Funding statement. The four base studies and the reported analysis were sponsored by Eli Lilly and Company (Lilly USA, LLC; Indianapolis, IN, USA).
Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline
Version of Record online: 4 OCT 2012
© 2012 International Society for Sexual Medicine
The Journal of Sexual Medicine
Volume 10, Issue 3, pages 844–856, March 2013
How to Cite
Shabsigh, R., Seftel, A. D., Kim, E. D., Ni, X. and Burns, P. R. (2013), Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline. Journal of Sexual Medicine, 10: 844–856. doi: 10.1111/j.1743-6109.2012.02898.x
Previous presentation. Selected findings were presented at the Sexual Medicine Society of North America 2011 Annual Fall Meeting, Las Vegas, NV, USA, November 10–13, 2011 (Moderated Poster 129).
ClinicalTrials.gov registration. Internal study identifiers H6D-MC-LVFZ (Clinicaltrials.gov identifier NCT00547183); H6D-MC-LVFP (NCT00381732); H6D-MC-LVGH (NCT00422734); and H6D-MC-LVCV (non–US trial; no NCT #).
- Issue online: 4 MAR 2013
- Version of Record online: 4 OCT 2012
- Drug Therapy;
- Erectile Dysfunction;
- Once-Daily Dosing;
- Treatment Outcome
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 5 mg (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 2.5 mg and to 46.4% with tadalafil 5 mg (each P < 0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5 mg and from 24.4% to 66.2% with 5 mg (each P < 0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5 mg and from 10.7 to 19.2 with 5 mg (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 2.5 mg and 5 mg, respectively, in men with no successful intercourse attempts at baseline. Shabsigh R, Seftel AD, Kim ED, Ni X, and Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med 2013;10:844–856.