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Relugolix + estradiol + norethisterone (Ryeqo°) in uterine fibroids: not acceptable

  Marketing Authorisations  The three-drug combination of relugolix + estradiol + norethisterone was mainly evaluated in two placebo-controlled trials. It markedly reduced menstrual bleeding in most women, but not fibroid volume, and no conclusive evidence of effects on other symptoms was obtained.
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  • Uterine fibroids (leiomyomas) are benign tumours of the uterus. Most are asymptomatic. When symptomatic, the most frequent symptom is heavy or prolonged, painful menstrual bleeding. This can lead to severe iron-deficiency anaemia and persistent fatigue.
  • In patients with uterine fibroids and troublesome, heavy menstrual bleeding, the combination of relugolix with estradiol and norethisterone usually induces a menopausal state, generally including a marked reduction in menstrual blood loss. But there is no conclusive evidence of effects on the clinical course of patients' fibroids or associated symptoms.

To prevent the adverse effects of the hypoestrogenism caused by the GnRH antagonist relugolix, the company added the oestrogen estradiol. And to prevent the adverse effects of oestrogen on the endometrium, in particular the risk of cancer, it added the progestogen norethisterone. It is sometimes in patients' interests to take a drug to relieve the adverse effects of another, very useful, drug. But before layering drug upon drug, the first step is to carefully consider how useful the first drug in the pile is to patients...

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 ©Prescrire 1 January 2023

Source: "Relugolix + estradiol + norethisterone (Ryeqo°) in uterine fibroids" Prescrire International 2023: 32 (244): 5-8. Subscribers only.

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See also:

"Bleeding associated
with uterine leiomyomas.
Tailor treatment to the
individual patient"
(Mai 2014)
Pdf, subscribers only

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