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Eficacia y aceptabilidad del beta-estradiol intranasal 17 para los síntomas de la menopausia: estudio aleatorizado de
1Chelsea and Westminster Hospital, London, UK. JStudd@harleyjs.prestel.co.uk
Lancet (London, England)
|May 20, 1999
Resumen
El spray intranasal de 17beta-estradiol trata eficazmente los síntomas de la menopausia, ofreciendo una alternativa al estrógeno oral con eficacia similar y mejor tolerabilidad. Este nuevo método de administración evita el metabolismo de primer paso, proporcionando dosis reproducibles para la terapia de reemplazo hormonal.
Área de la Ciencia:
- Endocrinología Endocrinología.
- Farmacología Farmacología.
- Salud de la Mujer Salud de la Mujer.
Sus antecedentes:
- La terapia con estrógenos es beneficiosa para los síntomas de la menopausia, pero los métodos de administración actuales tienen inconvenientes.
- El spray intranasal de 17beta-oestradiol (S21400) fue desarrollado para superar estas limitaciones.
- Este estudio evaluó la eficacia y tolerabilidad de S21400 para el alivio de los síntomas posmenopáusicos.
Objetivo del estudio:
- Para evaluar la efectividad de S21400 intranasal en el tratamiento de los síntomas posmenopáusicos.
- Para comparar S21400 con el valerato de estrógeno oral y el placebo.
- Para evaluar la tolerabilidad y seguridad de S21400.00 intranasal.
Principales métodos:
- Un estudio doble ciego en el que participaron 420 mujeres posmenopáusicas.
- Asignación aleatoria a placebo intranasal, S21400 (100-400 mcg) o al valerato de estradiol oral (1-2 mg) durante 12 semanas.
- Los resultados primarios incluyeron el Índice Kupperman (KI) y la incidencia de sofocos; la tolerabilidad se evaluó a través de la rinoscopia y las pruebas de función ciliar.
Principales resultados:
- S21400 dependiendo de la dosis redujo el KI y los sofocos, con dosis efectivas identificadas en 200-300 mcg/día.
- Intranasal S21400 alcanzado niveles séricos de estradiol comparables a los estrógenos orales con menor variabilidad.
- No hay diferencias significativas en la función ENT; se observaron reacciones leves en el lugar de aplicación (estornudo) con S21400, pero el cumplimiento y la comodidad del paciente fueron altos.
Conclusiones:
- El 17beta-oestradiol intranasal es un tratamiento bien tolerado y eficaz para los síntomas de la menopausia, comparable al estrógeno oral.
- Este método de administración evita el metabolismo de primer paso, ofreciendo dosis reproducibles y ajustables.
- Intranasal S21400 presenta una nueva opción viable para la terapia de reemplazo hormonal.
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