Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. (February 2015)

• Record Type: Journal Article
• Authors: Kim, Edward; Seftel, Allen; Goldfischer, Evan; Baygani, Simin; Burns, Patrick
• Is Part Of: Current medical research and opinion. Volume 31:Number 2(2015:Feb.)
• Page Start: 379
• Page End: 389
• Publication Date: 2015-02
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2014.989317
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>Phosphodiesterase type-5 inhibitors (PDE5Is) are first-line therapies for erectile dysfunction (ED). Sildenafil (SIL) and vardenafil (VAR) are approved for as-needed (PRN) dosing; tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED. Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy. This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy.</p> </sec> <sec id="ss2"> <title>Research design and methods:</title> <p>In this randomized, double-blind, placebo-controlled trial, men with a ≥3 month ED history received SIL 100 mg, TAD 20 mg, or VAR 20 mg during a 4 week open-label lead-in period. Those with International Index of Erectile Function – Erectile Function (IIEF-EF) domain scores <26 following lead-in treatment completed a 4 week washout period, then randomized to TAD 2.5 mg up-titrated to 5 mg, TAD 5 mg, or placebo (PBO) OaD for 12 weeks. Main outcome measures obtained from patients treated with TAD-OaD were compared to PBO-treated patients. Additionally, results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy.</p> </sec> <sec id="ss3"> <title>Clinical trial registration:</title> <p>NCT01130532.</p> </sec> <sec id="ss4"> <title>Main outcome measures:</title> <p>International Index of Erectile Function (IIEF) domain scores; Sexual Encounter Profile (SEP) questions 2–5.</p> </sec> <sec id="ss5"> <title>Results:</title> <p>Endpoint data was obtained from 590 men (391 TAD; 199 PBO). Results for all IIEF and SEP measures were significantly better for TAD-OaD (<italic>p</italic> < 0.001 for all) compared to PBO and were comparable to those observed during PRN-PDE5I treatment. TAD 2.5 mg and TAD 5 mg OaD therapy were safe and generally well tolerated.</p> </sec> <sec id="ss6"> <title>Conclusion:</title> <p>Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED. Key limitations include the lack of a PRN PDE5I study group during the double-blind period, and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period.</p> </sec> </abstract>