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Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT). A prospective, open-label, randomized study
DC Field | Value | Language |
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dc.contributor.author | Griffith, David E. | - |
dc.contributor.author | Eagle, Gina | - |
dc.contributor.author | Thomson, Rachel | - |
dc.contributor.author | Aksamit, Timothy R. | - |
dc.contributor.author | Hasegawa, Naoki | - |
dc.contributor.author | Morimoto, Kozo | - |
dc.contributor.author | Addrizzo-Harris, Doreen J. | - |
dc.contributor.author | O'Donnell, Anne E. | - |
dc.contributor.author | Marras, Theodore K. | - |
dc.contributor.author | Flume, Patrick A. | - |
dc.contributor.author | Loebinger, Michael R. | - |
dc.contributor.author | Morgan, Lucy | - |
dc.contributor.author | Codecasa, Luigi R. | - |
dc.contributor.author | Hill, Adam T. | - |
dc.contributor.author | Ruoss, Stephen J. | - |
dc.contributor.author | Yim, Jae-Joon | - |
dc.contributor.author | Ringshausen, Felix C. | - |
dc.contributor.author | Field, Stephen K. | - |
dc.contributor.author | Philley, Julie V. | - |
dc.contributor.author | Wallace, Richard J., Jr. | - |
dc.contributor.author | van Ingen, Jakko | - |
dc.contributor.author | Coulter, Chris | - |
dc.contributor.author | Nezamis, James | - |
dc.contributor.author | Winthrop, Kevin L. | - |
dc.contributor.author | CONVERT Study Grp | - |
dc.date.accessioned | 2024-08-08T01:30:49Z | - |
dc.date.available | 2024-08-08T01:30:49Z | - |
dc.date.created | 2019-08-21 | - |
dc.date.created | 2019-08-21 | - |
dc.date.issued | 2018-12 | - |
dc.identifier.citation | American Journal of Respiratory and Critical Care Medicine, Vol.198 No.12, pp.1559-1569 | - |
dc.identifier.issn | 1073-449X | - |
dc.identifier.uri | https://hdl.handle.net/10371/206356 | - |
dc.description.abstract | Rationale: Improved therapeutic options are needed for patients with treatment-refractory nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). Objectives: To evaluate the efficacy and safety of daily amikacin liposome inhalation suspension (ALIS) added to standard guideline-based therapy (GBT) in patients with refractory MAC lung disease. Methods: Adults with amikacin-susceptible MAC lung disease and MAC-positive sputum cultures despite at least 6 months of stable GBT were randomly assigned (2: 1) to receive ALIS with GBT (ALIS + GBT) or GBT alone. Once-daily ALIS was supplied in single-use vials delivering 590 mg amikacin to the nebulizer. The primary endpoint was culture conversion, defined as three consecutive monthly MAC-negative sputum cultures by Month 6. Measurements and Main Results: Enrolled patients (ALIS + GBT, n = 224; GBT-alone, n = 112) were a mean 64.7 years old and 69.3% female. Most had underlying bronchiectasis (62.5%), chronic obstructive pulmonary disease (14.3%), or both (11.9%). Culture conversion was achieved by 65 of 224 patients (29.0%) with ALIS + GBT and 10 of 112 (8.9%) with GBT alone (odds ratio, 4.22; 95% confidence interval, 2.08-8.57; P < 0.001). Patients in the ALIS + GBT arm versus GBT alone were more likely to achieve conversion (hazard ratio, 3.90; 95% confidence interval, 2.00-7.60). Respiratory adverse events (primarily dysphonia, cough, and dyspnea) were reported in 87.4% of patients receiving ALIS + GBT and 50.0% receiving GBT alone; serious treatment-emergent adverse events occurred in 20.2% and 17.9% of patients, respectively. Conclusions: Addition of ALIS to GBT for treatment-refractory MAC lung disease achieved significantly greater culture conversion by Month 6 than GBT alone, with comparable rates of serious adverse events. | - |
dc.language | 영어 | - |
dc.publisher | American Thoracic Society | - |
dc.title | Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT). A prospective, open-label, randomized study | - |
dc.type | Article | - |
dc.identifier.doi | 10.1164/rccm.201807-1318OC | - |
dc.citation.journaltitle | American Journal of Respiratory and Critical Care Medicine | - |
dc.identifier.wosid | 000453253600018 | - |
dc.identifier.scopusid | 2-s2.0-85056304905 | - |
dc.citation.endpage | 1569 | - |
dc.citation.number | 12 | - |
dc.citation.startpage | 1559 | - |
dc.citation.volume | 198 | - |
dc.description.isOpenAccess | N | - |
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 | INHALED AMIKACIN | - |
dc.subject.keywordPlus | PREVALENCE | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | DEPOSITION | - |
dc.subject.keywordPlus | MORTALITY | - |
dc.subject.keywordPlus | ONTARIO | - |
dc.subject.keywordPlus | CANADA | - |
dc.subject.keywordAuthor | nontuberculous mycobacteria | - |
dc.subject.keywordAuthor | guideline-based therapy | - |
dc.subject.keywordAuthor | culture conversion | - |
dc.subject.keywordAuthor | liposomal amikacin for inhalation | - |
dc.subject.keywordAuthor | ALIS | - |
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