An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients
Background Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods This was an open-label, multicentre...
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The Korean Academy of Tuberculosis and Respiratory Diseases
2023-01-01
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| Series: | Tuberculosis and Respiratory Diseases |
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| Online Access: | http://e-trd.org/upload/pdf/trd-2022-0055.pdf |
| _version_ | 1797962725079384064 |
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| author | Eun-Yeong Cho Jung-Eun Cho Eun-Bin Lee Seung Soo Yoo Jung Hyun Chang |
| author_facet | Eun-Yeong Cho Jung-Eun Cho Eun-Bin Lee Seung Soo Yoo Jung Hyun Chang |
| author_sort | Eun-Yeong Cho |
| collection | DOAJ |
| description | Background Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 μg/25 μg) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician’s evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment. |
| first_indexed | 2024-04-11T01:17:24Z |
| format | Article |
| id | doaj.art-6f64bff283e541e08ee36887253fbea8 |
| institution | Directory Open Access Journal |
| issn | 1738-3536 2005-6184 |
| language | English |
| last_indexed | 2024-04-11T01:17:24Z |
| publishDate | 2023-01-01 |
| publisher | The Korean Academy of Tuberculosis and Respiratory Diseases |
| record_format | Article |
| series | Tuberculosis and Respiratory Diseases |
| spelling | doaj.art-6f64bff283e541e08ee36887253fbea82023-01-03T23:11:59ZengThe Korean Academy of Tuberculosis and Respiratory DiseasesTuberculosis and Respiratory Diseases1738-35362005-61842023-01-01861334610.4046/trd.2022.00554803An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean PatientsEun-Yeong Cho0Jung-Eun Cho1Eun-Bin Lee2Seung Soo Yoo3Jung Hyun Chang4 GSK Korea, Seoul, Republic of Korea GSK Korea, Seoul, Republic of Korea GSK Korea, Seoul, Republic of Korea Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea Division of Pulmonary and Critical Care Medicine, Ewha Womans University College of Medicine, Seoul, Republic of KoreaBackground Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 μg/25 μg) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician’s evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.http://e-trd.org/upload/pdf/trd-2022-0055.pdfvilanterolgsk573719postmarketingsafetypulmonary disease, chronic obstructive |
| spellingShingle | Eun-Yeong Cho Jung-Eun Cho Eun-Bin Lee Seung Soo Yoo Jung Hyun Chang An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients Tuberculosis and Respiratory Diseases vilanterol gsk573719 postmarketing safety pulmonary disease, chronic obstructive |
| title | An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients |
| title_full | An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients |
| title_fullStr | An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients |
| title_full_unstemmed | An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients |
| title_short | An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients |
| title_sort | open label multicentre observational post marketing study to monitor the safety and effectiveness of umeclidinium vilanterol in korean patients |
| topic | vilanterol gsk573719 postmarketing safety pulmonary disease, chronic obstructive |
| url | http://e-trd.org/upload/pdf/trd-2022-0055.pdf |
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