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

To: BigKNY3 who wrote (4120)	12/30/1997 9:34:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 23519

Here's the abstracts from the AOL Vivus Motley Fool Board (3/21/97). BigKNY3 Abstracts were published on Monday 14 April, 1997 by two Sildenafil (Viagra) research groups. Dr. Tom Lue of San Francisco presented efficacy, safety, and toleration data on 416 patients from 22 sites during an 8 week double-blinded study. The study tested 4 strengths of sildenafil vs placebo given 1 hr before anticipated sexual activity. The erectile dysfunction of the men were assessed as 73% organic, 9% psychogenic, and 18% mixed. Efficacy was assessed by a self-administered questionnaire at week 8. Safety and toleration were evaluated by routine lab tests and recording of adverse events. The following results are highly statistically significant with a p value of <0.0001 Sildenafil question placebo 5mg 25mg 50mg 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 GAQ = Global Assessment Score: "Did treatment improve your erections?" Q3 : ability to achieve erection Q4: ability to maintain erection satisfactory for sexual intercourse responses to Q3 and Q4 were graded on a scale from 1 (almost never or never) to 5 (almost always or always). The mean responses are listed in the table above. Responses to other questionnaire questions showed "similar dose-response relationships for other aspects of erectile and sexual functioning". The most common adverse effects were headache (2.4-11%), vasodilation (0-8.5%), dyspepsia (0-8.5%), and diarrhea (0-4.9%). These ae's were predominantly of mild severity. "CONCLUSION: The results indicate that sildenafil is an effective, well-tolerated oral treatment for patients with erectile dysfunction associated with a broad range of etiologies." The second abstract is from Dr. Jacques Buvat et al with the European Multicentre Sildenafil Study Group. I don't have the energy to transcribe the entire study but will post the results and conclusions: RESULTS (abridged): " A total of 271 (89.1%) patients appeared to continue to derive benefit from taking sildenafil and completed the 1 year study; only 13 (4.2%) patients withdrew due to lack of efficacy. Four (1.3%) claimed that they no longer required treatment as their erectile dysfunction had improved. Of the 12 (3.9%) who withdrew due to adverse events, in only 3 (1%) were the ae's ascribed to sildenafil. The most frequently reported ae's were headache, facial flushing, and indigestion. None of the 25 serious ae's were attributed to sildenafil." CONCLUSIONS: "The results indicate that sildenafil, taken as required (not more than once daily) over a period of 1 year, is an effective and well-tolerated oral treatment for patients with ED of no known organic cause."

To: BigKNY3 who wrote (4120)	12/31/1997 3:50:00 PM
From: Tunica Albuginea	Respond to of 23519

BigKNY3 Re: " TA: You a real tough one to convince! Here's some data from the 1997 AUA meeting for you to ponder.". Big KNY3, I've seen it all in Medicine, and I have a jaundiced eye. I am completely aware of the data. Here are my thoughts 1) Re: "As you know, DrTom Lue is one of the most respected and influential ED specialists in the world." Yes I know Tom. He is the co-author of the original MUSE study in the NEJM that showed that MUSE is effective for purpose of having intercourse, in 65% of organic ED patients for MUSE study " 2)Re:"Here's a published abstract of the study that I found on the AOL Vivus Board (3/21/97). Note: that 73% of the patients had ED of organic origin." We have THEIR WORD on it that it was organic!I t is an ABSTRACT!.There is NO DEFINITION of what are their criteria for organic.Does having ED and Diabetes for 2 years make it organic? They may say yes, I say no. The MUSE study, requires that patients should have had NO ERECTION/intercourse for three months preceding the study!! Now THAT is good, solid, organic!! My understanding from hearsay is that one of the criteria for enrolling in the Viagra study is that you had to have been able to achieve at least PARTIAL erection in order to enroll in the study!! This is because Viagra is an erection-enhancer, NOT an erection -producer. 3) Re: "Efficacy was assessed by a self-administered questionnaire at week 8. Safety and toleration were evaluated by routine lab tests and recording of adverse events.". Well Big K , " ROUTINE LAB TESTS, are NOT going to pick up early retinal degeneration, or any myriad of other side effects that that caused the removal from the market of Phen-phen, Rezulin, Seldane and on and on and on. For that you need the in depth assessments such as those made at ColumbiePresbyterian University Eye Institute study I posted yesterday So Big K, bottom line is that several other folk and I are WAITING FOR PUBLISHED PEER REVIEWED DATA!!! Yes BigK, I remain hard to be convinced. And when I get on the Titanic I always ask what is plan A, B and C for evacuating this boat if - God forbid- the s...t hits the fan. TA: