A Return to Normal Erectile Function with Tadalafil Once Daily after an Incomplete Response to As- Needed PDE5 Inhibitor Therapy

作者：Kim Edward D^*; Seftel Allen D; Goldfischer Evan R; Ni Xiao; Burns Patrick R

来源：The Journal of Sexual Medicine, 2014, 11(3): 820-830.

DOI：10.1111/jsm.12253

• Erectile Dysfunction
• Oral Therapy
• Tadalafil
• Phosphodiesterase Type 5 Inhibitor
• Clinical Trial

IntroductionAn optimal outcome of an erectile dysED) treatment is to enable a return to normal erectile as defined by an International Index of Erectile FunctionErectile Function [IIEF-EF] domain score 26). As-needed (PRN) phosphodiesterase type 5 (PDE5) inhibitor treatment does not always result in a return-to-normal erectile function.
AimThe combined studies evaluated whether treatment with tadalafil once daily would allow men to return to normal erectile function who had less than normal IIEF-EF domain scores while using a maximum dose of a PRN PDE5 inhibitor treatment.
MethodsMen were 18 years of age, sexually active, reported a 3-month history of ED, and had been taking the maximum dose of sildenafil citrate, vardenafil, or tadalafil PRN. Randomization to once-daily therapy with tadalafil 2.5mg to 5mg (N=207), tadalafil 5mg (N=207), or placebo (N=209) for 12 weeks followed a 4-week maximum dose PRN PDE5 treatment and 4-week nondrug lead periods. Two identical double-blind, randomized, placebo-controlled studies were conducted; combined results are reported.
Main Outcome MeasureThe main outcome measure was the percentage of subjects with a return-to-normal erectile IIEF-EF domain score26) when treated with tadalafil once daily compared with placebo.
ResultsIn subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor, a higher percentage of subjects treated with tadalafil had an IIEF-EF domain score 26 at end point (tadalafil 2.5- to 5-mg group [39%]; tadalafil 5-mg group [40%]) compared with the placebo group (12.1%; P<0.001). Tadalafil was generally well tolerated and adverse events observed were consistent with previous reports of tadalafil once daily.
ConclusionsTreatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment. Kim ED, Seftel AD, Goldfischer ER, Ni X, and Burns PR. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. J Sex Med 2014;11:820-830.

• 出版日期2014-3