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Pasireotide decreased cortisol levels in Cushing’s disease
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Patients with Cushing’s disease experienced declines in cortisol levels when treated with the novel somatostatin analogue pasireotide, according to results of a double blind, phase 3 study.
“The majority of patients had a significant reduction in cortisol secretion with improvement in the clinical features of Cushing’s syndrome; however, only 25% of patients had normalization of cortisol,” James W. Findling, MD, FACP, of the division of endocrinology, metabolism and clinical nutrition at the Medical College of Wisconsin, told Endocrine Today. “The most surprising finding was that many patients (73%) had increases in glucose levels. Since diabetes mellitus complicates the course of many patients with Cushing’s disease, this problem will need to be addressed proactively.”
Pasireotide (SOM230, Novartis) is a potential therapy for Cushing’s disease that has been shown to have a unique, broad somatostatin-receptor–binding profile, with high binding affinity for somatostatin-receptor subtype 5.
Findling and colleagues randomly assigned 162 patients with Cushing’s disease who had a urinary free cortisol level of at least 1.5 times the upper limit of the normal range to receive subcutaneous pasireotide at a dose of 600 mcg (n=82 patients) or 900 mcg (n=80 patients) twice a day.
Those patients who had a urinary free cortisol that did not exceed two times the upper limit of the normal range and did not exceed the baseline level at 3 months continued to receive their randomly assigned dose; the rest received an additional 300 mcg twice a day.
At baseline, 78% of patients had moderate-to-very severe hypercortisolism.
Of the patients who received 600 mcg of pasireotide, 12 had a normalized urinary free cortisol level (the primary endpoint) compared with 21 of those in the 900-mcg group. Furthermore, the median urinary free cortisol level decreased by almost half by the second month of treatment and remained stable in both groups.
Hyperglycemia-related adverse events were common in patients treated with pasireotide; other adverse events were similar to those associated with other somatostatin analogues.
“If approved by the FDA, pasireotide should be considered in patients with persistent or recurrent hypercortisolism after pituitary surgery and/or radiotherapy for Cushing’s disease,” Findling said. “The effectiveness of therapy should be apparent within a short time (3 to 4 months), and careful attention to glucose levels during treatment will be essential.”
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Disclosure: Research was supported by Novartis Pharma. Dr. Findling and several of the other researchers report receiving consulting fees and/or support from Novartis.