Abstract
BackgroundInhaled bronchodilators are the first-line therapy for COPD. Indacaterol is a novel addition to existing long-acting bronchodilators.ObjectivesSystematic review of randomized controlled trials (RCT) on efficacy and safety of indacaterol as compared: 1) with placebo at different dosages, 2) with existing bronchodilators; (3) as add-on treatment to tiotropium.MethodsWe searched 13 electronic databases, including MEDLINE, EMBASE and CENTRAL, and contacted the manufacturer for unpublished data. Primary outcome was mean FEV1 change at 12th week, secondary outcomes included changes in SGRQ, TDI and BODE index at 6 months, exacerbation at 1 year, and worsening of symptoms.ResultsTwelve eligible RCTs of moderate risk of bias included data from 10,977 patients. Compared to placebo, indacaterol improved FEV1 by a weighted mean difference (WMD) of 0.16 L (95%CI: 0.15, 0.18 L, p<0.001), homogeneously above the minimally important difference of 0.10 L. It offered clinically relevant improvement in all secondary outcomes except exacerbation. Magnitude of benefit did not differ significantly by dosage, but one treatment related death was reported at 300 ug. Efficacy of Indacaterol was similar to formoterol and salmeterol (FEV1 WMD = 0.04L, 95%CI: 0.01L, 0.07 L, p = 0.02); and tiotropium (FEV1 WMD = 0.01L, 95%CI: −0.01, 0.03L, p = 0.61). The use of indacaterol on top of tiotropium yielded additional improvement on FEV1 (WMD = 0.07 L, 95%CI: 0.05L, 0.10 L, p<0.001).ConclusionIndacaterol is safe and beneficial for patients with COPD at dosage ≤150 ug. It may serve as a good alternative to existing bronchodilators, or as an add-on to tiotropium for unresponsive patients. Use of higher dosage requires further justification.
Highlights
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of mortality worldwide
Indacaterol is safe and beneficial for patients with COPD at dosage #150 ug. It may serve as a good alternative to existing bronchodilators, or as an add-on to tiotropium for unresponsive patients
Population aging directly raises the magnitude of economic burden caused by COPD, mainly due to higher cost incurred from acute care [3]
Summary
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of mortality worldwide. It contributes to 27.2 age adjusted deaths per 100,000 US populations; and the figure reached 130.5 in China [1]. COPD is characterized by persistent airflow limitation that is progressive, and is associated with major co-morbidities. It has been estimated it will be the fifth leading cause of disability by 2020 [2]. In the treatment of more symptomatic stable COPD patients, inhaled long acting b2 agonists or anticholinergic bronchodilators are superior to short-acting bronchodilators.
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