title: Comparison of clinical efficacy and safety between indacaterol and tiotropium in COPD: meta-analysis of randomized controlled trials.
abstract: Two once-daily inhaled bronchodilators, indacaterol and tiotropium, are widely used as first-line therapy in stable COPD patients. This study was performed to compare the clinical efficacy and safety between indacaterol and tiotropium in patients with moderate-to-severe COPD. MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched to identify all published randomized controlled trials (RCTs). The primary outcome was trough forced expiratory volume in 1 second (FEV1) at week 12. Four RCTs were eligible for inclusion (three RCTs with moderate-to-severe COPD patients and one RCT with only severe COPD patients). Trough FEV₁ at weeks 12 and 26 were not significantly different between indacaterol and tiotropium by the standardized mean difference with 0.014 (95% CI, -0.036, 0.063, I²= 23.5%) and with 0.037 (95% CI, -0.059 to 0.133, I²= 0%) along with differences in means of 0.003L and 0.014L, respectively. Indacaterol and tiotropium also showed similar St. George's Respiratory Questionnaire (SGRQ) total scores and percentages of patients with SGRQ improvement (≥ 4 units) at week 26. The incidences of nasopharyngitis, serious cardiovascular events, and serious adverse events were not different between indacaterol and tiotropium, while those of cough (OR = 1.68, P < 0.001, and RR = 1.63) and COPD worsening (OR = 1.18, P = 0.003, and RR = 1.12) were higher for indacaterol than tiotropium. However, when one study with only severe COPD patients was removed from the meta-analysis, the difference in the incidence of COPD worsening between indacaterol and tiotropium became non-significant (OR = 1.13, P = 0.204, and RR = 1.09). The clinical efficacy and serious adverse events between indacaterol and tiotropium were equivocal in patients with moderate-to-severe COPD. Cough is a common complaint associated with indacaterol, and COPD worsening needs to be carefully monitored in severe COPD patients when treated with indacaterol.
authors: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Jung Soo
authors: JS
authors: Kim
authors: Department of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea College of Medicine, Uijeongbu, Korea.
authors: Jinkyeong
authors: J
authors: Park
authors: Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Seong Yong
authors: SY
authors: Lim
authors: Department of Pulmonary and Critical Care Medicine, Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Yeon-Mok
authors: YM
authors: Oh
authors: Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
authors: Kwang Ha
authors: KH
authors: Yoo
authors: Department of Pulmonary, Allergy and Critical Care Medicine, Hallym University Medical Center, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.
authors: Yong Bum
authors: YB
authors: Park
authors: Department of Pulmonary and Critical Care Medicine, Ajou University School of Medicine, Yeongtong-gu, Suwon, Korea.
authors: Seung Soo
authors: SS
authors: Sheen
authors: Biostatistics team, Samsung Biomedial Research Institute, Seoul, Korea.
authors: Min-Ji
authors: MJ
authors: Kim
authors: Department of Mathematical and Statistical Sciences, University of Alberta, Edmonton, Alberta, Canada and Research Professor, Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul, Korea.
authors: K C
authors: KC
authors: Carriere
authors: Division of Pulmonology, Department of Internal Medicine, Institute of Chest Disease, Yonsei University College of Medicine, Seoul, Korea.
authors: Ji Ye
authors: JY
authors: Jung
authors: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Hye Yun
authors: HY
authors: Park
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D015363:Quinolones / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D000069447:Tiotropium Bromide / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; C510790:indacaterol; D000069447:Tiotropium Bromide