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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...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Sociedade Brasileira de Endocrinologia e Metabologia
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10528655/ https://www.ncbi.nlm.nih.gov/pubmed/31365632 http://dx.doi.org/10.20945/2359-3997000000159 |
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author | Boguszewski, Cesar L. Huayllas, Martha Katherine P Vilar, Lucio Naves, Luciana Ansaneli Ribeiro-Oliveira, 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_facet | Boguszewski, Cesar L. Huayllas, Martha Katherine P Vilar, Lucio Naves, Luciana Ansaneli Ribeiro-Oliveira, 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. |
collection | PubMed |
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 | Online Article Text |
id | pubmed-10528655 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Sociedade Brasileira de Endocrinologia e Metabologia |
record_format | MEDLINE/PubMed |
spelling | pubmed-105286552023-09-28 Brazilian multicenter study on pegvisomant treatment in acromegaly Boguszewski, Cesar L. Huayllas, Martha Katherine P Vilar, Lucio Naves, Luciana Ansaneli Ribeiro-Oliveira, 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 Arch Endocrinol Metab Original Article 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. Sociedade Brasileira de Endocrinologia e Metabologia 2019-07-11 /pmc/articles/PMC10528655/ /pubmed/31365632 http://dx.doi.org/10.20945/2359-3997000000159 Text en https://creativecommons.org/licenses/by/4.0/ 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. |
spellingShingle | Original Article Boguszewski, Cesar L. Huayllas, Martha Katherine P Vilar, Lucio Naves, Luciana Ansaneli Ribeiro-Oliveira, 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 |
title | 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_short | Brazilian multicenter study on pegvisomant treatment in acromegaly |
title_sort | brazilian multicenter study on pegvisomant treatment in acromegaly |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10528655/ https://www.ncbi.nlm.nih.gov/pubmed/31365632 http://dx.doi.org/10.20945/2359-3997000000159 |
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