title: Intracavernous Alprostadil Alfadex--an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study.
abstract: Long-term efficacy and safety of Alprostadil-Alfadex (EDEX/VIRIDAL) in intracavernous self-injection therapy for chronical erectile failure was investigated in a four year running multicenter European trial. Of the 16,886 protocolled injections 93% (15,713) resulted in rigid erections followed by successful sexual intercourse. Reported side effects by patients were prolonged erections > 6 h only occurring during the first year in 1.2% (2 out of 162), painful erections in 29% (47 out of 162) during the first year and decreasing to 12.1% by year 4, hematomas, neither requiring therapeutic measures nor impeding sexual performance in 33.3% (54 out of 162) in year 1 with a decrease to 12.1% by year 4, fibrotic penile alterations such as nodules, plaques or deviations in 11.7% (19 out of 162) with spontaneous healing in 48% (9 out of 19). Of the 162 patients involved in this trial 54 completed the 4 y. Of the 54 completers 91.4% considered the tolerability good or very good and were satisfied or very satisfied with self-injection therapy with Alprostadil-Alfadex. The respective rates of the female partners were 51.7% very satisfied and 39.7% satisfied. These data of the world-wide longest running prospective trial with a vasoactive drug in self-injection therapy provided impressive proof that Alprostadil-Alfadex represents a very effective and safe treatment for erectile dysfunction of both psychogenic and organogenic origin.
authors.affiliation: Urological Office, Hamburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Porst
authors.forename: J
authors.initials: J
authors.lastname: Buvat
authors.forename: E
authors.initials: E
authors.lastname: Meuleman
authors.forename: V
authors.initials: V
authors.lastname: Michal
authors.forename: G
authors.initials: G
authors.lastname: Wagner
mesh_terms: D000328:Adult; D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003075:Coitus; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D005060:Europe; D005260:Female; D005355:Fibrosis; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection; D010413:Penis / Q000187:drug effects / Q000473:pathology; D011446:Prospective Studies; D012646:Self Administration; D014665:Vasodilator Agents
chemical_list: D014665:Vasodilator Agents; D000527:Alprostadil