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Biotech / Medical : Vivus: into single digits

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To: MIKE DUBIS who wrote (269)4/22/1998 1:06:00 AM
From: BDR  Read Replies (3) of 1016
 
Mike- I have been perusing the May Supplement to the J. of Urology listing the abstracts to be presented at the Annual Meeting of the Amer. Urological Assoc. May 30-June 4 in San Diego. #903-909 discuss MUSE, #910-912 discuss Viagra, and # 919 discusses Vasomax. Some interesting stuff:

#903 Disappointing Results For Transurethral Alprostadil in a V.A.(Veterans Admin) Impotence Clinic. Bronx, NY. "Out of 107 patients, only 7 developed erections rated good or very good..."

#904 Efficacy of Transurethral Alprostadil (MUSEr) VS. Transurethral Alprostadil/Prazosin (Alibrar) in Men with Complete Organic Erectile Dysfunction. Washington, DC. Cites 40-50% success with MUSE (what happened to 67%?). Improved to 70% response rate when able to use both. Funded by MUSE Study Group.

#905 Disappointing Results With Transurethral Alprostadil in Men With Erectile Dysfunction (ED) in a Urology Practice Setting. All three doses (250, 500, 1000) were used. "Only 27% of pts achieved rigidity sufficient for intercourse despite being challenged to the highest dose.... Most disappointing is the fact that at follow-up only 18.6% of pts continue the use of the MUSE system....For a variety of possible reasons efficacy in a controlled clinical trial has not translated in clinical usefulness of the MUSE system for the majority of our patients suffering from ED."

#906 Combined Use of Transurethral Alprostadil and an Adjustable Penile Constriction Band in Men with Erectile Dysfunction: Results from a Multicenter Trial. Augusta, GA. Use of the band may augment the effect of the drug. Funded by MUSE-Actis Study Group.

#907 Transurethral Alprostadil for the Treatment of Erectile Dysfunction: Two Year Safety Update. Menlo Park, CA. Favorable long term safety profile. Funded by the MUSE Study Group.

#908 Evaluation of the Consistency of Response to Intra-urethral Prostaglandin (MUSEr) During At Home Use. Maywood, IL. "In patients who respond to MUSE in the office setting, significant variability of response in the home setting occurs. Patients should therefore be forewarned of the interdose variability in erectile response..."

#909 A Prospective, Randomized Patient/Partner Comparison of Intracorporal Vs. Intraurethral Delivery of Alprostadil. New York, NY. Office instruction along with home trials using both medications were performed prior to the patient's final choice of medication. Of 22 patients completing the study so far 64% chose Caverject and 36% chose MUSE. Hmmm.

#910 Meta-Analysis of the Efficacy of Sildenafil (Viagrar) in the Treatment of Severe Erectile Dysfunction. Charlottesville, VA. "...performed to assess the efficacy of sildenafil in a subgroup of men with sever ED." 3611 patients. "The results of this meta-analysis indicate that sildenafil, at doses of 50 and 100mg, is effective in men with severe ED, with response rates ranging from 46% to 73%." Response based on the International Index of Erectile Function (IIEF), frequency of penetration (Q3) and frequency of maintained erections (Q4). A little hard to relate that to use in the real world but it doesn't matter because Viagra doesn't work in severe cases. I know because TUNA and VLAD told me so.(g) Sildenafil Working Group.

#911 A 24 Week, Fixed Dose Study to Assess the Efficacy and Safety of Sildenafil (Viagrar) in Men with Erectile Dysfunction. Same measures as above (IIEF,Q3, Q4). ...effective and well-tolerated therapy for the treatment of ED of broad-spectrum etiology, with efficacy maintained with long-term treatment." Sildenafil Working Group.

#912 Analysis of the Efficacy of Sildenafil (Viagrar) in the Treatment of Male Erectile Dysfunction in Elderly Patients. Multicenter European Study. Same measures as above. "...equally effective in the elderly (>/=65) and <65 year-old men."

#919 Efficacy and Safety of Oral Phentolamine (Vasomax) for the Treatment of Minimal Erectile Dysfunction. Irwin Goldstein, Vasomax Study Group.
Placebo-controlled, parallel group, double-blind randomized study:
Placebo 16%
40mg 37%
80mg 45%

Placebo-controlled crossover
Placebo 21%
40mg 34%
"...safe and effective oral medication for the treatment of mild erectile dysfunction."

Without a scanner that's all you are going to get tonight. Good luck.
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