Abstract
Objective
This review aimed to assess the efficacy and safety of GnRH antagonists in patients
with symptomatic uterine fibroids.
Data Sources
A literature search was performed on PubMed, Web of Science, Embase, Cochrane, and
ClinicalTrials.gov using the MeSH and Emtree terms “leiomyoma” and “gonadotropin-releasing hormone.”
Study Selection
All clinical trials that provided efficacy and safety data in clinical terms (i.e.,
reduction in menstrual bleeding and discomfort, changes in the size of leiomyoma and
uterine volume, etc.) were included. We excluded all preclinical studies, case reports,
meta-analyses, review articles, and clinical studies irrelevant to the study question.
Data Extraction and Synthesis
Two authors extracted data from 9 clinical studies. The extracted data included the
study's characteristics, participants' baseline characteristics, treatment drugs,
efficacy measures, and toxicity.
Conclusion
Among oral GnRH antagonists, relugolix, elagolix, and linzagolix were safe in patients
with uterine fibroids. These drugs, alone and in combination with E2/NETA (estradiol/norethindrone
acetate), showed significantly better efficacy than placebo in improving bleeding,
discomfort, uterine/leiomyoma sizes, and quality of life in premenopausal patients
with symptomatic uterine fibroids. However, more randomized, double-blind, multicentre
clinical trials are needed to confirm these results and to see long-term benefits.
Résumé
Objectif
Cette revue visait à évaluer l’efficacité et l’innocuité des antagonistes de la GnRH
chez les patientes atteintes de fibromes utérins symptomatiques.
Sources de données
Une recherche d’articles a été effectuée dans les bases de données PubMed, Web of
Science, Embase, Cochrane et ClinicalTrials.gov à l’aide des termes MeSH et Emtree Leiomyoma et Gonadotropin-Releasing Hormone.
Sélection des études
Ont été inclus tous les essais cliniques donnant des données sur l’efficacité et l’innocuité
(c.-à-d. réduction des saignements menstruels et de l’inconfort, changements de la
taille des léiomyomes et du volume utérin, etc.). Les études précliniques, les études
de cas, les méta-analyses, les revues et les études cliniques non pertinentes pour
la question à l’étude ont été exclues.
Extraction et synthese des données
Deux auteurs ont extrait les données de 9 études cliniques. Les données extraites
étaient les caractéristiques de l’étude, les caractéristiques initiales des participantes,
les médicaments de traitement, les mesures de l’efficacité et la toxicité.
Conclusion
Parmi les antagonistes de la GnRH oraux, le rélugolix, l’élagolix et la linzagolix
étaient sûrs chez les patientes atteintes de fibromes utérins. Ces médicaments, seuls
ou en association avec E2/NETA (l’estradiol-acétate de noréthindrone), ont montré
une efficacité significativement supérieure à celle du placebo pour ce qui est de
l’amélioration des saignements, de l’inconfort, de la taille de l’utérus ou des léiomyomes
et de la qualité de vie chez les patientes non ménopausées atteintes de fibromes utérins
symptomatiques. Cependant, des essais cliniques randomisés multicentriques à double
insu sont nécessaires pour confirmer ces résultats et constater des bienfaits à long
terme.
Keywords
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Article info
Publication history
Published online: November 08, 2022
Accepted:
October 17,
2022
Received:
June 1,
2022
Footnotes
Disclosures: The authors declare they have nothing to disclose.
Each author has indicated they meet the journal’s requirements for authorship.
Identification
Copyright
© 2022 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.
