RESUMEN
OBJECTIVE: [corrected] To compare the efficacy and safety of tadalafil 20 mg administered 3 times/week (SCH) vs. on demand (OD) in a cohort of Spanish men with erectile dysfunction (ED), since Tadalafil period of responsiveness lasts up to 36 hours post-dosing. MATERIAL AND METHODS: The 418 Spanish patients participating in the European multicenter, crossover, open-label SURE clinical trial (comprising 4262 men) were randomly assigned to one of the treatment sequences: tadalafil 20 mg SCH for 5-6 weeks followed by tadalafil 20 mg OD for 5-6 weeks, or the inverse sequence. At completion, patients were asked to select the regimen they preferred to receive in an extension phase. RESULTS: In both regimens, tadalafil led to a similar improvement in erectile function compared to baseline. However, the SCH regimen showed statistically significant higher scores for several IIEF questions (i.e. sexual desire domain). Normal erectile function (IIEF EF domain score > or = 26) was achieved by 69.3% of patients on SCH and 64.3 % on OD, with a sexual intercourse success rate (SEP3) of 75.6% and 72.2% respectively (p<0.05). Nevertheless, more patients preferred to receive tadalafil OD for the extension phase (55.9% vs 44.1%, p<0.05). Tadalafil was well tolerated in both regimens. The most common TEAEs (> or = 5%) were headache, dyspepsia and back pain. There were no clinically significant differences in the incidence of TEAEs between regimens. CONCLUSIONS: Tadalafil 20 mg is efficacious and well tolerated for the treatment of ED, regardless the regimen of administration (OD or SCH). Patients can choose the pattern of administration that fits better with their expectations.
Asunto(s)
Carbolinas/administración & dosificación , Disfunción Eréctil/tratamiento farmacológico , Inhibidores de Fosfodiesterasa/administración & dosificación , Adulto , Anciano , Carbolinas/efectos adversos , Estudios Cruzados , Esquema de Medicación , Europa (Continente) , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Fosfodiesterasa/efectos adversos , España , TadalafiloRESUMEN
Fundamento y objetivo: Comparar eficacia y seguridad de tadalafilo 20 mg administrado 3 veces/semana ('pautado') vs. 'a demanda' en una cohorte de españoles con disfunción eréctil (DE) aprovechando que su efecto permanece hasta 36 horas postdosis. Material y método: Los 418 españoles participantes en el estudio europeo SURE (multicéntrico, cruzado y abierto en 4.262 pacientes), se distribuyeron aleatoriamente a una de las siguientes secuencias: tadalafilo 20 mg 'a demanda' (D) durante 5-6 semanas seguido de tadalafilo 20 mg pautado, 3 veces por semana (P) otras 5-6 semanas; o la inversa. Al finalizar los pacientes eligieron el régimen que preferían en una extensión del estudio. Resultados: Tadalafilo en ambos regímenes mejoró la función eréctil (FE) respecto a la basal. El régimen P obtuvo significativamente mejores puntuaciones que el D en ciertos dominios del cuestionario IIEF (p.ej. deseo sexual), y más pacientes (69,3% vs 64,3%, P5%) relacionados con el tratamiento fueron cefalea, dispepsia y dolor de espalda. No hubo diferencias significativas en la incidencia de los mismos. Conclusiones: Tadalafilo 20 mg es eficaz en el tratamiento de la DE en cualquiera de los regímenes de administración ('a demanda' ó 3 veces/semana) empleado, siendo bien tolerado. Los pacientes pueden escoger la pauta de administración mas adecuada
Objetive: To compare the efficacy and safety of tadalafil 20 mg administered 3 times/week (SCH) vs. on demand (OD) in a cohort of Spanish men with erectile dysfunction (ED), since Tadalafil period of responsiveness lasts up to 36 hours post-dosing. Material and methods: The 418 Spanish patients participating in the European multicenter, crossover, open-label SURE clinical trial (comprising 4262 men) were randomly assigned to one of the treatment sequences: tadalafil 20 mg SCH for 5-6 weeks followed by tadalafil 20 mg OD for 5-6 weeks, or the inverse sequence. At completion, patients were asked to select the regimen they preferred to receive in an extension phase. Results: In both regimens, tadalafil led to a similar improvement in erectile function compared to baseline. However, the SCH regimen showed statistically significant higher scores for several IIEF questions (i.e. sexual desire domain). Normal erectile function (IIEF EF domain score ≥26) was achieved by 69.3% of patients on SCH and 64.3 % on OD, with a sexual intercourse success rate (SEP3) of 75.6% and 72.2% respectively (p<0.05). Nevertheless, more patients preferred to receive tadalafil OD for the extension phase (55.9% vs 44.1%, p<0.05). Tadalafil was well tolerated in both regimens. The most common TEAEs (≥5%) were headache, dyspepsia and back pain. There were no clinically significant differences in the incidence of TEAEs between regimens. Conclusions: Tadalafil 20 mg is efficacious and well tolerated for the treatment of ED, regardless the regimen of administration (OD or SCH). Patients can choose the pattern of administration that fits better with their expectations