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Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation
CONTEXT: Pasireotide-LAR, a second-generation somatostatin receptor ligand (SRL), is recommended for patients with acromegaly as second-line treatment. Its efficacy and safety were assessed in clinical trials; however, the real-world evidence is still scarce. OBJECTIVE: The aim of this study was to...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821488/ https://www.ncbi.nlm.nih.gov/pubmed/34498217 http://dx.doi.org/10.1007/s11102-021-01185-w |
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author | Stelmachowska-Banaś, Maria Czajka-Oraniec, Izabella Tomasik, Agnieszka Zgliczyński, Wojciech |
author_facet | Stelmachowska-Banaś, Maria Czajka-Oraniec, Izabella Tomasik, Agnieszka Zgliczyński, Wojciech |
author_sort | Stelmachowska-Banaś, Maria |
collection | PubMed |
description | CONTEXT: Pasireotide-LAR, a second-generation somatostatin receptor ligand (SRL), is recommended for patients with acromegaly as second-line treatment. Its efficacy and safety were assessed in clinical trials; however, the real-world evidence is still scarce. OBJECTIVE: The aim of this study was to evaluate the impact of 1-year treatment with pasireotide-LAR on disease control and glucose metabolism in acromegaly patients resistant to first-generation SRLs. DESIGN: A single-center prospective study. METHODS: Twenty-eight patients with active acromegaly or acrogigantism on first-generation SRLs following ineffective pituitary surgery were switched to treatment with pasireotide-LAR 40 or 60 mg i.m. every 28 days. To assess the efficacy of the treatment GH and IGF-1 levels were measured every 3 months. Safety of treatment was carefully evaluated, especially its impact on glucose metabolism. RESULTS: Complete biochemical control (GH ≤ 1 ng/mL and IGF-1 ≤ 1 × ULN) was achieved in 26.9% of patients and partial + complete response (GH ≤ 2.5 ng/mL and IGF-1 ≤ 1.3 × ULN) in 50.0% of patients. Mean GH level decrease was the largest within first 6 months (P = 0.0001) and mean IGF-1 level decreased rapidly within the first 3 months (P < 0.0001) and they remained reduced during the study. Blood glucose and HbA1c levels increased significantly within 3 months (P = 0.0001) and stayed on stable level thereafter. Otherwise, the treatment was well tolerated and clinical improvement was noticed in majority of patients. CONCLUSIONS: This real-life study confirmed good effectiveness of pasireotide-LAR in patients resistant to first-generation SRLs. Pasireotide-LAR was overall safe and well tolerated, however significant glucose metabolism worsening was noted. |
format | Online Article Text |
id | pubmed-8821488 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-88214882022-02-23 Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation Stelmachowska-Banaś, Maria Czajka-Oraniec, Izabella Tomasik, Agnieszka Zgliczyński, Wojciech Pituitary Article CONTEXT: Pasireotide-LAR, a second-generation somatostatin receptor ligand (SRL), is recommended for patients with acromegaly as second-line treatment. Its efficacy and safety were assessed in clinical trials; however, the real-world evidence is still scarce. OBJECTIVE: The aim of this study was to evaluate the impact of 1-year treatment with pasireotide-LAR on disease control and glucose metabolism in acromegaly patients resistant to first-generation SRLs. DESIGN: A single-center prospective study. METHODS: Twenty-eight patients with active acromegaly or acrogigantism on first-generation SRLs following ineffective pituitary surgery were switched to treatment with pasireotide-LAR 40 or 60 mg i.m. every 28 days. To assess the efficacy of the treatment GH and IGF-1 levels were measured every 3 months. Safety of treatment was carefully evaluated, especially its impact on glucose metabolism. RESULTS: Complete biochemical control (GH ≤ 1 ng/mL and IGF-1 ≤ 1 × ULN) was achieved in 26.9% of patients and partial + complete response (GH ≤ 2.5 ng/mL and IGF-1 ≤ 1.3 × ULN) in 50.0% of patients. Mean GH level decrease was the largest within first 6 months (P = 0.0001) and mean IGF-1 level decreased rapidly within the first 3 months (P < 0.0001) and they remained reduced during the study. Blood glucose and HbA1c levels increased significantly within 3 months (P = 0.0001) and stayed on stable level thereafter. Otherwise, the treatment was well tolerated and clinical improvement was noticed in majority of patients. CONCLUSIONS: This real-life study confirmed good effectiveness of pasireotide-LAR in patients resistant to first-generation SRLs. Pasireotide-LAR was overall safe and well tolerated, however significant glucose metabolism worsening was noted. Springer US 2021-09-08 2022 /pmc/articles/PMC8821488/ /pubmed/34498217 http://dx.doi.org/10.1007/s11102-021-01185-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Stelmachowska-Banaś, Maria Czajka-Oraniec, Izabella Tomasik, Agnieszka Zgliczyński, Wojciech Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation |
title | Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation |
title_full | Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation |
title_fullStr | Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation |
title_full_unstemmed | Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation |
title_short | Real-world experience with pasireotide-LAR in resistant acromegaly: a single center 1-year observation |
title_sort | real-world experience with pasireotide-lar in resistant acromegaly: a single center 1-year observation |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821488/ https://www.ncbi.nlm.nih.gov/pubmed/34498217 http://dx.doi.org/10.1007/s11102-021-01185-w |
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