Tuberc Respir Dis.  2017 Jan;80(1):52-59. 10.4046/trd.2017.80.1.52.

Safety and Effectiveness of Indacaterol in Chronic Obstructive Pulmonary Disease Patients in South Korea

• Yum HK
• Kim HR
• Chang YS
• Shin KC
• Kim S
• Oh YM

• KMID: 2396341
• DOI: http://doi.org/10.4046/trd.2017.80.1.52

Abstract

BACKGROUND
Inhaled indacaterol (Onbrez Breezhaler), a long-acting β₂-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population.
METHODS
This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or 300 µg), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available.
RESULTS
Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator.
CONCLUSION
In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

Keyword

Indacaterol; Pulmonary Disease, Chronic Obstructive; Safety; Bronchodilator Agents; Therapeutics; South Korea

MeSH Terms

Bronchodilator Agents
Forced Expiratory Volume
Humans
Incidence
Korea*
Lung
Prospective Studies
Pulmonary Disease, Chronic Obstructive*
Research Personnel
Bronchodilator Agents

Figure

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  Figure 1 Selection of study patients (patient disposition). CRF: case report forms.

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  Figure 2 Severity of AE (safety set). *For 313 AEs reported by 228 patients. AEs: adverse events.

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  Figure 3 Effectiveness assessment at week 12 or 24 (effectiveness analysis set).

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