Intracavernous Alprostadil Alfadex—an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study

Abstract

Long-term ef®cacy and safety of Alprostadil-Alfadex (EDEX R /VIRIDAL R ) in intracavernous selfinjection 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 b 6 h only occurring during the ®rst year in 1.2% (2 out of 162), painful erections in 29% (47 out of 162) during the ®rst 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, ®brotic 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 satis®ed or very satis®ed with self-injection therapy with Alprostadil-Alfadex. The respective rates of the female partners were 51.7% very satis®ed and 39.7% satis®ed.These data of the world-wide longest running prospective trial with a vasoactive drug in selfinjection therapy provided impressive proof that Alprostadil-Alfadex represents a very effective and safe treatment for erectile dysfunction of both psychogenic and organogenic origin.

Current perspectives on intracavernosal pharmacotherapy for erectile dysfunction

“…43,46 Typical side-effects with alprostadil self-injection therapy are the occurrence of penile pain in 8 ± 52%, however, with long-term follow-up and individual dose adjustment, pain-rates decreased to 1 ± 11%. 45,46 Priapisms were almost exclusively observed in the titration-phase and varied between 0.25 and 1% (Table 2).…”

“…43,46 Typical side-effects with alprostadil self-injection therapy are the occurrence of penile pain in 8 ± 52%, however, with long-term follow-up and individual dose adjustment, pain-rates decreased to 1 ± 11%. 45,46 Priapisms were almost exclusively observed in the titration-phase and varied between 0.25 and 1% (Table 2). 27,43,46 In the two major trials with both alprostadil-preparations, penile ®brotic alterations were encountered in 7.5 ± 11.7% of patients during the course of the 4 ± 5 y of long-term follow-up.…”

Treatment satisfaction in patients with erectile dysfunction switching from prostaglandin E1 intracavernosal injection therapy to oral sildenafil citrate

“…1 Two effective medical treatments for ED of various aetiologies include intracavernosal (IC) injection therapy with vasoactive agents (eg, prostaglandin E 1 (PGE 1 ), papaverine, and phentolamine) 2,3 and oral therapy with phosphodiesterase type 5 inhibitors, sildenafil citrate (VIAGRA s ) being the first in the class. 4,5 Despite its efficacy, IC PGE 1 therapy is associated with patient-initiated discontinuation rates as high as 60%.…”

Intracavernosal prostaglandin E1 self vs office injection therapy in patients with erectile dysfunction

“…However, others have reported a decrease or even a complete resolving of the fibrosis. 32,33 Resolving of penile fibrosis could be due to discontinuation of self-injection therapy or improvement of the individual injection technique. However, the exact role of drug-related and techniquerelated fibrotic side effects remains unclear.…”

“…However, the exact role of drug-related and techniquerelated fibrotic side effects remains unclear. 32,33 It is therefore mandatory to properly instruct the patients on the self-injection program about the technique and its pitfalls. The use of ultra-thin needles (27-30 gauge) and frequent alteration of the injection site may provide appropriate precautions for the diminution of local side effects.…”