Clinical practice and research yields valuable data for management of uterine fibroids

There have been many valuable lessons learned from clinical practice and research on uterine fibroids (UFs), according to a presenter at the 2021 Fibroid Summit.

For example, although hysterectomy is the most common gynecologic procedure, “many clinicians are not aware of data linking hysterectomy to long-term health risks, even when both ovaries are conserved,” said Elizabeth A. Stewart, MD, a professor of ob/gyn and surgery at Mayo Clinic and Mayo Clinic Alix College of Medicine in Rochester, Minnesota.

This is one of the findings that Stewart presented on what has been discovered about UFs from clinical practice and clinical studies at the 2021 Fibroid Summit, sponsored by The Fibroid Foundation and the Campion Fund.

Elizabeth A. Stewart, MD

“New studies are showing significantly increased risks of cardiovascular disease, weight gain and mood disorders, even with bilateral ovarian conservation,” Stewart told Contemporary OB/GYN.

Hysterectomy benefits include substantial symptomatic improvement, as well as decreases in uterine, cervical, ovarian, and lung cancers. However, after roughly 20 years following hysterectomy with conservation of both ovaries, women can expect a 13% increased risk of hypertension, a 14% increased risk of hyperlipidemia, a 7% increased risk of cardiac arrhythmias, an 8% increased risk of obesity, and a 33% increased risk of coronary artery disease.

“Both patients and providers need to be educated about the risks and benefits of hysterectomy with ovarian conservation,” Stewart said.

Clinicians may also be unaware of a new FDA-approved drug for UFs: Oriahnn (AbbVie), a new oral gonadotropin-releasing hormone (GnRH) antagonist (elagolix) combined with low-dose estrogen and progestin.

Unlike GnRH-agonists like Lupron (AbbVie), “these combinations minimize hypoestrogenic symptoms so that in clinical trials there is not significant bone loss and rates of hot flashes are similar to those subjects receiving placebo,” Stewart said.

In addition, data now has been published on a second GnRH antagonist, relugolix combination treatment, “which shows comparable improvement in heavy menstrual bleeding to the elagolix combination, but also decreases pain and bulk symptoms,” Stewart said.

New studies also are providing comparative effectiveness data for UFs. For instance, the FEMME multicenter, randomized trial compared uterine artery embolization (UAE) to myomectomy.

“While both groups substantially improved at 2 years, women undergoing myomectomy had significantly improved quality of life,” Stewart said. “However, the numbers of pregnancies and livebirths were similar in both groups.”

This data adds to over seven randomized controlled trials of nearly 8,000 women that demonstrate that UAE as a fibroid treatment resulted in a consistent reduction in fibroid size; improvements in days of bleeding, hemoglobin and patient-related bleeding; and increases in a variety of quality-of-life measures.

Moreover, UAE has a significantly decreased risk of transfusion compared to myomectomy, along with more rapid recovery and fewer major complications. “Thus, UAE should be more widely used for women with symptomatic uterine fibroids,” Stewart said

Other studies, such as the COMPARE-UF registry, are providing new information about surgical and interventional fibroid treatments. “For example, when comparing quality of life 1 year following myomectomy or hysterectomy, hysterectomy achieved a significantly greater improvement, except when an abdominal route was chosen for surgery; in that case, results were equivalent,” Stewart said.

The growing list of alternatives to hysterectomy is a benefit to patients, according to Stewart. “Fortunately, most women have a least one effective alternative to hysterectomy,” she said. These include oral contraceptives, medicated intrauterine devices, tranexamic acid, GnRH analogues, myomectomy, uterine artery embolization, radiofrequency (RF) ablation, and focused ultrasound.

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Disclosures

Stewart has been a paid consultant to AbbVie, Bayer, Observe and Myovant within the past 3 years. She also receives royalties from UpToDate and is a paid consultant for the development of educational content for the Med Learning Group, PER, Massachusetts Medical Society and Peer View.