Gustavo J Rodrigo1, Vicente Plaza2. 1. Departamento de Emergencia (Dr Rodrigo), Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay, Spain; Servei de Pneumologia (Dr Plaza), Hospital de la Santa Creu i Sant Pau, Universitat Autonoma de Barcelona, Barcelona, Spain. Electronic address: gustavo.javier.rodrigo@gmail.com. 2. Departamento de Emergencia (Dr Rodrigo), Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay, Spain; Servei de Pneumologia (Dr Plaza), Hospital de la Santa Creu i Sant Pau, Universitat Autonoma de Barcelona, Barcelona, Spain.
Abstract
BACKGROUND: COPD guidelines recommend the combined use of inhaled, long-acting β2-agonists and long-acting muscarinic antagonists if symptoms are not improved by a single agent. This systematic review assessed the efficacy and safety of the fixed-dose combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium (QVA149) compared with its monocomponents (glycopyrronium and indacaterol) and tiotropium for the treatment of moderate to severe COPD. METHODS: This was a systematic review of randomized, placebo-controlled or crossover trials (3-64 weeks). Primary outcomes were trough FEV1, severe adverse events, and serious cardiovascular events. RESULTS: Five trials (4,842 patients) were included. Compared with tiotropium, QVA149 showed a significant increase in trough FEV1 (70 mL; P < .0001) and a decreased use of rescue medication (-0.63 puffs/d; P < .0001). Patients receiving QVA149 had a 19% greater likelihood of experiencing a minimal clinical important difference (MCID) in the number needed to treat for benefit (NNTB) (NNTB = 11) and a 16% greater likelihood of achieving an MCID in the St. George's Respiratory Questionnaire (SGRQ) (NNTB = 11). Similarly, QVA149 vs glycopyrronium showed a significant increase in trough FEV1 (70 mL; P < .0001), a significant reduction in rescue medication use (-0.59; P < .0001), and a significant increase in the rate of patients achieving an MCID in the SGRQ (NNTB = 12). QVA149 showed similar levels of safety and tolerability to both comparators. It was not possible to perform a pooled analysis of data comparing QVA149 vs indacaterol. CONCLUSIONS: Once-daily, inhaled QVA149 showed superior efficacy compared with glycopyrronium and the current standard of care, tiotropium, in patients with moderate to severe COPD.
BACKGROUND:COPD guidelines recommend the combined use of inhaled, long-acting β2-agonists and long-acting muscarinic antagonists if symptoms are not improved by a single agent. This systematic review assessed the efficacy and safety of the fixed-dose combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium (QVA149) compared with its monocomponents (glycopyrronium and indacaterol) and tiotropium for the treatment of moderate to severe COPD. METHODS: This was a systematic review of randomized, placebo-controlled or crossover trials (3-64 weeks). Primary outcomes were trough FEV1, severe adverse events, and serious cardiovascular events. RESULTS: Five trials (4,842 patients) were included. Compared with tiotropium, QVA149 showed a significant increase in trough FEV1 (70 mL; P < .0001) and a decreased use of rescue medication (-0.63 puffs/d; P < .0001). Patients receiving QVA149 had a 19% greater likelihood of experiencing a minimal clinical important difference (MCID) in the number needed to treat for benefit (NNTB) (NNTB = 11) and a 16% greater likelihood of achieving an MCID in the St. George's Respiratory Questionnaire (SGRQ) (NNTB = 11). Similarly, QVA149 vs glycopyrronium showed a significant increase in trough FEV1 (70 mL; P < .0001), a significant reduction in rescue medication use (-0.59; P < .0001), and a significant increase in the rate of patients achieving an MCID in the SGRQ (NNTB = 12). QVA149 showed similar levels of safety and tolerability to both comparators. It was not possible to perform a pooled analysis of data comparing QVA149 vs indacaterol. CONCLUSIONS: Once-daily, inhaled QVA149 showed superior efficacy compared with glycopyrronium and the current standard of care, tiotropium, in patients with moderate to severe COPD.
Authors: Jung Soo Kim; Jinkyeong Park; Seong Yong Lim; Yeon-Mok Oh; Kwang Ha Yoo; Yong Bum Park; Seung Soo Sheen; Min-Ji Kim; K C Carriere; Ji Ye Jung; Hye Yun Park Journal: PLoS One Date: 2015-03-23 Impact factor: 3.240