Frost, Adaani E. and Barst, Robyn J. and Hoeper, Marius M. and Chang, Hyuk-Jae and Frantz, Robert P. and Fukumoto, Yoshihiro and Galie, Nazzareno and Hassoun, Paul M. and Klose, Hans and Matsubara, Hiromi and Morrell, Nicholas W. and Peacock, Andrew J. and Pfeifer, Michael and Simonneau, Gerald and Tapson, Victor F. and Torres, Fernando and Vizza, Carmine Dario and Lawrence, David and Yang, Wei and Felser, James M. and Quinn, Deborah A. and Ghofrani, Hossein-Ardeschir (2015) Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. JOURNAL OF HEART AND LUNG TRANSPLANTATION, 34 (11). pp. 1366-1375. ISSN 1053-2498, 1557-3117
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND: Imatinib is an oral inhibitor of several protein kinases implicated in the pathophysiology of pulmonary hypertension. Treatment with imatinib resulted in improved hemodynamics and exercise capacity in a controlled trial (Imatinib [QTI571] in Pulmonary Arterial Hypertension, a Randomized Efficacy Study [IMPRES]), among pulmonary arterial hypertension (PAH) patients inadequately responsive to 2 to 3 PAH-specific therapies. METHODS: The long-term (up to 204 weeks) safety and efficacy of imatinib in this open-label extension study were reviewed until early study termination on April 16, 2014. Of 202 IMPRES-enrolled patients, 66 imatinib and 78 placebo recipients entered the extension. RESULTS: Overall, 93.8% (135 of 144) of patients discontinued the extension study; administrative issues (i.e., sponsor termination; 32.6%) and adverse events (31.3%) were the primary 'reasons for discontinuation. Nine patients completed the extension study before it was terminated. Serious and unexpected adverse events were frequent. These included 6 subdural hematomas in the extension study and 17 deaths during or within 30 days of study end. Although the patients who tolerated imatinib and remained in the extension for a longer duration did experience an improvement in functional class and walk distance, most discontinued the drug and the study. CONCLUSIONS: Severe adverse events, significant side effects, and a high discontinuation rate limit the utility of imatinib in the treatment of PAH. These risks outweigh any possible improvements in hemodynamics and walk distance seen in those patients able to remain on drug. The off-label use of this compound in PAH is discouraged. (C) 2015 International Society for Heart and Lung Transplantation. All rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | GROWTH-FACTOR EXPRESSION; 6-MINUTE WALK TEST; CONTROLLED-TRIAL; DOUBLE-BLIND; OPEN-LABEL; THERAPY; TREPROSTINIL; SURVIVAL; MESYLATE; PROSTACYCLIN; pulmonary arterial hypertension; imatinib; safety; long-term; efficacy |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 07 May 2019 13:18 |
| Last Modified: | 07 May 2019 13:18 |
| URI: | https://pred.uni-regensburg.de/id/eprint/4549 |
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