Wednesday, February 6, 2013 (Last Updated: 02/08/2013)
Lawrence Recht, M.D., of the Stanford University School of Medicine in Palo Alto, Calif., and colleagues conducted a 12-week, prospective, randomized, double-blind study involving 200 patients with a malignant brain tumor and PBE who had been on a stable dose of dexamethasone. The safety and efficacy of CrA was compared with placebo.
The researchers observed a clinically important but not statistically significant difference in the percentage of responders to CrA compared with placebo (57 and 46 percent, respectively). However, the maximum percent reduction in dexamethasone dose was significantly higher for CrA-treated versus placebo-treated patients (62.7 versus 51.4 percent). Overall, patients who received CrA were less likely to develop Cushing's syndrome signs and also experienced improved steroid-induced myopathy.
"This is the first randomized, placebo-controlled, double-blind study demonstrating an agent's corticosteroid-sparing effect for PBE," the authors write. "CrA administration was not only effective in lowering corticosteroid dosage over a several-week period but also was associated with decreased corticosteroid adverse effects as demonstrated by an improvement in the natural history of corticosteroid-associated myopathy, Cushingoid signs and symptoms, blood glucose, and adrenal suppression."
Several authors disclosed financial ties to Celtic Pharma, manufacturer of corticorelin acetate.
Hematology & Oncology