MADRID, 18 Feb. (EUROPA PRESS) –
Uterine fibroids are a common cause of heavy menstrual bleeding and pain in women of reproductive age, for which there are few treatment options other than surgery. Now, a medical researcher at the University of Chicago working with an international team of scientists, has developed a daily oral combination therapy that is reliable, safe and effective for the long-term treatment of uterine fibroids.
“This discovery is an important new tool that will be an important addition to this field,” said Ayman Al-Hendy, professor of obstetrics and gynecology and lead author of the study, published in the New England Journal of Medicine.
Al-Hendy led an international phase 3 clinical trial of a combination therapy focused on relugolix. This GnRH antagonist medication inhibits the production of estrogen and progesterone, the two hormones that drive fibroid growth. “When you deprive fibroids of these two hormones, they melt away,” he explains.
However, as previous research has shown and confirmed by Al-Hendy, the use of relugolix can only cause a cascade of menopausal symptoms, such as hot flashes, night sweats and a decrease in bone density, which result from a deficiency estrogen. For the study, Al-Hendy combined 40 mg of relugolix with small doses of synthetic estrogen (1 mg of estradiol) and synthetic progesterone (0.5 mg of norethindrone acetate).
This combination therapy not only prevented menopausal symptoms, but also produced dramatic improvements in fibroid-related measures. In two sessions throughout the 24-week clinical trial, a total of 770 patients, 73% and 71% of the participants, respectively, showed significant improvement in key measures such as menstrual blood loss volume, pain, anemia, bleeding and pelvic distress.
The trial was also noteworthy for how well its cohort reflected the patient population most affected by uterine fibroids. About half of the trial participants were black women, for whom uterine fibroids are four times more common.
Relugolix combination therapy presents a promising non-invasive alternative to surgical removal of the uterus (hysterectomy) or surgical removal of fibroids (myomectomy), Al-Hendy notes. The recurrence rate for fibroids after myomectomies is up to 70 percent in women of color.
“In my opinion, in the United States, we do too many hysterectomies and I think our uterine fibroid patients really deserve to have a wide range of options,” Al-Hendy notes.
“I see a lot of young black women in their 20s with significant fibroid problems who are not yet in a relationship or who have not yet started a family, so a hysterectomy is not on the horizon at all,” she explains. Combination therapy is especially a great option for this younger population who wants to preserve their fertility. But there are so many scenarios in which I believe this therapy will make a paradigm shift in the treatment of uterine fibroids and improve the quality of life for women. “.
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