当前位置： SCI文献检索 > CURRENT MEDICAL RESEARCH AND OPINION期刊下所有文献 > Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option.

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

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

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Donatucci CF,Wong DG,Giuliano F,Glina S,Dowsett SA,Watts S,Sorsaburu S

doi

10.1185/03007990802498440

subject

Has Abstract

pub_date

2008-12-01 00:00:00

pages

3383-92

issue

eissn

0300-7995

issn

1473-4877

journal_volume

pub_type

杂志文章,评审

在线工具

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