23 Jan Elagolix – ORILISSA® – for Heavy Menstrual Bleeding in Women with Uterine Fibroids
MedicalResearch.com Interview with:
William D Schlaff MD
Chair, Department of Obstetrics & Gynecology
MedicalResearch.com: What is the background for this study?
Response: Symptomatic uterine fibroids are the most common indication for hysterectomy in the US. Heavy bleeding is the most common and troublesome symptom. The primary treatment for this problem is surgery—either hysterectomy or (less commonly) myomectomy. Medical treatment which reduces the bleeding related to fibroids without surgery is a valuable treatment for many women. Existing medications include, most commonly GnRH agonists. These are injectable medications that are given every 1 or 3 months (depending on the formulation) and have been shown to reduce bleeding related to fibroids. They work by initially stimulating the ovaries to increase estrogen levels for 10-14 days before suppressing estrogen and thereby reducing bleeding. Even though the medication is given every 1 or 3 months, the effect of the medication can last quite a bit longer; in cases of adverse response, the medication cannot be immediately stopped. The medication reported in this trial, Elagolix, is a GnRH antagonist given by mouth twice daily and resulting in suppression of estrogen secretion within a matter of hours. The effect of this medication wears off much more rapidly than the depot formulations described and can be stopped in the uncommon cases of adverse side effects.
MedicalResearch.com: What are the main findings?
Response: Women with heavy bleeding due to uterine fibroids were treated with either Elagolix plus a small amount of hormone “add-back” or placebo. The purpose of the add-back was to reduce the symptomatic and metabolic side effects associated with decreased estrogen levels. The heavy menstrual bleeding was reduced by 50% or more in 72% of the women treated with the Elagolix plus “add back” and about 9% of women treated with placebo. Women treated with Elagolix plus “add back” were somewhat more likely to experience symptoms of hypoestrogenism (e.g. hot flushes) as compared to the placebo group (20% vs. 6-7%), but did not lose more bone mineral density over course of the trial.
MedicalResearch.com: What should readers take away from your report?
Response: Oral Elagolix plus “add-back” treatment was effective in significantly reducing heavy menstrual bleeding associated with uterine fibroids as compared to women treated with a placebo. This represents a new, oral, and more easily reversible approach to GnRH analog treatment of women with symptomatic fibroids. One can speculate (pending the findings of future research as described below) that this could represent a longer-term treatment of fibroid-related bleeding that could be of particular value to women towards the end of their reproductive years. If this approach could be used for several years in women as they approach menopause they might be more likely to avoid surgery.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Several studies should be pursued including, key among them being a) longer-term study of this combination—12 and more months of treatment and b) assessment of the impact of this combination on fibroid-related symptoms other than bleeding.
DISCLOSURES: The multicenter trial reported in this paper was an industry-sponsored study (Abbvie Pharmaceuticals); Thomas Jefferson University received a grant from Abbvie to perform this research. I serve as a consultant to Abbvie regarding the treatment of uterine fibroids.
William D. Schlaff, M.D., Ronald T. Ackerman, M.D., Ayman Al-Hendy, M.D., Ph.D., David F. Archer, M.D., Kurt T. Barnhart, M.D., Linda D. Bradley, M.D., Bruce R. Carr, M.D., Eve C. Feinberg, M.D., Sandra M. Hurtado, M.D., JinHee Kim, M.D., Ran Liu, Ph.D., R. Garn Mabey, Jr., M.D.,
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