WEDNESDAY, March 7 (HealthDay News) -- For patients with Cushing's disease, treatment with pasireotide is associated with reduced cortisol levels, according to a phase 3 study published in the March 8 issue of the New England Journal of Medicine.
Annamaria Colao, M.D., Ph.D., from the University of Naples Federico II in Italy, and colleagues randomly allocated 162 adult patients with Cushing's disease and a urinary free cortisol level of at least 1.5 times the upper limit of the normal range to receive twice daily subcutaneous pasireotide at 600 µg (82 patients) or 900 µg (80 patients). Patients in either group with urinary free cortisol exceeding two times the upper limit of the normal range and exceeding the baseline level at three months received an additional 300 µg twice daily. Having a urinary free cortisol level at or below the upper limit of normal at six months, without increasing the dose, was defined as the primary end point.
The researchers found that the primary end point was achieved by 12 of 82 patients in the 600-µg group and 21 of 80 patients in the 900-µg group. By month two, the median urinary free cortisol level decreased by approximately 50 percent, and remained stable in both groups. There was a decrease seen in serum and salivary cortisol and plasma corticotropin levels, and a reduction in the clinical signs and symptoms of Cushing's disease. Treatment with pasireotide was linked with hyperglycemia-related adverse events in 118 of 162 patients. Blood glucose and glycated hemoglobin levels increased soon after the start of treatment and subsequently stabilized; treatment with a glucose-lowering agent was administered in 74 of 162 patients.
"Elevated cortisol levels in patients with Cushing's disease were significantly reduced during treatment with pasireotide, a finding that supports the potential use of this agent as a pituitary-specific treatment for Cushing's disease," the authors write.
The study was funded by Novartis Pharma, which manufactures pasireotide; several authors disclosed financial relationships with pharmaceutical companies, including Novartis.
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