Authors' objectives:

As the costs of, and demand for, sexual dysfunction medicines grow and new products enter the market, ACC needs to determine the relative effectiveness and cost-effectiveness of the products available in order to establish a consistent policy on which medicines to fund. This review evaluates the relative effectiveness, safety and cost-effectiveness of medicines for the treatment of male claimants with erectile dysfunction due to accident or injury.

Authors' results and conclusions: Few studies with populations similar to ACC claimants were located. Sildenafil was the only medicine for which good quality studies were available for some of this group and that was for men with spinal cord injury. On the basis of the efficacy, safety and cost-effectiveness evidence available, the oral medicine sildenafil is the preferred treatment for men whose erectile dysfunction is due to accident or injury. While studies to date on the newer medicines vardenafil and tadalafil demonstrate good efficacy and safety profiles, and there are some indications for preference for tadalafil with its extended period of effectiveness, longer-term efficacy and safety data is not yet available. Many of the trials with these medicines also excluded men with spinal cord injury, the group most similar to ACC claimants located in the literature. There is evidence for the efficacy of intracavernous injection therapy (alprostadil, papaverine or combinations of vasoactive agents) for those who continue with its use in the treatment of erectile dysfunction, although the evidence is generally at a lower level and from poorer quality studies than that found for sildenafil, vardenafil or tadalafil. There are high drop-out rates from intracavernosal injection programmes however, and higher rates of serious adverse events (particularly for papaverine monotherapy), including prolonged erection, for this method of treatment. Comparative studies have demonstrated greater efficacy for intracavernosal alprostadil than for intraurethral alprostadil (MUSE). While some evidence for the efficacy of apomorphine SL has been demonstrated, it is considered to be less effective than the PDE5 inhibitors sildenafil, vardenafil and tadalafil and its efficacy has not been demonstrated with men with erectile dysfunction due to spinal cord injury.

Authors' recommendations: On the basis of the studies reviewed, oral medication with PDE5 inhibitors appear to be the first line treatment for ACC claimants whose erectile dysfunction is due to accident or injury. Sildenafil, as the oldest and most researched to date of these medicines, is the preferred treatment on the basis of its efficacy, safety and cost-effectiveness. Results from comparative studies between sildenafil, vardenafil and tadalafil and investigation of vardenafil and tadalafil use with men with spinal cord injury should continue to be monitored with regard to purchasing decisions as new evidence emerges. Intracavernosal injection of alprostadil (monotherapy or in a combination treatment) may be considered as a second line treatment when sildenafil or other PDE5 are contraindicated or there is non-response to those treatments.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://nzhta.chmeds.ac.nz/publications.htm

Year Published: 2004

URL for published report: n/a

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: New Zealand

Organisation Name: New Zealand Health Technology Assessment

Contact Address: Department of Public Health and General Practice, Christchurch School of Medicine and Health Sciences, University of Otago, P.O. Box 4345, Christchurch, New Zealand. Tel: +64 3 364 1145; Fax: +64 3 364 1152;

Contact Name: nzhta@chmeds.ac.nz

Contact Email: nzhta@chmeds.ac.nz

Copyright: <p>Clearing House for Health Outcomes and Health Technology Assessment.</p>