A return to normal erectile function with vardenafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy
Introduction: An optimal outcome of an erectile dysfunction (ED) treatment is to enable a return to normal erectile function (as defined by an International Index of Erectile Function-Erectile 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.
Aim: The combined studies evaluated whether treatment with vardenafil 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.
Methods: Men were ≥ 18 years of age, sexually active, reported a ≥ 3-month history of ED, and had been taking the maximum dose of sildenafil citrate, tadalafil, or vardenafil PRN. Randomization to once-daily therapy with vardenafil 2.5 mg to 5 mg (N = 207), vardenafil 5 mg (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 measure: The main outcome measure was the percentage of subjects with a return-to-normal erectile function (IIEF-EF domain score ≥ 26) when treated with vardenafil once daily compared with placebo.
Results: In subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor, a higher percentage of subjects treated with vardenafil had an IIEF-EF domain score ≥ 26 at end point (vardenafil 2.5- to 5-mg group [39%]; vardenafil 5-mg group [40%]) compared with the placebo group (12.1%; P < 0.001). vardenafil was generally well tolerated and adverse events observed were consistent with previous reports of vardenafil once daily.
Conclusions: Treatment with vardenafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment.
Trial registration: ClinicalTrials.gov NCT01130532.
Keywords: Clinical Trial; Erectile Dysfunction; Oral Therapy; Phosphodiesterase Type 5 Inhibitor; vardenafil.
© 2013 International Society for Sexual Medicine.
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A return to normal erectile function with vardenafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy
Introduction: An optimal outcome of an erectile dysfunction (ED) treatment is to enable a return to normal erectile function (as defined by an International Index of Erectile Function-Erectile 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.
Aim: The combined studies evaluated whether treatment with vardenafil 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.
Methods: Men were ≥ 18 years of age, sexually active, reported a ≥ 3-month history of ED, and had been taking the maximum dose of sildenafil citrate, tadalafil, or vardenafil PRN. Randomization to once-daily therapy with vardenafil 2.5 mg to 5 mg (N = 207), vardenafil 5 mg (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 measure: The main outcome measure was the percentage of subjects with a return-to-normal erectile function (IIEF-EF domain score ≥ 26) when treated with vardenafil once daily compared with placebo.
Results: In subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor, a higher percentage of subjects treated with vardenafil had an IIEF-EF domain score ≥ 26 at end point (vardenafil 2.5- to 5-mg group [39%]; vardenafil 5-mg group [40%]) compared with the placebo group (12.1%; P < 0.001). vardenafil was generally well tolerated and adverse events observed were consistent with previous reports of vardenafil once daily.
Conclusions: Treatment with vardenafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment.
Trial registration: ClinicalTrials.gov NCT01130532.
Keywords: Clinical Trial; Erectile Dysfunction; Oral Therapy; Phosphodiesterase Type 5 Inhibitor; vardenafil.
© 2013 International Society for Sexual Medicine.
Trial registration: ClinicalTrials.gov NCT01130532.
Similar articles
Porst H, Burnett A, Brock G, Ghanem H, Giuliano F, Glina S, Hellstrom W, Martin-Morales A, Salonia A, Sharlip I; ISSM Standards Committee for Sexual Medicine.
29.05.2022 01:23:46
2022-05-29 01:23:46