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Re: DewDiligence post# 98842

Wednesday, 09/22/2010 9:26:48 AM

Wednesday, September 22, 2010 9:26:48 AM

Post# of 257257
NVS...SOM230 for Cushings...

http://ca.news.finance.yahoo.com/s/22092010/31/link-f-prnewswire-novartis-drug-som230-first-medical-therapy-show-efficacy.html

A lot of side effects and only efficacy at the high dose.

58% had diarrhea.

I am in CORT and they have PIII data due in December so I will be reading more of your NVS posts.

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 cortisol 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).

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