To: Zebra 365 who wrote (9329 ) 6/8/1998 6:47:00 AM From: DaiS Respond to of 23519
Zebra, I don't know is this is relevant to your post about the combination, but the unpublished results of Costabile show good effect. Alprostadil alone 47% Combination 70% There is a "retreat" in the alprostadil effectiveness. However if one accepts this then one must accept that the combination is 50% better. Taken together with the earlier Peterson results it seems that the improvement of the combination might have been largely in the lower alprostadil doses. DaiS Efficacy of transurethral alprostadil (MUSEr) versus transurethral alprostadil/prazosin (ALIBRA(TM)) in men with complete, organic erectile dysfunction Raymond A. Costabile, Washington, DC (Presented by Dr. Costabile). Introduction: Clinical studies of transurethral alprostadil (MUSEr) have shown that 40-50% of men with complete, organic erectile dysfunction (ED) are successfully treated with this therapy. A new transurethral bi-mix (ALIBRA(TM)), consisting of alprostadil and the alpha blocker prazosin, was shown in preliminary studies to be effective in men with ED. We compared the efficacy of transurethral alprostadil vs. alprostadil/prazosin in a multicenter, double-blind trial. Methods: 394 men with complete, organic ED were titrated at home in a double-blind manner with transurethral alprostadil and alprostadil/prazosin combinations. Men were then treated at home for up to 6 months with their selected dose of medication supplied in kits of 8 with an interspersed placebo. Active medication included doses of alprostadil (125 mcg, 250 mcg, 500 mcg, and 1000 mcg) alone or in combination with prazosin (250 mcg, 500 mcg, 1000 mcg, and 2000 mcg). The mean age of the men was 63 years and duration of ED was 34 months. The primary endpoint was sexual intercourse. Results: Intercourse during home titration was reported by 70% (276/394) of men. Of the 276 men reporting sexual intercourse, 89 succeeded only with the alprostadil/prazosin combination(s) and were not responsive to alprostadil alone. Penile pain, the most common side effect, occurred in 7.6 to 19.8% of administrations. Hypotension was observed in 1.5 to 9.2% of administrations, most commonly in men receiving high doses of combination therapy. During 6 months of home treatment, alprostadil alone and alprostadil/prazosin combinations each demonstrated high efficacy vs. placebo. Conclusions: Treatment with transurethral alprostadil/prazsin combinations resulted in successful sexual intercourse in a significant number of men unresponsive to alprostadil alone, thus expanding the pool of men with complete ED who can be treated with transurethral therapy. These data confirm that alprostadil/prazosin combinations will be a promising "second generation" transurethral therapy. Source: 1998 AUA Meeting