Robert L. Barbieri, MD reviewing Taylor HS et al. N Engl J Med 2017 May 19.

Treatment was effective, but balancing pain reduction against loss of bone mass remains a clinical challenge.

Endometriosis affects 5% to 10% of reproductive-aged women and is a common cause of moderate-to-severe dysmenorrhea and pelvic pain. To evaluate the efficacy of a novel oral gonadotropin-releasing hormone (GnRH) antagonist, elagolix, for managing endometriosis pain, investigators conducted two manufacturer-funded trials involving 1689 women randomized to placebo or elagolix at a low dose (150 mg daily) or high dose (200 mg twice daily). Overall, 76% of participants completed 6 months of treatment.

In both trials at 3 months, meaningful reductions in dysmenorrhea pain were reported by about 44% of the low-dose elagolix group, 74% of the high-dose elagolix group, and 21% of the placebo group. Nonmenstrual pelvic pain was diminished in 50%, 56%, and 36% of women in the low-dose, high-dose, and placebo groups, respectively. At 6 months, these responses persisted (P<0.001 for comparisons with placebo). Also at 6 months, mean changes from baseline in lumbar spine bone density were about −0.5%, −2.6%, and +0.5% in the low-dose, high-dose, and placebo groups, respectively (P<0.01 for comparisons with placebo).

CITATION(S):

Taylor HS et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med 2017 May 19; [e-pub].

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