jessica Marvel; Peter D’Andrea, MD; Donald Banerji, MD; Robert Fogel, MD
Author and Funding Information

University of North Carolina School of Medicine, Chapel Hill, NC; Novartis Pharma AG, Basel, Switzerland; Novartis Pharmaceuticals Corporation, East Hanover, NJ

Chest. 2015;148(4_MeetingAbstracts):719A. doi:10.1378/chest.2276207
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SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM

PURPOSE: Measuring change in FEV1 and COPD patient reported outcomes (PROs) such as St. George's Respiratory Questionnaire (SGRQ), Transition Dyspnea Index (TDI), rescue medication use and exacerbations are important to assess the overall effect of therapy in patients with COPD. However, the relationship between these changes has been rarely reported. Here we report the relationship between the change in trough FEV1 and PROs in COPD patients on bronchodilator therapy.

METHODS: Individual patient data on lung function (trough FEV1) and PROs from 23 (3 to18 months; 23,213 patients) randomized, parallel-group, placebo or active controlled studies in COPD patients treated with LABA [indacaterol (IND), salmeterol and formoterol], LAMA [glycopyrronium (GLY) and tiotropium] and LABA/LAMA dual bronchodilator (QVA149, fixed-dose combination of IND/GLY) were pooled and analyzed.

RESULTS: Improvements in PROs were observed across all treatment arms whenever an improvement in trough FEV1 was observed. In general, treatments with higher improvements in FEV1 (LABA/LAMA>LABA~LAMA>placebo) resulted in larger improvements of PROs. For SGRQ, LABA and LAMA treatments had comparable efficacy as was the case for FEV1 while in case of other endpoints, a difference between LAMA and LABA treatments was observed. For rescue medication use, LABA provided greater reduction than LAMA for any given level of FEV1 improvement. For exacerbation reduction, there appeared to be a greater effect with LAMA treatments versus LABA although within both treatments the relationship between FEV1 and outcome remained. Over all the endpoints, LABA/LAMA resulted in better treatment outcomes than either of the LABA or LAMA treatments alone. No plateau of effect was observed and further increase in FEV1 response translated into improvements in SGRQ, TDI, rescue medication use and exacerbations.

CONCLUSIONS: Statistically significant and clinically relevant relationships exist between improvements in trough FEV1 and COPD patient reported outcomes at a population level. These beneficial relationships can be further improved when bronchodilators from different pharmacological class are combined.

CLINICAL IMPLICATIONS: Dual bronchodilation with IND/GLY combines the benefits of both LABAs and LAMAs and may be a more beneficial treatment option for COPD patients.

DISCLOSURE: James F Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Prof. James F Donohue is a consultant and advisor for Boehringer Ingelheim, Forest, GlaxoSmithKline, Mylan, Novartis, Sunovion, and is a consultant for PneumRx on the data safety monitoring board. Christian Bartels: Employee: Employee of the study sponsor company (Novartis) and no other conflicts Jessica Marvel: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Peter D’Andrea: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Donald Banerji: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Francesco Patalano: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Robert Fogel: Employee: Employee of the study sponsor company (Novartis) and no other conflicts.

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