Danish Registry Links Oral HRT to Higher VTE Risk Regardless of Dose or Duration
Large Danish observational study shows oral HRT raises VTE risk irrespective of dose or duration, with stroke and MI signals limited to high-dose prolonged use; transdermal therapy shows no overall thrombotic increase. Absolute risks remain small yet clinically relevant for shared decision-making. Evidence quality is moderate: population-based design with detailed prescriptions reduces some bias, but residual confounding persists and causality is unproven.
Clinical guidelines are likely to shift toward transdermal preference for women with any VTE risk factors, while oral high-dose regimens may face stricter duration limits. Future studies must incorporate randomized comparisons of transdermal estradiol doses below 50 µg and include ethnically diverse populations to test generalizability. Ongoing pharmacovigilance using linked electronic records could detect whether guideline changes reduce population-level VTE incidence within five years.
EMA pharmacovigilance committee: Updated HRT labeling will recommend transdermal first-line for women over 60 within 24 months, contingent on a 15% drop in oral prescriptions in Nordic registries.
Sources (3)
- [1]Primary Source(https://www.bmj.com/content/386/bmj-2024-080902)
- [2]Supporting Source(https://jamanetwork.com/journals/jama/fullarticle/2798843)
- [3]Supporting Source(https://www.ema.europa.eu/en/documents/referral/hormone-replacement-therapy-hrt-risk-assessment_en.pdf)