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Efficacy and safety of switching to pasireotide in acromegaly patients controlled with pegvisomant and somatostatin analogues: PAPE extension study.
- Source :
- European Journal of Endocrinology; Nov2018, Vol. 179 Issue 5, p269-277, 9p
- Publication Year :
- 2018
-
Abstract
- Objective: To assess the efficacy and safety after 48 weeks of treatment with pasireotide long-acting-release (PAS-LAR) alone or in combination with pegvisomant in patients with acromegaly. In addition, we assessed the relation between insulin secretion and pasireotide-induced hyperglycemia. Design: The PAPE extension study is a prospective follow-up study until 48 weeks after the core study of 24 weeks. Methods: Fifty-nine out of 61 patients entered the extension study. Efficacy was defined as the percentage of patients achieving IGF-I normalization (=1.2× the upper limit of normal (ULN)) at 48 weeks through protocol-based adjustment of pegvisomant and PAS-LAR doses. At baseline, insulin secretion was assessed by an oral glucose tolerance test (OGTT). Results: At the end of the study, median IGF-I was 0.98× ULN, and 77% of patients achieved normal IGF-I levels with a mean pegvisomant dose of 64 mg/week, and an overall cumulative pegvisomant dose reduction of 52%. Frequency of diabetes mellitus increased from 68% at 24 weeks to 77% at 48 weeks, and nine patients discontinued PAS-LAR treatment, mainly because of severe hyperglycemia. Pasireotide-induced hyperglycemia was inversely correlated with baseline insulin secretion (r = -0.37, P < 0.005). Conclusions: PAS-LAR normalizes IGF-I levels in most acromegaly patients, with a 50% pegvisomant-sparing effect. However, PAS-LAR treatment coincided with a high incidence of diabetes mellitus. The risk for developing diabetes during PAS-LAR treatment seems inversely related to insulin secretion at baseline. [ABSTRACT FROM AUTHOR]
- Subjects :
- ACROMEGALY
SOMATOSTATIN
DRUG efficacy
Subjects
Details
- Language :
- English
- ISSN :
- 08044643
- Volume :
- 179
- Issue :
- 5
- Database :
- Complementary Index
- Journal :
- European Journal of Endocrinology
- Publication Type :
- Academic Journal
- Accession number :
- 133358574
- Full Text :
- https://doi.org/10.1530/EJE-18-0353