Briefing you on the latest in reproductive health research
TL;DR: A new treatment for uterine fibroids is under FDA review, the intersection between repro health and… restless leg syndrome? Plus, a new study about heart health during pregnancy and how that translates to the child even years on. Here’s your February update.
New treatment for uterine fibroids, pending FDA review
Here at Flex®, we’re always looking for ways to open up the conversation to more than just periods. Reproductive health is so expansive: There are so many conditions that can influence, and be influenced by, your period. Uterine fibroids are one of these.
For those of us who may not have heard of these before, uterine fibroids, also known in medical language as leiomyomas, are collections of smooth muscle tissues found in the uterus. Depending on the location of the fibroids, they can cause symptoms like heavy menstrual bleeding, large clots, pelvic pain, pelvic pressure, and even changes like constipation or rectal pain.
People with uteruses who also have fibroids often struggle with finding products that can accommodate this heavy menstrual bleeding. They find themselves going through more tampons or pads than they may have been accustomed to, spending more money each month on period products. Fibroid-related bleeding may also come at seemingly random times (even outside of the regular menstrual period) – creating additional stress and anxiety.
The current treatments for fibroids are limited to hormonal treatment to control the bleeding or gynecological surgery to remove the fibroid itself. Gonadotropin-releasing hormone (GnRH) agonists are another option that are sometimes used to treat fibroids. However, to date, only limited data has been published on their use for therapeutic treatment of fibroids, especially in diverse populations.
This changes this month, with a NEJM article hot off the presses showing data that a drug called Relugolix resulted in symptomatic improvement for women with fibroids.((Al-Hendy, A., & Al., E. (2021, February 18). Treatment of uterine fibroid symptoms with relugolix combination therapy: Nejm. Retrieved February 20, 2021, from https://www.nejm.org/doi/full/10.1056/NEJMoa2008283)) Relugolix is an interesting drug, because it is currently FDA-approved for adult patients with advanced prostate cancer.((Center for Drug Evaluation and Research. (2020, December 18). FDA approves Relugolix for advanced prostate cancer. Retrieved February 20, 2021, from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-relugolix-advanced-prostate-cancer)) Knowing what we know about how hormones play into the reproductive system, it makes sense that this drug could be potentially applied to a number of different conditions in sexual and reproductive health, especially if they are affected in any way by GnRH.
Quick reminder here, GnRH is a hormone that is responsible for stimulating the anterior pituitary to secrete LH and FSH, both of which are crucial hormones for individuals AFABAFAB stands for “assigned female at birth.” as well as AMABAMAB stands for “assigned male at birth.”.
Back to the study at hand: To investigate the use of this drug in uterine fibroids, an international team of researchers divided women into three groups. One group received a once-daily placebo, the second group received Relugolix plus estradiol/progestin, and the third group received a sequence of Relugolix monotherapy followed by the Relugolix combo therapy. These patients were followed for about six months, following menstrual cycle characteristics as well as bone density.
The analysis showed that both Relugolix groups had significant responses and improvements compared to the placebo group. “Response” in this study was defined as volume changes in the menstrual cycle, including <80 mL total of blood loss as well as a greater than or equal to 50% reduction in volume from baseline.
To summarize: this drug in combo with estradiol-progestin was associated with a significant decrease in menstrual blood volume loss for women with fibroids. Given that one of the more concerning after-effects of fibroids is chronic anemia due to blood loss, this is an overall promising result. Currently, Relugolix is under FDA review for use in symptomatic fibroids.((Myovant Sciences. (2020, August 17). Myovant Sciences Announces FDA Acceptance of New Drug Application for Once-Daily Relugolix Combination Tablet for Uterine Fibroids. GlobeNewswire News Room. https://www.globenewswire.com/news-release/2020/08/17/2079230/0/en/Myovant-Sciences-Announces-FDA-Acceptance-of-New-Drug-Application-for-Once-Daily-Relugolix-Combination-Tablet-for-Uterine-Fibroids.html.)) It is slated to have an announcement about the status of its review by June 1, 2021. More to come!
No rest for restless leg syndrome
In other news, here’s an interesting study that compared premenopausal bilateral oophorectomy, or, in other words, the removal of both ovaries prior to time of menopause with… restless leg syndrome? You heard that right. And, FYI, restless leg syndrome isn’t just a term for when that deadly combo of cold brew plus chocolate-covered espresso beans hits at midnight the night before finals (just us?).
It’s actually a legit medical condition, characterized by an intense desire to move the legs which can get in the way of sleep and other activities.((U.S. Department of Health and Human Services. (2020, March 17). Restless Legs Syndrome Fact Sheet. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Restless-Legs-Syndrome-Fact-Sheet.)) It’s estimated that up to 10% of the U.S. population has restless leg syndrome, and there are a ton of hypotheses out there about what causes it – from genetic conditions to low-iron states to other comorbidities, like diabetes or nerve damage.
But the fact of the matter is that we just don’t know enough about this condition to know what causes it – most likely, it’s a mixture of many factors.
It’s still so important to continue to research restless leg syndrome and other conditions like it, though, to better understand how it affects all of us (including menstruating people). These researchers did just that.((Huo N, Smith CY, Gazzuola Rocca L, Rocca WA, Mielke MM. Association of Premenopausal Bilateral Oophorectomy With Restless Legs Syndrome. JAMA Netw Open. 2021;4(2):e2036058. doi:10.1001/jamanetworkopen.2020.36058))
Using a cohort study of over 3000 women, they followed patients who were undergoing ovary removal for both benign and non-benign conditions (and doing so just prior to menopause). They also looked at whether these patients had other medical conditions and whether or not they were taking estrogen exogenously.
Interestingly enough, they found that there was an increased risk of restless leg syndrome overall for the women who had an oophorectomy when compared to the general population… and that the risk was higher for women who went into the surgery for a non-benign condition.
It’s important to note that, overall, women who were undergoing this procedure had on average more chronic medical conditions compared to the index population, which could have played a role in these results. Estrogen therapy was not associated with either an increase or decrease in risk for restless leg syndrome, which is in contrast to other studies.
Overall, this study is especially interesting because it shows that there are multiple considerations that should be discussed prior to undergoing procedures like an ovary removal surgery – and that some of the lingering effects of the procedure may be outside of what we think of as the “typical” OB/GYN realm.
It also provides further insight into the ways that all of our organ systems interact with each other, which is pretty dang interesting (and a topic we’d love to nerd out on all day long).
Heart-healthy, and just in time for V-Day
Here’s one more for you to ponder as you meal prep for the week: A new study was recently published that explores the relationship between a pregnant person’s cardiovascular health, and that of their child.((Perak AM, Lancki N, Kuang A, et al. Associations of Maternal Cardiovascular Health in Pregnancy With Offspring Cardiovascular Health in Early Adolescence. JAMA. 2021;325(7):658–668. doi:10.1001/jama.2021.0247)) This study followed over 2000 mother-child pairings and collected data about how the mother fared during pregnancy: What her body mass index (BMI) was, along with measuring blood pressure, cholesterol levels, glucose levels, and smoking habits throughout her pregnancy.
Why these seemingly random data points? Although they may seem unrelated, these are all super important for assessing risk of cardiovascular disease, like coronary artery disease or metabolic syndrome. Especially during pregnancy, there is an increased amount of work that the pregnant person’s heart needs to do to supply blood to herself as well as the child.
This means that people in pregnancy are checked often for things like their blood pressure or whether or not they have gestational diabetes to ensure that both mother and child are healthy and safe.
What this study shows us is that it isn’t just about birth. The pregnant parent’s cardiovascular status during pregnancy was actually associated with the child’s cardiovascular health years after birth, all the way up into adolescence.
In total, these researchers found that pregnant people who had better cardiovascular health at the 28-week gestational age were significantly associated with their child also having better cardiovascular health at ages 10-14.
This study and others like it reaffirm that taking care of yourself is so important, both during pregnancy and generally throughout your life. Keeping an eye on your cholesterol levels, choosing fresh fruits and veg over the tempting vending machine snacks whenever possible, and exercising regularly can all help you live a heart-healthy life. Who knows… those ripple effects may even last for generations to come.
This article is informational only and is not offered as medical advice, nor does it substitute for a consultation with your physician. If you have any gynecological/medical concerns or conditions, please consult your physician.
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