| Imatinib treatment for idiopathic pulmonary fibrosis: Randomized placebo-controlled trial results. | |
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MedLine Citation:
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PMID: 20007927 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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RATIONALE: Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with no known efficacious therapy. Imatinib is a tyrosine kinase inhibitor with potential efficacy to treat fibrotic lung disease. OBJECTIVES: To investigate the safety and clinical effects of imatinib in patients with IPF. METHODS: We studied 119 patients in an investigator-initiated, multicenter, multinational, double-blind clinical trial to receive imatinib or placebo for 96 weeks. MEASUREMENTS AND MAIN RESULTS: Over 96 weeks of follow-up, imatinib did not differ significantly from placebo (log rank P = 0.89) for the primary endpoint defined as time to disease progression (10% decline in percent predicted FVC from baseline) or time to death. There was no effect of imatinib therapy on change in FVC at 48, 72, or 96 weeks (P > or = 0.39 at all time points) or change in diffusing capacity of carbon monoxide at 48, 72, or 96 weeks (P > or = 0.26 at all time points). Change in resting Pa(O(2)) favored imatinib therapy at 48 weeks (P = 0.005) but not at 96 weeks (P = 0.074). During the 96-week trial there were 8 deaths in the imatinib group and 10 deaths in the placebo group (log rank test P = 0.64). Thirty-five (29%) patients discontinued the study without reaching the primary endpoint (imatinib, 32%; placebo, 27%; P = 0.51). Serious adverse events (SAEs) were not more common in the imatinib group (imatinib, 18 SAEs in 17 patients; placebo, 19 SAEs in 18 patients). CONCLUSIONS: In a randomized, placebo-controlled trial of patients with mild to moderate IPF followed for 96 weeks, imatinib did not affect survival or lung function. Clinical trial registered with www.clinicaltrials.gov (NCT00131274). |
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Authors:
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Craig E Daniels; Joseph A Lasky; Andrew H Limper; Kathleen Mieras; Edith Gabor; Darrell R Schroeder; |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-12-10 |
Journal Detail:
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Title: American journal of respiratory and critical care medicine Volume: 181 ISSN: 1535-4970 ISO Abbreviation: Am. J. Respir. Crit. Care Med. Publication Date: 2010 Mar |
Date Detail:
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Created Date: 2010-03-08 Completed Date: 2010-04-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9421642 Medline TA: Am J Respir Crit Care Med Country: United States |
Other Details:
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Languages: eng Pagination: 604-10 Citation Subset: AIM; IM |
Affiliation:
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Mayo Clinic, Rochester, Minnesota, USA. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00131274 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Anemia / chemically induced Disease Progression Double-Blind Method Dyspnea / chemically induced Feasibility Studies Female Follow-Up Studies Gastrointestinal Diseases / chemically induced Hematoma, Subdural / chemically induced Humans Idiopathic Pulmonary Fibrosis / drug therapy* Leukopenia / chemically induced Male Middle Aged Piperazines / adverse effects, therapeutic use* Protein Kinase Inhibitors / adverse effects, therapeutic use* Pyrimidines / adverse effects, therapeutic use* Respiratory Function Tests / methods, statistics & numerical data Survival Analysis Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Piperazines; 0/Protein Kinase Inhibitors; 0/Pyrimidines; 152459-95-5/imatinib |
| Investigator | |
Investigator/Affiliation:
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Jeffrey Chapman / ; Steven Nathan / ; Moises Selman / ; Charles Alex / ; Augustine Lee / ; Craig E Daniels / ; Andrew H Limper / ; Leo Ginns / ; Joaode de Andrade / ; Imre Noth / ; Marilyn Glassberg / ; Janice Lieber / ; Joseph Lasky / ; Lisa Lancaster / ; Paul Nobel / ; Stephen Pascoe / ; Jo Ann Duffy / |
| Comments/Corrections | |
Comment In:
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Am J Respir Crit Care Med. 2010 Mar 15;181(6):532-3
[PMID:
20208038
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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