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Comparison of Efficacy, Safety, and Tolerability of On-Demand Tadalafil and Daily Dosed Tadalafil for the Treatment of Erectile Dysfunction
Abstract
Objective: To assess and compare the efficacy of on-demand tadalafil and daily tadalafil in the treatment of erectile dysfunction. Materials and Methods: A total of 145 men with a mean age of 57.3 years (range 19–82 years) and mild to severe erectile dysfunction of various etiologies were randomized to receive on-demand tadalafil (20 mg) or daily tadalafil (10 mg) taken without food or alcohol restrictions in a trial lasting 26 weeks. The three primary outcome measures were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF), the proportion of “yes” responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question administered at completion of the study. Results: Compared with baseline, on-demand and daily tadalafil enhanced all efficacy outcomes. Patients receiving on-demand tadalafil (20 mg) and daily tadalafil (10 mg) experienced a significant mean improvement of 8.3 and 11.9, respectively, in the erectile function domain of the IIEF from baseline (P < 0.001). The mean change from baseline was significantly higher for daily dosed tadalafil than for on-demand tadalafil (P < 0.05). Sexual intercourse was successfully completed (SEP3) in 69% and 84% of patients taking on-demand tadalafil and daily tadalafil, respectively, compared with 30% at baseline (P < 0.001). Successful completion of sexual intercourse was statistically higher for daily tadalafil than for on-demand tadalafil (P < 0.05). Treatment with on-demand tadalafil or daily tadalafil was well tolerated, and headaches, facial flushing, and dyspepsia were the most frequently observed adverse events. Conclusion: Tadalafil was effective and well tolerated in this patient population. Treatment with daily tadalafil was associated with a significantly higher IIEF erectile function domain score and completion of successful intercourse compared with on-demand tadalafil.
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“Several recent studies have shown a significant treatment benefit from once-daily, low-dose tadalafil (McMahon 2004; McMahon 2005; Porst et al 2006; Rajfer et al 2007; Hatzichristou et al 2008; Porst et al 2008).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as McMahon 2005
In the citing paper
“The longer half-life provides a steady state of serum drug concentration with low dose, once-daily administration, a benefit not shared with the other two PDE5 inhibitors (McMahon 2004; McMahon 2005; Porst et al 2006; Porst et al 2008; Rajfer et al 2007).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as McMahon 2005
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“While both dosing strategies were efficacious, the once-daily dosing of tadalafil improved the IIEF-EF score by 11.9, compared to an improvement of 8.3 with the on-demand dosing (p < 0.05).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as McMahon 2005
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“McMahon then compared once-daily tadalafil 10 mg with on-demand tadalafil 20 mg in an open-label, parallel-arm, crossover study of 145 Australian men with ED (McMahon 2005).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as McMahon 2005
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“Additionally, compared with 30% at baseline, successful intercourse was reported in the SEP-Q3 in 69% and 84% of patients taking on-demand and once-daily tadalafil, respectively (p < 0.05).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as McMahon 2005
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Cited by
Tadalafil in the treatment of erectile dysfunction
Coward, R., & Carson, C. (2008) · Therapeutics and Clinical Risk Management · doi:10.2147/tcrm.s3336 · Cited by 138
Metadata
- Authors
- McMahon, C.
- Affiliations
- Australian Centre for Sexual Health , Sydney, NSW , Australia
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-05-01
- Volume
- 2
- Issue
- 3
- Pages
- 415-427
- ISSN
- 1743-6109
- 1743-6095
- Cited by
- 79
- References
- 1
- Language
- en
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