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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

achieved normalization of UFC after six months without dose up-titration relative to randomized dose(1). UFC is typically used to diagnose and monitor Cushing's disease. In this test, urine is collected over 24 hours to assess average cortisol secretion(2). The primary endpoint was met for the higher dose tested (900ug sc twice daily)(1). Secondary endpoints included safety, time to response, response duration and changes from baseline in clinical signs, symptoms, tumor volume and health-related quality of life(10).

After six months, the primary efficacy responder rate was 26.3% (95% confidence interval [CI], 16.6 to 35.9) and 14.6% (95% CI, 7.0 to 22.3), respectively, for the 900ug and 600ug groups. Based on pre-specified criteria (lower bound of 95% CI >15%), the 900ug group met the primary endpoint and the 600ug group did not meet the primary endpoint. After 12 months, the proportion of responders regardless of dose up-titration was 13.4% and 25.0%, respectively, for the 600ug and 900ug groups. The median reduction in UFC after six months was 47.9% for both groups. The median reduction in UFC after 12 months was 67.6% (600ug) and 62.4% (900ug). Patients who showed little to no improvement in UFC levels (<50% reduction from baseline) by month two were unlikely to show improvement by month six or 12. The most frequently reported adverse events suspected by the investigators to be related to the study drug were diarrhea (58%), nausea (46.9%), hyperglycemia (38.9%), cholelithiasis (29.6%), abdominal pain (20.4%), diabetes mellitus (17.9%), fatigue (11.7%) and increased glycosylated hemoglobin (10.5%), with most events being Grade 1-2. Overall, the tolerability profile of SOM230 is similar to other somatostatin analogs with the exception of the greater degree of hyperglycemia, which appears manageable with early detection and appropriate intervention following established treatment guidelines. As may be expected with a treatment that lowers co
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SOURCE Novartis Pharmaceuticals Corporation
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