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An Evaluation of an Alternative Dosing Regimen with Tadalafil, 3 Times/Week, for Men with Erectile Dysfunction: SURE Study in 14 European Countries

Mirone V, Costa P, Damber J-E, Holmes S, Moncada I, Van Ahlen H, Wespes E, Cordell WH, Chan M, Lembo D, Varanese L; European Urology 2005 (47):846-854

KEY WORDS: Erectile dysfunction; SURE study; On demand; 3 times/week; Alternate; Tadalafil

In most trials conducted with tadalafil to date, the drug has been administered on demand. With effectiveness that lasts up to 36 hours, tadalafil could provide nearly continuous coverage when taken on a regular basis, allowing patients to choose when to have sexual intercourse. This study was done to assess the patient's preference for an alternative dosing regimen, 3 times/week, which takes advantage of the 36 hours of efficacy of tadalafil. The standard assessments of effi- cacy and safety were used and the treatment preference question (TPQ) was administered in this study to determine patient preference for tadalafil 20 mg taken on demand or 3 times/week.

• SURE is a 14 European country, multicenter, crossover, and open-label study. Men with ED (N = 4262) were randomized to tadalafil 20 mg treatment on demand (maximum one dose per day and before sexual activity) or 3 times/week for 5-6 weeks. After a 1-week washout period, patients were crossed over to the alternate regimen for 5-6 weeks. The patient's response to a treatment preference question (TPQ) was used to determine the preferred treatment regimen.
• In this multicenter, randomized study, while 57.8% of men preferred the on-demand regimen of tadalafil 20 mg, a substantial number (42.2%) preferred the 3 times/week regimen of tadalafil. This study, which uses a treatment of 3 times/week, is the first to compare such a regimen to traditional on-demand treatment options and demonstrates that an efficacious and safe alternative to the conventional on-demand treatment regimen for ED is available using tadalafil. The unique pharmacokinetic properties of tadalafil provide flexible dosing regimens and may allow patients to choose a regimen that provides a more spontaneous and normal sex life.

See the abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15925082&dopt=Citation