Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline

Ridwan Shabsigh, Allen D. Seftel, Edward Kim, Xiao Ni, Patrick R. Burns

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction. Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear. Aim. To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline. Methods. Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period. Main Outcome Measures. Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models. Results. Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (±standard deviation) age was 58.2±10.7 years; and most subjects had ED for ≥1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5mg and to 46.4% with tadalafil 5mg (each P<0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5mg and from 24.4% to 66.2% with 5mg (each P<0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5mg and from 10.7 to 19.2 with 5mg (each P<0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo. Conclusions. The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5mg and 5mg, respectively, in men with no successful intercourse attempts at baseline.

Original languageEnglish (US)
Pages (from-to)844-856
Number of pages13
JournalJournal of Sexual Medicine
Volume10
Issue number3
DOIs
StatePublished - Jan 1 2013

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Erectile Dysfunction
Safety
Placebos
Tadalafil
Diabetes Mellitus
Outcome Assessment (Health Care)
Hypertension

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

Cite this

Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline. / Shabsigh, Ridwan; Seftel, Allen D.; Kim, Edward; Ni, Xiao; Burns, Patrick R.

In: Journal of Sexual Medicine, Vol. 10, No. 3, 01.01.2013, p. 844-856.

Research output: Contribution to journalArticle

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title = "Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline",
abstract = "Introduction. Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with {"}complete ED{"} are unclear. Aim. To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline. Methods. Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 {"}yes{"} responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period. Main Outcome Measures. Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models. Results. Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (±standard deviation) age was 58.2±10.7 years; and most subjects had ED for ≥1 year (95.0{\%}). ED was severe in 61.5{\%} and moderate in 26.4{\%}. Approximately 45{\%} had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0{\%} to 32.4{\%} with tadalafil 2.5mg and to 46.4{\%} with tadalafil 5mg (each P<0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1{\%} to 48.2{\%} with tadalafil 2.5mg and from 24.4{\%} to 66.2{\%} with 5mg (each P<0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5mg and from 10.7 to 19.2 with 5mg (each P<0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo. Conclusions. The posttreatment intercourse success rate was 32{\%} and 46{\%} for tadalafil 2.5mg and 5mg, respectively, in men with no successful intercourse attempts at baseline.",
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T1 - Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline

AU - Shabsigh, Ridwan

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AU - Kim, Edward

AU - Ni, Xiao

AU - Burns, Patrick R.

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N2 - Introduction. Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear. Aim. To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline. Methods. Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period. Main Outcome Measures. Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models. Results. Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (±standard deviation) age was 58.2±10.7 years; and most subjects had ED for ≥1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5mg and to 46.4% with tadalafil 5mg (each P<0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5mg and from 24.4% to 66.2% with 5mg (each P<0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5mg and from 10.7 to 19.2 with 5mg (each P<0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo. Conclusions. The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5mg and 5mg, respectively, in men with no successful intercourse attempts at baseline.

AB - Introduction. Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear. Aim. To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline. Methods. Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period. Main Outcome Measures. Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models. Results. Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (±standard deviation) age was 58.2±10.7 years; and most subjects had ED for ≥1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5mg and to 46.4% with tadalafil 5mg (each P<0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5mg and from 24.4% to 66.2% with 5mg (each P<0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5mg and from 10.7 to 19.2 with 5mg (each P<0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo. Conclusions. The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5mg and 5mg, respectively, in men with no successful intercourse attempts at baseline.

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