Can a daily pill lighten heavy menstrual bleeding caused by fibroids? – Harvard Health Blog

Fibroids are usually benign (non-cancerous) tumors that form in the tissues of the uterus. They are very common in women of childbearing age: studies report that up to 70% of white women and 80% of black women can develop fibroids at 50 years of age. And research suggests that black women are more likely to experience severe or very severe symptoms associated with fibroids, such as heavy and sometimes prolonged monthly periods.

In some cases, women seek medical attention because of heavy menstrual bleeding that they develop anemia and require iron supplements or, much more rarely, blood transfusions. The FDA recently approved a new drug, taken in pill form, which may help some women reduce the heavy bleeding caused by fibroids.

Surgery and injections help some women

Until recently, treatment options for heavy bleeding from fibroids were limited to surgery or an injection of a drug called leuprolide, which is given monthly or every three months to help reduce fibroids and to ease the bleeding. Although these treatments are effective for some women, each presents risks and disadvantages:

  • Any surgical intervention carries a risk of infection. In addition, excessive bleeding requiring a transfusion, hysterectomy (removal of the uterus), damage to other pelvic or abdominal organs, and recurrence of fibroids is possible. In some cases, fertility is also affected.
  • Regular injections of leuprolide have significant side effects, as this medication essentially puts women into medically induced menopause. Therefore, it is generally only used as a bridge to surgery.

What does research tell us about a new approach to heavy menstrual bleeding from fibroids?

The new FDA approved drug to treat heavy menstrual bleeding from fibroids is Oriahnn. Taken twice daily in pill form, it combines two hormones (a form of estrogen called estradiol, plus norethindrone acetate) with a drug called elagolix. Elagolix helps to inhibit a hormone that causes a woman’s body to release estrogen and progesterone during her monthly menstrual cycle.

A recently published trial has shown that elagolix effectively decreases blood loss during menstruation and causes high rates of amenorrhea (no bleeding at all). The test was performed in collaboration with AbbVie, the company that produces and markets Oriahnn. He studied 433 women who had fibroids and heavy menstrual bleeding for 12 months per woman over a period of 2.5 years.

One of the strengths of the study was that 67% of the women who participated were black. Black women have higher rates of uterine fibroids, so their inclusion in this study is particularly important.

The study compared two groups of women for one year: one group received only elagolix and the other received elagolix with estradiol and norethindrone acetate (“therapy d ‘extra’). Because elagolix suppresses the hormonal release of estrogen and progesterone, it can cause hot flashes, night sweats, and decreased bone mineral density (a marker for bone loss) which can predispose women to fractures. bone. In theory, adjunct therapy could reduce the risk of hot flashes, night sweats, and bone loss.

For women taking elagolix with adjunct therapy, the researchers found that at the end of 12 months:

  • Almost 90% of women lost less blood during their period; compared to their blood loss before starting the drug, these women experienced at least a 50% reduction in blood loss.
  • 64% of women on elagolix on add-back therapy did not have a period at all.
  • Among anemic women at the start of the study period, almost 73% showed a statistically significant improvement in their blood count.
  • The size of the uterus has also decreased, but not the size of fibroids.

The most common side effects in both groups were hot flashes and headaches. Serious side effects were rare. However, compared to women taking only elagolix, women on elagolix with add-back treatment experienced fewer and less severe hot flashes and night sweats, and suffered significantly less loss of bone mineral density. (although both groups demonstrated bone loss).

Based on a questionnaire given to both groups, women taking elagolix with adjunctive therapy reported a better quality of life.

Who could find this new option useful?

This new FDA-approved drug could potentially be a great option for women who want to avoid surgery and instead try medical management of their fibroids. The caveat is that the trial studied this drug for 12 months. The FDA has not approved its use for more than 24 months, which may not be a lifelong solution for patients.

However, elagolix with adjunct therapy could be a great option for women in perimenopause, who are likely to go through menopause in one to two years and who want to avoid a hysterectomy. It would also be a great option for women who want to conceive in one to two years and who want to reduce menstrual bleeding without resorting to surgery.

It has long been said to women who seek lasting relief from heavy menstrual bleeding from fibroids that their best option is a hysterectomy. This new data may have the potential to change this opinion.

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Jothi Venkat

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