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

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 recognized as a persistent and chronic condition impacting men's sexual health; however, conventional therapies are typically administered on an as-needed basis utilizing oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Due to tadalafil's prolonged half-life of approximately 17.5 hours, maintaining therapeutic plasma concentrations is feasible with daily administration, making tadalafil a highly suitable candidate for once-daily dosing therapies.

Methods: This rigorous multicenter, randomized, double-blind, placebo-controlled study employed a parallel-group design over a period of 12 weeks and enrolled a total of 268 male participants. Random allocation occurred in a ratio of 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg, with doses taken once daily. Primary endpoints for efficacy included evaluations of changes in the International Index of Erectile Function - Erectile Function domain (IIEF EF), as well as responses from Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration) and Question 3 (SEP3: successful completion of intercourse). Tolerability was also assessed. Secondary endpoints encompassed the percentage of patients at the study's conclusion who self-reported an improvement in erectile function (EF), as well as those who reported achieving "no ED" with an IIEF EF score ranging from 26-30.

Results: Data analysis revealed that changes from baseline to endpoint for patients receiving placebo, tadalafil 5mg, and tadalafil 10mg were respectively as follows: for IIEF EF, scores improved by 0.9, 9.7, and 9.4; for SEP2, improvements of 11.2, 36.5, and 39.4; and for SEP3, enhancements of 13.2, 45.5, and 50.1 were recorded. At the end of the study, 28.3% of the placebo group, 84.5% of the tadalafil 5mg group, and 84.6% of the tadalafil 10mg group reported noticeable improvements in erectile function, while 8.3%, 51.5%, and 50.5% confirmed achieving "no ED," respectively. Statistical analyses indicated that all comparisons between tadalafil groups and placebo were significant with a p-value of less than 0.001. The most common adverse events, affecting at least 5% of participants, included symptoms such as dyspepsia, headache, back pain, upper abdominal pain, and myalgia. Nine patients, equating to 3.4%, discontinued treatment due to adverse reactions.

Conclusions: The once-daily administration of tadalafil at dosages of either 5mg or 10mg exhibited a favorable safety profile and significantly ameliorated erectile function in men diagnosed with ED, thus demonstrating its efficacy as a long-term treatment option for this condition.

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Treatment of erectile dysfunction with chronic dosing of tadalafil.
McMahon CG. McMahon CG. Eur Urol. 2006 Aug;50(2):215-7. doi: 10.1016/j.eururo.2006.03.018. Epub 2006 Mar 29. Eur Urol. 2006. PMID: 16844542 No abstract available.

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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

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

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