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Elagolix reduces menstrual bleeding from most common uterine tumours

DALLAS – Nov. 8, 2018 – A new oral drug significantly reduced menstrual bleeding for women with the most common gynecologic tumours in the United States – benign tumours that disproportionately affect African-Americans, an international clinical trial found.

In the five-country study, Elagolix reduced bleeding in more than 90 per cent of premenopausal women who had heavy menstrual bleeding associated with fibroid tumours – noncancerous growths of the uterus known as uterine leiomyomas that often appear during childbearing years.

Surgery has traditionally been the gold standard for treatment, resulting in hysterectomy or myomectomy, so a nonsurgical option offers new hope, said Dr Bruce Carr, Professor of Obstetrics and Gynecology at UT Southwestern Medical Center and lead author on the study appearing in the journal Obstetrics & Gynecology.

“There are no orally approved drugs to decrease bleeding and prevent anaemia in women with these tumours,” said Dr Carr, Director of the Reproductive Endocrinology and Infertility Fellowship Program at UT Southwestern, who holds the Paul C. MacDonald Distinguished Chair in Obstetrics & Gynecology. “Now, there is a medical option for this devastating disease that affects up to 75 per cent of women.”

Prescribing hormone therapy together with the new drug prevented estrogen-deficiency induced side effects like hot flashes and bone loss, the researchers found.

Fibroid tumours can be associated with infertility, miscarriage, and early onset of labour and are the most common reason for hysterectomy worldwide, costing an estimated $2.2 billion in the U.S. alone. For women in their 40s and 50s, abnormal uterine bleeding also is the most common reason to see a gynaecologist, and fibroids are one of the most common causes of the symptom.

Researchers examining health disparities of uterine fibroids found that 80 per cent of African-American women and approximately 70 per cent of white women will have uterine fibroids by age 50, although the tumours cause symptoms in only about a quarter to half of the women who have them. Research in the Journal of Women’s Health reported that African-American women:

Had a higher cumulative risk of uterine fibroids.

Experienced a threefold greater incidence and relative risk of fibroids.

Had an earlier age of onset.

Were 2.4 times more likely to undergo a hysterectomy.

Had a 6.8-fold increase in the number of uterine-sparing myomectomies.

Researchers conducted the clinical trial at 86 sites in the United States, Puerto Rico, Canada, Chile, and the United Kingdom and involved the Mayo Clinic, Eastern Virginia Medical School, the University of Illinois, the Cleveland Clinic, Mercy Health Osteoporosis and Bone Health Services, Augusta University, and The George Washington University in Washington, D.C., along with the maker of the new drug (elagolix), AbbVie Inc. Dr Carr received research support from AbbVie and Agile Therapeutics and served on the Repros Therapeutics Data and Safety Monitoring Board.

About UT Southwestern Medical Center

UT Southwestern, one of the premier academic medical centres in the USA, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 22 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 15 Howard Hughes Medical Institute Investigators. The faculty of more than 2,700 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments.

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