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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (61)	8/31/2006 4:34:59 PM
From: dr.praveen	Respond to of 285

I don't actively follow the SNY's multaq. I remember it being moderately effective. It doesn't have amiadarone like thyroid/Pulmonary complications.Also there was no incidence of proarrhythmia. But one of it's trials Andromeda was stopped for excess mortality.It was a mortality trial in heart failure patients, was stopped early by the DSMB with 627 of the planned 1,000 patients enrolled when more deaths were found in the drug group than in placebo (25 vs. 12). There were many reasons given for that increased mortality. Some thought patients were started in the trial too soon, and the drug has a peculiar effect that it can raise serum creatinine but not because of renal dysfunction. Also a fair number of patients had their ACE or ARB stopped, and that could be a reason. There also wasn’t sufficient monitoring of the patients. But I don't actively follow Multaq now. I have some concern regd approval of IV RSD1235. I have some conflicts in my mind like FDA is going to closely scrutiny the safety data. But will the FDA ask for one more trial giving it an approvable letter is the question lingering in my mind. So I may sell some of it before the FDA decision.