How effective is elagolix treatment in women with fibroids and HMB?
Elagolix with hormonal add-back therapy (estradiol/norethindrone) was effective: 87.9% of participants who received combination therapy met both primary endpoints: 1) percentage of women with less than 80 mL menstrual blood loss during the final month, and 2) a 50% or greater reduction in menstrual blood loss from baseline to final month. Treatment was for up to 12 months as an extension of 1 of 2 randomized, double-blinded, placebo-controlled studies using elagolix.
Study strengths and limitations
Strengths of this study include its overall design; efficacy endpoints, which were all established a priori; the fact that measurement of menstrual blood loss was done with the objective alkaline hematin method; and the statistical analysis, which is thorough and well presented. This extension study allowed further evaluation of efficacy and safety for elagolix. Although the authors point out that there may be some selection bias in an extension study, the fact that so many women elected to continue into the extended study is a positive reflection of the treatment.
As providers learn of new therapies for management of HMB associated with fibroids, it is important to consider who will benefit the most. In my opinion, any woman with heavy periods associated with fibroids could be a candidate for elagolix with add-back therapy. This treatment is highly effective, well tolerated, and safe. My approach to management includes educating a woman on all potential therapies and this new option of elagolix and add-back therapy is an important one. The decision for an individual woman on how to manage heavy periods associated with fibroids should consider her contraceptive needs, medical issues, and the risk and benefit of individual therapies. ●
Elagolix and hormonal add-back therapy offer a long-term medical option for women with HMB associated with fibroids that is both effective and safe.
ANDREA S. LUKES, MD, MHSc
