1. Once-daily relugolix combination therapy resulted in a significant reduction in heavy menstrual bleeding compared with placebo in women with uterine fibroids.
2. The combination therapy preserved bone mineral density and minimized the incidence of hot flashes.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Uterine fibroids can be associated with heavy menstrual bleeding, anemia, and pain. First-line treatment with contraceptives has low-quality evidence for their use. Relugolix is an oral GnRH antagonist suitable for daily use. This study reported the results of two phases 3 trials, which assessed the efficacy and safety of once-daily relugolix combination therapy in women with fibroid-associated heavy menstrual bleeding. Relugolix combination therapy resulted in a significant reduction in fibroid-associated bleeding with the resolution of anemia and an improvement in pain and discomfort. Preservation of bone mineral density and minimized incidence of hot flashes were also noted in comparison to relugolix monotherapy. Limitations include limited generalizability given many women were excluded due to stringent criteria. The trial regimen was also restricted to six months, therefore long-term effects remain to be assessed. Nonetheless, this study’s results are significant, and its findings highlight evidence of relugolix combination therapy decreased fibroid-associated bleeding and improved patient comfort.
In-Depth [randomized controlled trial]: This study reported the results of two replicate, randomized controlled phase 3 trials. The trials enrolled 770 women from North America, South America, Africa, and Europe between both trials. Women between the ages of 18 to 50 years old, known diagnoses of fibroids, and who had heavy menstrual bleeding were included in the study. Participants on hormonal therapy or with other causes for menstrual bleeding were excluded from the study. Participants were randomized to the relugolix combination group or the placebo group. The primary endpoint was trial response defined as blood loss less than 80 mL and a reduction of at least 50% from baseline menstrual blood loss. Overall, 73% of participants in the first trial and 71% in the second trial achieved the primary endpoint in the treatment group, compared with 19% and 15% in the placebo groups, respectively (P < 0.001 for each comparison). More than 50% of participants with anemia in the treatment group had an increase of more than 2 g/dL in hemoglobin levels compared to placebo (first trial, P = 0.04; second trial, P < 0.001). Percent changes in bone mineral density from baseline were similar between the relugolix combination therapy group and placebo group. Taken together, relugolix combination therapy was shown to decrease menstrual bleeding and improve fibroid-related symptoms in premenopausal women.
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