For common outcomes there was similar efficacy between PDE-5 inhibitors
Background There are no r and omised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting .
Valid indirect comparisons with a common comparator must examine equivalent doses , similar duration , similar population s , with the same outcomes reported in the same way .
Population Dose-Response Model for Tadalafil in the Treatment of Male Erectile Dysfunction
Abstract Purpose . To determine the population dose-response relationship for tadalafil during on-dem and ( as-needed ) administration for treatment of erectile dysfunction ( ED ) . Methods . A total of 212 male patients with mild , moderate , or severe ED participated in a multicenter , r and omized , double-blind , placebo-controlled , parallel-group study . Patients were r and omized to receive placebo or 2 , 5 , 10 , or 25 mg tadalafil , taken on dem and over an 8-week period . Efficacy was assessed on the basis of questions 2 and 3 of the Sexual Encounter Profile ( SEP ) and questions 3 and 4 of the International Index of Erectile Function ( IIEF ) question aires . These scores were modeled using logistic regression . A fifth patient response , the IIEF EF ( erectile function ) domain score , was modeled as a continuous variable . Results . The dose-response relationship for each efficacy variable was best described with an Emax model , in which maximum effect increased with ED severity at baseline . Response scores increased substantially between 10 and 25 mg tadalafil doses , and the dose-response parameter estimates suggested possibly higher responses at even higher doses . Conclusions . Population dose-response modeling of all five oucome measures indicated that efficacy in all ED severity groups in the studied population generally increased across the 2 to 25 mg tadalafil dose range . Estimates of maximal improvement ( Emax ) in the IIEF EF domain score were 7.5 , 11.4 , and 16.3 points for patients with mild , moderate , and severe ED , respectively . Corresponding tadalafil doses to attain half-maximal improvement ( ED50 estimates ) were 4.7 mg , 7.1 mg , and 10.1 mg
For common outcomes there was similar efficacy between PDE-5 inhibitors
Background There are no r and omised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting .
Valid indirect comparisons with a common comparator must examine equivalent doses , similar duration , similar population s , with the same outcomes reported in the same way .