PMID- 24556877 OWN - NLM STAT- MEDLINE DCOM- 20141031 LR - 20181202 IS - 1931-3543 (Electronic) IS - 0012-3692 (Linking) VI - 146 IP - 2 DP - 2014 Aug TI - Efficacy and safety of a fixed-dose combination of indacaterol and Glycopyrronium for the treatment of COPD: a systematic review. PG - 309-317 LID - S0012-3692(15)48820-8 [pii] LID - 10.1378/chest.13-2807 [doi] AB - BACKGROUND: COPD guidelines recommend the combined use of inhaled, long-acting beta2-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 beta2-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. FAU - Rodrigo, Gustavo J AU - Rodrigo GJ AD - 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. FAU - Plaza, Vicente AU - Plaza V AD - 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. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review PL - United States TA - Chest JT - Chest JID - 0231335 RN - 0 (Indans) RN - 0 (Muscarinic Antagonists) RN - 0 (Quinolones) RN - 8OR09251MQ (indacaterol) RN - V92SO9WP2I (Glycopyrrolate) SB - IM MH - Dose-Response Relationship, Drug MH - Drug Therapy, Combination MH - Glycopyrrolate/*administration & dosage MH - Humans MH - Indans/*administration & dosage MH - Muscarinic Antagonists/administration & dosage MH - Practice Guidelines as Topic MH - Pulmonary Disease, Chronic Obstructive/*drug therapy MH - Quinolones/*administration & dosage MH - Randomized Controlled Trials as Topic MH - Treatment Outcome EDAT- 2014/02/22 06:00 MHDA- 2014/11/02 06:00 CRDT- 2014/02/22 06:00 PHST- 2014/02/22 06:00 [entrez] PHST- 2014/02/22 06:00 [pubmed] PHST- 2014/11/02 06:00 [medline] AID - S0012-3692(15)48820-8 [pii] AID - 10.1378/chest.13-2807 [doi] PST - ppublish SO - Chest. 2014 Aug;146(2):309-317. doi: 10.1378/chest.13-2807.