Intracavernous alprostadil alfadex is more efficacious, better tolerated, and preferred over intraurethral alprostadil plus optional actis: A comparative, randomized, crossover, multicenter study

Objectives. To compare the efficacy, safety, and patient preference of intracavernously administered alprostadil alfadex and intraurethrally administered alprostadil. Methods. A crossover, randomized, open-label multicenter study of 111 patients with erectile dysfunction of at least 6 months' duration compared the efficacy, safety, and patient preference of intracavernosal alprostadil (EDEX/Viridal) with MUSE plus optional ACTIS. All patients underwent an in-office dose titration with either drug before undertaking an at-home treatment phase. The most frequently used doses during the at-home phase were 40 mu g (44.1% of men) and 1000 mu g (86.8% of men) for EDEX and MUSE, respectively; the mean doses were 26. 1 mu g and 922.5 mu g for EDEX and MUSE, respectively. Results. More EDEX than MUSE administrations resulted in an erection sufficient for sexual intercourse (82.5% versus 53.0%); significantly more patients using EDEX achieved at least one erection sufficient for sexual intercourse (92.6% versus 61.8%; P < 0.0001); and EDEX use resulted in a significantly greater percentage of patients attaining at least 75% of erections sufficient for sexual intercourse (75% versus 36.8%; P < 0.0001). Penile pain was the most common side effect for both medications: 20.0% versus 30.5% (in-office) and 33.8% versus 25.0% (at-home) for EDEX and MUSE, respectively. Similar numbers of adverse events were reported with either treatment during the at-home phase. Patient and partner satisfaction was greater with EDEX, and more patients preferred this therapy, choosing to continue it during a patient preference period at the end of the study. Conclusions. Since intracavernous injection therapy was more efficacious, better tolerated, and preferred by the patients and their partners, it should be offered as the first-choice treatment if oral therapy fails or is contraindicated. (C) 2000, Elsevier Science Inc.