AI Article Synopsis
- The study examined the effectiveness of elagolix combined with estradiol and norethindrone add-back therapy for women with uterine fibroids (UFs) and heavy menstrual bleeding.
- It analyzed data from two phase 3 trials involving a total of 591 women to compare the treatment's outcome against a placebo over six months.
- Results showed that women receiving the treatment reported significant improvements in both nonbleeding symptoms and menstrual bleeding, particularly among those with higher disease burden characteristics.
Article Abstract
Objective: To investigate the efficacy of elagolix plus add-back therapy (estradiol [1 mg] and norethindrone acetate [0.5 mg] once daily) on patient-reported nonbleeding symptoms and menstrual bleeding associated with uterine fibroids (UFs) across different subpopulations.
Design: Post hoc analysis of two phase 3 clinical trials-Elaris UF-1 and UF-2.
Setting: A total of 76 (UF-1) and 77 (UF-2) US clinical sites.
Patients: Women (N = 591) with UFs and heavy menstrual bleeding.
Interventions: Elagolix (300 mg) twice daily with add-back therapy (the indicated dose for UF-associated heavy menstrual bleeding) vs. placebo for 6 months.
Main Outcome Measures: "Very much improved" or "much improved" change in nonbleeding symptoms (abdominal/pelvic pain, abdominal/pelvic pressure/cramping, back pain, and abdominal bloating) and menstrual bleeding measured using a Patient Global Impression of Change scale. Improvements were assessed in subpopulations stratified using baseline characteristics (age, race [self-reported], body mass index, and International Federation of Gynecology and Obstetrics fibroid classification).
Results: Across subpopulations, differences favored elagolix plus add-back therapy (vs. placebo) for most symptoms at month 1 and all symptoms at months 3 as well as 6. In patients with characteristics commonly associated with high disease burden (age >40 years, Black/African American), those treated with elagolix plus add-back therapy reported significantly greater improvements vs. placebo at months 1-6 (<.05) for all nonbleeding and bleeding symptoms (≤.05).
Conclusions: Premenopausal women with heavy menstrual bleeding and UFs receiving elagolix plus add-back therapy experienced significant improvements in nonbleeding as well as bleeding symptoms from months 1-6, regardless of baseline characteristics.
Clinical Trial Registration Number: NCT02654054 and NCT02691494.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11456625 | PMC |
| http://dx.doi.org/10.1016/j.xfre.2024.06.002 | DOI Listing |
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Article Synopsis
- The study examined the effectiveness of elagolix combined with estradiol and norethindrone add-back therapy for women with uterine fibroids (UFs) and heavy menstrual bleeding.
- It analyzed data from two phase 3 trials involving a total of 591 women to compare the treatment's outcome against a placebo over six months.
- Results showed that women receiving the treatment reported significant improvements in both nonbleeding symptoms and menstrual bleeding, particularly among those with higher disease burden characteristics.
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