Ilan Shimon1,2, Wolfgang Saeger3, Luiz Eduardo Wildemberg4, Monica R Gadelha4. 1. Institute of Endocrinology and Metabolism, Rabin Medical Center, Beilinson Hospital, Petah Tiqva, 49100, Israel. ilanshi@clalit.org.il. 2. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. ilanshi@clalit.org.il. 3. Institute of Neuropathology, Hamburg University, Hamburg, Germany. 4. Department of Internal Medicine and Endocrine Unit, Medical School and Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Abstract
OBJECTIVE: To present two female patients with acromegaly inadequately controlled with long-actingoctreotide who were subsequently treated with the multireceptor-targeted somatostatin analogue pasireotide that over-suppressed IGF-1 levels. METHODS: We report two patients who failed surgery and receivedlong-acting octreotide 20-30 mg/month as part of two double-blind, Phase III clinical trials. After 6-12 months of octreotide treatment, both patients remained inadequately controlled and were switched to long-acting pasireotide 40 mg/month as part of a crossover extension phase. RESULTS: During the core phase of the studies the patients received octreotide 20-30 mg/month, but GH and IGF-1 levels remained above normal. They were switched to pasireotide 40 mg/month after 6 and 12 months, according to the study protocols. After crossover, GH and IGF-1 decreased and normalized, but continued treatment led to further reduction of IGF-1 to below the normal; these reduced levels mildly increased following pasireotide dose reduction to 20 mg/month. Tumour volume was reduced and the clinical signs and symptoms of acromegaly also improved. CONCLUSION: These patients achieved long-term biochemical control, tumour volume reduction and improvement of clinical signs/symptoms after switching from octreotide to pasireotide. IGF-1 over-suppression is observed in a few patients and requires dose adjustment of pasireotide.
RCT Entities:
OBJECTIVE: To present two female patients with acromegaly inadequately controlled with long-acting octreotide who were subsequently treated with the multireceptor-targeted somatostatin analogue pasireotide that over-suppressed IGF-1 levels. METHODS: We report two patients who failed surgery and received long-acting octreotide 20-30 mg/month as part of two double-blind, Phase III clinical trials. After 6-12 months of octreotide treatment, both patients remained inadequately controlled and were switched to long-acting pasireotide 40 mg/month as part of a crossover extension phase. RESULTS: During the core phase of the studies the patients received octreotide 20-30 mg/month, but GH and IGF-1 levels remained above normal. They were switched to pasireotide 40 mg/month after 6 and 12 months, according to the study protocols. After crossover, GH and IGF-1 decreased and normalized, but continued treatment led to further reduction of IGF-1 to below the normal; these reduced levels mildly increased following pasireotide dose reduction to 20 mg/month. Tumour volume was reduced and the clinical signs and symptoms of acromegaly also improved. CONCLUSION: These patients achieved long-term biochemical control, tumour volume reduction and improvement of clinical signs/symptoms after switching from octreotide to pasireotide. IGF-1 over-suppression is observed in a few patients and requires dose adjustment of pasireotide.
Authors: Amit Akirov; Alexander Gorshtein; Idit Dotan; Nariman Saba Khazen; Yulia Pauker; Michal Gershinsky; Ilan Shimon Journal: Endocrine Date: 2021-06-03 Impact factor: 3.633
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Authors: Daniel G Henriques; Elisa B Lamback; Romulo S Dezonne; Leandro Kasuki; Monica R Gadelha Journal: Int J Mol Sci Date: 2022-08-04 Impact factor: 6.208