NDLI: Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option.

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Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Donatucci, Craig F. Wong, David G. Giuliano, Francois Glina, Sidney Dowsett, Sherie A. Watts, Steven Sorsaburu, Sebastian
Description	Country affiliation: United States Author Affiliation: Donatucci CF ( Department of Surgery, Division of Urology, Duke University Medical Center, Durham, NC 27710, USA. donat001@mc.duke.edu)
Abstract	OBJECTIVE: To provide clinically relevant information on tadalafil 2.5 or 5 mg once daily for the treatment of erectile dysfunction (ED), by reviewing safety and efficacy study findings. Findings from an integrated analysis of trials of tadalafil 10 and 20 mg as needed are presented to provide context for the daily dosing regime. RESEARCH DESIGN AND METHODS: Of the three studies that included approved once-daily doses, two were conducted in the general ED population and one in a diabetic ED population. An integrated analysis was performed using 12-week efficacy and safety data from the studies conducted in the general ED population. RESULTS: In the general ED population, the 12-week mean International Index of Erectile Function (IIEF) erectile function (EF) domain scores increased by 6.2 to an endpoint score of 19.2 and by 8.6 to 21.9 for 2.5 and 5 mg doses, respectively, versus an increase of 1.3 to 14.9 for placebo (p < 0.01). Mean successful intercourse attempts (SEP3) were 50% and 62% for tadalafil 2.5 and 5 mg once daily, respectively, versus 33% for placebo (p < 0.01). These findings were consistent with those for tadalafil as needed. In 1- and 2-year open label extensions of tadalafil 5 mg once daily, efficacy was maintained. In the diabetic ED population, 12-week mean IIEF EF scores increased by 4.8 to 18.3 and 4.5 to 17.2 with tadalafil 2.5 and 5 mg, respectively, versus an increase of 1.3 to 14.7 for placebo (p < 0.01). Mean successful intercourse attempts were more than 40% for each tadalafil dose, versus 28% for placebo (p < 0.01). The profile of treatment-emergent adverse events with tadalafil once daily was similar to that previously reported with as-needed treatment; the most common adverse events with tadalafil (dyspepsia, nasopharyngitis, headaches) were reported in
File Format	HTM / HTML
ISSN	03007995
Issue Number	12
Volume Number	24
e-ISSN	14734877
Journal	Current Medical Research and Opinion
Language	English
Publisher	Taylor & Francis
Publisher Date	2008-12-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Medicine Carbolines Administration & Dosage Erectile Dysfunction Drug Therapy Phosphodiesterase Inhibitors Safety Adult Aged Adverse Effects Clinical Trials As Topic Physiopathology Humans Male Middle Aged Tadalafil Journal Article Research Support, Non-u.s. Gov't Review
Content Type	Text
Resource Type	Article
Subject	Medicine

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Chronic PDE-5 inhibition in patients with erectile dysfunction - a treatment approach using tadalafil once-daily.

Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline.

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

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Efficacy of Continuous Dosing of Tadalafil Once Daily vs Tadalafil On Demand in Clinical Subgroups of Men with Erectile Dysfunction: A Descriptive Comparison Using the Integrated Tadalafil Databases

Safety, efficacy, and pharmacokinetic overview of low-dose daily administration of tadalafil.

A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naïve to PDE5 inhibitors.

Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option.

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Chronic PDE-5 inhibition in patients with erectile dysfunction - a treatment approach using tadalafil once-daily.

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Long-term safety and efficacy of tadalafil 5 mg dosed once daily in men with erectile dysfunction.

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Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option.