| LEAUTE-LABREZE, C., P. HOEGER, J. MAZEREEUW-HAUTIER, L. GUIBAUD, E. BASELGA, G. POSIUNAS, R. J. PHILLIPS, H. CACERES, J. C. LOPEZ GUTIERREZ, R. BALLONA, S. F. FRIEDLANDER, J. POWELL, D. PEREK, B. METZ, S. BARBAROT, A. MARUANI, Z. Z. SZALAI, A. KROL, O. BOCCARA, R. FOELSTER-HOLST, M. I. FEBRER BOSCH, J. SU, Hana BUČKOVÁ, A. TORRELO, F. CAMBAZARD, R. GRANTZOW, O. WARGON, D. WYRZYKOWSKI, J. ROESSLER, J. BERNABEU-WITTEL, A. M. VALENCIA, P. PRZEWRATIL, S. GLICK, E. POPE, N. BIRCHALL, L. BENJAMIN, A. J. MANCINI, P. VABRES, P. SOUTEYRAND, I. J. FRIEDEN, C. I. BERUL, C. R. MEHTA, S. PREY, F. BORALEVI, C. C. MORGAN, S. HERITIER, A. DELARUE and J-J VOISARD. A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma. New England Journal of Medicine. Waltham: MASSACHUSETTS MEDICAL SOC, 2015, vol. 372, No 8, p. 735-746. ISSN 0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa1404710. |
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@article{1230641,
author = {LeauteandLabreze, C. and Hoeger, P. and MazereeuwandHautier, J. and Guibaud, L. and Baselga, E. and Posiunas, G. and Phillips, R. J. and Caceres, H. and Lopez Gutierrez, J. C. and Ballona, R. and Friedlander, S. F. and Powell, J. and Perek, D. and Metz, B. and Barbarot, S. and Maruani, A. and Szalai, Z. Z. and Krol, A. and Boccara, O. and FoelsterandHolst, R. and Febrer Bosch, M. I. and Su, J. and Bučková, Hana and Torrelo, A. and Cambazard, F. and Grantzow, R. and Wargon, O. and Wyrzykowski, D. and Roessler, J. and BernabeuandWittel, J. and Valencia, A. M. and Przewratil, P. and Glick, S. and Pope, E. and Birchall, N. and Benjamin, L. and Mancini, A. J. and Vabres, P. and Souteyrand, P. and Frieden, I. J. and Berul, C. I. and Mehta, C. R. and Prey, S. and Boralevi, F. and Morgan, C. C. and Heritier, S. and Delarue, A. and Voisard, JandJ},
article_location = {Waltham},
article_number = {8},
doi = {http://dx.doi.org/10.1056/NEJMoa1404710},
keywords = {TREATMENT SELECTION; NATURAL-HISTORY; INFANCY; CORTICOSTEROIDS; MANAGEMENT; ANOMALIES; CHILDREN; THERAPY; DESIGNS},
language = {eng},
issn = {0028-4793},
journal = {New England Journal of Medicine},
title = {A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma},
volume = {372},
year = {2015}
}
TY - JOUR
ID - 1230641
AU - Leaute-Labreze, C. - Hoeger, P. - Mazereeuw-Hautier, J. - Guibaud, L. - Baselga, E. - Posiunas, G. - Phillips, R. J. - Caceres, H. - Lopez Gutierrez, J. C. - Ballona, R. - Friedlander, S. F. - Powell, J. - Perek, D. - Metz, B. - Barbarot, S. - Maruani, A. - Szalai, Z. Z. - Krol, A. - Boccara, O. - Foelster-Holst, R. - Febrer Bosch, M. I. - Su, J. - Bučková, Hana - Torrelo, A. - Cambazard, F. - Grantzow, R. - Wargon, O. - Wyrzykowski, D. - Roessler, J. - Bernabeu-Wittel, J. - Valencia, A. M. - Przewratil, P. - Glick, S. - Pope, E. - Birchall, N. - Benjamin, L. - Mancini, A. J. - Vabres, P. - Souteyrand, P. - Frieden, I. J. - Berul, C. I. - Mehta, C. R. - Prey, S. - Boralevi, F. - Morgan, C. C. - Heritier, S. - Delarue, A. - Voisard, J-J
PY - 2015
TI - A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma
JF - New England Journal of Medicine
VL - 372
IS - 8
SP - 735-746
EP - 735-746
PB - MASSACHUSETTS MEDICAL SOC
SN - 00284793
KW - TREATMENT SELECTION
KW - NATURAL-HISTORY
KW - INFANCY
KW - CORTICOSTEROIDS
KW - MANAGEMENT
KW - ANOMALIES
KW - CHILDREN
KW - THERAPY
KW - DESIGNS
N2 - BACKGROUND Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. METHODS We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. RESULTS Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. CONCLUSIONS This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma.
ER -
LEAUTE-LABREZE, C., P. HOEGER, J. MAZEREEUW-HAUTIER, L. GUIBAUD, E. BASELGA, G. POSIUNAS, R. J. PHILLIPS, H. CACERES, J. C. LOPEZ GUTIERREZ, R. BALLONA, S. F. FRIEDLANDER, J. POWELL, D. PEREK, B. METZ, S. BARBAROT, A. MARUANI, Z. Z. SZALAI, A. KROL, O. BOCCARA, R. FOELSTER-HOLST, M. I. FEBRER BOSCH, J. SU, Hana BUČKOVÁ, A. TORRELO, F. CAMBAZARD, R. GRANTZOW, O. WARGON, D. WYRZYKOWSKI, J. ROESSLER, J. BERNABEU-WITTEL, A. M. VALENCIA, P. PRZEWRATIL, S. GLICK, E. POPE, N. BIRCHALL, L. BENJAMIN, A. J. MANCINI, P. VABRES, P. SOUTEYRAND, I. J. FRIEDEN, C. I. BERUL, C. R. MEHTA, S. PREY, F. BORALEVI, C. C. MORGAN, S. HERITIER, A. DELARUE and J-J VOISARD. A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma. \textit{New England Journal of Medicine}. Waltham: MASSACHUSETTS MEDICAL SOC, 2015, vol.~372, No~8, p.~735-746. ISSN~0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa1404710.
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