New Drug Combo Could Help Treat Uterine Fibroids
For their trial, Al-Hendy and his colleagues recruited 770 women from several countries, including the United States. All had heavy menstrual bleeding due to fibroids and were randomly assigned to take the drug combination or a placebo for six months.
Treatment involves a relugolix tablet, which blocks the activity of a natural hormone known as GnRH. This, in turn, prevents the ovaries from producing estrogen and progesterone.
To help counter the negative effects of suppressing these hormones – such as decreased bone density – the trial patients also took a synthetic estrogen and progesterone capsule as a “supplement.”
Over six months, the trial found that more than 70% of the patients in the study saw a substantial reduction in their menstrual bleeding, according to results released Feb. 17 in the New England Journal of Medicine.
A big advantage of oral medications over hysterectomy is that younger women can preserve their fertility, Al-Hendy said.
One downside is that despite the hormonal addition, some bone loss can occur. For this reason, the FDA has approved Oriahnn for use for only two years.
In this trial, however, there was a positive signal: Bone density was not lower in the women taking the relugolix combination therapy than in those taking placebo.
This raises the possibility, Al-Hendy said, that the relugolix combination might be a bit easier on bone density and could be used for a longer stretch.
Shirazian agreed, but also said longer-term data is needed to answer this question.
So far, the two doctors have said oral medications can be seen as “a bridge to something else” for some patients.
Shirazian referred to a scenario: Women who are nearing menopause and need symptom relief until the fibroids naturally shrink.
Al-Hendy said the drugs could also be a shorter-term option for women who plan to become pregnant in the near future.
There is, however, a question of cost. GnRH blockers are expensive, and Oriahnn’s average retail price would be around $ 1,000 for a one-month supply. According to Al-Hendy, depending on a woman’s insurance coverage, the price could be a barrier.
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