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Wednesday, 23 November 2016 11:04

Paper 2016_11.1

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Randomized Trial of Liposomal Amikacin for Inhalation in Nontuberculous Mycobacterial Lung Disease


Kenneth N. Olivier, David E. Griffith, Gina Eagle, John P. McGinnis II, Liza Micioni, Keith Liu, Charles L. Daley, Kevin L. Winthrop, Stephen Ruoss, Doreen J. Addrizzo-Harris,  Patrick A. Flume, Daniel Dorgan, Matthias Salathe, Barbara A. Brown-Elliott, Renu Gupta, Richard J. Wallace, Jr.


Scientific Knowledge on the Subject

At a Glance Commentary: Management of pulmonary nontuberculous mycobacterial (PNTM) disease is limited by lengthy multi-drug regimens, drug toxicity and/or intolerance, and poor drug efficacy. Liposomes are taken up by lung macrophages, allowing intracellular delivery of high levels of amikacin into nontuberculous mycobacteria (NTM)–infected cells, and inhalation allows localized drug delivery. In select patients with treatment-refractory PNTM disease, liposomal amikacin for inhalation (LAI) added to guidelines-based therapy may be able to achieve early and sustained negative sputum cultures with limited systemic toxicity. What This Study Adds to the Field


This multi-center clinical trial assessed the novel drug formulation LAI in patients with persistently positive NTM cultures despite having received guidelines-based treatment for at least 6 months prior to screening. Although the primary end point was not achieved, more patients receiving LAI treatment than patients receiving placebo had a negative NTM sputum culture at Day 84 (32% [14/44] vs. 9% [4/45]; P = 0.006). Most of these patients (n=14/18) also had a negative culture at 28 days after LAI discontinuation. Culture conversion, used in tuberculosis trials to predict lasting mycobacterial eradication, occurred mainly in non-cystic fibrosis patients with Mycobacterium avium complex infection. Results of this study indicate that in select patients with treatment-refractory PNTM disease, LAI added to guidelines-based therapy can achieve early and sustained negative sputum cultures. Further, culture conversion in response to treatment with LAI may be associated with improvements in functional capacity and relative to treatment with parenteral amikacin, limited systemic toxicity.



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