Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial - PubMed
Randomized Controlled Trial
doi: 10.1016/j.eururo.2006.02.052. Epub 2006 Mar 20.
Affiliations
- PMID: 16766116
- DOI: 10.1016/j.eururo.2006.02.052
Randomized Controlled Trial
Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial
Hartmut Porst et al. Eur Urol. 2006 Aug.
Abstract
Background: Erectile dysfunction (ED) is a chronic condition affecting a significant number of men worldwide. Although treatment approaches often focus on as-needed therapy with oral phosphodiesterase type 5 (PDE5) inhibitors such as tadalafil, the pharmacokinetics of tadalafil, particularly its half-life of 17.5 hours, allow for the potential benefits of daily dosing. This makes tadalafil an excellent candidate for a once-daily therapeutic regimen aimed at improving erectile function in men suffering from ED.
Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study was designed to evaluate the efficacy and safety of tadalafil administered once daily at doses of 5 mg and 10 mg. A total of 268 men were enrolled and assigned in a 1:2:2 ratio to receive placebo, tadalafil 5mg, or tadalafil 10mg over a treatment duration of 12 weeks. Key measures of efficacy included changes in the International Index of Erectile Function (IIEF) Erectile Function (EF) domain, as well as responses from the Sexual Encounter Profile diary Questions 2 (SEP2) and 3 (SEP3). Additionally, tolerability assessments were conducted. Secondary outcomes included the proportion of patients reporting improved EF and those reporting 'no ED' based on IIEF EF scores of 26-30 at the conclusion of the study.
Results: The analysis revealed significant improvements in erectile function across treatment groups. For patients receiving placebo, tadalafil 5mg, and tadalafil 10mg, the changes from baseline to endpoint for the IIEF EF scores were 0.9, 9.7, and 9.4, respectively. Responses to SEP2 showed scores of 11.2, 36.5, and 39.4, while SEP3 responses yielded scores of 13.2, 45.5, and 50.1. By the endpoint, 28.3% of those receiving placebo, 84.5% on tadalafil 5mg, and 84.6% on tadalafil 10mg reported improved erections, and the percentages reporting 'no ED' stood at 8.3%, 51.5%, and 50.5%, respectively. Importantly, all comparisons between tadalafil and placebo were statistically significant (p<0.001). The adverse effects reported in at least 5% of participants included dyspepsia, headaches, back pain, upper abdominal pain, and myalgia; further, nine participants (3.4%) chose to discontinue the study due to adverse events.
Conclusions: The findings from this trial indicate that once-a-day dosing of tadalafil at either 5mg or 10mg is both well-tolerated and associated with significant improvements in erectile function among men with ED. This offers valuable insights into long-term management strategies for ED.
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Comment in
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Treatment of erectile dysfunction with chronic dosing of tadalafil.
McMahon CG. Eur Urol. 2006 Aug;50(2):215-7. doi: 10.1016/j.eururo.2006.03.018. Epub 2006 Mar 29.PMID: 16844542 No abstract available.
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