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Efficacy and safety of high-dose long-acting repeatable octreotide as monotherapy or in combination with pegvisomant or cabergoline in patients with acromegaly not adequately controlled by conventional regimens: results of an open-label, multicentre study
Affiliations- Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy
- Department of Endocrinology, Medical Centre of Postgraduate Education, Warsaw, Poland
- Department of Clinical Endocrinology, Medical University of Lodz, Lodz, Poland
- Department of Endocrinology, Medical University of Silesia, Katowice, Poland
- Department of Endocrinology, University Hospital, Bordeaux, France
- Department of Endocrinology, Diabetes, and Metabolic Disorders, CHU Brest, Hôpital de la Cavale Blanche, Brest, France
- Department of Internal Medicine, University of Genova, Genova, Italy
- Endocrine Unit, Department of Medicine, University of Padua, Medical School, Padova, Italy
- Department of Endocrinology, Diabetes and Isotope Therapy, Medical University, Wroclaw, Poland
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Abstract
Introduction: Long-acting repeatable (LAR) octreotide i.m. is a potent, synthetic somatostatin analogue (SSA) that requires less frequent dosing and offers quality of life (QoL) benefits in acromegaly patients compared to its shorter-acting predecessor. This study investigated the efficacy and safety of high-dose Sandostatin® LAR® as monotherapy or in combination with pegvisomant or cabergoline in acromegalic patients with pituitary adenomas following previous failure of conventional SSA treatment.
Material and methods: After three months of high-dose Sandostatin® LAR® monotherapy (40 mg), patients who achieved biochemical control (n = 7) continued to receive the same treatment for an additional four months, whereas uncontrolled patients were randomised to receive high-dose Sandostatin® LAR® in combination with pegvisomant (n = 31) or cabergoline (n = 32). Outcomes included biochemical response at eight months, QoL, and safety.
Results: After three months, 3 of 68 (4.4%) evaluable patients achieved a biochemical control (BC) as assessed by levels of growth hormone and insulin-like growth factor-1. At eight months, 4 of 67 (6.0%) patients achieved BC, including one receiving monotherapy and three receiving Sandostatin® LAR® plus cabergoline. Partial response rate, improvements in acromegaly signs and symptoms, and changes in QoL were similar for all three groups. All treatments were well tolerated with a slight excess of adverse events in the combination arms. There were no deaths or serious adverse events leading to treatment discontinuation.
Conclusion: These data demonstrate that high-dose Sandostatin® LAR® as monotherapy or in combination with pegvisomant or cabergoline is a feasible salvage option in patients with pituitary adenomas not adequately controlled on conventional SSA regimens.
Abstract
Introduction: Long-acting repeatable (LAR) octreotide i.m. is a potent, synthetic somatostatin analogue (SSA) that requires less frequent dosing and offers quality of life (QoL) benefits in acromegaly patients compared to its shorter-acting predecessor. This study investigated the efficacy and safety of high-dose Sandostatin® LAR® as monotherapy or in combination with pegvisomant or cabergoline in acromegalic patients with pituitary adenomas following previous failure of conventional SSA treatment.
Material and methods: After three months of high-dose Sandostatin® LAR® monotherapy (40 mg), patients who achieved biochemical control (n = 7) continued to receive the same treatment for an additional four months, whereas uncontrolled patients were randomised to receive high-dose Sandostatin® LAR® in combination with pegvisomant (n = 31) or cabergoline (n = 32). Outcomes included biochemical response at eight months, QoL, and safety.
Results: After three months, 3 of 68 (4.4%) evaluable patients achieved a biochemical control (BC) as assessed by levels of growth hormone and insulin-like growth factor-1. At eight months, 4 of 67 (6.0%) patients achieved BC, including one receiving monotherapy and three receiving Sandostatin® LAR® plus cabergoline. Partial response rate, improvements in acromegaly signs and symptoms, and changes in QoL were similar for all three groups. All treatments were well tolerated with a slight excess of adverse events in the combination arms. There were no deaths or serious adverse events leading to treatment discontinuation.
Conclusion: These data demonstrate that high-dose Sandostatin® LAR® as monotherapy or in combination with pegvisomant or cabergoline is a feasible salvage option in patients with pituitary adenomas not adequately controlled on conventional SSA regimens.
Keywords
octreotide LAR; acromegaly; pegvisomant; cabergoline; combination; monotherapy
About this articleTitle
Efficacy and safety of high-dose long-acting repeatable octreotide as monotherapy or in combination with pegvisomant or cabergoline in patients with acromegaly not adequately controlled by conventional regimens: results of an open-label, multicentre study
Journal
Issue
Article type
Original paper
Pages
305-312
Published online
2019-06-18
Page views
2021
Article views/downloads
1570
DOI
Pubmed
Bibliographic record
Endokrynol Pol 2019;70(4):305-312.
Keywords
octreotide LAR
acromegaly
pegvisomant
cabergoline
combination
monotherapy
Authors
Annamaria Colao
Wojciech Zgliczyński
Jan Komorowski
Beata Kos-Kudła
Antoine Tabarin
Veronique Kerlan
Francesco M. Minuto
Carla Scaroni
Marek Bolanowski
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