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

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To: Zebra 365 who wrote (2363)11/12/1997 9:24:00 AM
From: Zebra 365  Read Replies (3) of 23519
 
First a recap of the Published Facts:

exchange2000.com
The above URL has the link to the published study on the web

Sildenafil, a novel effective oral therapy for male erectile dysfunction.

Boolell M, Gepi-Attee S, Gingell JC, Allen MJ
Department of Urology, Southmead Hospital, Westbury on Trym, Bristol, UK.

OBJECTIVES: To determine the efficacy and safety of sildenafil, a novel orally active inhibitor of the type-V cyclic guanosine monophosphate-specific phosphodiesterase (the predominant isoenzyme in the human corpus cavernosum) on penile erectile activity in patients with male erectile dysfunction of no established organic cause. PATIENTS AND METHODS: Twelve patients (aged 36-63 years) with male erectile dysfunction of no established organic cause were entered into a double-blind, randomized, placebo-controlled, crossover study which was conducted in two phases. In the first phase (four-way crossover), treatment efficacy was evaluated by measurements of penile rigidity using penile plethysmography during visual sexual stimulation at different doses of sildenafil (10, 25 and 50 mg or placebo). In the second phase (two-way crossover), efficacy was assessed by a diary record of penile erectile activity after single daily doses of sildenafil (25 mg) or placebo for 7 days.

RESULTS: The mean (95% confidence interval, CI) duration of rigidity of > 80% at the base of the penis was 1.3 min (0.4-3.1) in patients on placebo, 3.5 min (1.6-7.3; P = 0.009) on 10 mg, 8.0 min (3.7-16.7; P = 0.003) on 25 mg and 11.2 min (5.6-22.3; P < 0.001) on 50 mg of sildenafil.

The mean (95% CI) duration of rigidity of > 80% at the tip of the penis was 1.2 min (0.4-2.7) on placebo and 7.4 min (2.4-8.5; P = 0.001) on 50 mg sildenafil.

From the diary record of daily erectile activity, the mean (95% CI) total number of erections was significantly higher in patients receiving sildenafil was 6.1 (3.2-11.4), compared with 1.3 (0.5-2.7) in those on placebo; 10 of 12 patients reported improved erectile activity while receiving sildenafil, compared with two of 12 on placebo (P = 0.018). Six patients on active treatment and five on placebo reported mild and transient adverse events which included headache, dyspepsia and pelvic musculo-skeletal pain.

This is just a published peer-reviewed study on the duration of the EFFECT of Viagra. Now I know this is weak evidence agaist Padma-Nathan's unsupported statement implied on the Barbara Walters show, but I read this as an average about 7-11 minutes duration of the effect for which the medication was used. Yes, the blood levels (and therefore the side-effects) will persist for hours. So your partner will be looking "blue" for a while in more ways than one (referring to the visual color changes in some patients on Viagra.) Maybe send out for a pizza while you're waiting for "round two"? If anyone has any abstracts or newer published research, I'll be happy to update the information.

BTW, of course I explained to the patient about the currently available teatments, MUSE and Caverject. He wasn't interested, but if his wife had been part of the discussion.....

Looks like another grey day ahead for the markets in general.

Zebra
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