6533b85bfe1ef96bd12bbebe

RESEARCH PRODUCT

Evaluation of an alternative dosing regimenwith tadalafil, three times per week, for men with erectile dysfunction: SURE study in Italy.

V MironeC ImbimboA RossiR SicuteriD ValleN LongoF FuscoV MironeG AleiG AnselmoM AquiliniC BellorofonteA BonnoM BoscaroW BozzoG BredaMm CaotortaC CaraniA CasaricoV CassuttiM CecchiV CicaleseG ComeriM CordariL CormioG D'agataO D'aliaC De DominicisG De GrandeU Di MarioA Di RienzoG FasolisCb FasoloD FedeleV FerraraC ForestaG FortiS FrancavillaB FreaS GenoveseV GentileE GhigoO GiampietroC ImbimboU JacobellisB JandoloE JanniniG La PeraA LemboA LenziG LudovicoE MacchiaA MaffucciG MaioG MalossiniF ManteroA MarinG MazzaF MazzarellaF Menchini FabrisF MontorsiG MuzzonigroA NastaG NicitaC NobileA PaganoR PaoliniM ParadisoE PescatoriIi PittalugaPoletti P. DPontiroli F. DPorena A. DProvenzano M. DPycha C. DRanno A. DRuggeri S. DScarano M. DScarpa P. DScionti R. M. DSelli L. DSerao C. DSidari A. DSorrentino V. DSpera F. DSpera E. DStrada G. DTasca G. DTatti A. DToscano P. DTrevisan V. DTrinchera R. DTurchi A. DUsai P. DVecchio E. DVentrice D. DVita G. A. DVolpi A. DZenico R. DT. D.Carlo Pavone

subject

Malemedicine.medical_specialtyAlternate; Erectile dysfunction; On demand; SURE study; Tadalafil; Three times per week; Carbolines; Cross-Over Studies; Drug Administration Schedule; Erectile Dysfunction; Humans; Italy; Male; Middle Aged; Phosphodiesterase Inhibitors; Tadalafil; Treatment Outcome; Nephrology; EndocrinologyPhosphodiesterase Inhibitorserectile dysfunctionUrologyerectile dysfunction; SURE study; on demand; three times per week; alternate; tadalafilon demandDrug Administration Schedulelaw.inventionSettore MED/24 - UrologiaEndocrinologyRandomized controlled triallawOn demandInternal medicinealternateMedicineHumansClinical significanceDosingthree times per weekErectile dysfunction SURE Study on demand three times per week alternate tadalafilSURE studyCross-Over Studiesbusiness.industryGeneral MedicineMiddle Agedmedicine.diseaseCrossover studyTadalafilSurgeryRegimenErectile dysfunctionTreatment OutcomeItalyNephrologyAlternate; Erectile dysfunction; On demand; SURE study; Tadalafil; Three times per week; Carbolines; Cross-Over Studies; Drug Administration Schedule; Erectile Dysfunction; Humans; Italy; Male; Middle Aged; Phosphodiesterase Inhibitors; Tadalafil; Treatment Outcomebusinesstadalafilmedicine.drugCarbolines

description

AIM: To examine the preference for two dosing regimens of 20 mg of tadalafil, on demand or three times per week, in men affected with erectile dysfunction (ED) in Italy. METHODS: Scheduled Use versus on demand Regimen Evaluation (SURE) is a multicenter, crossover and open-label study, involving 94 urology centers in Italy. Patients aged 18 years or older affected with ED for at least 3 months were enrolled and randomized to 20 mg of tadalafil treatment on demand or three times per week for 5-6 weeks. After a 1-week washout, patients were crossed over to the alternate regimen for 5-6 weeks. A treatment preference question was used to determine the preferred treatment regimen. International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) questionnaire were used as efficacy measures. RESULTS: A total of 1 058 men (mean age 54.8 years), were randomized to treatment. Overall, 59.1% of patients preferred the on-demand regimen and 41.9% preferred the three times per week dosing. Both regimens were efficacious and well tolerated. Although a statistically higher improvement of the IIEF erectile function (IIEF-EF) domain score and the SEP questionnaire was reported for the three times per week compared to the on-demand treatment regimen, this difference was numerically minimal and lacking in clinical significance. CONCLUSION: Tadalafil is effective and well tolerated whether used on demand or three times per week. Patients should be given the option to choose the best treatment regimen according to personal needs and preferences.

10.1111/j.1745-7262.2007.00214.xhttp://hdl.handle.net/11568/801014