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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: BigKNY3 who wrote (19755)3/14/1999 6:02:00 PM
From: DaiS  Read Replies (4) | Respond to of 23519
 
BigK,

I could not see explicit reference to the Kaplan study not using placebos in that news item you posted, but I agree that it looks like that that is what happened. The study made use of an ED scale analogous to that used in the definitive male viagra studies published in NEJM and represented on the Pfizer site.

I thought that this was the bottom line, to measure the response of the patient. Ultrasonography studies come earlier on to show a physiological effect. But as is apparent in both male and female studies a positive result here does not guarantee a favourable patient reaction.

It would seem that Drs Kaplan and Berman would be as one in accepting that viagra causes increased blood flow to the female genitalia. But they are concerned with whether or this translates into increased sexual satisfaction?

The male viagra studies included trials without placebo (I can't remember the technical work for these) towards the end. This seems to me perfectly reasonable if it has already been established that there is an effect over placebo. The absence of a placebo is of little relevance in the Kaplan study because the treatment effects were in any case smallish!!

It is early days, obviously. But it looks to me like both viagra and topical alprostadil will give the necessary increased blood flow. Some factors of potential importance for efficacy alone are,

1. The clitoris is small and uptake of alprostadil might be good, there may be not the problem with men of low efficiency of transfer between the corpus spongiosum and corpus cavernosum. However maybe viagra might give a better response throughout the genitalia.
2. It seems to be widely accepted in the US that a pill is the optimal approach. Many women might have a preference to use a cream over a pill.
3. The technique-bound muse method is easy for critics to ridicule compared with viagra. This disadvantage disappears with a cream.

Just speculations!

DaiS