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 Uterine fibroids are non-cancerous growths in the uterus that can
cause problems such as pain, pressure, heavy periods and infertility
in as many as half the women who have them. They are very common,
particularly among African American women.
The elagolix treatment, if approved by the U.S. Food and Drug
Administration, could give women a new option for dealing with the
bleeding. Current treatment sometimes involves injections given
monthly or every three months. Elagolix is a pill whose effects
appear and fade much more rapidly and predictably. The new studies
did not directly compare the two treatments.
"This does provide a different approach and many women may prefer
that," lead study author Dr. William Schlaff of Thomas Jefferson
University in Philadelphia told Reuters Health in a telephone
interview. "We know it's effective for at least six months. If that
can be prolonged, it could act as a bridge to get to menopause,
where hormone levels drop naturally."
"But if you're 32 years old (with a fibroid bleeding problem) this
may not be a bridge you want to use for 20 years," he said. Such
women may want to consider a hysterectomy or some other option.
The two new studies - which were identical - followed a total of 790
women with a menstrual blood loss of more than 80 milliliters (about
2.7 ounces) per month.
At the six-month mark, among women getting placebo treatment, 8.7%
in one study and 10% in the other saw their monthly blood loss
reduced by at least 50%.
When the women were given elagolix alone, the success rates were
84.1% in one study and 77% in the other.
The treatment suppresses ovarian sex hormones, increasing the odds
of osteoporosis. So in some women, doctors also gave hormone therapy
to compensate.
With that hormonal "add-back therapy," monthly flow was still
reduced by at least 50% in 68.5% of women in one study and in 76.5%
in the other.
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Add-back therapy alleviated decreases in bone mineral density caused
by elagolix but it also increased the number of hot flushes in both
trials, and in one trial, it increased the likelihood of spotting
between periods, the researchers found.
Most side effects of the drug "were considered by the investigators
to be mild or moderate in severity," they reported.
The studies, known as Elaris UF-1 and Elaris UF-2, were financed by
AbbVie, which sells the drug under the brand name Orilissa.
The 300-milligram twice-daily elagolix treatment would cost more
than $47,000 per year, according to prices on goodrx.com. In
contrast, monthly leuprolide injections, which are an established
treatment, costs roughly $7,000 per year.
Compared with placebo recipients, elagolix recipients with add-back
therapy also had higher levels of the oxygen-carrying protein
hemoglobin in their blood and were more likely to have their periods
cease altogether.
They also tended to score higher on quality of life questionnaires.
Schlaff, who chairs the department of obstetrics and gynecology at
Thomas Jefferson, predicted that if the drug is approved for fibroid
bleeding, it will change the way women are treated.
"A lot of women want to use oral medication" instead of periodic
injections, he said. "Women are going to say, 'I don't want to
commit to a 1- or 3-month dose.' Or they may want to start with one
and move to another."
(This story has been refiled to correct brand name of drug in
paragraph 12)
SOURCE: https://bit.ly/3ayo3zN The New England Journal of Medicine,
online January 22, 2020.
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