Safety and efficacy of indacaterol in treatment of chronic obstructive pulmonary disease: a Meta-analysis
10.3760/cma.j.issn.1008-5734.2017.03.009
- VernacularTitle:茚达特罗治疗慢性阻塞性肺疾病有效性及安全性的Meta分析
- Author:
Ning XIA
1
;
Zhihong FENG
1
;
Bing WEI
1
;
Xiuhong NIE
1
Author Information
1. 首都医科大学宣武医院呼吸科, 北京,100053
- Publication Type:Journal Article
- Keywords:
Pulmonary disease;
chronic obstructive;
Safety;
Meta-analysis;
Indacaterol
- From:
Adverse Drug Reactions Journal
2017;19(3):200-207
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and efficacy of indacaterol in treatment of stable chronic obstructive pulmonary disease (COPD).Methods The related databases were electronically searched for the randomized controlled trials (RCT) on the treatment of stable COPD with indacaterol published before November 1st, 2016.The quality of the reports enrolled into the Meta-analysis was evaluated by Jadad scoring system.The Meta-analysis was conducted using Review Manager 5.3 software.The results were presented as relative risk (RR) and 95% confidence intervals (CI).Results A total of 10 RCTs involving 7 315 patients were enrolled, including 4 439 in the indacaterol group and 2 876 in the placebo group.The Jadad score of all literatures was 3 to 5.They were all high quality documents.The results of Meta-analysis showed that the incidence of COPD acute exacerbation in the indacaterol group was lower than that in the placebo group, the difference was statistically significant[20.6% (914/4 439) vs.22.4% (643/2 876), RR=0.85, 95%CI: 0.77-0.92, P<0.01].The results of subgroup analysis showed that the incidence of COPD acute exacerbation in doses of 150 μg/d and 600 μg/d in the indacaterol group were lower than those in the placebo group, the differences were statistically significant[(20.4% (384/1 878) vs.22.2% (359/1 617), RR=0.84, 95%CI: 0.74-0.95, P<0.01;27.5% (117/425) vs.34.7% (150/432), RR=0.79, 95%CI: 0.65-0.97, P=0.02)].The incidence of severe COPD acute exacerbation in the indacaterol group was lower than that in the placebo group, the difference was statistically significant[2.3% (103/4 439) vs.2.9% (84/2 876),RR=0.72, 95%CI: 0.54-0.96, P=0.03].The results of subgroup analysis showed that the incidence of severe COPD acute exacerbation at dose of 600 μg/d in the indacaterol group was lower than that in the placebo group, the difference was statistically significant[0.9% (4/425) vs.3.9% (17/432), RR=0.24, 95%CI: 0.08-0.7, P<0.01].The overall fatality rate in the indacaterol group was lower than that in the placebo group, but the difference was no statistically significant [0.25% (8/3 164) vs.0.58% (11/1 906), RR=0.48, 95%CI: 0.20-1.14, P=0.10].The fatality rate due to cardiovascular events in the indacaterol group was lower than that in the placebo group, but the difference was not statistically significant [0.22% (7/3 164) vs.0.42% (8/1 906), RR=0.56, 95%CI: 0.22-1.42, P=0.22].The fatality rate due to respiratory diseases in the indacaterol group was lower than that in the placebo group, but the difference was no statistically significant [0.12% (2/1 668) vs.0.20% (2/999), RR=0.65, 95%CI: 0.13-3.31, P=0.61].The result of sensitivity analysis showed that the outcome of the study was stable and not influenced by simplex trial.Conclusion Indacaterol is effective and relatively safe of treatment in patients with stable COPD.
