Brazilian multicenter study on pegvisomant treatment in acromegaly

Objective Investigate the therapeutic response of acromegaly patients to pegvisomant (PEGV) in a real-life, Brazilian multicenter study. Subjects and methods Characteristics of acromegaly patients treated with PEGV were reviewed at diagnosis, just before and during treatment. All patients with at...

Full description

Main Authors: Boguszewski, Cesar L., Huayllas, Martha Katherine P, Vilar, Lucio, Naves, Luciana Ansaneli, Ribeiro-Oliveira Junior, Antonio, Soares, Beatriz Santana, Czepielewski, Mauro Antonio, Abucham, Julio, Correa-Silva, Silvia Regina, Bronstein, Marcello Delano, Jallad, Raquel Soares, Duarte, Felipe Gaia, Musolino, Nina Rosa, Kasuki, Leandro, Gadelha, Monica Roberto
Format: Artigo
Language: English
Published: Sociedade Brasileira de Endocrinologia e Metabologia 2020
Subjects:
Online Access: https://repositorio.unb.br/handle/10482/36696
https://doi.org/10.20945/2359-3997000000159
http://orcid.org/0000-0001-7285-7941
http://orcid.org/0000-0002-1042-5083
http://orcid.org/0000-0003-4815-6963
http://orcid.org/0000-0002-3363-3803
http://orcid.org/0000-0002-5686-7899
http://orcid.org/0000-0002-6114-5786
http://orcid.org/0000-0001-5083-5776
http://orcid.org/0000-0003-4804-1525
http://orcid.org/0000-0003-2405-0013
http://orcid.org/0000-0002-0113-5201
http://orcid.org/0000-0003-0477-1892
http://orcid.org/0000-0002-3495-1301
http://orcid.org/0000-0003-1562-4476
http://orcid.org/0000-0003-1339-3192
http://orcid.org/0000-0002-9250-3558
Tags: Add Tag
No Tags, Be the first to tag this record!
id ir-10482-36696
recordtype dspace
spelling ir-10482-366962020-04-22T13:14:56Z Brazilian multicenter study on pegvisomant treatment in acromegaly Boguszewski, Cesar L. Huayllas, Martha Katherine P Vilar, Lucio Naves, Luciana Ansaneli Ribeiro-Oliveira Junior, Antonio Soares, Beatriz Santana Czepielewski, Mauro Antonio Abucham, Julio Correa-Silva, Silvia Regina Bronstein, Marcello Delano Jallad, Raquel Soares Duarte, Felipe Gaia Musolino, Nina Rosa Kasuki, Leandro Gadelha, Monica Roberto Acromegalia Somatotropina Pegvisomanto Estudo multicêntrico Objective Investigate the therapeutic response of acromegaly patients to pegvisomant (PEGV) in a real-life, Brazilian multicenter study. Subjects and methods Characteristics of acromegaly patients treated with PEGV were reviewed at diagnosis, just before and during treatment. All patients with at least two IGF-I measurements on PEGV were included. Efficacy was defined as any normal IGF-I measurement during treatment. Safety data were reviewed. Predictors of response were determined by comparing controlled versus uncontrolled patients. Results 109 patients [61 women; median age at diagnosis 34 years; 95.3% macroadenomas] from 10 Brazilian centers were studied. Previous treatment included surgery (89%), radiotherapy (34%), somatostatin receptor ligands (99%), and cabergoline (67%). Before PEGV, median levels of GH, IGF-I and IGF-I % of upper limit of normal were 4.3 µg/L, 613 ng/mL, and 209%, respectively. Pre-diabetes/diabetes was present in 48.6% and tumor remnant in 71% of patients. Initial dose was 10 mg/day in all except 4 cases, maximum dose was 30 mg/day, and median exposure time was 30.5 months. PEGV was used as monotherapy in 11% of cases. Normal IGF-I levels was obtained in 74.1% of patients. Glycemic control improved in 56.6% of patients with pre-diabetes/diabetes. Exposure time, pre-treatment GH and IGF-I levels were predictors of response. Tumor enlargement occurred in 6.5% and elevation of liver enzymes in 9.2%. PEGV was discontinued in 6 patients and 3 deaths unrelated to the drug were reported. Conclusions In a real-life scenario, PEGV is a highly effective and safe treatment for acromegaly patients not controlled with other therapies. 2020-01-24T10:33:18Z 2020-01-24T10:33:18Z 2019 Artigo BOGUSZEWSKI, Cesar L. et al. Brazilian multicenter study on pegvisomant treatment in acromegaly. Archives of Endocrinology and Metabolism, v. 63, n. 4, p. 328-336, 2019. DOI: https://doi.org/10.20945/2359-3997000000159. Disponível em: http://scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972019000700328. Acesso em: 23 jan. 2020. https://repositorio.unb.br/handle/10482/36696 https://doi.org/10.20945/2359-3997000000159 http://orcid.org/0000-0001-7285-7941 http://orcid.org/0000-0002-1042-5083 http://orcid.org/0000-0003-4815-6963 http://orcid.org/0000-0002-3363-3803 http://orcid.org/0000-0002-5686-7899 http://orcid.org/0000-0002-6114-5786 http://orcid.org/0000-0001-5083-5776 http://orcid.org/0000-0003-4804-1525 http://orcid.org/0000-0003-2405-0013 http://orcid.org/0000-0002-0113-5201 http://orcid.org/0000-0003-0477-1892 http://orcid.org/0000-0002-3495-1301 http://orcid.org/0000-0003-1562-4476 http://orcid.org/0000-0003-1339-3192 http://orcid.org/0000-0002-9250-3558 en Acesso Aberto (CC BY) - This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. application/pdf Sociedade Brasileira de Endocrinologia e Metabologia
institution REPOSITORIO UNB
collection REPOSITORIO UNB
language English
topic Acromegalia
Somatotropina
Pegvisomanto
Estudo multicêntrico
spellingShingle Acromegalia
Somatotropina
Pegvisomanto
Estudo multicêntrico
Boguszewski, Cesar L.
Huayllas, Martha Katherine P
Vilar, Lucio
Naves, Luciana Ansaneli
Ribeiro-Oliveira Junior, Antonio
Soares, Beatriz Santana
Czepielewski, Mauro Antonio
Abucham, Julio
Correa-Silva, Silvia Regina
Bronstein, Marcello Delano
Jallad, Raquel Soares
Duarte, Felipe Gaia
Musolino, Nina Rosa
Kasuki, Leandro
Gadelha, Monica Roberto
Brazilian multicenter study on pegvisomant treatment in acromegaly
description Objective Investigate the therapeutic response of acromegaly patients to pegvisomant (PEGV) in a real-life, Brazilian multicenter study. Subjects and methods Characteristics of acromegaly patients treated with PEGV were reviewed at diagnosis, just before and during treatment. All patients with at least two IGF-I measurements on PEGV were included. Efficacy was defined as any normal IGF-I measurement during treatment. Safety data were reviewed. Predictors of response were determined by comparing controlled versus uncontrolled patients. Results 109 patients [61 women; median age at diagnosis 34 years; 95.3% macroadenomas] from 10 Brazilian centers were studied. Previous treatment included surgery (89%), radiotherapy (34%), somatostatin receptor ligands (99%), and cabergoline (67%). Before PEGV, median levels of GH, IGF-I and IGF-I % of upper limit of normal were 4.3 µg/L, 613 ng/mL, and 209%, respectively. Pre-diabetes/diabetes was present in 48.6% and tumor remnant in 71% of patients. Initial dose was 10 mg/day in all except 4 cases, maximum dose was 30 mg/day, and median exposure time was 30.5 months. PEGV was used as monotherapy in 11% of cases. Normal IGF-I levels was obtained in 74.1% of patients. Glycemic control improved in 56.6% of patients with pre-diabetes/diabetes. Exposure time, pre-treatment GH and IGF-I levels were predictors of response. Tumor enlargement occurred in 6.5% and elevation of liver enzymes in 9.2%. PEGV was discontinued in 6 patients and 3 deaths unrelated to the drug were reported. Conclusions In a real-life scenario, PEGV is a highly effective and safe treatment for acromegaly patients not controlled with other therapies.
format Artigo
author Boguszewski, Cesar L.
Huayllas, Martha Katherine P
Vilar, Lucio
Naves, Luciana Ansaneli
Ribeiro-Oliveira Junior, Antonio
Soares, Beatriz Santana
Czepielewski, Mauro Antonio
Abucham, Julio
Correa-Silva, Silvia Regina
Bronstein, Marcello Delano
Jallad, Raquel Soares
Duarte, Felipe Gaia
Musolino, Nina Rosa
Kasuki, Leandro
Gadelha, Monica Roberto
author_sort Boguszewski, Cesar L.
title Brazilian multicenter study on pegvisomant treatment in acromegaly
title_short Brazilian multicenter study on pegvisomant treatment in acromegaly
title_full Brazilian multicenter study on pegvisomant treatment in acromegaly
title_fullStr Brazilian multicenter study on pegvisomant treatment in acromegaly
title_full_unstemmed Brazilian multicenter study on pegvisomant treatment in acromegaly
title_sort brazilian multicenter study on pegvisomant treatment in acromegaly
publisher Sociedade Brasileira de Endocrinologia e Metabologia
publishDate 2020
url https://repositorio.unb.br/handle/10482/36696
https://doi.org/10.20945/2359-3997000000159
http://orcid.org/0000-0001-7285-7941
http://orcid.org/0000-0002-1042-5083
http://orcid.org/0000-0003-4815-6963
http://orcid.org/0000-0002-3363-3803
http://orcid.org/0000-0002-5686-7899
http://orcid.org/0000-0002-6114-5786
http://orcid.org/0000-0001-5083-5776
http://orcid.org/0000-0003-4804-1525
http://orcid.org/0000-0003-2405-0013
http://orcid.org/0000-0002-0113-5201
http://orcid.org/0000-0003-0477-1892
http://orcid.org/0000-0002-3495-1301
http://orcid.org/0000-0003-1562-4476
http://orcid.org/0000-0003-1339-3192
http://orcid.org/0000-0002-9250-3558
_version_ 1672205687459938304
score 13.657419