Hormone Replacement Therapy Update

Course Transcript (Excerpt)

Introduction & Objectives

Excited to be here with you all today. So my name is Chelsea Kitty. I'm a clinical assistant professor at the University of Georgia College of Pharmacy. I'll be talking with you this morning about two topics. So we'll dig into that today and talk about what that evidence showed, what that means, and how perspective and information has changed in data collection as we continue to get information on these patients over longer periods of time. So defining.

What is Hormone Replacement Therapy

The first of that is gonna be hormone replacement therapy, specifically in our postmenopausal population. So I don't have anything to disclose for this presentation. Our objectives are going to be to discuss new guidelines for hormone replacement therapy or HRT, specifically in our postmenopausal and menopausal patients, and to discuss the risks and benefits of newer formulations and delivery methods for these medications.

So how do we define menopause? Menopause is defined as the permanent cessation of menstruation caused by loss of ovarian function. It can occur at different ages in different individuals, but the overall mean age is 52 years, and in the United States, we estimate that about 6,000 women enter menopause each day. I think this is really pertinent because menopause is is something that,, every woman is going to reach that stage eventually. So I think this is really important to understand for our patients and talk about, because it's something that we're all probably going to encounter regularly, regardless of,, the patients that it is that you're treating. And there can be a lot of things that go along with menopause and patient education surrounding menopause and treatment of various things within menopausal and postmenopausal women.

Before we talk about the treatment options for hormone replacement therapy, I wanna spend a good bit of time talking about the history of hormone replacement therapy and the history of treatment surrounding hormone replacement therapy in the United States because it's been a bit of an up and down journey, it's led to a lot of confusion and misperceptions surrounding hormone replacement therapy. There's a lot of information out there, there's a lot of conflicting information out there,, from reputable bodies of evidence. So it can be challenging for clinicians to decide what to do and how to treat individualized patients.

So in 1942, conjugated equine estrogen was first introduced on the market. So this was huge. So you see on that left hand column, we're looking at the trends in hormone therapy prescriptions per year in the millions. So we see a drop in the prescriptions related to hormone replacement therapy around the 1980 mark. So once that happened, they designed a product that was our first combined product on the market. So that combined estrogen with progestin therapy, which was found to give some protective effect against the estrogen's likelihood of causing that disruption of the endometrial line. So from here, we really saw a rapid increase over that next 10 to 20 years of the prescriptions for hormone replacement therapy. So at the all time high, we were at 90 to a hundred million prescriptions per year of hormone replacement therapy.

So things were going great in the world of hormone replacement therapy until about the late nineties, early two thousands when we had two series of landmarks trials published, the hers trial and the WHI trial, which were initially intended to look more into that potential protective or positive benefit of cardiovascular health. They however, found that there was a increased cardiovascular risk with hormone replacement therapy. And from there we saw a dramatic decrease in the number of hormone replacement therapy prescriptions.

So by the year 2010, we were down below,, that,, down down below that initial prescribing rates when these came on the market almost a hundred years prior. So that's where we've been in the last 20 years, is hormone replacement therapy is not used very often and there's a lot of hesitancy and concern around the prescribing of these medications and often rightfully so because of what some of these trials showed.

Indications & Symptoms

But the most concerning or the most bothersome of those is often these vasomotor symptoms are also referred to as VMS. So vasomotor symptoms can be very uncomfortable for women. They can cause a lot of both physical and mental implications. So we're talking about things like hot flashes, night sweats, sudden cessation of heat or flushing in the face and chest anxiety, sleep disruption. Ultimately, all of these things often lead to an overall reduced quality of life. It's thought that vasomotor symptoms occur in 75% of women during the menopause transition. So again, this is not something that is rare or unheard of. So African American patients, those who use tobacco, those with a history of mood disorders or those with lower income. So certainly far reaching and widespread and can be very concerning and ultimately reduce that quality of life for our patients.

Genital urinary syndrome of menopause or GSM is less common than vasomotor symptoms. This affects the vulva, the vagina and or the lower urinary tract. Symptoms that occur with this phenomenon are vaginal dryness, painful intercourse, or urinary difficulties. These symptoms are ultimately due to declining estrogen levels. So when we get into our therapy options, when we're talking about GSM, we're often talking about localized or vaginal treatment options that don't necessarily need systemic therapy the way that our vasomotor symptoms do. So prior to that, there was no widely recognized treatment for post-menopausal women for these vasomotor symptoms. So all of the sudden now there's a treatment option on the market, which was really exciting. There was even some thought at that point that not only were these medications successfully treating these vasomotor symptoms, but perhaps they were also giving some protective effects with regards to cardiovascular risks.

Forms & Routes of Therapy

So this is certainly not something that is rare or not commonly occurring. It's very common during this time. It can be more common in certain populations.

Risks & Safety Considerations

However, around 1975 prescriptions had reached about 60 million prescriptions a year for our estrogen therapy studies came out that revealed there was an increased risk of endometrial cancer with this therapy, obviously, and rightfully so that was concerning. So adding the progestin supplement to the estrogen allowed for a decrease in the risk of developing that endometrial cancer.

Monitoring & Follow-Up

So all of a sudden you have this gradual increase and in terms of tens of millions of additional prescriptions per year following the release of that product on the market.