Conference Coverage

Elagolix shows long-term efficacy

View on the News

A much-needed advancement in long-term treatment


Having had the opportunity to review Dr. Eric Surrey's abstract for this year's annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, entitled "Long-term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-associated Pain," I believe use of Elagolix, an oral nonpeptide gonadotropin-releasing hormone (GnRH) antagonist, is a much-needed advancement in the long-term treatment of endometriosis-related pain. The fact that it is an oral medication, thus, not requiring a monthly or 3-month injection as does Lupron Depot (leuprolide acetate), the most popular GnRH agonist in the United States, is advantageous both for the patient and the busy office staff.

Dr. Charles E. Miller
Furthermore, the reduction in dysmenorrhea and nonmenstrual pain is rapid at both the 150-mg once daily as well as the 200-mg twice daily dose. This is consistent with Elagolix being a GnRH antagonist, which immediately down-regulates the pituitary and thus, suppresses the release of follicle-stimulating hormones and luteinizing hormonesboth are on acceptable abbrevs list but we could spell out since they're used once//dw. Without gonadotropin stimulation to the ovaries, estrogen production decreases, resulting in diminishment of endometriosis.

While I certainly understand that it is easy to compare data regarding bone loss in the use of an oral antagonist, Elagolix, with historical data with the GnRH agonist and note a lessening of bone loss in the Elagolix patients, it would be interesting to compare bone loss in patients utilizing Elagolix with bone loss in those treated with GnRH-agonist plus add-back therapy. Many practitioners will utilize progesterone supplementation or estrogen/progesterone supplementation when using GnRH-agonist therapy to decrease this risk. Furthermore, it would be interesting, in the future, to evaluate the impact on efficacy and bone loss if progesterone and estrogen/progesterone add-back were utilized in Elagolix therapy.

While I certainly realize and deeply respect Dr. Surrey's vast experience as both a clinical researcher and clinician utilizing a GnRH-agonist regimen, I am curious as to the basis of Dr. Surrey's comments regarding less severe hot flashes in comparison to GnRH-agonist treatment. I am not aware of any head-to-head studies comparing hot flashes between GnRH agonists (in particular, leuprolide acetate) and Elagolix.

Without a side-by-side comparison utilizing a validated scoring system, I find it hard to accept this conclusion.

Nevertheless, after reviewing this study and Dr. Surrey's comments, I look forward to utilizing Elagolix in my practice for long-term treatment of endometriosis-related pain.

Charles Miller, MD, is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He is a consultant and involved in research for AbbVie.


 

REPORTING FROM ACOG 2018


After 12 months of consecutive treatment, patients given 150 mg of Elagolix saw mean dysmenorrhea scores improve by 49%-53% from baseline, and by 82% for those at 200 mg, with certain expected adverse events, according to Dr. Surrey.

One of the most common adverse events associated with Elagolix was hot flashes, an unsurprising finding for Dr. Surrey and his colleagues considering Elagolix is a drug that lowers estrogen levels. However, any hot flashes patients experienced during the trial were still better than those associated with current medications, according to Dr. Surrey.

“In this extension study nobody dropped out because of hot flashes in the additional 6-month extension time,” Dr. Surrey explained. “If you look at the gold standard drug for endometriosis now, which is a GnRH agonist, which are highly available and are either injectable or implants, [patients taking these drugs] can have very severe hot flashes that require additional medication to alleviate the hot flashes at the same time.”

Patients did also experience some loss in bone density; however, Dr. Surrey argues the frequency and level of these adverse events is still better than current treatment options. One patient was required to discontinue the trial for bone density loss.

Recommended Reading

Estrogen patch counters eating disorders in women athletes
MDedge Family Medicine
Study: Preop EKGs have little utility for benign hysterectomy
MDedge Family Medicine
MDedge Daily News: Where doctors stand on Medicaid work requirements
MDedge Family Medicine
ERAS reduced opioid use, improved same-day discharge after gyn surgery
MDedge Family Medicine
Endometriosis pain stemming from pelvic spasms improved with botulinum toxin
MDedge Family Medicine
FDA advisory committee votes to recommend first once-daily aminoglycoside antibiotic
MDedge Family Medicine
VIDEO: Few transgender patients desire care in a transgender-only clinic
MDedge Family Medicine
Inadequate antibiotic use persists in gonorrhea
MDedge Family Medicine
MDedge Daily News: Do HPV vaccines really cut cancer risk?
MDedge Family Medicine
VIDEO: Few ob.gyns. asking in detail about sexual behavior
MDedge Family Medicine