Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.

Autor: Kerwin E; Clinical Research Institute, Medford, OR, USA., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA., Sanjar S; Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA., Goodin T; Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA., Yadao A; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Fogel R; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Maitra S; Novartis Healthcare Pvt. Ltd., Hyderabad, India., Sen B; Novartis Healthcare Pvt. Ltd., Hyderabad, India., Ayers T; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Banerji D; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. donald.banerji@novartis.com.
Jazyk: angličtina
Zdroj: Lung [Lung] 2017 Dec; Vol. 195 (6), pp. 739-747. Date of Electronic Publication: 2017 Oct 09.
DOI: 10.1007/s00408-017-0055-9
Abstrakt: Purpose: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI).
Methods: Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62.5/25 μg, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV 1 AUC 0-24 ). Rescue medication use, symptom control, and safety were assessed throughout.
Results: Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV 1 AUC 0-24h at week 12 of 232 and 185 mL for IND/GLY, and 244 and 203 mL with UMEC/VI in Studies A2349 and A2350, respectively. The primary efficacy objective of non-inferiority of IND/GLY relative to UMEC/VI was not met as the lower bound of the confidence interval for the LS treatment comparison was below the pre-specified non-inferiority margin of -20 mL in both studies: -26.9 and -34.2 mL, respectively (LS mean between-treatment differences: -11.5 and -18.2 mL). Both drugs were well tolerated, with AE profiles consistent with their respective prescribing information.
Conclusions: IND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498).
Databáze: MEDLINE
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