One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis

被引：15

作者：

Konstan, Michael W. ^{[1
,2
]}

Flume, Patrick A. ^{[3
]}

Galeva, Ivanka ^{[4
]}

Wan, Robert ^{[5
]}

Debonnett, Laurie M. ^{[5
]}

Maykut, Robert J. ^{[5
]}

Angyalosi, Gerhild ^{[6
]}

机构：

[1] Case Western Reserve Univ, Sch Med, Cleveland, OH 44106 USA

[2] Rainbow Babies & Childrens Hosp, 11100 Euclid Ave, Cleveland, OH 44106 USA

[3] Med Univ S Carolina, Charleston, SC 29425 USA

[4] Med Univ, Alexandrovska Hosp, Sofia, Bulgaria

[5] Novartis Pharmaceut, E Hanover, NJ USA

[6] Novartis Pharma AG, Basel, Switzerland

来源：

PEDIATRIC PULMONOLOGY | 2016年 / 51卷 / 04期

关键词：

Cystic fibrosis; forced expiratory volume in one second; Pseudomonas aeruginosa; tobramycin powder for inhalation; long-term safety; AERUGINOSA; TRIAL;

D O I：

10.1002/ppul.23358

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

This is an integrated analysis of data from patients with cystic fibrosis (CF) aged 6-21 years who were treated with up to seven cycles of tobramycin powder for inhalation (TIPTM) over a period of at least 1 year. Safety and key efficacy endpoints were analyzed. Results: The improvement in lung function and decrease in sputum P. aeruginosa (Pa) density from baseline were sustained over the 1-year treatment period. The number of adverse events (AEs) was low and did not increase with additional cycles of TIP treatment. Some increase in tobramycin minimum inhibitory concentration (MIC) was observed, but there was no significant increase in emergence of resistant strains based on the parenteral breakpoint for tobramycin. Conclusion: Efficacy of TIP was maintained for up to seven cycles. Long-term treatment with TIP was generally safe and well tolerated with no increase in AEs. Pediatr Pulmonol. 2016;51:372-378. (c) 2015 Wiley Periodicals, Inc.

引用

页码：372 / 378

页数：7

共 8 条

[1]

[Anonymous], 2014, AUDIOLOGIC MANAGEMEN, V2014

[2]

Doring Gerd, 2004, J Cyst Fibros, V3, P67, DOI 10.1016/j.jcf.2004.03.008

[3] Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis [J].

Emerson, J ;

Rosenfeld, M ;

McNamara, S ;

Ramsey, B ;

Gibson, RL .

PEDIATRIC PULMONOLOGY, 2002, 34 (02) :91-100

[4] Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial [J].

Galeva, Ivanka ;

Konstan, Michael W. ;

Higgins, Mark ;

Angyalosi, Gerhild ;

Brockhaus, Florian ;

Piggott, Simon ;

Thomas, Karen ;

Chuchalin, Alexander G. .

CURRENT MEDICAL RESEARCH AND OPINION, 2013, 29 (08) :947-956

[5] Clinical Use of Tobramycin Inhalation Solution ( TOBI1) Shows Sustained Improvement in FEV1 in Cystic Fibrosis [J].

Konstan, Michael W. ;

Wagener, Jeffrey S. ;

Pasta, David J. ;

Millar, Stefanie J. ;

Morgan, Wayne J. .

PEDIATRIC PULMONOLOGY, 2014, 49 (06) :529-536

[6] Tobramycin Inhalation Powder for P. aeruginosa Infection in Cystic Fibrosis: The EVOLVE Trial [J].

Konstan, Michael W. ;

Geller, David E. ;

Minic, Predrag ;

Brockhaus, Florian ;

Zhang, Jie ;

Angyalosi, Gerhild .

PEDIATRIC PULMONOLOGY, 2011, 46 (03) :230-238

[7] Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial [J].

Konstan, Michael W. ;

Flume, Patrick A. ;

Kappler, Matthias ;

Chiron, Raphael ;

Higgins, Mark ;

Brockhaus, Florian ;

Zhang, Jie ;

Angyalosi, Gerhild ;

He, Ellie ;

Geller, David E. .

JOURNAL OF CYSTIC FIBROSIS, 2011, 10 (01) :54-61

[8] Intermittent administration of inhaled tobramycin in patients with cystic fibrosis [J].

Ramsey, BW ;

Pepe, MS ;

Quan, JM ;

Otto, KL ;

Montgomery, AB ;

Williams-Warren, J ;

Vasiljev-K, M ;

Borowitz, D ;

Bowman, CM ;

Marshall, BC ;

Marshall, S ;

Smith, AL .

NEW ENGLAND JOURNAL OF MEDICINE, 1999, 340 (01) :23-30

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