1. The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI And UMEC/VI In Patients With COPD: Efficacy And Safety In A Japanese Population.
- Author
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Kato M, Tomii K, Hashimoto K, Nezu Y, Ishii T, Jones CE, Kilbride S, Gross AS, Clifton CS, and Lipson DA
- Subjects
- Administration, Inhalation, Adrenergic beta-2 Receptor Agonists adverse effects, Aged, Androstadienes adverse effects, Benzyl Alcohols adverse effects, Bronchodilator Agents adverse effects, Chlorobenzenes adverse effects, Disease Progression, Double-Blind Method, Drug Combinations, Female, Forced Expiratory Volume, Health Status, Humans, Japan, Lung physiopathology, Male, Middle Aged, Muscarinic Antagonists adverse effects, Nebulizers and Vaporizers, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Quinuclidines adverse effects, Recovery of Function, Time Factors, Treatment Outcome, Adrenergic beta-2 Receptor Agonists administration & dosage, Androstadienes administration & dosage, Benzyl Alcohols administration & dosage, Bronchodilator Agents administration & dosage, Chlorobenzenes administration & dosage, Lung drug effects, Muscarinic Antagonists administration & dosage, Pulmonary Disease, Chronic Obstructive drug therapy, Quinuclidines administration & dosage
- Abstract
Purpose: The Informing the Pathway of COPD Treatment (IMPACT) study demonstrated that single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduces moderate/severe exacerbation rates and improves lung function and health status versus FF/VI or UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations. This analysis evaluated the efficacy and safety of FF/UMEC/VI in patients enrolled in Japan., Patients and Methods: IMPACT was a 52-week, randomized, double-blind, multicenter study comparing FF/UMEC/VI 100/62.5/25 µg with FF/VI 100/25 µg or UMEC/VI 62.5/25 µg in patients ≥40 years with symptomatic COPD and ≥1 moderate/severe exacerbation in the previous year. Endpoints included annual rate of on-treatment moderate/severe exacerbations (primary endpoint), time-to-first on-treatment moderate/severe exacerbation and change from baseline at Week 52 in trough FEV
1 , post-bronchodilator FEV1 , St. George's Respiratory Questionnaire, and COPD Assessment Test score. Safety was also assessed., Results: The Japan subgroup accounted for only 4% (378/10,355) of the overall IMPACT intent-to-treat (ITT) population. In the Japan subgroup, FF/UMEC/VI reduced the annual rate of on-treatment moderate/severe exacerbations by 15% (95% CI: -20, 40) versus FF/VI (compared with 15% [10, 20] in the ITT) and 36% (95% CI: 6, 57) versus UMEC/VI (compared with 25% [19, 30] in the ITT). FF/UMEC/VI reduced moderate/severe exacerbation risk (time-to-first), improved lung function and health status at Week 52 versus both dual therapies. These results were in the same direction and of a generally similar magnitude to those seen in the overall ITT population. No new safety signals were identified in the Japan subgroup compared with the ITT population. Pneumonia incidence was higher with FF/UMEC/VI and FF/VI versus UMEC/VI., Conclusion: These results highlight the favorable benefit-risk profile of FF/UMEC/VI single-inhaler triple therapy compared with FF/VI or UMEC/VI dual therapy in patients in Japan with symptomatic COPD and ≥1 exacerbation in the prior year., Competing Interests: Motokazu Kato has received lecture honoraria from GSK, AstraZeneca, Nippon Boehringer Ingelheim, and Novartis Pharma. Keisuke Tomii has received lecture honoraria from Nippon Boehringer Ingelheim, AstraZeneca, GSK, Novartis Pharma, and Teijin Pharma. Kenichi Hashimoto, Takeo Ishii, C. Elaine Jones, Sally Kilbride, Annette S. Gross, Christine S. Clifton, and David A. Lipson are GSK employees and hold stock/shares in GSK. Yasuko Nezu is an employee of GSK. Ellipta is owned by or licensed to the GSK Group of Companies. The authors report no other conflicts of interest in this work., (© 2019 Kato et al.)- Published
- 2019
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