Effects of baseline symptom burden on treatment response in COPD

• Published in: International journal of chronic obstructive pulmonary disease 2019-01, Vol.14, p.181-194
• Main Authors: Martinez, Fernando J, Abrahams, Roger A, Ferguson, Gary T, Bjermer, Leif, Grönke, Lars, Voß, Florian, Singh, Dave
• Format: Article
• Language: English
• Subjects: Adrenergic beta-2 Receptor Agonists - adverse effects; Adrenergic beta-2 Receptor Agonists - therapeutic use; Aged; Analysis; Benzoxazines - adverse effects; Benzoxazines - therapeutic use; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Cholinergic Antagonists - adverse effects; Cholinergic Antagonists - therapeutic use; Chronic obstructive pulmonary disease; Clinical Medicine; COPD; Councils; Drug Combinations; Drug therapy; Dyspnea; Dyspnea - diagnosis; Dyspnea - drug therapy; Dyspnea - physiopathology; Female; Forced Expiratory Volume; Health Status; Humans; Klinisk medicin; Lung - drug effects; Lung - physiopathology; Lung diseases; Lung diseases, Obstructive; Lungmedicin och allergi; Male; Medical and Health Sciences; Medical research; Medicin och hälsovetenskap; Medicine, Experimental; Middle Aged; Multicenter Studies as Topic; olodaterol; Original Research; Patients; Pharmaceutical industry; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Questionnaires; Randomized Controlled Trials as Topic; Recovery of Function; Respiratory Medicine and Allergy; Response rates; Severity of Illness Index; Steroids; Time Factors; Tiotropium; Tiotropium Bromide - adverse effects; Tiotropium Bromide - therapeutic use; Treatment Outcome; Vital Capacity
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S179912

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. To investigate whether baseline symptomatic status influences response to tiotropium/olodaterol treatment. 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. 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]; =0.0007; SGRQ response rate ORs 2.09 [95% CI: 1.41, 3.10]; =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];