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Novartis Drug SOM230 is First Medical Therapy to Show Efficacy in a Phase III Trial in Cushing's Disease, a Debilitating Hormonal Disorder
Date:9/21/2010

rtisol levels in Cushing's disease, 13 (8.0%) patients experienced adverse events associated with cortisol levels below the normal range. This was managed by dose reduction without loss of efficacy(1).

About Cushing's diseaseCushing's disease is a rare but serious disease that affects approximately 10 to 15 patients per million per year. It most commonly affects adults who are as young as 20 to 50 years and affects women three times more often than men. Cushing's disease presents with weight gain, central obesity, moon face, severe fatigue and weakness, striae (purple stretch marks), depression and anxiety(2),(5). To date, no known causes or risk factors have been identified for the development of the benign tumors in the pituitary gland that cause Cushing's disease.

Complications of Cushing's disease can include osteoporosis and subsequently fractures, insulin resistance with higher prevalence of impaired glucose tolerance and diabetes mellitus, high blood pressure, lipid disorders, infections, kidney stones and mental illnesses, including depression and psychosis(1),(3),(4). Cardiovascular complications resulting from untreated Cushing's disease, including coronary artery disease, congestive heart failure and stroke, contribute to a mortality rate up to four times higher than the healthy population(4).

The most common treatment approach for Cushing's disease is surgical removal of the tumor. Persistent disease and/or relapse can occur in up to 50% of surgery patients(2),(5). If surgery is not appropriate or effective, other treatment options include radiation to the pituitary gland, stereotactic radiosurgery or gamma knife radiation, removal of the adrenal glands and inhibition of cortisol production(2).

About SOM230 (pasireotide)SOM230 is an investigational pituitary-directed therapy that targets the cause of Cushing's disease, with the aim to control excess cortisol secretion and its debilitating complications(1),(2). SOM
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SOURCE Novartis Pharmaceuticals Corporation
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