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." |
