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

Edward Kim, Allen D. Seftel, Evan R. Goldfischer, Xiao Ni, Patrick R. Burns

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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 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. 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, 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 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 tadalafil 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 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. Conclusions: Treatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment.

Original languageEnglish (US)
Pages (from-to)820-830
Number of pages11
JournalJournal of Sexual Medicine
Volume11
Issue number3
DOIs
StatePublished - Jan 1 2014

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Phosphodiesterase 5 Inhibitors
Placebos
Therapeutics
Erectile Dysfunction
Tadalafil
Outcome Assessment (Health Care)
Type 4 Cyclic Nucleotide Phosphodiesterase
Type 5 Cyclic Nucleotide Phosphodiesterases
Random Allocation

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

Cite this

A Return to Normal Erectile Function with Tadalafil Once Daily after an Incomplete Response to As-Needed PDE5 Inhibitor Therapy. / Kim, Edward; Seftel, Allen D.; Goldfischer, Evan R.; Ni, Xiao; Burns, Patrick R.

In: Journal of Sexual Medicine, Vol. 11, No. 3, 01.01.2014, p. 820-830.

Research output: Contribution to journalArticle

Kim, Edward ; Seftel, Allen D. ; Goldfischer, Evan R. ; Ni, Xiao ; Burns, Patrick R. / A Return to Normal Erectile Function with Tadalafil Once Daily after an Incomplete Response to As-Needed PDE5 Inhibitor Therapy. In: Journal of Sexual Medicine. 2014 ; Vol. 11, No. 3. pp. 820-830.
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AB - 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 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. 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, 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 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 tadalafil 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 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. Conclusions: Treatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment.

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