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

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Abstract

Background

Inhaled indacaterol (Onbrez Breezhaler), a long-acting β ₂-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.

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Most cited references 11

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Long-term safety and efficacy of indacaterol, a long-acting β₂-agonist, in subjects with COPD: a randomized, placebo-controlled study.

Kenneth Chapman, Stephen Rennard, Angeli Dogra … (2011)

Indacaterol is an inhaled, long-acting β(2)-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV(1) at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV(1) relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P 4 units. During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes. ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov.

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Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: a 12-week, placebo-controlled study.

, Naoko Okino, Motoi Hosoe … (2012)

The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β(2) -agonist was evaluated in COPD patients in six Asian countries/areas. This study was primarily designed to obtain the regulatory approval of indacaterol in Japan. Moderate-to-severe COPD patients were randomized to indacaterol 150 µg, indacaterol 300 µg or placebo once daily. Efficacy variables: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety/tolerability was evaluated. A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post-bronchodilator FEV(1) % predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV(1) at week 12 for indacaterol 150 µg, indacaterol 300 µg and placebo were 1.34 L, 1.37 L and 1.17 L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12 L (0.17 L and 0.20 L for indacaterol 150 µg and 300 µg, respectively, both P < 0.001). The week 12 LSM transition dyspnoea index score was statistically superior for both indacaterol doses versus placebo (differences of 1.30 and 1.26, P < 0.001; both exceeding the minimal clinically important difference of 1). At week 12, both indacaterol doses provided statistically significant (P ≤ 0.005) and clinically meaningful (≥4 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: -4.8 and -5.7 units). Adverse events for indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild/moderate in severity; no deaths were reported. Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients. © 2011 Novartis Pharma AG (Basel, Switzerland).

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Safety of indacaterol in the treatment of patients with COPD

James Donohue, Dave Singh, Oliver Kornmann … (2011)

Purpose Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β2-agonist for chronic obstructive pulmonary disease (COPD). Patients and methods Data were pooled from clinical studies of 3–12 months’ duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 μg (n = 449), 150 μg (n = 2611), 300 μg (n = 1157), or 600 μg once daily (n = 547); formoterol 12 μg twice daily (n = 556); salmeterol 50 μg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 μg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs. Results The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were <1 for all indacaterol doses. Notable values for vital signs and measures of systemic β2-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07–0.660], P = 0.008). Conclusion Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.

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Author and article information

Journal

Journal ID (nlm-ta): Tuberc Respir Dis (Seoul)

Journal ID (iso-abbrev): Tuberc Respir Dis (Seoul)

Journal ID (publisher-id): TRD

Title: Tuberculosis and Respiratory Diseases

Publisher: The Korean Academy of Tuberculosis and Respiratory Diseases

ISSN (Print): 1738-3536

ISSN (Electronic): 2005-6184

Publication date (Print): January 2017

Publication date (Electronic): 30 December 2016

Volume: 80

Issue: 1

Pages: 52-59

Affiliations

[1 ]Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.

[2 ]Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea.

[3 ]Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

[4 ]Division of Pulmonology and Allergy, Department of Internal Medicine, Regional Center for Respiratory Disease, Yeungnam University College of Medicine, Daegu, Korea.

[5 ]Novartis Korea Ltd., Seoul, Korea.

[6 ]Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Author notes

Address for correspondence: Yeon-Mok Oh, M.D. Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea. Phone: 82-2-3010-3136, Fax: 82-2-3010-6968, ymoh55@ 123456amc.seoul.kr

Article

DOI: 10.4046/trd.2017.80.1.52

PMC ID: 5256353

PubMed ID: 28119747

SO-VID: cb492912-cf77-4f76-8d91-2c5c4962f9d6

License:

It is identical to the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/)

History

Date received : 23 February 2016

Date revision received : 12 April 2016

Date accepted : 22 June 2016

Funding

Funded by: Novartis Korea Ltd.;

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

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Most cited references 11

Long-term safety and efficacy of indacaterol, a long-acting β₂-agonist, in subjects with COPD: a randomized, placebo-controlled study.

Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: a 12-week, placebo-controlled study.

Safety of indacaterol in the treatment of patients with COPD

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