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Efficacy and Safety of Oral GnRh Antagonists in Patients With Uterine Fibroids: A Systematic Review

Published:November 08, 2022DOI:https://doi.org/10.1016/j.jogc.2022.10.012

      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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