REVISTA DE MENOPAUSIA
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
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.