Elagolix monotherapy Safe Against Heavy Menstrual Bleeding associated with Uterine Leiomyomas
A new phase 4 study published in The Journal of Obstetrics and Gynecology found elagolix 150 mg monotherapy taken once-daily to solve heavy menstrual bleeding associated with uterine leiomyomas were the safe and effective. This offers promise to premenopausal patients aged 18–51 years.
This randomized, double-blind, placebo-controlled study assessed a total of 82 patients, with 54 receiving elagolix 150 mg and 28 receiving a placebo. The primary endpoint was a reduction in menstrual blood loss volume to less than 80 mL at the final month, coupled with at least a 50% reduction from baseline to the final month.
The results found 49.4% of patients in the elagolix group who met the primary endpoint, compared with 23.3% in the placebo group (P=.035). The differences in mean reduction of menstrual blood loss were significant as early as month 1 (P<.05 for months 1–3 and 5).
Moreover, elagolix demonstrated its effectiveness in suppressing bleeding (P=.036). The patients on elagolix experienced greater improvements in the proportion of those with amenorrhea, hemoglobin concentrations, and health-related quality of life.
Elagolix treatment was well-tolerated. There were no serious or severe adverse events reported, in stark contrast to the 7.1% of participants in the placebo group facing serious adverse events, including coronavirus disease 2019 (COVID-19) and an enlarged uvula. Only 5.6% of patients discontinued elagolix due to adverse events.
This study brings out a significant improvement in addressing heavy menstrual bleeding associated with uterine leiomyomas in premenopausal patients. The positive outcomes of elagolix 150 mg once-daily monotherapy, coupled with its favorable safety profile, underscore its potential as a transformative treatment option.
Source:
Brown, E., Kroll, R., Li, H., Ng, J., Pinsky, B., Rodriguez, J. W., Thomas, J., & Snabes, M. C. (2023). Low-dose elagolix for the treatment of heavy menstrual bleeding in patients with uterine leiomyomas: A randomized controlled trial. Obstetrics and Gynecology, 142(5), 1068–1076. https://doi.org/10.1097/aog.0000000000005380
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.