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Imatinib Mesylate as Add-On Therapy for Pulmonary Arterial Hypertension: Results of the Randomized IMPRES Study.
MedLine Citation:
PMID:  23403476     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: By its inhibitory effect on platelet-derived growth factor signaling, imatinib could be efficacious in treating patients with pulmonary arterial hypertension (PAH). METHODS AND RESULTS: IMPRES, a randomized, double-blind, placebo-controlled 24-week trial evaluated imatinib in patients with pulmonary vascular resistance (PVR) ≥800 dynes•sec•cm(-5) symptomatic on ≥2 PAH therapies. The primary outcome was change in 6-minute walk distance (6MWD). Secondary outcomes included changes in hemodynamics, functional class, serum levels of N-terminal brain natriuretic peptide (NT-proBNP), and time to clinical worsening (TTCW). After completion of the core study, patients could enter an open-label long-term extension study. Of 202 patients enrolled, 41% patients received 3 PAH therapies with the remainder on 2 therapies. After 24 weeks, the mean placebo-corrected treatment-effect on 6MWD was 32 m (95% confidence interval [CI], 12, 52; P=0.002), an effect maintained in the extension study in patients remaining on imatinib. PVR decreased by 379 dynes•sec•cm(-5) (95% CI: -502, -255; P<0.001; between-group difference). Functional class, TTCW and mortality did not differ between treatments. Serious adverse events and discontinuations were more frequent with imatinib than placebo (44% versus 30%, 33% versus 18% respectively). Subdural hematoma occurred in 8 patients (2 in the core study, 6 in the extension) receiving imatinib and anticoagulation. CONCLUSIONS: Imatinib improved exercise capacity and hemodynamics in patients with advanced PAH but serious adverse events and study drug discontinuations were common. Further studies are needed to investigate the long-term safety and efficacy of imatinib in patients with PAH. CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://www.clinicaltrials.gov. Identifier: NCT00902174 (core study); NCT01392495 (extension).
Authors:
Marius M Hoeper; Robyn J Barst; Robert C Bourge; Jeremy Feldman; Adaani E Frost; Nazzareno Galié; Miguel Angel Gómez-Sánchez; Friedrich Grimminger; Ekkehard Grünig; Paul M Hassoun; Nicholas W Morrell; Andrew J Peacock; Toru Satoh; Gérald Simonneau; Victor F Tapson; Fernando Torres; David Lawrence; Deborah A Quinn; Hossein-Ardeschir Ghofrani
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-2-12
Journal Detail:
Title:  Circulation     Volume:  -     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-2-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
1Medizinische Hochschule, Hannover, Germany.
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