REVISTA DE MENOPAUSIA

 

 

ACTUALIDAD INMEDIATA

   

PRINCIPALES MORBILIDADES REGISTRADAS

EN EL ESTUDIO INTERNACIONAL DE MUJERES

SOBRE LARGA DURACIÓN DE ESTRÓGENOS LUEGO

DE LA MENOPAUSIA (WISDOM): UN ESTUDIO ALEATORIO

CONTROLADO DE TERAPIA DE REEMPLAZO

HORMONAL EN MUJERES POSMENOPÁUSICAS*

 

Volumen 14 - No. 2- Año 2008

 

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Conclusiones. La terapia de reemplazo hormonal aumenta el riesgo cardiovascular y tromboembólico cuando se inicia muchos años después de la menopausia. Los resultados son consistentes con los hallazgos del estudio de iniciativa de salud de las mujeres y estudios de prevención secundaria. Se necesitan investigaciones para evaluar los riesgos a largo plazo de iniciar la terapia de reemplazo hormonal cerca de la menopausia, cuando el efecto puede ser diferente.

 

Registro del estudio. Estudios controlados actuales ISRCTN 63718836.

 

ABSTRACT

 

Objective. To assess the long term risks and benefits of hormone replacement therapy (combined hormona therapy versus placebo, and oestrogen alone versus combined hormone therapy).

 

Design. Multicentre, randomised, placebo controlled, double blind trial. Setting General practices in UK (384), Australia (91), and New Zealand (24)

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Participants. Postmenopausal women aged 50-69 years at randomisation. At early closure  of the trial, 56583 had been screened, 8980 entered run-in, and 5692 (26% of target of 22300) started treatment.

 

Interventions. Oestrogen only therapy (conjugated equine oestrogens 0.625 mg orally daily) or combined hormona therapy (conjugated equine oestrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily). Ten years of treatment planned.

 

Main outcome measures. Primary outcomes: major cardiovascular disease, osteoporotic fractures, and breast cancer. Secondary outcomes: other cancers, death from all causes, venous thromboembolism, cerebrovascular disease, dementia, and quality of life.

 

Results. The trial was prematurely closed during recruitment, after a median follow-up of 11.9 months (interquartile range 7.1-19.6, total 6498 women years) in those enrolled, after the publication of early results from the women’s health initiative study. The mean age of randomised women was 62.8 (SD 4.8) years. When combined hormone therapy (n=2196) was compared with placebo (n=2189), there was a significant increase in the number of major cardiovascular events (7 v 0, P=0.016) and venous thromboembolisms (22 v 3, hazard ratio 7.36 [95% CI 2.20 to 24.60]). There were no statistically significant differences in numbers of breast or other cancers (22 v 25, hazard ratio 0.88 [0.49 to 1.56]), cerebrovascular events (14 v 19, 0.73 [0.37 to 1.46]), fractures (40 v 58,  0.69 [0.46 to 1.03]), and overall deaths hormone therapy (n=815) versus oestrogen therapy (n=826) outcomes revealed no significant differences.

 

Conclusions. Hormone replacement therapy increases cardiovascular and thromboembolic risk when started many years after the menopause. The results are consistent with the findings of the women’s health initiative study and secondary prevention studies. Research is needed to assess the long term risks and benefits of starting hormone replacement therapy near the menopause, when the effect may be different.

 

Trial registration. Current Controlled Trials ISRCTN 63718836.

 

Introducción

 

Aunque el uso de terapia hormonal de reemplazo para el control de síntomas moderados a severos de la menopausia está bien establecido, su uso a largo plazo para la prevención de enfermedades en la mujer posmenopáusica está en disputa1-3. Diez estudios aleatorios y controlados han investigado los riesgos y beneficios de la terapia de reemplazo hormonal en las mujeres posmenopáusicas.4-13 Tres estudios en los Estados Unidos4,7,12, dos en el Reino Unido8,9 y uno en Estonia13 mostraron que tal terapia no protege contra el desarrollo de la enfermedad cardiovascular y que puede incrementar su riesgo. 

 

 

 

 

 

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