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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: RT who wrote (5870)3/11/1998 10:10:00 AM
From: g.w. barnard  Read Replies (2) of 23519
 
has anyone posted this from aol board:
in correspondence bigkny3. if this data is correct it would seem very harmful to viagra claims???
gw

This is from pfe documentation which has been send to me by pfizer in regards to viagra:
Abstracted Presented at the 1997 American Urological Association Ninety-second Annual Meeting:Documentation # 701
J Urology 1997;157(4);181
(Presented by Dr. Lue)
<<416 patients from 22 sites were randomly allocated to receive placebo,
5,25,50,or 100 mg of sidenafil by self-adminstrated questionaire (IIEF) at week 8.
A global assessment question (GAQ) was asked at week 8 (Did treatment
improve your erection?).
Specifically the IIEF addressed the ability to achieve (Q3)
andmaintain (Q4) an erection satisfactory for sexual intercourse,
with responses graded on a scale from 1 (almost never or never) to 5 (almost always or always). Safety and toleration were evaluated by routine labratory texts and recording of adverse events (AEs),

RESULTS:* Sidenafil
----------------------------------------------------
Question Placebo 5mg 25 mg 50 mg 100mg
GAQ (%yes) 27.7 47.7 60.9 72.9 77.8
Q3 (mean**) 2.00 2.69 2.93 3.28 3.69
Q4 (mean**) 2.05 2.40 2.95 3.32 3.60
*p-value < 0.0001 by ANOVA; ** Mean response scores
Responses to other IIEF questions showes similar dose-response relationships for other aspects of erectile and sexual functioning.
The most common AEs were headache (2.4-11%),
vasodialation 0-8.5%),
dyspepsia (0-8.5%), and
Diarrhea (0-4.9%),
which were predominantlyof mild severity.>>

So now lets analyse above:
1- from 416 patients after 8 weeks using the pill, 95 patients never had any improvements in their erection at all during whole usage of the pill within 8 weeks...
2- Only a mean of 3.69 among 321 had ability to achieve erection during 8 weeks usage of the pill...
3- It reveals no one or a few among the whole patients during the whole 8 weeks had achieved an erection for satisfactory intercourse...
imo, the study reveals very negative aspects regarding the effectiveness of
sidenafil (viagra)...

PS Docment #702 of pfe mailed to me reveals viagra by itself is not effective for SCI patients, a viberator has to be included...what is that all about? I will post that in later time....

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