Once-daily relugolix combination therapy was well tolerated and reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas in the LIBERTY 1 and LIBERTY 2 placebo-controlled trials. Bone mineral density (BMD) was also preserved through 24 weeks. For a study, researchers sought to report the effectiveness and safety of relugolix combination therapy treatment over the course of up to 52 weeks.

A 28-week long-term extension study was open to women with uterine leiomyoma-related heavy monthly bleeding who had finished any treatment arm in either the LIBERTY 1 or LIBERTY 2 trial. In the extension trial, everyone who took part got once-daily relugolix combination medication (40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate). The percentage of women who achieved or sustained a monthly blood loss volume of less than 80 mL and a 50% or higher reduction in menstrual blood loss volume from baseline to the final 35 days of therapy was the primary effectiveness outcome (defined as responders). All three of the randomized treatment groups from the pivotal trials underwent analysis.

In all, 477 women signed up, 476 received treatment, and 363 (76.1%) finished the 52-week period. 87.7% (responders) of patients receiving relugolix combo medication for 52 weeks (n=163) experienced durable relief from excessive menstrual bleeding. The volume of monthly blood loss was reduced by 89.9% on a least squares basis, and amenorrhea was achieved in 70.6% of patients. At week 52, higher than 2 g/dL improvements in hemoglobin concentration were seen in 59.0% of individuals who had anemia at baseline. The BPD (Bleeding and Pelvic Discomfort) scale score, which measures distress brought on by uterine leiomyoma-related symptoms, decreased by 51.3 points. Volumes of the uterus and the uterine leiomyoma both gradually decreased. Through week 52, bone mineral density remained stable.

In women with uterine leiomyomas, improvements in heavy menstrual bleeding, anemia, and the burden of symptoms related to uterine leiomyoma were maintained for up to 52 weeks with relugolix combination therapy. In addition, BMD was kept at its current level, and no new safety issues were found.

Reference: journals.lww.com/greenjournal/Fulltext/2022/12000/Long_term_Relugolix_Combination_Therapy_for.4.aspx