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Re: turtlepower post# 83374

Wednesday, 09/09/2009 11:04:34 PM

Wednesday, September 09, 2009 11:04:34 PM

Post# of 257375
VVUS and Qnexa safety -

I'm not too familiar with the drug but I believe it contains two ingredients which individually cause serious side effects.



Had to relook at the safety data to regather my facts (I looked at this and dismissed it because I considered the likely ph iii pop fairly low because the trial results were too obvious - that the real pop would come with FDA approval, which was much more of a wild card.)

Phentermine might have a bad rep as part of fen-phen, but it is fairly well accepted that by itself it doesn't have the PAH et al issues. (and note that fen-phen didn't have Qt problems)

And topiramate's 'only' SAE are suicidal thoughts (especially upon quiting) and kidney stones.

So altogether the Qt data is expected. The lack of suicidal thoughts is perhaps at least somewhat reassuring, but even the pessimistic case would have perhaps 4 suicidal thoughts patients (label for top says 1 in 500) in 2000 treated patients. Not likely to be even noticed in a trial this small. So again a mostly expected result.

C'est la vie.

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