Safety and efficacy of elagolix (with and without add-back therapy) for the treatment of heavy menstrual bleeding associated with uterine leiomyomas: a systematic review and meta-analysis

Mustafa Ali, Aruna Kumari Hira, Haris Jawaid, Faiza Zakaria, Zehra Somjee
In: Middle East Fertility Society Journal · 2021 · vol. 26(1) · doi:10.1186/s43043-021-00064-5 · W3178662809
review OA: diamond CC0
📄 Open PDF View on OpenAlex View at publisher
⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This meta-analysis found elagolix alone most effectively reduced bleeding in uterine leiomyomas but had more adverse events; add-back therapy improved safety without significantly compromising efficacy.

One-sentence paraphrase of the abstract; not a substitute for reading it. No clinical advice. How this works

⚙ AI-generated deep summary by claude@2026-06, 2026-06-08 ⓘ

This systematic review and meta-analysis pooled randomized controlled trial data to evaluate the safety and efficacy of the oral GnRH antagonist elagolix, with and without add-back therapy, for heavy menstrual bleeding associated with uterine leiomyomas in nonpregnant premenopausal adults. Across 4 eligible trials (916 patients total), elagolix alone showed greater odds of meeting the primary endpoint (menstrual blood loss 50% reduction from baseline) versus placebo and versus elagolix with add-back, while both elagolix regimens improved post-treatment hemoglobin levels compared with placebo. Add-back therapy reduced the overall incidence of adverse effects compared with elagolix alone, without a statistically significant difference in serious (life-threatening) adverse events among groups. The paper’s limitations include that efficacy and safety comparisons rely on only four RCTs and pooled heterogeneity varied across outcomes. This paper does not explicitly discuss endometriosis or adenomyosis as study targets; it was included in the corpus because it mentions that elagolix has proven efficacy for endometriosis-related pain.

Read from the paper's body, not the abstract. Not a substitute for reading the paper. No clinical advice. How this works

Abstract

Abstract Background Heavy menstrual bleeding (HMB) is a common clinical finding in patients with uterine leiomyomas that can negatively impact their quality of life. Recently, a novel oral GnRH-antagonist (elagolix) has emerged as a possible therapeutic agent for this ailment. Herein data was pooled from clinical trials assessing the safety and efficacy of elagolix with and without add-back therapy. Main text PubMed and Cochrane library were systematically searched for RCTs that measured the efficacy and safety of elagolix for the treatment of uterine fibroid-associated HMB. All safety and efficacy endpoints were compared between elagolix-alone, elagolix w/add-back therapy, and placebo. The primary efficacy endpoint was defined as the number of women who achieved menstrual blood loss (MBL) 50% at the end of treatment. Secondary outcomes assessed included change in hemoglobin levels, incidence suppression of bleeding and amenorrhea, and the incidence of adverse events. The random effects model was used to pool data, and heterogeneity was assessed using I 2 . Our search identified 4 clinical trials meeting our PICO criteria, with a total of 916 patients. Analysis of the primary outcome revealed that elagolix-alone was the most effective treatment compared to both placebo (LOR = 3.47, CI = 3.03–3.91, p = 0.000, I 2 = 0.0%) and add-back therapy (LOR = 0.64, CI = 0.12–1.16, p = 0.016, I 2 = 43.1%). Furthermore, both elagolix groups (irrespective of add-back therapy) observed a significant improvement in post-treatment hemoglobin levels as compared to the placebo group (elagolix-alone vs PBO: LOR = 1.44, CI = 0.66–2.22, I 2 = 66.0%, p = 0.000; elagolix-w/add-back therapy vs PBO: LOR = 1.22, CI = 0.78–1.66, I 2 = 0.0%, p = 0.000). Concerning safety, while elagolix without add-back therapy had the highest overall incidence of adverse effects (elagolix-alone vs placebo LOR = 0.84, CI = 0.48–1.20, I 2 = 7.8%, p = 0.000; elagolix-alone vs elagolix-w/add-back LOR = 0.68, CI = 0.09–1.26, p = 0.024, I 2 = 64.6%), the incidence of serious (life threatening) adverse events between all 3 treatment groups was not statistically different. The inclusion of add-back therapy with elagolix made the treatment noticeably safer (elagolix-w/add-back vs placebo: LOR = 0.19, CI = − 0.10 to 0.48, I 2 = 0.0%, p = 0.194) without seriously compromising its efficacy. Conclusion High-quality evidence from 4 trials suggests that elagolix is an effective treatment for leiomyoma-associated HMB, with a marked improvement in all efficacy endpoints. Furthermore, the inclusion of add-back therapy in the treatment regimen should be considered as it mitigates the hypoestrogenic effects of elagolix.

My notes (saved in your browser only)

Citation neighborhood

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

References (24)

Source provenance

openalex
last seen: 2026-06-10T17:14:06.276822+00:00
License: CC0 · commercial use OK