Learn more about how Divigel® works
00:00:01;04(MUSIC NOT TRANSCRIBED)
DR. SABRINA SAHNI:
00:00:04;22I'm Dr. Sabrina Sahni, and I'm a women's health specialist and breast medicine physician in Jacksonville. And I'm a paid speaker presenting on behalf of Avion Pharmaceuticals, and Avion is a sponsor of this program and event. The content of this promotional slide deck and program was developed by Avion Pharmaceuticals, LLC. This is not a continuing education event, and no CE credit will be provided.
00:00:27;24(MUSIC NOT TRANSCRIBED)
DR. SABRINA SAHNI:
00:00:42;24Divigel is actually a great option because it's indicated for the treatment for moderate to severe vasomotor symptoms due to menopause. And there was a fantastic Phase III randomized trial that was done that looked at the efficacy of Divigel across various doses.
00:00:56;24So they had 500 women, they gave them all different doses of Divigel, and they followed them for 12 weeks. And the great part is is that most of the side effects were actually mild to moderate in severity. So you can see here on this chart things like breast tenderness, post-menopausal bleeding, those common side effects that we would see.
00:01:15;01Now, the other side of that is what did the efficacy show, right? So we know from this study that Divigel significantly reduced the frequency of vasomotor symptoms in just two weeks. And I absolutely love this chart because I think it does a great job of kind of breaking down efficacy of different doses of Divigel, and at different time periods.
00:01:33;24So you can see, if you put a woman even on the lowest dose of Divigel, she's gonna still have a 71% benefit at 12 weeks, which is pretty fantastic, 90% in the higher dose. And these women are gonna see benefit as early as two weeks.
00:01:47;24And so, for our patients that want that fast, immediate result-- because, again, these hot flashes and these other symptoms are gonna be debilitating for them, right? They want that fast onset. This is such a great option with really great da-- great data to back up the efficacy of it.
SARA DIAMOND:
00:02:03;09And who doesn't want relief quickly?
DR. SABRINA SAHNI:
00:02:05;14Exactly. Exactly. Absolute--
SARA DIAMOND:
00:02:06;24When you're taking any kinda medication?
DR. SABRINA SAHNI:
00:02:08;10Exactly. So this is something you can also tell your patients, you know, when you kind of do that anticipatory guidance: "All right: We're gonna start this medication, and you're gonna feel better in about two weeks. And if you don't, let me know."
00:02:18;24And the benefit of having that kinda conversation is that you allow the patient to kind of set the bar that she's not gonna notice immediate side eff-- or immediate benefit within 24 hours of taking it, right? But, if at two weeks she's really not noticing a significant improvement, there's a lot of other doses that can help her get to where she wants to be.
SARA DIAMOND:
00:02:38;01Mmm-Hmm. Let me ask you: What about patients who come to you because they can't stand the side effects of oral hormone therapy that they're on? Could you, and would you, consider Divigel in these patients as well?
DR. SABRINA SAHNI:
00:02:50;21Absolutely. I think that there's, you know, a lot of really great factors associated with Divigel. We know the efficacy was great. We looked back at those charts earlier, which really showed significant improvement, as early as two weeks. And up to 90% im-- improvement in reduction of hot flashes by week 12.
00:03:08;00So certainly the efficacy is there. Again, from that side effect profile, if somebody doesn't wanna be on an oral and I'm concerned about things like stroke and blood clot, this is another great option, to put 'em on a transdermal or topical option.
00:03:21;00It's convenient, Divigel is really convenient, meaning you can use it whenever, you can throw the pouch in your purse, you can do it discreetly, and, again, there's flexible dosing. So that really allows us to kinda tailor our-- our treatment plan for each individual woman.
00:03:34;24Because, like we've been saying, it really isn't a one-size-fit-all. And the other thing I'll really comment about is anytime you're thinking about prescribing menopausal hormone therapy, you gotta look at whole picture, right? So you gotta look at the whole woman.
00:03:47;23I think lifestyle is really important, right? So is she busy? Is she working? How-- accessible is this gonna be for her to use? Does she want to be taking pills in front of people, you know? Is the patch gonna show through clothes? Things like that: These are all factors that-- that sh-- really should be-- considered.
References:
- Divigel® [package insert]. Vertical Pharmaceuticals, LLC; 2019.
- Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
See the differences between Divigel® and a transdermal patch
* * *TRANSCRIBER'S NOTE: DR. SAHNI WEARING BANGLES THAT RATTLE WHEN SHE USES HER HANDS.* * *
00:00:00;00(MUSIC NOT TRANSCRIBED)
DR. SABRINA SAHNI:
00:00:05;03I'm Dr. Sabrina Sahni, and I'm a women's health specialist and breast medicine physician in Jacksonville. And I'm a paid speaker presenting on behalf of Avion Pharmaceuticals, and Avion is a sponsor of this program and event. The content of this promotional slide deck and program was developed by Avion Pharmaceuticals, LLC. This is not a continuing education event, and no CE credit will be provided.
00:00:28;00(MUSIC NOT TRANSCRIBED)
SARA DIAMOND:
00:00:42;19Let's look at 50-year-old Jennifer. She is coming in with complaints of discomfort-- irritation. She was started on an estrogen patch and an oral progesterone two weeks ago. She is experiencing quite a bit of discomfort with that patch and irritation at the site of application. So, given this, would you consider another topical like Divigel-- in this situation with this patient?
DR. SABRINA SAHNI:
00:01:10;02This is also another really important point to make, is that up to 50% of women that are on a transdermal estrogen actually may-- notice application-site symptoms. So things like tenderness or itching or swelling at the site of their patch.
00:01:23;15And it can be really bothersome for patients. I know that-- I practice down here in Florida, and so I have patients that are in the-- the humidity and the heat, or at-- or at the beach-- or in pools, and so that adhesive may not stick that well. So this is actually a very valid and common concern. I do think that Divigel would be a really great option for-- for somebody like her, who-- who's having some of that issues.
SARA DIAMOND:
00:01:46;00I don't think a lot of people think about--
DR. SABRINA SAHNI:
00:01:48;20Yeah.
SARA DIAMOND:
00:01:48;19--things like that. So a topical gel like Divigel would probably be a great option in-- in patients who can't stand the-- the problems that may be associated with that transdermal patch. And I think some women may-- may not choose to go on a therapy because they have--
DR. SABRINA SAHNI:
00:02:02;24Yeah.
SARA DIAMOND:
00:02:03;00--some misconceptions that-- that it is going to be messy, with the application; it's gonna be hard to take; it's gonna be visible under their clothing, they don't want people to see that, you know? So what would you say or recommend to these women when they come to you with these concerns?
DR. SABRINA SAHNI:
00:02:17;00I mean, Divigel's great. It's colorless, it clears, it dries very quickly. I tell women, "You know, once you apply it to the upper thigh, just wait a couple of minutes. I want you to wait about 60 minutes before-- getting into any kind of pool, or get-- taking a shower or a bath, or really coming into contact with any other-- individual.
00:02:35;12It's portable. Again, you can throw it in your purse. You can go run errands. You can put it on throughout the day. It's discreet. It's really easy, I think, for people to use. And, again, that efficacy factor really kinda sticks in my head in terms of how great of a product it is.
References:
- Ale I, Lachapelle JM, Maibach HI. Skin tolerability associated with transdermal drug delivery systems: an overview. Adv Ther. 2009;26(10):920-935.
Transdermal or oral medication— which is best for your patients?
00:00:00;00(MUSIC NOT TRANSCRIBED)
DR. SABRINA SAHNI:
00:00:05;01I'm Dr. Sabrina Sahni, and I'm a women's health specialist and breast medicine physician in Jacksonville. And I'm a paid speaker presenting on behalf of Avion Pharmaceuticals, and Avion is a sponsor of this program and event. The content of this promotional slide deck and program was developed by Avion Pharmaceuticals, LLC. This is not a continuing education event, and no CE credit will be provided.
00:00:27;12(MUSIC NOT TRANSCRIBED)
SARA DIAMOND:
00:00:42;11Let's talk about-- and there are many, treatment options and-- something you called "the route of administration."
DR. SABRINA SAHNI:
00:00:50;18Yes. And this is really important. So this is a great chart that really does a great job summarizing different preparations that are available. So we have oral estrogens, we have oral estrogens plus progesterones, we have oral estrogens plus newer progesterone derivatives that are available.
00:01:05;24We have patches, combination patches, gels, we have vaginal preparations specific for vaginal-- symptoms. So route of administration, as we'll talk about throughout this program, really has a profound impact on our patients and-- and how we treat them.
SARA DIAMOND:
00:01:21;04So let's talk about non-oral administration-- and something called "first-pass liver metabolism."
DR. SABRINA SAHNI:
00:01:28;24Yes. This is a-- I'm glad that you brought this up. So oral agents, especially when it comes to estrogens, are-- go through the liver and are metabolized in the liver. Topical products like transdermal patches, or topical gels like Divigel, actually bypass that completely. So there's a lot of benefit to that. So you can use it safely without-- fear of con-- contraindicating with other medications.
00:01:53;11The other thing that's a benefit is that we know that things like cholesterol is metabolized in the liver. So sometimes we see an increase of cholesterol levels with oral agents, and we don't see that as much with topicals or transdermals. So, again, something you should be considering in our women that may have some of those risk factors.
SARA DIAMOND:
00:02:09;14So, speaking of risk factors, let's go over the risks of topical therapy.
DR. SABRINA SAHNI:
00:02:16;02With any estrogen-containing product-- you know, there are benefits and there are risks. So the benefits of a topical product in particular is that there's flexibility with dosages. And the lower the doses, the better the side effect profile will be.
00:02:28;03Again, we talked about bypassing that first-pass metabolism, which also will lead to fewer discontinuation rates. Now, the off side of that are the risks that we were talking, about, right? So any estrogen-containing product can carry the risk for breast tenderness, which we see even with a generic birth control pill, right?
00:02:44;13Post-menopausal bleeding is another common side effect that we may notice with menopausal hormone therapy. And that's really seen with "unopposed" estrogen, so meaning people that are given systemic doses of estrogen without a progesterone for uterine protection; and certain cancers, as well as cardiovascular disease, as well.
SARA DIAMOND:
00:03:03;04Let's talk about the benefits and the risks involved with hormone therapy in general.
DR. SABRINA SAHNI:
00:03:09;24Absolutely.
SARA DIAMOND:
00:03:09;24This is a hot topic, and it--
DR. SABRINA SAHNI:
00:03:11;24Absolutely.
SARA DIAMOND:
00:03:11;24--has been for several years--
DR. SABRINA SAHNI:
00:03:13;16Yes.
SARA DIAMOND:
00:03:13;15--now. We also want to talk about the additional risks in patients with a hysterectomy.
DR. SABRINA SAHNI:
00:03:18;05Yeah, absolutely. So this is-- I mean, we could do an entire session just talking about risks and benefits. But generally what I tell people is that, "If you have menopausal symptoms, the most effective treatment is menopausal hormone therapy." And that's been proven time and time again.
00:03:32;11I think we've come a really, really long way in terms of studies over the last 20 years kind of helping us understand hormone therapy as it relates to risks and benefits. I think for the thing that we know, is we like to prescribe hormone therapy early, which I sort of alluded to earlier with Maria.
SARA DIAMOND:
00:03:50;05Exactly.
DR. SABRINA SAHNI:
00:03:50;07This idea of a timing hypothesis, right? So you want to prescribe under the age of 60 or within ten years of the onset of menopause, and, generally, the benefits will outweigh the risks. We start to see a lot of the risks associated with hormone therapy kinda creep up around that 60-to-65 mark.
00:04:07;23We also know through other studies that route of administration matters, right? So that table really comes into play when we think about different risks associated with-- with hormones. Transdermal topical agents really don't carry the same side effects of stroke and blood clot that an oral agent does, right?
00:04:23;24Oral agents, whether it's a birth-control pill or-- a menopausal dose, will increase the risk for stroke or blood clot, and it's dose-dependent. So the higher the dose you are, the higher the risk. The benefit of the study that looked at topicals is that, across the board, there was really no increased risk for VTE in any of the doses.
00:04:40;12So this is a really reassuring-- study that-- that allows us to safely prescribe patients that may be at an increased risk, or that may have had an unprovoked-- DVT-- or provoked DVT in the past. The other thing about route of administration is vaginal estrogens are different.
00:04:56;11So vaginal estrogens are really different than systemic doses. So we think about things like breast cancer risk, which I think is a huge thing that a lot of women are concerned about; or cardiovascular risk. Vaginal preparations don't carry that risk, so women can use that very freely without concern for increased risk for c-- for cancers or for cardiovascular disease.
00:05:16;10The other big study that I think came out or-- in early 2017 was an 18-year follow-up from the original Women's Health Initiative. And what it did it-- was it looked at all of those women, and looked at their all-cause mortality. And they found that women that were post-menopausal that took hormone therapy actually did not have an increased risk for all-cause mortality, cardiovascular disease, and cancer. So, again, a lot of really great evidence-based data that's come out regarding hormone therapy in the last 20 years.
SARA DIAMOND:
00:05:42;04If a woman wants to transition from an oral to a transdermal, is-- is it a tough process to totally switch the way this is being administered, I guess?
DR. SABRINA SAHNI:
00:05:52;24It's actually really seamless. I mean--
SARA DIAMOND:
00:05:54;19Oh.
DR. SABRINA SAHNI:
00:05:54;17--if we're going from an oral estradiol to-- a topical estradiol, I just, you know, say, "If you took your dose today, start this tomorrow," right? And it's-- it's pretty seamless, especially when you're converting estradiol to an estradiol and you're keeping things at the same dose. So it's actually a very easy transition for-- for women to-- to j-- to do.
SARA DIAMOND:
00:06:11;21Patients like "easy."
DR. SABRINA SAHNI:
00:06:12;19Yes: Patients (LAUGH) like "easy," patients like "convenience," patients like all of that. So this is-- you know, and that's what I tell them, you know? "If you took your pill today, first thing tomorrow morning, you go ahead and you use your Divigel, you know, kind of on the upper thigh, and then you go about your day. You don't have to think about it after that.
SARA DIAMOND:
00:06:26;22Right.
DR. SABRINA SAHNI:
00:06:26;22So, yeah, it's great.
References:
- Hill DA, Crider M, Hill SR. Hormone Therapy and Other Treatments for Symptoms of Menopause. Am Fam Physician. 2016;94(11):884-889.
- Ogen® product information. Accessed April 22, 2022. https://www.pfizer.com/products/product-detail/ogen
- FDA Approved Drugs. Ogen®. Accessed April 22, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=083220
- Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
- Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.
- Bhupathiraju SN, Grodstein F, Stampfer MJ, et al. Vaginal estrogen use and chronic disease risk in the Nurses' Health Study. Menopause. 2018;26(6):603-610.
- Manson JE, Aragaki AK, Rossouw JE, et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA. 2017;318(10):927-938.
What you should know about hormone pellet therapy
00:00:00;07(MUSIC NOT TRANSCRIBED)
DR. SABRINA SAHNI:
00:00:04;23I'm Dr. Sabrina Sahni, and I'm a women's health specialist and breast medicine physician in Jacksonville. And I'm a paid speaker presenting on behalf of Avion Pharmaceuticals, and Avion is a sponsor of this program and event. The content of this promotional slide deck and program was developed by Avion Pharmaceuticals, LLC. This is not a continuing education event, and no CE credit will be provided.
00:00:28;00(MUSIC NOT TRANSCRIBED)
SARA DIAMOND:
00:00:42;24This is 64-year-old Maria. She is presenting to your office: no major complaints here. It's her annual-- and she's coming in and she does have concerns, though, about the long-term use of oral HT. She has a history of osteopenia, hypothyroidism, and well-controlled hypertension. She's also had a partial hysterectomy for fibroids. So what are you thoughts on this case?
DR. SABRINA SAHNI:
00:01:11;08This is a really great case, and a really common ano-- again, another common patient that we'll see in our practice, of somebody who's already been on hormones for a long period of time that is now coming to you and asking like, you know, "Should I really be on this anymore?"
00:01:24;09So I think her case in particular brings up a lot of really great points. So she's 64 years old, she's been on this for several years. We'll talk a little bit about this later, but this thought of the "timing hypothesis," meaning prescribing hormone therapy early to our patients: Really, the benefits generally outweigh the risks at that point.
00:01:43;04We have different combinations, right? So estrogen alone can be given to women with-- an-- without a uterus-- because they won't require that progesterone for the-- for the endometrial protection. And then we can use it locally for vaginal symptoms. So that can be used, really, in any woman with or without a uterus-- safely.
00:02:01;24Estrogen plus a progesterone, again, we use specifically for women that have a uterus intact. And then kinda this buzz about "bioidentical" hormones, which is somewhat of a newer phenomenon. But really what that means are struct-- or-- hormones that are chemically or structurally similar to what your own body would make.
00:02:18;24And within that, there are two types: There's FDA-approved forms of bioidentical hormone therapies that's really backed by great evidence-based medicine. And then there's, unfortunately, a whole subset of unregulated hormones that can be, oftentimes, dangerous for our patients. So kind of debunking some-- some of those treatment options is important.
SARA DIAMOND:
00:02:35;11What are your thoughts on non-FDA-approved hormone pellets?
DR. SABRINA SAHNI:
00:02:41;03So this is, like, another really good question. I think there's been this huge buzz about bioidentical hormones. And, for those that may not be as familiar with what pellets are, they're basically subcutaneous implants of various doses of estrogen or progesterone or testosterone. And in my experience of treating patients that have come to see me that have had pellets in them, I tend to see more-- risks associated with their use. So they--
SARA DIAMOND:
00:03:03;07Oh.
DR. SABRINA SAHNI:
00:03:03;08--tend to have much higher levels of estrogen than indicated for a post-menopausal woman-- much higher levels of testosterone-- than indicated for a post-menopausal woman. So I generally don't prescribe or don't perform pellet-- pellets in my office. But, you know, when I do see a patient that has been on pellets, I try to talk to them about some of those risks.
00:03:22;21Because, again, even though it's not an oral agent, those high levels of estrogen she may be getting can increase things like risk of stroke or blood clot or different cancers. So I think really talking to her about alternative options might be a good opt-- a good way to go.
SARA DIAMOND:
So maybe because you're-- you're feeling better, that doesn't necessarily mean that—
DR. SABRINA SAHNI:
00:03:41;12It's the safest.
SARA DIAMOND:
00:03:42;15Right.
DR. SABRINA SAHNI:
00:03:43;13And we just don't have enough data behind it, to be honest with you. The good thing about things like an estradiol-based hormone therapy is we have a lot of really good data for several, several years. And I think that that makes physicians and clinicians really comfortable with prescribing these medications.
References:
- Hill DA, Crider M, Hill SR. Hormone Therapy and Other Treatments for Symptoms of Menopause. Am Fam Physician. 2016;94(11):884-889.
Get the full Divigel® story from our webcast with Dr. Sahni, a women's health specialist
SARA DIAMOND:
00:00:03;00(MUSIC) Welcome to the Uniquely Hers educational series. My name is Sara Diamond and I'll be your host for our program today. Before we begin and introduce our speaker, I want to let you know that the important safety information that you see here onscreen for Divigel, the product we'll be speaking about today, can be read in its entirety by visiting www.divigel.com.
00:00:29;05And we want to welcome Dr. Sahni for our viewers-- our-- Dr. Sabrina Sahni is an expert in the treatment of menopause. She is passionate about educating the community on the risks and the benefits of hormone therapy. It's so good to have you here today to discuss this topical menopause hormone therapy with us today.
DR. SABRINA SAHNI:
00:00:50;05Thank you so much. And thank you so much for having me. I'm Dr. Sabrina Sahni and I'm a women's health specialist and breast medicine physician in Jacksonville. And I'm a paid speaker presenting on behalf of Avion Pharmaceuticals. And Avion is a sponsor of this program and event. The content of this promotional slide deck and program was developed by Avion Pharmaceuticals LLC. This is not a continuing education event. And no CE credit will be provided.
SARA DIAMOND:
00:01:15;24So, Dr. Sahni, I'm hoping that by speaking with you today, we can better understand the approach to menopause hormone therapy. We can learn about the benefits and the risks associated with it and also learn about a specific topical therapy called Divigel.
00:01:32;12So for our audience, please submit your questions for Dr. Sahni. You can do it at any time during the program at the bottom of your screen. We will get to as many questions as possible during our Q&A session that will be at the end of our program.
00:01:48;22So let's start off with talking about what menopause is and what kinds of signs and symptoms to watch out for. Dr. Sahni, I have read that-- up to 74% of menopausal women may experience vasomotor systems, but only 7% receive treatment for those symptoms.
00:02:10;05We wanna know what's going on here and what do you do when a patient comes to you with VMS symptoms. So we have a patient case we'd like to present to you. Our first one, a 46-year-old patient named Michelle, she presents to your office with complaints of hot flashes and night sweats and it's gone on for about six months now.
00:02:31;05Her last menstrual period was in September of last year. Now, she has tried several over-the-counter things with minimal relief. She has a history of two pregnancies. And currently, she is not on any contraception because she's in a monogamous relationship with her husband, who has had a vasectomy. So what's going on here?
DR. SABRINA SAHNI:
00:02:53;21So this is a really great case and certainly, a prime example of what we could see in our primary care office or even our OBGYN offices. And so the first thing that really kind of stands out to me about this patient is that she is in fact in perimenopause.
00:03:07;01So she hasn't quite gone through the 12 consecutive months without a period that would indicate menopause. So perimenopause is really kind of that transitional period that-- that women can experience before that final menstrual period.
00:03:20;00And in women, really perimenopause is not only the most symptomatic time for women, but it can be pretty long, in terms of duration. So eight to ten years is kind of the average-- average length for-- for perimenopause. So, I mean, if you think about it, women who are just turning 40 may start to experience perimenopausal symptoms pretty early on. But the good news is that we have really good treatments available for these patients.
SARA DIAMOND:
00:03:44;16That's wonderful. Let's take a look at-- you were talking about perimenopause and menopause. Okay, let's talk about menopause, what exactly it is.
DR. SABRINA SAHNI:
00:03:52;05Absolutely. So if a perimenopause is that transition period, then menopause is really marked by that final menstrual part-- period, so 12 consecutive months with no-- vaginal bleeding. And this is really due to the kind of-- the-- loss of ovarian function over time.
00:04:07;19And this is a natural process that women will experience. The average age of menopause in the United States is about 51 to 51.5. so-- that would be the time that women would might-- might start to experience some of their-- their changing in bleeding patterns.
00:04:21;24Now, it can also occur surgically. So we can also surgically remove the or-- ovaries for benign or malignant reasons. And that would be kind of a surgical menopause, or sometimes menopause can occur from different medications, like chemotherapies or even radiation for certain cancers, and then something called primary ovarian insufficiency, which is really a menopause that occurs before the age of 40.
SARA DIAMOND:
00:04:43;09Well, let's talk about the signs and the symptoms of menopause.
DR. SABRINA SAHNI:
00:04:45;21Yeah. Definitely. So there is a constellation of signs and symptoms with menopause. So you can see here on this chart the classic signs and symptoms. And the first, you know-- the-- probably the earliest symptom that women may experience is kind of this change in bleeding pattern.
00:05:00;04So women may experience that their periods are more erratic than normal, that they're skipping cycles every couple of months. But interestingly, women may also come to you and say, "Hey. My bleeding is a lot heavier than normal," or, "It's a lot lighter than normal." So it's not just the frequency; it also could be the severity.
00:05:15;24Vasomotor symptoms, again, like you talked about, can affect almost 80% of women, in terms of hot flashes and night sweats. But one symptom from a vasomotor standpoint that can sometimes go unnoticed is palpation. So women can sometimes feel that-- racing heart rate and think that they have some sort of cardiovascular thing going on, but sometimes it's really just related to menopause.
00:05:35;24Genital urinary syndrome of menopause or GSM really kind of encompasses the constellation of vaginal symptoms and sexual dysfunction, as well as urinary symptoms. But, you know, women can experience symptoms from head to toe. We have estrogen receptors really throughout the entire body.
00:05:52;05So when-- we have fluctuating hormone levels or decreased levels of estrogen, all of those symptoms are gonna get hit. So you can have things like mood changes, you can have difficulties with sleep, you can have changes in your weight-- which is another common concern we hear about a lot that can be really kind of stressful for women, for sure-- bone loss is another big one, and joint pain. So there's really a variety of different symptoms that a woman can present with, not just the hot flashes and night sweats.
SARA DIAMOND:
00:06:18;00Well, with this constellation-- and I love that you use that word-- a constellation of different signs and symptoms, why do you think that so few of these patients are going and receiving treatment for them?
DR. SABRINA SAHNI:
00:06:31;03Right. So I think it really is multi-factorial. I think for so long, women have been kind of pressured to think that they just kind of go through the menopause transition and that's something that they have to deal with. So whether it's-- not being aware of certain options that are available for treatment, or just kind of following in suit with our mothers and grandmothers when they went through menopause, things have really changed in-- in really the last 20 to 25 years.
00:06:54;01And so I think part of that is-- is kind of this-- this societal pressure that we just kind of go through it, it happens, and we get past it, and we continue on with our lives, we don't need to do anything about it. And then, I also think it's-- you know, in part, you know, as physicians and clinicians, you know, maybe we're not asking the right questions to really capture these women. I mean, we talked about things outside of hot flashes and night sweats. A woman could be in the 20% that don't experience them, but really experience all of the other symptoms that maybe aren't getting asked during their visit.
SARA DIAMOND:
00:07:23;09That's a good point. That-- so let's talk about the consideration in this-- case patient in Michelle. What are some of the most-- the most important considerations you take away from this for her case?
DR. SABRINA SAHNI:
00:07:35;01Sure. So because she's perimenopausal, I want to know how debilitating are her symptoms. Again, this is the most symptomatic time for women. And the other part are what are her contraceptive needs? We know that she's in a monogamous relationship and she doesn't actually require contraception.
00:07:47;24So I think something like a Divigel would be a really great option for her. She does have a uterus intact, so we have to consider the progesterone component. And really, the options are endless, really. I mean, it's never a one-size-fits-all for patients when it comes to hormone therapy.
00:08:01;24So you could-- offer her things like cycled progesterone, where you offer her progesterone for half of the month and allow her to have a cycle, if she needs to. You know, if Michelle was-- desiring contraception, she could still go on something like a Divigel and be offered a progesterone-containing IUD, or she could be offered a progesterone-containing birth control pill, so again, lots of options.
SARA DIAMOND:
00:08:24;15Okay. So (LAUGH) it's not a one-size-fits-all.
DR. SABRINA SAHNI:
00:08:28;01Absolutely.
SARA DIAMOND:
00:08:28;02We can definitely take that away. A lot of treatment options out there for women with menopause. And I wanna actually talk about that a little bit more and get a little bit deeper with that. With so many options out there for-- for women, would you consider the use of a topical in a patient who is concerned about the risks of HT? And HT is something we're gonna be talking about now and a little bit later, as well.
00:08:54;06I wanna give you another example of a patient. This is 64-year-old Maria. She is presenting to your office-- no major complaints here-- it's her annual-- and she's coming in. And she does have concerns, though, about the long-term use of oral HT. She has a history of osteopenia hypothyroidism and well-controlled hypertension. She's also had a partial hysterectomy for fibroids. So what are your thoughts on this case?
DR. SABRINA SAHNI:
00:09:25;24This is a really great case and a really common-- and again, another common patient that we'll see in our practice of somebody who's already been on hormones for a long period of time that is not coming to you and asking, like, "You know, should I really be on this anymore?"
00:09:38;16So I think her case in particular brings up a lot of really great points. So she's 64 years old. She's been on this for several years. We'll talk a little bit about this later, but the thought of the timing hypothesis, meaning prescribing hormone therapy early to our patients, really, the benefits generally outweigh the risks, at that point.
00:09:57;21We have different combinations, right? So estrogen alone can be given to women with-- without a uterus-- because they won't require that progesterone for that-- for the endometrial protection. And then, we can use it locally for vaginal symptoms. So that can be used-- really in any woman with or without a uterus-- safely.
00:10:16;08Estrogen plus a progesterone, again, we use specifically for women that have a uterus intact. And then, kind of this buzz about bioidentical hormones, which is somewhat of a newer phenomenon, but really what that means are-- is-- hormones that are chemically or structurally similar to what your own body would make.
00:10:33;12And within that, there are two types. There's FDA-approved forms of bioidentical hormone therapies that really backed by great evidence-based medicine. And then, there's unfortunately a whole subset of unregulated hormones that can be oftentimes dangerous for our patients. So kind of debunking some-- some of those treatment options is important.
SARA DIAMOND:
00:10:50;02Okay. Let's talk about-- and there are many-- treatment options and-- something you call the route of administration.
DR. SABRINA SAHNI:
00:10:59;12Yes. And this is really important. So this is great chart that really does a great job summarizing different preparations that are available. So we have oral estrogens. We have oral estrogens plus progesterones. We have oral estrogens plus newer progesterone derivatives that are available.
00:11:15;04We have patches, combination patches, gels. We have vaginal preparation specific for vaginal-- symptoms. So route of administration, as we'll talk about throughout this program, really has a profound impact on our patients and-- and how we treat them.
SARA DIAMOND:
00:11:29;18So let's talk about non-oral administration and something called first pass liver metabolism.
DR. SABRINA SAHNI:
00:11:37;13Yes. This is-- I'm glad that you brought this up. So oral agents, especially when it comes to estrogens, are-- go through the liver and are metabolized in the liver. Topical products like transdermal patches or topical gels like Divigel actually bypass that completely.
00:11:52;24So there's a lot of benefit to that. So you can use it safely without-- fear of con-- contra-indicating with other medications. The other things that's a benefit is that we know that things like cholesterol is metabolized in the liver. So sometimes, we see an increase of cholesterol levels with oral agents. And then, we don't see that as much with topical or transdermals, so again, something you should be considering in our women that may have some of those risk factors.
SARA DIAMOND:
00:12:18;00So speaking of risk factors, let's go over the risks of topical therapy.
DR. SABRINA SAHNI:
00:12:23;24Yeah. So with any estrogen-- containing product, you know, there are benefits and there are risks. So the benefits of a topical product, in particular, is that there's flexibility with dosages. And the lower the doses, the better the side effect profile will be.
00:12:36;24Again, we talked about bypassing that first-pass metabolism, which also will lead to fewer discontinuation rates. Now, the offside of that are the risks that we were talking about, right? So any estrogen-containing product can carry the risk for breast tenderness, which we see even with generic birth control pill, right?
00:12:53;17Post-menopausal bleeding is another common side effect that we may notice with menopausal hormone therapy. And that's really seen with unopposed estrogen, so meaning people that are given systemic doses of estrogen without a progesterone for uterine protection and certain cancers, as well as vascular disease, as well.
SARA DIAMOND:
00:13:11;24Well, it sounds like this is a good option for a wide variety of patients?
DR. SABRINA SAHNI:
00:13:15;24Yeah. Absolutely. So Divigel is actually a great option because it's indicated for the treatment for moderate to severe vasomotor symptoms, due to menopause. And there was a fantastic phase 3 randomized trial that was done that looked at the efficacy of Divigel across various doses.
00:13:32;01So they had 500 women. They gave them all different doses of Divigel. And they followed them for 12 weeks. And the great part is is that most of the side effects were actually mild to moderate in severity. So you can see here on this chart things like breast tenderness, post-menopausal bleeding, those common side effects that we would see.
00:13:49;22Now, the other side of that is what does the efficacy show, right? So we know from this study that Divigel significantly reduced the frequency of vasomotor symptoms in just two weeks. And I absolutely love this chart because I think it does a great job of kind of breaking down efficacy of different doses of Divigel and at different time periods.
00:14:08;22So you can see if you put a woman even on the lowest dose of Divigel, she's gonna still have a 71% benefit at 12 weeks-- which is pretty fantastic-- 90% in the higher dose. And these women are gonna see benefit as early as two weeks.
00:14:23;13And so for our patients that want that fast, immediate result-- because again, these hot flashes and these other symptoms are gonna be debilitating for them, right, they want that fast onset-- this is such a great option with really great-- great data to back up the efficacy of it.
SARA DIAMOND:
00:14:37;13Uh-huh (AFFIRM). And who doesn't want relief quickly?
DR. SABRINA SAHNI:
00:14:40;14Exactly. Exactly. Absolutely.
SARA DIAMOND:
00:14:41;24When you're taking any kind of medication.
DR. SABRINA SAHNI:
00:14:42;24Exactly. So this is something you can also tell your patients, you know, when you kind of do that anticipatory guidance. "All right. We're gonna start this medication. And you're gonna feel better in about two weeks. And if you don't, let me know."
00:14:53;21And the benefit of having that kind of conversation is that you allow the patient to kind of set the bar that she's not gonna notice immediate side effect-- or immediate benefit within 24 hours of taking it, right? But if at two weeks, she's really not noticing a significant improvement, there's a lot of other doses that can help her get to where she wants to be, so.
SARA DIAMOND:
00:15:14;05And that goes back with-- it's not a one-size-fits-all kind of a thing?
DR. SABRINA SAHNI:
00:15:16;24Absolutely. Absolutely.
SARA DIAMOND:
00:15:18;15Every patient is different. Okay. So let's talk about-- we've seen the-- the hormone therapy options available to our patients with menopause. Let's talk about the benefits and the risks involved with hormone therapy, in general. This is a hot topic. And it has been for several years now. We also want to talk about the additional risks in patients with a hysterectomy.
DR. SABRINA SAHNI:
00:15:44;15Yeah. Absolutely. So this is-- I mean, we could do an entire session just talking about risks and benefits. But generally, what I tell people is that if you have menopausal symptoms, the most effective treatment is menopausal hormone therapy. And that's been proven time and time again.
00:15:58;16I think we've come a really, really long way, in terms of studies over the last 20 years kind of helping us understand hormone therapy, as it relates to risks and benefits. I think for the first thing that we know is we like to prescribe hormone therapy early, which I sort of alluded to earlier with Maria--
SARA DIAMOND:
00:16:16;08Exactly.
DR. SABRINA SAHNI:
00:16:16;14--through this idea of a timing hypothesis, right? So you want to prescribe under the age of 60 or within ten years of the onset of menopause. And generally, the benefits will outweigh the risks. We start to see a lot of the risks associated with hormone therapy kind of creep up around that 60 to 65 mark.
00:16:33;24We also know through other studies that route of administration matters, right? So that table really comes into play when we think about different risks associated with-- with hormones. Transdermal topical agents really don't carry the same side effects of stroke and blood cot that an oral agent does, right?
00:16:49;24Oral agents, whether it's a birth control pill or-- a menopausal dose will increase the risk for stroke or blood cot and it's dose-dependent. So the higher the dose you are, the higher the risk. The benefit of the study that looked at topicals is that across the board, there was really no increased risk for VTE in any of the doses.
00:17:06;22So this is a really reassuring-- study that-- that allows us to safely prescribe patients that may be at an increased risk or that may have had an unprovoked-- DVT-- or provoked DVT in the past. The other thing about route of administration is vaginal estrogens are different.
00:17:22;21So vaginal estrogens are really different than systemic doses. So we think about things like breast cancer risk, which I think is a huge thing that a lot of women are concerned about, or cardiovascular risk. Vaginal preparations don't carry that risk. So women can use that very freely without concern for increased risk for c-- for cancers or for cardiovascular disease.
00:17:42;10The other big study that I think came out around early 2017 was an 18-year follow-up from the original Women's Health Initiative. And what it did, it was-- it looked at all of those women and looked at their all-cause mortality. And they found that women that were post-menopausal that took hormone therapy actually did not have an increased risk for all-cause mortality, cardiovascular disease, and cancer-- so again, a lot of really great evidence-based data that's come out regarding hormone therapy in the last 20 years.
SARA DIAMOND:
00:18:07;20Yeah. I think the studies that you just mentioned are going to alleviate a lot of-- at least, the main concerns that some patients may have around the safety of hormone therapy, particularly-- transdermal hormone therapy. You know, people are just-- are cautious and-- and rightly so.
00:18:26;07So a transdermal hormone therapy like Divigel really seems to be a great option in a patient-- let's go back to Maria-- who's been on an oral estrogen for many years. But we-- would you still use Divigel in patients who may have recently started on a topical therapy, like a transdermal patch, maybe looking for something different?
00:18:48;07And let me give you another pat-- patient case. Let's look at 50-year-old Jennifer. She is coming in with complaints of discomfort, irritation. She was started on an estrogen patch and an oral progesterone two weeks ago. She is experiencing quite a bit of discomfort with that patch and irritation at the site of application. So given this, would you consider another topical like Divigel-- in this situation with this patient?
DR. SABRINA SAHNI:
00:19:19;09This is also another really important point to make is that up to 50% of women that are on a transdermal estrogen actually may-- notice application-site symptoms, so things like tenderness, or itching, or swilling at the side of their patch. And it can be really bothersome for patients.
00:19:34;14I know that-- I practice down here in Florida. And so I have patients that are in the-- the humidity and the heat, or at-- or at the beach-- or in pools. And so that adhesive may not stick that well. So this is actually a very valid and common concern. I do think that Divigel would be a really great option for-- for somebody like her who-- who's having some of that issues.
SARA DIAMOND:
00:19:54;05Uh-huh (AFFIRM). I don't think a lot of people think about things like that. So a topical gel like Divigel would probably be a great option in-- in patients who-- can't stand the-- the problems that may be associated with that transdermal patch. So let me ask you-- what about patients who come to you because they can't stand the side effects of oral hormone therapy that they're on? Could you and would you consider Divigel in these patients, as well?
DR. SABRINA SAHNI:
00:20:20;13Absolutely. I think that there is, you know, a lot of really great factors associated with Divigel. We know the efficacy was great. We looked back at those charts earlier, which really showed significant improvement as early as two weeks-- and up to 90% im-- improvement and reduction of hot flashes by week 12. So certainly, the efficacy is there.
00:20:40;13Again, from that side effect profile, if somebody doesn't wanna be on an oral and I'm concerned about things like stroke and blood clot, this is another great option to put 'em on a transdermal or topical option. It's convenient. Divigel is really convenient, meaning you can use it whenever. You can throw the pouch in your purse. You can do it discreetly.
00:20:57;24And again, there's flexible dosing. So that-- really allows us to kind of tailor our-- our treatment plan for each individual woman because like we've been saying, it really isn't a one-size-fit-all. And the other thing I'll really comment about is any time (NOISE) you're thinking about prescribing menopausal hormone therapy, you gotta look at the whole picture, right?
00:21:16;02So you gotta look at the whole woman. I think lifestyle is really important, right? So is she busy? Is she working? How-- accessible is this gonna be for her to use? Does she wanna be taking pills in front of people? You know, is the patch gonna show through clothes, things like that? These are all factors that-- that should really-- should be-- considered.
SARA DIAMOND:
00:21:32;13That is true. And I think some women may-- may not choose to go on a therapy because they have some misconceptions that-- that it is going to be messy with the application, it's gonna be hard to take, it's gonna be visible under their clothing. They don't want people to see that, you know? So what would you say or recommend to these women when they come to you with these concerns?
DR. SABRINA SAHNI:
00:21:52;02I mean, Divigel's great. It's colorless. It clears. It dries very quickly. I tell women, you know, once you apply it to the upper thigh, just wait a couple of minutes. I want you to wait about 60 minutes before-- getting into any kind of pool or getting-- taking a shower, or bath, or really coming into contact with any other-- individual.
00:22:10;07It's portable. Again, you can throw it in your purse. You can go run errands. You can put it on throughout the day. It's discreet. It's really easy, I think, for people to use. And again, that efficacy factor really kind of sticks in my head, in terms of how great of a product it is.
SARA DIAMOND:
00:22:24;05That is true. (LAUGH) So-- so Divigel, it seems, is a great treatment choice for really any of the patients that we discussed today and-- and their-- you know, different needs. So let's-- let's take some key take-home messages that the audience should remember about Divigel. You made some great points, first of all, starting that it's clear. You don't have to worry about-- about seeing it when-- when it's applied.
DR. SABRINA SAHNI:
00:22:48;11Right. It's not a colored cream. It-- it rubs into the skin very, very quickly. Absolutely. I mean, I think the take-home messages here from a menopausal hormone perspective is that really each individual should have an individualized approach, right?
00:23:01;20I think that we need to consider things like timing in our initiation of-- of our menopausal hormone therapy. Really, there should be four factors to consider, in terms of-- women in mid life and things we need to be thinking about. So I always talk about bone health because we know that estrogen can help our bones; cardiovascular risk; breast cancer risk, so understanding a woman's family history, her individual risk factors for breast cancer, her breast density, and cognitive function.
00:23:28;24We know that, you know, all the data that we talked about recently, in terms of knowing that there is no increased risk with topical or transdermal hormone therapies, in terms of VTE. We know the 18-year followup data that really shows no increase in all-cause mortality.
00:23:43;24We know that route of administration matters. So it's not equal in terms of oral, to topical, to vaginal preparations. And then, there's-- you know, great access for things like Divigel because it's convenient, it's affordable, it's discreet, and really a fantastic product and option for patients.
SARA DIAMOND:
00:23:59;24It sounds like Avion has thought of the whole woman in this.
DR. SABRINA SAHNI:
00:24:03;10Absolutely. Yeah. And I think that they're really committed to kind of catering to women throughout their entire life, right? So they offer things like prescription prenatal supplements, low-dose birth control pills for our reproductive patients, and obviously menopausal support, as well, so.
SARA DIAMOND:
00:24:17;08That's right. Dr. Sahni, thank you so much.
DR. SABRINA SAHNI:
00:24:20;07Thank you.
SARA DIAMOND:
00:24:20;15A lot of information we've covered today, but-- but-- useful information and things that we need to keep in mind. So I think that's wonderful. And now, I would like for us to take some time to answer some questions that our audience members have submitted, some really great questions. And-- well, let's go to our first one. Our first one: Does a higher BMI or weight affect your dosing recommendation?
DR. SABRINA SAHNI:
00:24:47;05So not necessarily. I think it more so matters, in terms of route of administration. This is a great question, right? So women who have a higher BMI may be at a higher risk for stroke or blood clots. So I would-- probably avoid things like those oral agents because, again, those are gonna drive up those risk factors. But-- and certainly, I would tailor it more towards what her clinical need for the medication is, how debilitating are her symptoms, and less about that.
SARA DIAMOND:
00:25:10;12Okay. That's a good one. Second question: Do you recommend any specific regimen for progesterone therapy for people with an intact uterus?
DR. SABRINA SAHNI:
00:25:22;19That's a good question, too. So there's are tons of options. So for women that are-- in menopause that don't need the contraceptive factor, I think giving something like a Divigel for your estrogen would be great. And then, the progesterone component-- really, you have options, in terms of a micronized progesterone every evening at bedtime.
00:25:40;16So you tell the woman, "Take your Divigel," or, "Use your Divigel every day, the the same time. Take your progesterone at bedtime and don't skip a day." If she was perimenopausal, you could similarly still use that micronized progeresterone if she didn't need contraception, and cycle her, meaning she takes progesterone the first 12 days of the month. And if she's gonna have a cycle, she'll have a cycle in the latter half of the month.
00:26:01;05If she would require contraception, things like a progesterone-containing IUD, or a progesterone-only birth control pill are really great options in conjunction-- in conjunction with a topical estrogen. So tons of options-- it really should be individualized.
00:26:13;12And like I mentioned before, understanding the lifestyle of the patient, right, you know, like-- what-- how active is she, is she likely to miss pills? A big thing when it comes to progesterone is you wanna make sure that if you give progesterone, that they take it, right?
00:26:26;04Because that unopposed estrogen really comes-- does increase that risk for uterine cancer, which we certainly want to avoid. If they take it together, we-- we're not worried about that risk. So things like an IUD might be great, if she's not gonna remember to do something like that. But there's really a lot of options available.
SARA DIAMOND:
00:26:41;02That is true. And-- (LAUGH) and thankfully, our medical providers are educated and they can steer-- steer patients on the right path that's gonna be best for them.
DR. SABRINA SAHNI:
00:26:49;16Absolutely. Absolutely.
SARA DIAMOND:
00:26:51;12Let's go to another question. The question is, "What are your thoughts on non-FDA-approved hormone pellets?"
DR. SABRINA SAHNI:
00:27:00;08So this is another really good question. I think there's been this huge buzz about bioidentical hormones. And for those that may not be as familiar with what pellets are, they're basically subcutaneous implants of various doses of estrogen, or progesterone, or testosterone.
00:27:13;24And in my experience of treating patients that have come to see me, that have had pellets in them, I tend to see more-- risks associated with their use. So they tend to have much higher levels of estrogen than indicated for a post-menopausal woman, much higher levels of testosterone-- than indicated for a post-menopausal woman.
00:27:31;24So I generally don't prescribe or don't perform-- pellet-- pellets in my office. But, you know, when I do see a patient that has been on pellets, I try to talk to them about some of those risks because again, even though it's not an oral agents, those high levels of estrogen she may be getting can increase things like risk of stroke, or blood clot, or different cancers. So I think really talking to her about alternative options might be a good op-- a good way to go.
SARA DIAMOND:
00:27:56;04So maybe because you're-- you're feeling better, that doesn't necessarily mean that--
DR. SABRINA SAHNI:
00:28:00;08It's the safest.
SARA DIAMOND:
00:28:01;05Right.
DR. SABRINA SAHNI:
00:28:02;06And we just don't have enough data behind it, to be honest with you. The good thing about things like an estradiol-based hormone therapy is we have a lot of really good data for several, several years. And I think that that makes physicians and clinicians really comfortable with prescribing these medications.
SARA DIAMOND:
00:28:17;07Definitely. That's for sure. Okay. So we have more questions. Let's get to them. "Does the .5-milligram dose of Divigel give equivalent dosing to a 1.5-milligram dose of an oral estrogen?"
DR. SABRINA SAHNI:
00:28:31;14So it depends. So there's different types of estrogens, right? So an oral estradiol pill and a topical Divigel are both estradiol. So really, it's gonna be 1:1. If they're on 1 milligram of an oral estradiol, 1 milligram of Divigel, which is an estradiol-based topical gel, is fine.
00:28:48;07It becomes a little bit more tricky when you have things like synthetic progestins and you're trying to convert to an alternative form. There are really great resources online for that, but it certainly isn't a 1:1. So I always encourage providers to just, you know, be sure about looking things up before they make that transition.
SARA DIAMOND:
00:29:04;20All right. Great question. Let's go to another long-- another question. "How long can patients be on transdermal HT?" And a follow up question to that-- "Do you recommend to discontinue it at a certain age?"
DR. SABRINA SAHNI:
00:29:18;20Another really good question. And I think we kind of alluded to it before in-- in that timing hypothesis, right? So we're prescribing hormones early now, right? We wanna do it within that ten-year window-- where the benefits really outweigh the risks.
00:29:31;03And I think previously, there was kind of this notion that you had to discontinue hormone therapy by age 60, right? The Women's Health Initiative in the early 2000s really showed a lot of those risks start to creep up around that time, too.
00:29:44;16So I-- I-- I under-- I understand the-- the-- the fear in that. I think for women that have been on hormone therapy when they're younger and within that ten-year window that now-- pass the age of 60, I don't think 60 nec-- necessarily becomes the magic number anymore.
00:29:58;24I think it's more individualized and we kind of have to have that shared decision-making with our patient to really understand, "Okay. How is this benefiting you? What other risk factors have you developed due to just kind of natural aging and-- and other-- other things that have gone on," and really kind of evaluate that way.
00:30:15;05I don't recommend stopping at a certain age. But I've had women that are, you know, much, much older, in their 90s, that have done really well on-- on hormone therapy that have been on it for 50-some years. And, you know, each year, we're kind of re-restratifying them. And, you know, they're in good shape. So again, it-- it really needs to be individualized, but that's a great question.
SARA DIAMOND:
00:30:35;04Wonderful. Let's go to our next question. "If a woman wants to transition from an oral to a transdermal, is-- is it a tough process to totally switch the way this is being administered, I guess?"
DR. SABRINA SAHNI:
00:30:48;20It's actually really seamless. I mean, if you're going from an oral estradiol to a topical estradiol, I just, you know, say, "If you took your dose today, start this tomorrow," right? And it's-- it's pretty seamless, especially when you're converting estradiol to an estradiol and you're keeping things at the same dose. So it's actually a very easy transition for-- for women to-- to do.
SARA DIAMOND:
00:31:07;06Patients like easy.
DR. SABRINA SAHNI:
00:31:08;17Yes. Patients like (LAUGH) easy. Patients like convenience. Patients like all of that. So this is-- you know, and that's what I tell them, you know? "You took your pill today. First thing tomorrow morning, you go ahead and you use your Divigel, you know, kind of on the upper thigh, and then you go about your day. You don't have to think about it after that," so, yeah, it's great.
SARA DIAMOND:
00:31:24;04I like that. Okay. Let's see. We have another question here. "Should we approach the menopause discussion in all women of a certain age regardless of their symptoms?" This is a really good question.
DR. SABRINA SAHNI:
00:31:38;24It is. I think that it really shouldn't be age-specific. I think if, you know, we remember that constellation of signs and symptoms that can happen for women, and if we think about perimenopause lasting ten years, I mean, this could affect women as early as their 30s, right?
00:31:54;05I mean, you could have these symptoms very early on. And I think, you know, we-- we-- we really focus on things like hot flashes and night sweats because like you said, it affects the vast majority of women, but all of those other signs and symptoms, we can be asking about, right?
00:32:09;07And I think that that opens up the discussion a little bit because then, you say, you know, "All right. You're-- well, you're not having any of these symptoms, but if you ever do, let me know. We've got options for that. There are things we can talk about. There are ways we can treat you."
00:32:21;05And I think that anticipatory guidance really allows patients to feel trust in their doctor so that when these conversations may come up in maybe one year, two years, five years, they feel-- they feel comfortable coming to you, regard-- because some of this stuff can be embarrassing or uncomfortable for a woman to talk about, right, whether it's hot flashes, or night sweats, or even genital urinary syndromes, right, so things like vaginal dryness, or sexual dysfunction, not-- not a common thing that a lot of women wanna be talking about with-- with-- with people. But I think if you just-- you set the stage, open up conversation, and kind of re-- keep bringing it up, I think that that really helps kind of entrust that relationship.
SARA DIAMOND:
00:33:00;03I think that goes back to what you said earlier, and I loved how you said it, that this is no longer a thing that women (NOISE) need to put up with and struggle with.
DR. SABRINA SAHNI:
00:33:08;18Absolutely.
SARA DIAMOND:
00:33:09;10You know, it's just, "Okay. Well, this is what my mom and my grandmother did. So now, it's my turn to struggle and just power through it." It's-- it's no longer like that.
DR. SABRINA SAHNI:
00:33:17;06It's no longer like that. And I think you can always kind of gauge if a woman's like, "Oh, you know, I'm good. Don't worry about it." But, you know, chances are in the next two to three years, she's gonna come back and be like, "Remember that one time you kinda mentioned this thing to me? So now, I've-- I'm starting to notice it."
00:33:30;21And I think they feel far more comfortable because you've kind of already broken the ice about it a little bit, right? So they know that they can come to you. They know it's a safe place. But I think certainly, regardless of age, we should be having these discussions earlier about what to anticipate.
SARA DIAMOND:
00:33:44;14It's not your mom's menopause anymore.
DR. SABRINA SAHNI:
00:33:45;24No. It's not your mom's menopause. (LAUGH)
SARA DIAMOND:
00:33:47;04This is a whole new era.
DR. SABRINA SAHNI:
00:33:48;06I agree. I agree. (LAUGH)
SARA DIAMOND:
00:33:50;09All right. Let's-- take another question. "What are your thoughts on estrogen and bone health?"
DR. SABRINA SAHNI:
00:33:56;24Great question. So we know that estrogen can-- can help bones significantly. So when we think about the risk for something like osteoporosis, what I tell women is within one to two years of the onset of menopause, women lose bone rapidly, about 1% to 2% per year for the first couple years of menopause. It's pretty significant.
00:34:14;23And to be honest, they lose bone mostly from their spine because that's estrogen-sensitive bone. So that tends to be the-- the area that takes-- that you notice when you do things like a bone density. So I do think there is a role for estrogen, especially women who are dealing with not only debilitating symptoms of menopause, but also have pretty significant bone loss. So I think absolutely there's a role for estrogen to be used in women that have osteopenia or even-- a low-grade osteoporosis.
SARA DIAMOND:
00:34:42;09Okay. That's interesting because I know a lot-- a lot of women that's-- that's one of their concerns, for sure.
DR. SABRINA SAHNI:
00:34:46;19Yeah. Absolutely and it's a huge concern. I think osteoporosis-- I mean, it's-- it's another thing that would affect your quality of life, right, where we don't want you to break a bone. You l-- you lose your independence. Things change. Your quality of life changes.
00:34:59;11I mean, I certainly think it's something that we need to be considering. And again, it goes back to those four things that I talked about before-- of what we should be considering of-- of women in mid-life. These are all things that are changing, so.
SARA DIAMOND:
00:35:10;24Boy. (LAUGH) You are right about that. All right. Let's take at least one more question here. "If a patient requests a specific hormone therapy, do you grant that request?"
DR. SABRINA SAHNI:
00:35:23;06Not necessarily. I think we talked a little bit about this, too, is, you know, what wor-- maybe worked for your friend or your colleague may not necessarily work for you and everybody has their own individual set of risk factors for chronic disease, or bone status, or breast cancer risk.
00:35:37;24And so all of those components really need to come into play when we prescribe hormones. So I understand that, you know, so and so did really well on a regimen and that's what you wanna be on, but it actually may not be the best thing for you.
00:35:49;17And so my goal and my job as the physician is really to prescribe something that's the safest for you, that's gonna get you the most benefit, and that's gonna make you feel good. So I think, you know, I can consider it, but if it's not the optimal one, I don't necessarily, you know, hold back in saying, "I think there's a better option for you."
SARA DIAMOND:
00:36:07;01Uh-huh (AFFIRM). And I think that's what most women want. They want the best and the safest option for them.
DR. SABRINA SAHNI:
00:36:12;19Absolutely. They want that individualized-- individualized care. And I think that's kind of what we're moving towards in medicine, to some degree, so.
SARA DIAMOND:
00:36:19;21That is true. All right. We're gonna take one more question-- for today. It says, "Sometimes, patients are hesitant about hormone therapy, based on what they've head in the media or from doing their own research." And then, the question is, "How do you counsel these patients?"
DR. SABRINA SAHNI:
00:36:37;09Another really good question because I think whether it's you read it on the internet or you hear it from a friend, you're gonna get a lot of different opinions from a lot of different sources. And so it can be very challenging to kind of debunk some of that.
00:36:49;11I don't necessarily think all of that goes away in a single office visit. So I think, you know, providing them with the appropriate resources, the appropriate websites with, you know, evidence-based information. Things like the North American Menopause Society has great patient information that we can use to kind of help counsel our patients on risks and benefits.
00:37:07;24I think, you know, we are kind of in an era of things like social media, where people are getting their information from new resources, from new places, right, whether it's-- TV shows, or Twitter, or all of these social media outlets. And some of that may not all be accurate, so you have to be really careful.
00:37:24;23One thing I do is-- you know, if a patient comes to me and they're hesitant about, you know, whether it's their breast cancer risk or cardiovascular risk, I say, "Okay. Tell me about your r-- tell me about your concerns and where-- where did you find that information," because I'm always curious of the source, right, and then kind of meeting them where they are.
00:37:41;16And again, you may not be successful on the first visit, but I think having that continuity of care as physicians, that's-- that's what we're here for, right? We want to see our patients. And we-- we grow with them. And we treat them as they-- as they get older.
00:37:52;10So certainly, I think it's, you know, meeting them where they are, providing adequate resources, and-- and, you know, kind of keeping it as-- as an ongoing conversation 'cause as we've seen in the last 20 years, things are always changing, right?
SARA DIAMOND:
00:38:03;13That is true.
DR. SABRINA SAHNI:
00:38:04;02New data is always coming out. So I think-- you know, I think to keep it ongoing is important.
SARA DIAMOND:
00:38:09;12Definitely thank you so much for taking the time to talk with us, Dr. Sahni. Such great information-- res-- risks and benefits involved with-- menopause hormone therapy-- and about Divigel, as well. And we hope to have you back here in the future.
DR. SABRINA SAHNI:
00:38:27;24Thank you so much for having me.
SARA DIAMOND:
00:38:29;11It was a pleasure. Okay. So for our audience today, thank you for joining us for the Uniquely Hers educational program. And if you can, (MUSIC) please take a brief moment to complete the survey. You'll see the link-- on your screen. We'd love to hear your thoughts on our presentation today. (MUSIC)
References:
- Gartoulla P, Worsley R, Bell RJ, Davis SR. Moderate to severe vasomotor and sexual symptoms remain problematic for women aged 60 to 65 years. Menopause. 2015;22(7):694-701.
- Cleveland Clinic. Menopause. Accessed March 9, 2022. https://my.clevelandclinic.org/health/diseases/21841-menopause
- Harvard Health Publishing. Perimenopause: Rocky road to menopause. Accessed April 18, 2022. https://www.health.harvard.edu/womens-health/perimenopause-rocky-road-to-menopause
- Hill DA, Crider M, Hill SR. Hormone Therapy and Other Treatments for Symptoms of Menopause. Am Fam Physician. 2016;94(11):884-889.
- Ogen® product information. Accessed April 22, 2022. https://www.pfizer.com/products/product-detail/ogen
- FDA Approved Drugs. Ogen®. Accessed April 22, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=083220
- Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
- Divigel® [package insert]. Vertical Pharmaceuticals, LLC; 2019.
- Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.
- Bhupathiraju SN, Grodstein F, Stampfer MJ, et al. Vaginal estrogen use and chronic disease risk in the Nurses' Health Study. Menopause. 2018;26(6):603-610.
- Manson JE, Aragaki AK, Rossouw JE, et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA. 2017;318(10):927-938.
- Ale I, Lachapelle JM, Maibach HI. Skin tolerability associated with transdermal drug delivery systems: an overview. Adv Ther. 2009;26(10):920-935.
Get to know more about Divigel® administration
With fewer hot flashes and night sweats, you can do menopause on your terms.1,2
Meet Divigel Estradiol Gel.
Divigel isn't a pill or a patch.
It's a clear, odorless gel that's easy to apply. 2
And the best part?
It's been shown to reduce hot flashes by nearly 90% after twelve weeks of daily use. 1,2
Here's how it works.
Every day, around the same time each day, make sure your upper thigh area is clean, dry, and free of cuts or scrapes. 2
Then, apply the pre-measured packet to your upper thigh. 2
Make sure to use its entire contents.
Let the gel dry, wash your hands, and you could start experiencing fewer hot flashes in as little as 2 weeks. 1,2
Thanks to Divigel, life without hot flashes and night sweats can be whatever you want it to be.
Learn more about how to use Divigel at Divigel.com1,2
Do not use Divigel if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus (womb), had a stroke or heart attack; currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, or if you are allergic to Divigel or any of its ingredients.
Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.
Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.
The most common side effects of Divigel include irregular vaginal bleeding or spotting; breast tenderness, vaginal yeast infection, cold, and upper respiratory tract (nose, sinuses, pharynx or larynx) infection.
Serious but less common side effects include stroke, blood clots, heart attack, cancer of the lining of the uterus (womb), breast cancer, cancer of the ovary, dementia, gallbladder disease, high blood calcium (hypercalcemia), high blood pressure, high triglyceride (fat levels in your blood), liver problems, low thyroid levels in your blood, fluid retention, low blood calcium (hypocalcemia), enlargement of benign uterus tumors ("fibroids"), worsening of angioedema (swelling of face and tongue), changes in certain laboratory test results, and high blood sugar.
Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.
References:
- Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
- Divigel® [package insert]. Vertical Pharmaceuticals, LLC; 2022.
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