| Imatinib Mesylate as Add-On Therapy for Pulmonary Arterial Hypertension: Results of the Randomized IMPRES Study. | |
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MedLine Citation:
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PMID: 23403476 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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). |
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Authors:
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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:
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Type: JOURNAL ARTICLE Date: 2013-2-12 |
Journal Detail:
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Title: Circulation Volume: - ISSN: 1524-4539 ISO Abbreviation: Circulation Publication Date: 2013 Feb |
Date Detail:
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Created Date: 2013-2-13 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0147763 Medline TA: Circulation Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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1Medizinische Hochschule, Hannover, Germany. |
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