Jonathan Douxfils on VTE Risk Associated With Relugolix–Estradiol–Norethisterone Acetate Combination
Jonathan Douxfils, Board Member of Belgian Society on Thrombosis and Haemostasis, shared on LinkedIn:
”New mini-review just out in Journal of the Endocrine Society
I’m very happy to share that our article:
“Venous Thromboembolism Risk Associated With Relugolix–Estradiol–Norethisterone Acetate Combination Therapy”
has just been published online in Journal of the Endocrine Society:
Relugolix –estradiol–norethisterone acetate (Relugolix CT – Richter Gedeon Nyrt. / Magyarország) is increasingly used for the management of uterine fibroids and endometriosis-associated pain.
Because it contains estrogen and a progestin, its venous thromboembolism (VTE) risk is a key concern for many clinicians and patients.
In this mini-review, we bring together:
– The pharmacology of relugolix-CT, including the appropriate estradiol exposure (within the early follicular range) to overcome menopause like symptoms without compromising vascular safety.
– Data from pivotal trials and extension studies, as well as regulatory assessments and early real-world evidence.
– The broader context of estradiol- vs ethinylestradiol-based combinations and what is known about their thrombotic risk.
Take-home message:
Based on currently available evidence, the VTE data for relugolix-CT are very reassuring.
The observed VTE risk appears lower than that of traditional ethinylestradiol-containing combined oral contraceptives, when relugolix-CT is used in premenopausal women.
At the same time, we underline that:
– Standard VTE risk assessment and patient selection remain essential.
– Ongoing pharmacovigilance and real-world studies, including in women with higher baseline thrombotic risk or comorbidities, are crucial to further refine its safety profile.
My hope is that this work helps colleagues feel more confident with this innovative combination when discussing benefit–risk and VTE concerns with women who need effective long-term treatment for fibroid- or endometriosis-related symptoms.”
Read the full article here.
Article: Venous Thromboembolism Risk Associated with Relugolix-Estradiol-Norethisterone Acetate Combination Therapy
Authors: Jonathan Douxfils, Marie Didembourg, Lorraine Maitrot-Mantelet, Charles Chapron, Philippe Descamps, Florence Tremollières, Nathalie Chabbert-Buffet
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