Effects of baseline symptom burden on treatment response in COPD.

Autor:	Martinez FJ; Division of Pulmonary and Critical Care Medicine, Weill Cornell Medical College, New York, NY, USA, fjm2003@med.cornell.edu., Abrahams RA; Morgantown Pulmonary Clinical Research, Morgantown, WV, USA.; Department of Pulmonary & Critical Care, Mon Health Care, Morgantown, WV, USA., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA., Bjermer L; Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden., Grönke L; Biotechnology, CSL Behring, Wiesbaden, Germany., Voß F; Biostatistics + Data Sciences Corp., Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany., Singh D; Medicines Evaluation Unit, University of Manchester, Manchester, UK.
Jazyk:	angličtina
Zdroj:	International journal of chronic obstructive pulmonary disease [Int J Chron Obstruct Pulmon Dis] 2019 Jan 04; Vol. 14, pp. 181-194. Date of Electronic Publication: 2019 Jan 04 (Print Publication: 2019).
DOI:	10.2147/COPD.S179912
Abstrakt:	Rationale: In symptomatic patients with COPD, the decision whether to initiate maintenance treatment with a single agent or a combination of long-acting bronchodilators remains unclear. Objective: To investigate whether baseline symptomatic status influences response to tiotropium/olodaterol treatment. Materials and Methods: Post hoc analysis of the randomized OTEMTO ® studies (NCT01964352; NCT02006732), in which patients with moderate-to-severe COPD received placebo, tiotropium 5 µg, tiotropium/olodaterol 2.5/5 µg, or tiotropium/olodaterol 5/5 µg once daily for 12 weeks via the Respimat ® inhaler (Boehringer Ingelheim, Ingelheim am Rhein, Germany). Impact of baseline symptomatic status (modified Medical Research Council [mMRC] score) on response to treatment with tiotropium/olodaterol 5/5 µg, tiotropium 5 µg, or placebo at Week 12 was assessed by St George's Respiratory Questionnaire (SGRQ) total score and response rate, transition dyspnea index (TDI) focal score and response rate, and trough forced expiratory volume in 1 second response. Results: Tiotropium/olodaterol improved SGRQ total scores and response rates compared with placebo and tiotropium for patients with baseline mMRC scores 0-1 and ≥2. For tiotropium/olodaterol vs tiotropium, greater improvements were observed for patients with mMRC ≥2 (SGRQ score adjusted mean treatment difference -3.44 [95% CI: -5.43, -1.46]; P =0.0007; SGRQ response rate ORs 2.09 [95% CI: 1.41, 3.10]; P =0.0002). Dyspnea, measured by TDI score, was consistently improved with tiotropium/olodaterol vs placebo for patients with mMRC scores 0-1 and ≥2 (adjusted mean treatment difference 1.63 [95% CI: 1.06, 2.20]; P <0.0001 and 1.60 [95% CI: 1.09, 2.10]; P <0.0001, respectively). In patients with mMRC scores 0-1 and ≥2, tiotropium/olodaterol consistently improved TDI response rate and lung function vs placebo and tiotropium. Conclusions: Patients with COPD with more severe baseline dyspnea appear to derive greater health status benefit with tiotropium/olodaterol compared with tiotropium alone. Competing Interests: Disclosure FJM reports grants from NHLBI during the conduct of the study, grants from National Institutes of Health, personal fees from Continuing Education, Forest Laboratories, GlaxoSmithKline, Nycomed/Takeda, AstraZeneca, Boehringer Ingelheim, Bellerophon Therapeutics (formerly Ikaria), Genentech, Novartis, Pearl, Roche, Sunovion, Theravance, CME Incite, Annenberg Center for Health Sciences at Eisenhower, Integritas, InThought, National Association for Continuing Education, Paradigm Medical Communications, LLC, PeerVoice, UpToDate, Haymarket Communications, Western Society of Allergy and Immunology, ProterixBio (formerly Bioscale), Unity Biotechnology, Concert Pharmaceuticals, Lucid, Methodist Hospital, Columbia University, Prime Healthcare Ltd, WebMD, PeerView Network, California Society of Allergy and Immunology, Chiesi, and Puerto Rico Thoracic Society, and advisory board participation for Janssen. RA reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline, and grants from Pearl Therapeutics. GTF reports consulting and advisory board fees from Boehringer Ingelheim, AstraZeneca, Pearl Therapeutics, Novartis, Forest, Sunovion, and Verona, consulting fees from Receptos, speaker fees from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Pearl Therapeutics, Forest, and Sunovion, and research grants from Boehringer Ingelheim, AstraZeneca, Pearl Therapeutics, Sunovion, Novartis, Theravance, Sanofi, Forest, and GlaxoSmithKline. LB reports advisory board participation or personal fees for lectures from ALK, Airsonett, AstraZeneca, Boehringer Ingelheim, Chiesi, Glaxo SmithKline, Novartis, Takeda, and Teva. FV is an employee of Boehringer Ingelheim. LG was an employee at the time of the conduct of the study, and is currently employed by CSL Behring. DS reports personal fees from Apellis, Cipla, Genentech, Peptinnovate, and Vectura (formerly Skyepharma), and grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Glenmark, Merck, Mundipharma, Novartis, Pfizer, Pulmatrix, Teva, Theravance, and Verona. The authors report no other conflicts of interest in this work.
Databáze:	MEDLINE
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