Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil
| Autor: | Evan R. Goldfischer, Edward Kim, Simin K. Baygani, Allen D. Seftel, Patrick R. Burns |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Sildenafil Urology Placebo Washout period Piperazines Sildenafil Citrate Tadalafil chemistry.chemical_compound Double-Blind Method Erectile Dysfunction Vardenafil Dihydrochloride Humans Medicine Sulfones Dosing Sulfonamides Dose-Response Relationship Drug Triazines business.industry Imidazoles Patient Preference General Medicine Middle Aged Phosphodiesterase 5 Inhibitors medicine.disease Treatment Outcome Erectile dysfunction chemistry Purines Vardenafil Anesthesia Drug Monitoring Once daily business Carbolines medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 31:379-389 |
| ISSN: | 1473-4877 0300-7995 |
| Popis: | 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.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 scores26 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.NCT01130532.International Index of Erectile Function (IIEF) domain scores; Sexual Encounter Profile (SEP) questions 2-5.Endpoint data was obtained from 590 men (391 TAD; 199 PBO). RESULTS for all IIEF and SEP measures were significantly better for TAD-OaD (p 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.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. |
| Databáze: | OpenAIRE |
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