Baseline Description of the Spanish Academy of Dermatology Infantile Haemangioma Nationwide Prospective Cohort. Comparison of Patients Treated with Propranolol in Routine Clinical Practice with Previous Pivotal Clinical Trial Data
Por:
Cuenca-Barrales C, Baselga E, Del Boz-González J, Vicente-Villa MA, Palencia-Pérez SI, Campos-Domínguez M, Valdivieso-Ramos M, Martín-Santiago A, Montserrat-García MT, Azón-Masoliver A, Feito-Rodríguez M, Domínguez-Cruz JJ, Roé-Crespo E, Salas-Márquez C, Giacaman A, Lorente-Lavirgen AI, Quintana-Castanedo L, de Vega-Martínez M, García-Doval I and Bernabéu-Wittel J
Publicada:
1 oct 2021
Ahead of Print:
1 oct 2021
Resumen:
Background: There are several therapeutic options for infantile haemangiomas (IH). Propranolol is used according to a pivotal trial. We aimed to describe the characteristics of IH in clinical practice, including the therapies used, and to compare the characteristics of patients treated with propranolol with those of the trial to assess its external validity.
Methods: Consecutive patients attending 12 Spanish hospitals from June 2016 to October 2019 were included (n =601).
Results: The mean age was 3.9 (SD:1.9) months, with a 2:1 female-to-male ratio. Most IHs were localized (82%, 495), superficial (64%, 383) and located in the face (25%, 157) and trunk (31%, 188). Median size was 17 (IR: 10-30) x 12 (IR: 7-20) mm. Complications were found in 16 (3%) patients. Treatment was initiated for 52% (311). Most patients received timolol (76%, 237); propranolol was reserved for complications or high-risk IHs. Aesthetic impairment was the main reason for starting therapy (64%, 199). Several characteristics of the patients and IHs treated with propranolol are similar to those of the pivotal clinical trial, but 1/3 of IHs did not reach the minimum diameter to meet the inclusion criteria, and important prognostic information was not reported.
Conclusions: As most patients receive treatment for aesthetic impairment, there is a need to better understand the aesthetic results of therapies and to increase evidence on the use of timolol, which is currently the most common therapy. Propranolol is being used in a population generally similar to that of the trial; however, this statement cannot be definitely confirmed. (C) 2021 Published by Elsevier Espana, S.L.U. on behalf of AEDV.
Filiaciones:
Cuenca-Barrales C:
Unidad de investigación, Fundación Piel Sana Academia Española de Dermatología y Venereología, Madrid, España
Departamento de Dermatología, Hospital Universitario Virgen de las Nieves, Granada, España
Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, España
Baselga E:
Departamento de Dermatología, Hospital Sant Joan de Déu, Barcelona, España
Clínica Dermik, Barcelona, España
Del Boz-González J:
Departamento de Dermatología, Hospital Costa del Sol, Marbella, Málaga, España
Vicente-Villa MA:
Departamento de Dermatología, Hospital Sant Joan de Déu, Barcelona, España
Palencia-Pérez SI:
Departamento de Dermatología, Hospital 12 de Octubre, Madrid, España
Campos-Domínguez M:
Departamento de Dermatología, Hospital Gregorio Marañón, Madrid, España
Valdivieso-Ramos M:
Departamento de Dermatología, Hospital Infanta Leonor, Madrid, España
Martín-Santiago A:
Departamento de Dermatología, Hospital Son Espases, Palma de Mallorca, España
Montserrat-García MT:
Departamento de Dermatología, Hospital Virgen del Rocío, Sevilla, España
Departamento de Dermatología, Hospital Viamed Santa Ángela de la Cruz, Sevilla, España
Azón-Masoliver A:
Departamento de Dermatología, Hospital Sant Joan de Reus, Tarragona, España
Feito-Rodríguez M:
Departamento de Dermatología, Hospital La Paz, Madrid, España
Domínguez-Cruz JJ:
Departamento de Dermatología, Hospital Virgen del Rocío, Sevilla, España
Departamento de Dermatología, Hospital Viamed Santa Ángela de la Cruz, Sevilla, España
Roé-Crespo E:
Departamento de Dermatología, Hospital Santa Creu i Sant Pau, Barcelona, España
Salas-Márquez C:
Departamento de Dermatología, Hospital Costa del Sol, Marbella, Málaga, España
Giacaman A:
Departamento de Dermatología, Hospital Son Espases, Palma de Mallorca, España
Lorente-Lavirgen AI:
Departamento de Dermatología, Hospital Viamed Santa Ángela de la Cruz, Sevilla, España
Quintana-Castanedo L:
Departamento de Dermatología, Hospital La Paz, Madrid, España
de Vega-Martínez M:
Unidad de investigación, Fundación Piel Sana Academia Española de Dermatología y Venereología, Madrid, España
García-Doval I:
Unidad de investigación, Fundación Piel Sana Academia Española de Dermatología y Venereología, Madrid, España
Departamento de Dermatología, Complexo Hospitalario Universitario de Vigo, España
Bernabéu-Wittel J:
Departamento de Dermatología, Hospital Virgen del Rocío, Sevilla, España
Departamento de Dermatología, Hospital Viamed Santa Ángela de la Cruz, Sevilla, España
Green Submitted, gold
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