Chest
Volume 142, Issue 5, November 2012, Pages 1104-1110
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Original Research
COPD
Comparison of Indacaterol With Tiotropium or Twice-Daily Long-Acting β-Agonists for Stable COPD: A Systematic Review

https://doi.org/10.1378/chest.11-2252Get rights and content

Background

Bronchodilators are central to the symptomatic management of patients with COPD. Previous data have shown that inhaled indacaterol improved numerous clinical outcomes over placebo.

Methods

This systematic review explored the efficacy and safety of indacaterol in comparison with tiotropium or bid long-acting β2-agonists (TD-LABAs) for treatment of moderate to severe COPD. Randomized controlled trials were identified after a search of different databases of published and unpublished trials.

Results

Five trials (5,920 participants) were included. Compared with tiotropium, indacaterol showed statistically and clinically significant reductions in the use of rescue medication and dyspnea (43% greater likelihood of achieving a minimal clinically important difference [MCID] in the transitional dyspnea index [TDI]; number needed to treat for benefit [NNTB] = 10). Additionally, the MCID in health status was more likely to be achieved with indacaterol than with tiotropium (OR = 1.43; 95% CI, 1.22–1.68; P = .00001; NNTB = 10). Trough FEV1 was significantly higher at the end of treatment with indacaterol than with TD-LABAs (80 mL, P = .00001). Similarly, indacaterol significantly improved dyspnea (61% greater likelihood of achieving an MCID in TDI, P = .008) and health status (21% greater likelihood of achieving an MCID in St. George's Respiratory Questionnaire, P = .04) than TD-LABA. Indacaterol showed similar levels of safety and tolerability to both comparators.

Conclusions

Available evidence suggests that indacaterol may prove useful as an alternative to tiotropium or TD-LABA due to its effects on health status, dyspnea, and pulmonary function.CHEST 2012; 142(5):1104–1110

Section snippets

Materials and Methods

We adopted Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to perform this systematic review.7 A protocol was prospectively developed detailing the study objectives, primary and secondary outcomes, criteria for study selection, approach to assessing study quality, data synthesis, and statistical analysis. This study was registered with the International Prospective Register of Systematic Reviews (www.crd.york.ac.uk/PROSPERO) as CRD42011001539.

Results

Five randomized controlled trials18, 19, 20, 21, 22 enrolling 5,920 subjects (3,377 in the indacaterol arms and 2,543 in the comparators arms) met the entry criteria (Fig 1). Participants were symptomatic at baseline with moderate to severe airway obstruction. All studies were multicenter, randomized, parallel groups and were sponsored by a single pharmaceutical company (Table 1). Two studies compared indacaterol with tiotropium,18,19 and three compared indacaterol with a TD-LABA (salmeterol or

Discussion

Indacaterol is a novel inhaled LABA providing 24-h bronchodilation on once-daily dosing recently approved in many countries for the treatment of patients with COPD. Previous data have shown that inhaled indacaterol improved numerous clinical outcomes over placebo, with a similar safety and tolerability profile.5 This review has found a similar efficacy between indacaterol (150-300 μg/d) and tiotropium (18 μg/d) on trough FEV1 after 12 to 26 weeks of treatment. Since the relationship between

Acknowledgments

Author contributions: Dr Rodrigo: contributed to study conception and design; acquisition, analysis, and interpretation of data; drafting the submitted article and revising it critically for important intellectual content; and providing final approval of the version to be published.

Dr Neffen: contributed to study conception and design, interpretation of data, revising the article critically for important intellectual content, and providing final approval of the version to be published.

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    Funding/Support: This study was funded by salary support from Hospital Central de las Fuerzas Armadas for Dr Rodrigo.

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.

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