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HealthDay News – For women with uterine fibroids, elagolix with add-back hormonal therapy is associated with a reduction in heavy menstrual bleeding compared with placebo, according to a study published in the January 23 issue of the New England Journal of Medicine.
William D. Schlaff, MD, from Thomas Jefferson University in Philadelphia, and colleagues conducted 2 randomized, placebo-controlled phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to assess the efficacy and safety of elagolix twice daily with hormonal add-back therapy to replace reduced levels of endogenous hormones. Overall, 412 women in UF-1 and 378 in UF-2 were randomly assigned in a 2:1:1 ratio to receive elagolix with add-back therapy, elagolix alone, or placebo. The primary end point was menstrual blood loss <80mL in the final month of treatment and ≥50% reduction in menstrual blood loss from baseline to the final month.
The researchers found that in UF-1 and UF-2, the criteria for the primary end point were met by 68.5% of 206 and 76.5% of 189 women, respectively, who received elagolix plus add-back therapy, compared with 8.7% of 102 and 10% of 94 women, respectively, who received placebo. The primary end point was met by 84.1% of 104 women and 77% of 95 women in UF-1 and UF-2, respectively, who received elagolix alone. With add-back therapy, hypoestrogenic effects of elagolix were attenuated.
“In both trials reported here, the risk of heavy menstrual bleeding among premenopausal women with uterine fibroids was significantly lower among women who received elagolix,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including AbbVie, which manufactures elagolix and funded the study.
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