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Long-term safety and efficacy of imatinib in pulmonary arterial hypertension

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Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. / Frost, Adaani E; Barst, Robyn J; Hoeper, Marius M; Chang, Hyuk-Jae; Frantz, Robert P; Fukumoto, Yoshihiro; Galié, Nazzareno; Hassoun, Paul M; Klose, Hans; Matsubara, Hiromi; Morrell, Nicholas W; Peacock, Andrew J; Pfeifer, Michael; Simonneau, Gérald; Tapson, Victor F; Torres, Fernando; Dario Vizza, Carmine; Lawrence, David; Yang, Wei; Felser, James M; Quinn, Deborah A; Ghofrani, Hossein-Ardeschir.

in: J HEART LUNG TRANSPL, Jahrgang 34, Nr. 11, 11.2015, S. 1366-75.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Frost, AE, Barst, RJ, Hoeper, MM, Chang, H-J, Frantz, RP, Fukumoto, Y, Galié, N, Hassoun, PM, Klose, H, Matsubara, H, Morrell, NW, Peacock, AJ, Pfeifer, M, Simonneau, G, Tapson, VF, Torres, F, Dario Vizza, C, Lawrence, D, Yang, W, Felser, JM, Quinn, DA & Ghofrani, H-A 2015, 'Long-term safety and efficacy of imatinib in pulmonary arterial hypertension', J HEART LUNG TRANSPL, Jg. 34, Nr. 11, S. 1366-75. https://doi.org/10.1016/j.healun.2015.05.025

APA

Frost, A. E., Barst, R. J., Hoeper, M. M., Chang, H-J., Frantz, R. P., Fukumoto, Y., Galié, N., Hassoun, P. M., Klose, H., Matsubara, H., Morrell, N. W., Peacock, A. J., Pfeifer, M., Simonneau, G., Tapson, V. F., Torres, F., Dario Vizza, C., Lawrence, D., Yang, W., ... Ghofrani, H-A. (2015). Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. J HEART LUNG TRANSPL, 34(11), 1366-75. https://doi.org/10.1016/j.healun.2015.05.025

Vancouver

Frost AE, Barst RJ, Hoeper MM, Chang H-J, Frantz RP, Fukumoto Y et al. Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. J HEART LUNG TRANSPL. 2015 Nov;34(11):1366-75. https://doi.org/10.1016/j.healun.2015.05.025

Bibtex

@article{ffaba6928f7c45e2ab7180a6a40e53e1,
title = "Long-term safety and efficacy of imatinib in pulmonary arterial hypertension",
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.",
author = "Frost, {Adaani E} and Barst, {Robyn J} and Hoeper, {Marius M} and Hyuk-Jae Chang and Frantz, {Robert P} and Yoshihiro Fukumoto and Nazzareno Gali{\'e} and Hassoun, {Paul M} and Hans Klose and Hiromi Matsubara and Morrell, {Nicholas W} and Peacock, {Andrew J} and Michael Pfeifer and G{\'e}rald Simonneau and Tapson, {Victor F} and Fernando Torres and {Dario Vizza}, Carmine and David Lawrence and Wei Yang and Felser, {James M} and Quinn, {Deborah A} and Hossein-Ardeschir Ghofrani",
note = "Copyright {\textcopyright} 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.",
year = "2015",
month = nov,
doi = "10.1016/j.healun.2015.05.025",
language = "English",
volume = "34",
pages = "1366--75",
journal = "J HEART LUNG TRANSPL",
issn = "1053-2498",
publisher = "Elsevier USA",
number = "11",

}

RIS

TY - JOUR

T1 - Long-term safety and efficacy of imatinib in pulmonary arterial hypertension

AU - Frost, Adaani E

AU - Barst, Robyn J

AU - Hoeper, Marius M

AU - Chang, Hyuk-Jae

AU - Frantz, Robert P

AU - Fukumoto, Yoshihiro

AU - Galié, Nazzareno

AU - Hassoun, Paul M

AU - Klose, Hans

AU - Matsubara, Hiromi

AU - Morrell, Nicholas W

AU - Peacock, Andrew J

AU - Pfeifer, Michael

AU - Simonneau, Gérald

AU - Tapson, Victor F

AU - Torres, Fernando

AU - Dario Vizza, Carmine

AU - Lawrence, David

AU - Yang, Wei

AU - Felser, James M

AU - Quinn, Deborah A

AU - Ghofrani, Hossein-Ardeschir

N1 - Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

PY - 2015/11

Y1 - 2015/11

N2 - 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.

AB - 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.

U2 - 10.1016/j.healun.2015.05.025

DO - 10.1016/j.healun.2015.05.025

M3 - SCORING: Journal article

C2 - 26210752

VL - 34

SP - 1366

EP - 1375

JO - J HEART LUNG TRANSPL

JF - J HEART LUNG TRANSPL

SN - 1053-2498

IS - 11

ER -