The efficacy and safety of tadalafil: an update.
BJU Int
; 93(9): 1276-81, 2004 Jun.
Article
en En
| MEDLINE
| ID: mdl-15180622
ABSTRACT
OBJECTIVE:
To provide an update on the efficacy and safety of tadalafil, a phosphodiesterase-5 inhibitor, in the treatment of erectile dysfunction (ED). PATIENTS ANDMETHODS:
In all, 2102 men (mean age 56 years) with mild-to-severe ED of various causes were randomized to placebo or tadalafil, taken as needed with no food restrictions, at fixed 'on-demand' doses of 10 or 20 mg in 11 randomized, double-blind, placebo-controlled trials lasting 12 weeks. The three co-primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF) and the proportion of 'yes' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question (GAQ).RESULTS:
Compared with placebo, tadalafil gave significantly better outcomes. Patients receiving either dose of tadalafil had a significant mean improvement of 6.5 and 8.6, respectively, in the IIEF erectile function domain score from baseline (P < 0.001 vs placebo). At both doses the mean success rate for intercourse attempts (SEP-Q3) was 58% and 68%, respectively, compared with 31% in the placebo group (P < 0.001), and 71% and 84% reported improved erections at the endpoint (GAQ), vs 33% on placebo (P < 0.001). Tadalafil was effective up to 36 h after dosing and was effective regardless of disease severity and causes, and in patients of all ages. The most frequent adverse events were headache, dyspepsia, back pain and myalgia.CONCLUSION:
Tadalafil was an effective and well-tolerated treatment for ED.
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Base de datos:
MEDLINE
Asunto principal:
Inhibidores de Fosfodiesterasa
/
Carbolinas
/
Disfunción Eréctil
Tipo de estudio:
Clinical_trials
/
Systematic_reviews
Idioma:
En
Revista:
BJU Int
Asunto de la revista:
UROLOGIA
Año:
2004
Tipo del documento:
Article