Uterine leiomyomas are common, nonmalignant, gonadal steroid-dependent, monoclonal neoplasms. They are reported in about 70–80% of premenopausal women. Although many women with uterine leiomyomas are asymptomatic, nearly 25% develop symptoms, like heavy menstrual bleeding and pain, requiring treatment.
Relugolix combination therapy (relugolix-CT), an oral once-daily nonpeptide, gonadotropin-releasing hormone receptor antagonist (relugolix 40 mg) with estradiol 1 mg and norethindrone acetate 0.5 mg, is the approved drug for managing uterine leiomyoma–associated heavy menstrual bleeding for up to 2 years (U.S.) or moderate-to-severe uterine leiomyoma symptoms without limitation on the duration of use (E.U.).
A recent study assessed the effect of once-daily relugolix combination therapy compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding by conducting two replicate, multinational, double-blind, 24-week, randomized, phase 3 studies (LIBERTY 1 and 2).
Premenopausal women with uterine leiomyoma–associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle) were included.
Additionally, a predefined secondary objective determined the effect of relugolix-CT on moderate-to-severe uterine leiomyoma–associated pain in the pain subpopulation (women with maximum pain scores of 4 or higher on the 0–10 numerical rating scale at baseline, with pain score reporting compliance of 80% (ie, 28 days or more over the last 35 days of treatment)). This critical secondary endpoint was described as the proportion of women achieving minimal-to-no uterine leiomyoma–associated pain (maximum numerical rating scale score 1 or lower) at week 24; menstrual and nonmenstrual pain was assessed in prespecified secondary analyses.
The observations were as follows-
Thus, over 24 weeks, relugolix-CT greatly reduced moderate-to-severe uterine leiomyoma–associated pain, rendering a more prominent effect on menstrual pain.
Hence, relugolix-CT delivers clinically meaningful effects on uterine leiomyoma–associated pain.
Stewart EA, Lukes AS, Venturella R, et al. Relugolix Combination Therapy for Uterine Leiomyoma–Associated Pain in the LIBERTY Randomized Trials. Obstetrics & Gynecology. 2022 ;10.1097/AOG.0000000000004787
Subscribe To Our Newsletter
Filter out the noise and nurture your inbox with health and wellness advice that's inclusive and rooted in medical expertise.
Medtalks is India's fastest growing Healthcare Learning and Patient Education Platform designed and developed to help doctors and other medical professionals to cater educational and training needs and to discover, discuss and learn the latest and best practices across 100+ medical specialties. Also find India Healthcare Latest Health News & Updates on the India Healthcare at Medtalks
Please update your details