Impact of low testosterone on response to treatment with tadalafil 5 mg once daily for erectile dysfunction

Evan R. Goldfischer, Edward Kim, Allen D. Seftel, Simin K. Baygani, Patrick R. Burns

Research output: Contribution to journalArticle

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Abstract

Objective To evaluate, posthoc, the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction (ED). Methods Men were aged ≥18 years, with ≥3-month history of ED and partial prior response to on-demand (PRN) phosphodiesterase type 5 inhibitor (PDE5I) therapy. A 4-week maximum-dose PRN PDE5I run-in was followed by a 4-week nondrug washout period, then randomization to tadalafil 2.5 mg titrated to 5 mg or tadalafil 5 mg (pooled for analyses) or placebo once daily for 12 weeks. Analyses compared endpoint efficacy results between low- (<300 ng/dL) vs normal-testosterone (≥300 ng/dL) level subgroups. Results Improvements for tadalafil vs placebo were significant for the International Index of Erectile Function (IIEF) Erectile Function domain, Intercourse Satisfaction domain, Overall Satisfaction domain, and Question 15 (confidence in the ability to get and keep an erection; all P <.001), and for the Sexual Encounter Profile Questions 1-5 (all P ≤.011). Analysis of covariance modeling identified significant treatment-by-subgroup interactions for the IIEF-Overall Satisfaction domain and erection confidence question and Sexual Encounter Profile Question 3. Comparing between tadalafil-treated testosterone subgroups, the IIEF-Erectile Function domain scores improved significantly more in men with normal vs low testosterone (P =.022); no other significant differences were identified for either placebo or tadalafil. No significant differences in pre-existing conditions were observed between tadalafil and placebo within the normal- and low-testosterone subgroups. Conclusion In men with partial response to a PRN PDE5I, tadalafil 5 mg once daily significantly improved ED and sexual function vs placebo irrespective of testosterone levels.

Original languageEnglish (US)
Pages (from-to)1326-1333
Number of pages8
JournalUrology
Volume83
Issue number6
DOIs
StatePublished - Jan 1 2014

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Erectile Dysfunction
Testosterone
Phosphodiesterase 5 Inhibitors
Placebos
Therapeutics
Preexisting Condition Coverage
Aptitude
Tadalafil
Random Allocation
Serum

All Science Journal Classification (ASJC) codes

  • Urology

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Impact of low testosterone on response to treatment with tadalafil 5 mg once daily for erectile dysfunction. / Goldfischer, Evan R.; Kim, Edward; Seftel, Allen D.; Baygani, Simin K.; Burns, Patrick R.

In: Urology, Vol. 83, No. 6, 01.01.2014, p. 1326-1333.

Research output: Contribution to journalArticle

Goldfischer, Evan R. ; Kim, Edward ; Seftel, Allen D. ; Baygani, Simin K. ; Burns, Patrick R. / Impact of low testosterone on response to treatment with tadalafil 5 mg once daily for erectile dysfunction. In: Urology. 2014 ; Vol. 83, No. 6. pp. 1326-1333.
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abstract = "Objective To evaluate, posthoc, the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction (ED). Methods Men were aged ≥18 years, with ≥3-month history of ED and partial prior response to on-demand (PRN) phosphodiesterase type 5 inhibitor (PDE5I) therapy. A 4-week maximum-dose PRN PDE5I run-in was followed by a 4-week nondrug washout period, then randomization to tadalafil 2.5 mg titrated to 5 mg or tadalafil 5 mg (pooled for analyses) or placebo once daily for 12 weeks. Analyses compared endpoint efficacy results between low- (<300 ng/dL) vs normal-testosterone (≥300 ng/dL) level subgroups. Results Improvements for tadalafil vs placebo were significant for the International Index of Erectile Function (IIEF) Erectile Function domain, Intercourse Satisfaction domain, Overall Satisfaction domain, and Question 15 (confidence in the ability to get and keep an erection; all P <.001), and for the Sexual Encounter Profile Questions 1-5 (all P ≤.011). Analysis of covariance modeling identified significant treatment-by-subgroup interactions for the IIEF-Overall Satisfaction domain and erection confidence question and Sexual Encounter Profile Question 3. Comparing between tadalafil-treated testosterone subgroups, the IIEF-Erectile Function domain scores improved significantly more in men with normal vs low testosterone (P =.022); no other significant differences were identified for either placebo or tadalafil. No significant differences in pre-existing conditions were observed between tadalafil and placebo within the normal- and low-testosterone subgroups. Conclusion In men with partial response to a PRN PDE5I, tadalafil 5 mg once daily significantly improved ED and sexual function vs placebo irrespective of testosterone levels.",
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AB - Objective To evaluate, posthoc, the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction (ED). Methods Men were aged ≥18 years, with ≥3-month history of ED and partial prior response to on-demand (PRN) phosphodiesterase type 5 inhibitor (PDE5I) therapy. A 4-week maximum-dose PRN PDE5I run-in was followed by a 4-week nondrug washout period, then randomization to tadalafil 2.5 mg titrated to 5 mg or tadalafil 5 mg (pooled for analyses) or placebo once daily for 12 weeks. Analyses compared endpoint efficacy results between low- (<300 ng/dL) vs normal-testosterone (≥300 ng/dL) level subgroups. Results Improvements for tadalafil vs placebo were significant for the International Index of Erectile Function (IIEF) Erectile Function domain, Intercourse Satisfaction domain, Overall Satisfaction domain, and Question 15 (confidence in the ability to get and keep an erection; all P <.001), and for the Sexual Encounter Profile Questions 1-5 (all P ≤.011). Analysis of covariance modeling identified significant treatment-by-subgroup interactions for the IIEF-Overall Satisfaction domain and erection confidence question and Sexual Encounter Profile Question 3. Comparing between tadalafil-treated testosterone subgroups, the IIEF-Erectile Function domain scores improved significantly more in men with normal vs low testosterone (P =.022); no other significant differences were identified for either placebo or tadalafil. No significant differences in pre-existing conditions were observed between tadalafil and placebo within the normal- and low-testosterone subgroups. Conclusion In men with partial response to a PRN PDE5I, tadalafil 5 mg once daily significantly improved ED and sexual function vs placebo irrespective of testosterone levels.

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