Elsevier

Urology

Volume 55, Issue 4, April 2000, Pages 477-480
Urology

Rapid Communications
Intracavernous alprostadil alfadex (EDEX/VIRIDAL) is effective and safe in patients with erectile dysfunction after failing sildenafil (Viagra)☆

https://doi.org/10.1016/S0090-4295(99)00612-3Get rights and content

Abstract

Objectives. Sildenafil (Viagra), an oral treatment for erectile dysfunction, has proved popular since its introduction in 1998. However, not all patients respond to this form of therapy. Consequently, this study investigated the efficacy of intracavernous alprostadil alfadex (EDEX/VIRIDAL) treatment in patients not responding to sildenafil.

Methods. In an open-label, multicenter study, patients with erectile dysfunction were treated with sildenafil for 4 weeks. The initial dose was 50 mg, which was increased to 100 mg if no response was achieved. Patients not responding to treatment, measured using the International Index of Erectile Function (IIEF) questionnaire, entered an alprostadil alfadex in-office titration phase, to determine the optimal dose, up to 40 μg. A 6-week alprostadil alfadex at-home treatment phase followed.

Results. In 67 patients who did not respond satisfactorily to sildenafil, the alprostadil alfadex at-home therapy resulted in improvements in questions 3 and 4 of the IIEF in 60 (89.6%) and 57 (85.1%) patients, respectively. The mean improvement in IIEF score for these patients was 2.75 and 2.63 for questions 3 and 4, respectively. The most common side effect was penile pain in 25 (29.4%) of 85 patients treated with alprostadil alfadex in-office and at home.

Conclusions. Alprostadil alfadex therapy can be used effectively and safely in men who fail initial therapy with sildenafil.

Section snippets

Patients

A total of 134 men, 18 to 80 years old, with ED, who had an International Index of Erectile Function (IIEF) score of 3 or less for question 3 or 4, or both (Table I), were enrolled in the study. Standard inclusion/exclusion criteria for this type of trial were used. Patients were enrolled in compliance with the prescribing information for both products. Institutional Review Board approval of the trial was obtained, as well as informed consent from all patients.

Study design

The study was conducted at six

Results

The mean ± SD patient age was 58.6 ± 9.3 years and the mean ± SD duration of ED was 4.8 ± 2.9 years. The cause of the ED was determined by the medical and sexual history and by urologic examinations in the study populations (Table II). The mean baseline score for questions 3 and 4 at the beginning of the trial was 1.03 and 0.85, respectively.

The mean number of administrations of sildenafil for the patients entering phase 2 of the study was 4.9; the mean number of tablets taken per

Comment

Sildenafil has proved immensely popular as the first oral treatment for ED since its introduction in 1998. A total of 88.1% of patients in the current study reported a positive response to alprostadil alfadex at home after they had been identified as nonresponders to sidlenafil. Since the response rate of alprostadil alfadex in this trial is as high as in previously published trials, it can be concluded that the response rate of intracavernous self-injection therapy is not different in the

References (7)

There are more references available in the full text version of this article.

Cited by (0)

☆

This multicenter clinical trial was sponsored by a grant from Schwarz Pharma. R. Shabsigh and H. Padma-Nathan are paid consultants to the sponsor. J. G. McMurray holds stock in Pfizer, Inc.

View full text
Copyright © 2000 Elsevier Science Inc. All rights reserved.