• 
• 
• 
• 
• 
• 
• 

• 
• 
• 
• 

• 
• 
• 

• 
• 
• 
• 
• 

Evaluating Preference Trials of Oral Phosphodiesterase 5 Inhibitors for Erectile Dysfunction

Mulhall JP, Montorsi F; Eur Urol 49:30–37.

KEY WORDS: Erectile dysfunction, Phosphodiesterase Inhibitors, Sildenafil, Vardenafil

More treatment options are available now for the treatment of ED than ever. Treatments include oral phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections, vacuum constriction devices, and penile implants. Clinicians, researchers, and patients are interested in making direct comparisons between the response of newer treatments and that of established and more developed therapies. A recent review highlighted several key factors to consider when interpreting safety and efficacy data from erectile dysfunction (ED) drug trials.

• To make an informed decision on the most appropriate treatment option available, physicians and their patients require a thorough understanding of the methodology of these studies. Clinical comparison or preference trials must establish internal and external validity if the data are to be used in a generalized patient population.
• The authors reviewed preference studies that compared sildenafil, tadalafil, and vardenafil, and highlight study designs that can introduce bias that may influence the design or interpretation of preference trials. Like safety and efficacy trials, randomized controlled trials (RCTs) should be the gold standard for evaluating patient preference treatments for ED. Even so, any single patient preference trial must be scrutinized for internal validity and external generalizability. Internal and external validity must be demonstrated, particularly if the results are to be compared across studies or with other patient populations. In addition to RCTs that are properly designed and executed, the clinical characteristics of ED treatments should be considered to help determine the most favorable treatment option for patients.

See the abstract

http://www.journals.elsevierhealth.com/periodicals/eururo/article/PIIS0302283805005634/abstract