Case study: Evaluating the safety of hormone therapies for menopausal symptoms

September 2024

This European Medicines Agency-required post-authorization safety study provided clearer safety insights into hormone therapies for menopausal symptoms

The European Medicines Agency sought to evaluate the safety of hormone therapies for menopausal symptoms, particularly breast and endometrial cancer risks. Conjugated estrogens/bazedoxifene (CE/BZA) were compared to the estrogen/progestin (EP) combination in a post-authorization safety study using healthcare claims data of 92 million women from 2014-2019. This research suggested CE/BZA may be a safer alternative to EP in hormone therapy, reducing breast cancer risk and assisting clinicians and patients in making informed decisions.

 

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