Publications
Detailed Information
Amikacin Liposome Inhalation Suspension for Mycobacterium avium Complex Lung Disease A 12-Month Open-Label Extension Clinical Trial
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Winthrop, Kevin L. | - |
dc.contributor.author | Flume, Patrick A. | - |
dc.contributor.author | Thomson, Rachel | - |
dc.contributor.author | Mange, Kevin C. | - |
dc.contributor.author | Yuen, Dayton W. | - |
dc.contributor.author | Ciesielska, Monika | - |
dc.contributor.author | Morimoto, Kozo | - |
dc.contributor.author | Ruoss, Stephen J. | - |
dc.contributor.author | Codecasa, Luigi R. | - |
dc.contributor.author | Yim, Jae-Joon | - |
dc.contributor.author | Marras, Theodore K. | - |
dc.contributor.author | van Ingen, Jakko | - |
dc.contributor.author | Wallace, Richard J., Jr. | - |
dc.contributor.author | Brown-Elliott, Barbara A. | - |
dc.contributor.author | Coulter, Chris | - |
dc.contributor.author | Griffith, David E. | - |
dc.date.accessioned | 2024-08-08T01:23:52Z | - |
dc.date.available | 2024-08-08T01:23:52Z | - |
dc.date.created | 2021-07-28 | - |
dc.date.created | 2021-07-28 | - |
dc.date.issued | 2021-07 | - |
dc.identifier.citation | Annals of the American Thoracic Society, Vol.18 No.7, pp.1147-1157 | - |
dc.identifier.issn | 1546-3222 | - |
dc.identifier.uri | https://hdl.handle.net/10371/205692 | - |
dc.description.abstract | Rationale: Patients with refractory Mycobacterium avium complex (MAC) lung disease have limited treatment options. In the CONVERT study, amikacin liposome inhalation suspension (ALIS) added to guideline-based therapy (GBT) increased culture conversion rates versus GBT alone by Month 6. Limited data are available regarding.6-month treatment in a refractory population. Objectives: Evaluate 12-month safety, tolerability, and efficacy of ALIS1GBT. Methods: Adults with refractory MAC lung disease not achieving culture conversion by CONVERT Month 6 could enroll in this openlabel extension (INS-312) to receive 590 mg once-daily ALIS1GBT for 12 months. Two cohorts enrolled: the "ALIS-naive" cohort included patients randomized to GBT alone in CONVERT, and the "prior-ALIS" cohort included those randomized to ALIS1GBT in CONVERT. Safety and tolerability of ALIS over 12 months (primary endpoint) and culture conversion by Months 6 and 12 were assessed. Results: In the ALIS-naive cohort, 83.3% of patients (n = 75/90) experienced respiratory treatment-emergent adverse events (TEAEs), and 35.6% (n= 32) had serious TEAEs; 26.7% (n = 24) achieved culture conversion by Month 6 and 33.3% (n= 30) by Month 12. In the prior-ALIS cohort, 46.6% of patients (n= 34/73) experienced respiratory TEAEs, and 27.4% (n= 20) had seriousTEAEs; 9.6% (n = 7) achieved culture conversion by Month 6 (<14 mo ALIS exposure) and 13.7% (n= 10) byMonth 12 (<20 mo ALIS exposure). Nephrotoxicity-related TEAEs and measured hearing decline were infrequent in both cohorts. Conclusions: In up to 20 months of ALIS use, respiratory TEAEs were common, nephrotoxicity and hearing decline were infrequent, and culture conversion continued beyond 6 months of therapy. | - |
dc.language | 영어 | - |
dc.publisher | American Thoracic Society | - |
dc.title | Amikacin Liposome Inhalation Suspension for Mycobacterium avium Complex Lung Disease A 12-Month Open-Label Extension Clinical Trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1513/AnnalsATS.202008-925OC | - |
dc.citation.journaltitle | Annals of the American Thoracic Society | - |
dc.identifier.wosid | 000672723800011 | - |
dc.identifier.scopusid | 2-s2.0-85103609848 | - |
dc.citation.endpage | 1157 | - |
dc.citation.number | 7 | - |
dc.citation.startpage | 1147 | - |
dc.citation.volume | 18 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Yim, Jae-Joon | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | NONTUBERCULOUS MYCOBACTERIA | - |
dc.subject.keywordPlus | PULMONARY-DISEASE | - |
dc.subject.keywordPlus | ESTABLISHMENT | - |
dc.subject.keywordPlus | VNTR | - |
dc.subject.keywordPlus | ALIS | - |
dc.subject.keywordAuthor | nontuberculous mycobacteria | - |
dc.subject.keywordAuthor | culture conversion | - |
dc.subject.keywordAuthor | Mycobacterium avium | - |
dc.subject.keywordAuthor | amikacin liposome inhalation suspension | - |
dc.subject.keywordAuthor | ALIS | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.