A comparative, crossover study of the efficacy and safety of sildenafil and apomorphine in men with evidence of arteriogenic erectile dysfunction

The aim of the study was to establish and compare the efficacy and safety of sildenafil and apomorphine in men with arteriogenic erectile dysfunction (ED). In all, 43 men with ED and postinjection max penile systolic velocity <25 cm/s in repeated Doppler ultrasonography were included. Of these, 24 men started on apomorphine 2 mg and 19 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg according to effectiveness and tolerability. Safety was evaluated according to adverse events (AEs) and patient withdrawal. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on event log data. The incidence of AEs with apomorphine 3 mg was higher than with sildenafil 100 mg. Two men on apomorphine 3 mg discontinued treatment due to AEs. The overall success rate of sildenafil was 63.7% compared to 32.1% of apomorphine (Pearson χ2, P<0.01). Of all men, 25 (58.1%) responded to sildenafil 50 mg without the need for dose increase, while only one responded to apomorphine 2 mg. The response to sildenafil 50 mg was age related (analysis of variance, p=0.04). Satisfaction was reported by 76.75 and 13.95% of patients for sildenafil and apomorphine, respectively, but 20.9% were not satisfied with any of the two drugs. In conclusion, this study provides clear evidence that sildenafil, even at 50 mg dose, is more effective than apomorphine 3 mg in men with arteriogenic ED. The fact that one out of five patients is not satisfied with the above-studied drugs shows that new oral agents need to be evaluated for the treatment of this disorder.

[1]  D. Ralph,et al.  Adverse Events and Patient Tolerability of Apomorphine SL 2 and 3 mg: A Cross-Study Analysis of Phase II and III Studies , 2002 .

[2]  A. Burnett,et al.  Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment. , 1999, The Journal of urology.

[3]  B. Bemelmans,et al.  Penile pharmacological duplex ultrasonography: a dose-effect study comparing papaverine, papaverine/phentolamine and prostaglandin E1. , 1992, The Journal of urology.

[4]  F. Montorsi,et al.  Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies. , 1999, Urology.

[5]  G. Hackett,et al.  Patient Choice is Critical in Managing Erectile Dysfunction , 2002 .

[6]  O. Rampin Mode of action of a new oral treatment for erectile dysfunction: apomorphine SL , 2001, BJU international.

[7]  Tom F. Lue,et al.  Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. , 1998, New England Journal of Medicine.

[8]  F. Montorsi,et al.  A 4-year update on the safety of sildenafil citrate (Viagra). , 2002, Urology.

[9]  J. Cappelleri,et al.  Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction , 1999, International Journal of Impotence Research.

[10]  S. Kaul,et al.  Writing Group Members , 2022 .

[11]  F. Montorsi,et al.  Guidelines on erectile dysfunction. , 2002, European urology.

[12]  E. Laumann,et al.  Diabetes and sexual function in older adults: results of an international survey , 2002 .

[13]  C. Stief,et al.  Cross-Study Review of the Clinical Efficacy of Apomorphine SL 2 and 3 mg:: Pooled Data from Three Placebo-Controlled, Fixed-Dose Crossover Studies , 2002 .

[14]  I. Goldstein,et al.  Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. , 1998, The New England journal of medicine.

[15]  J. Levy Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study , 2002 .

[16]  G. Broderick Evidence based assessment of erectile dysfunction. , 1998, International journal of impotence research.

[17]  A. Boulton,et al.  Sildenafil citrate for the treatment of erectile dysfunction in men with Type II diabetes mellitus , 2001, Diabetologia.

[18]  K. W. Marich,et al.  Vasculogenic impotence evaluated by high-resolution ultrasonography and pulsed Doppler spectrum analysis. , 1985, Radiology.

[19]  A. Burnett,et al.  The efficacy of sildenafil citrate (Viagra) in clinical populations: an update. , 2002, Urology.

[20]  F. Dorey,et al.  Treatment of erectile dysfunction with sildenafil. , 1999, Urology.

[21]  J. Martínez-Jabaloyas,et al.  Prognostic Factors for Response to Sildenafil in Patients with Erectile Dysfunction , 2001, European Urology.

[22]  P. Nana-Sinkam,et al.  Outcome analysis of goal directed therapy for impotence. , 1996, The Journal of urology.

[23]  D. Udelson,et al.  Cavernosal expandability is an erectile tissue mechanical property which predicts trabecular histology in an animal model of vasculogenic erectile dysfunction. , 1998, The Journal of urology.

[24]  M. Adams,et al.  Safety and tolerability of Apomorphine SL in men with cardiovascular disorders , 2002 .

[25]  W. Steers,et al.  Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study of 329 patients. Sildenafil Study Group. , 1998, International journal of clinical practice.

[26]  T. Lue Impotence: A patient's goal-directed approach to treatment , 1990, World Journal of Urology.

[27]  S. Bukofzer,et al.  Safety and tolerability of apomorphine SL (Uprima®) , 2001, International Journal of Impotence Research.

[28]  S. S. Davis,et al.  Impotence and Aging: Clinical and Hormonal Factors , 1988, Journal of the American Geriatrics Society.

[29]  C. Stief,et al.  Efficacy of apomorphine SL in erectile dysfunction , 2001, BJU international.

[30]  S. Bukofzer,et al.  Double–Blind, Crossover Comparison of 3 mg Apomorphine SL with Placebo and with 4 mg Apomorphine SL in Male Erectile Dysfunction , 2001, European Urology.