Ergebnisse und Kommentare zu der WHI-Studie mit Estrogen-Monotherapie

The study-arm of the Women's Health Initiative (WHI) with estrogen monotherapy for hysterectomised women was terminated early after an average of 6.8 years - only one year before the planned ending - due to increased risk of adverse effects (HR 1.39, per 10000 women 12 additional cases). However, according to the regulations of Good Clinical Practice, the early termination was not necessary, as the fixed termination criteria such as exceeding a defined absolute excessive risk were not met. The risk of cardiac infarction was not increased at any time, and was even reduced by 44% in women under 60 years of age, although women with a high cardiovascular risk were treated (48% hypertensive, 45% BMI >30, 48% were smokers etc.). The risk of breast cancer was reduced by 23% even though 48% of women had already been treated with HRT before the study. Indeed, both risk reductions narrowly missed significance, possibly because of the premature termination of the study. Despite a reduced risk for women under 60, colorectal cancer was not prevented on the whole, as a significantly increased risk was identified in women over 70 years. The increased risk of venous thromboembolism was not significant (HR 1.33). The risk of vertebral fracture as well as that of hip fracture was significantly reduced by 40%.