Managing Hypertension Remotely; Hormone Therapy and Trans Youth

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine in Baltimore, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.

This week’s topics include the impact of hormone therapy on transgender youth, aspirin versus heparin for clot prevention after lower extremity surgery, update on COVID vaccines in those 55+, and remote management of cholesterol and blood pressure.

Program notes:

0:42 COVID vaccines in those 55+

1:43 Seroresponse and titer

2:43 They’re effective and safe

3:46 Lower-extremity fracture, surgery, and clot prevention

4:47 No difference in pulmonary embolism

5:44 Hormone therapy, transgender youth and psychosocial measures

6:43 Assessed four times for 2 years

7:43 Decreases in depression and anxiety

8:43 Depression decrease largely modest

9:44 Have a lot of work to do now

10:00 Can we effectively remotely monitor and treat blood pressure, cholesterol

11:00 40% stayed with the program

12:01 Putting more onus on the patient

12:38 End

Transcript:

Elizabeth: Psychosocial functioning in transgender youth after 2 years of hormones.

Rick: After you’ve had a lower-extremity fracture, do you need to take blood thinners or is an aspirin sufficient?

Elizabeth: An update on COVID vaccines in those over 55.

Rick: Can you remotely deliver good care of blood pressure and cholesterol control with non-licensed providers?

Elizabeth: That’s what we’re talking about this week on TTHealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: Let us turn first, Rick, to COVID material. We haven’t had any for actually many weeks now and that’s been a bit of a relief in some respects. Let’s turn to the New England Journal of Medicine. This is a look at an ongoing phase III trial in adults older than 55 years who had previously received three doses of a COVID vaccine. These folks were randomly assigned to receive either the monovalent vaccine or the bivalent vaccine in either a 30- or a 60-mcg dose. Interestingly, another part of this population were folks who had previously had COVID infection.

They had a total of 1,846 participants 1 month after vaccination with this bivalent or monovalent vaccine at these two dosages. They said, “OK, what did our neutralizing activity against one of the forms of the coronavirus look like?” and then they also looked at seroresponses and titers.

They were more or less the same. There was really not that much of a difference between all of them. They did note that the adverse events were more common in the 30-mcg monovalent and 60-mcg bivalent groups than in the other groups.

Rick: When you talk about mono- and bivalent, this is the Pfizer vaccine we’re talking about. About the time they recommended the booster, there was a different variant and so the bivalent vaccine hits the original COVID virus and then the variants as well.

When you have the bivalent vaccine, you develop neutralizing antibody to the original, but also to the Omicron as well. It is effective in terms of developing neutralizing antibodies. This is what’s called sequence vaccine distribution. It’s what we see in the flu, for example. You don’t get the same flu shot every year. We’re going to do the same thing with COVID vaccines. We’ll continue to immunize against old ones, but we’ll add new ones as they become more prevalent.

Now, the virtue of this particular study is that you can give these bivalent vaccines and they’re effective at providing antibodies, but they are also safe. That means we don’t have to do clinical trials every time we put out a new vaccine, just like we don’t do for the flu. That’s what I think the major value of this particular study is.

Elizabeth: I think one of the things that’s comforting about this study was that they reported sort of the “same old, same old” with regard to side effects. Those included injection site pain and fatigue as a systemic effect were most common. Also, they tested this in about one-third of their participants who were obese and about 13% of them had been previously infected with COVID.

Rick: They want to show that they can have a robust response and do it safely. The constituents are very much similar. It’s just the mRNA is a little bit different, but everything else that surrounds it is the same. The fact that it has a very similar side effect profile means we don’t have to keep reinventing the wheel.

Elizabeth: I suppose what we all need to be worried about is whether there are significant variations in the spike protein at some point, since all of them are really targeting that. Which one of yours would you like to choose?

Rick: Let’s move on to the New England Journal of Medicine. When individuals have fractures that require hospitalization and a surgery to repair them in a lower extremity, or if they have pelvic fractures or femur fractures, they oftentimes in the hospital can develop thromboembolism — clots in the legs — particularly true in traumatic injuries.

To prevent that, we’ve been giving anticoagulants. It requires an injection, especially if the person goes home on these so the person has to administer them. It’s more costly than for example, aspirin and is associated with bleeding risks. The question is, could you prevent thromboembolism, the complications like pulmonary embolism, or more importantly death associated with this?

These investigators took over 12,000 participants, 18 years or older, that had an operatively treated limb fracture or a pelvic fracture, and they randomized them to receive anticoagulation with a low-molecular-weight heparin twice daily or aspirin 81 mg twice daily. When they did that, the occurrence of death from any cause at 90 days was 0.7%. There was no difference in pulmonary embolism and no difference in bleeding as well. There was a slight increased risk of deep vein thrombosis with aspirin, 2.5% versus 1.7%.

Elizabeth: It’s always so nice to have something simplified rather than have something more complicated, I think, especially when you’re being discharged after a fracture that had to be managed operatively.

Rick: It’s simplified and importantly it’s less expensive, with the results that are just as good.

Elizabeth: Talk to me about expansion of this strategy and to other patient populations in whom heparin might have been used previously.

Rick: This is used for prevention. When anybody is immobilized in the hospital for any particular reason, they have the risk of having thromboembolic events and we try to use a non-pharmacologic method first. You might say, “Well, let’s just replace it with aspirin in all these patients,” but I’ll remind you that low-molecular-weight heparin has a fairly short half-life of 12 to maybe at most 24 hours, but aspirin lasts for 10 days.

Elizabeth: Remaining then in the New England Journal of Medicine, let’s turn to something we have never talked about. This study is entitled, “Psychosocial Functioning in Transgender Youth After 2 Years of Hormones.”

We’re aware of course, that there are youths in the United States who experience gender dysphoria. They feel that there is a divergence between who they feel they are gender-wise and who their anatomy says they are.

There are ways that are used to manage and treat this. In this case, they were looking at “What happens if youths receive gender-affirming hormones — that’s testosterone, of course, or estradiol — to their psychosocial functioning after 2 years?”

They used a number of metrics in order to assess this — something called the Transgender Congruence Scale, the Beck Depression Inventory, the Revised Children’s Manifest Anxiety Scale, and the Positive Affect and Life Satisfaction Measures from the NIH. They assessed this at baseline, 6, 12, 18, and 24 months after they started this gender-affirming hormone treatment. They wanted to see individual trajectories of appearance, congruence, depression, anxiety, positive affect, and life satisfaction.

They had 315 transgender and non-binary participants who were 12 to 20 years of age. A total of 190 were transmasculine and that’s people who were designated female at birth. The remainder, of course, were transfeminine. About 8% of them had received previous pre-pubertal suppression treatment, and that’s gonadotropin-releasing hormone agonists that are given to people before they start showing secondary sexual characteristic expression.

The upshot of it was they found that there were increases in appearance congruence, as well as increases in positive affect and life satisfaction, and decreases in depression and anxiety symptoms. Their most common adverse event was suicidal ideation in 3.5% of their participants and death by suicide in 2%. The upshot of this study seems to suggest that in those who identify as transgender or non-binary and who want to have this kind of treatment, that it results in some positive changes in their lives.

Rick: It had a very robust interdisciplinary team and services that were provided.

A couple of interesting things about this. One is it’s a relatively short timeframe. There is no comparator group unfortunately. As we know as kids age, their depression, anxiety, satisfaction, and how they view themselves, it all changes, especially in this particular timeframe. And so without a comparator group, it’s a little bit harder to make conclusions about this particular study and needs some follow-up before we can firmly state that there is a causal relationship between the changes associated with it and the psychosocial-functioning changes.

Elizabeth: They also say that on average, depression started in the mild range and decreased to subclinical by 24 months. So depression, how big a problem was it? It doesn’t sound like it was especially problematic.

Some of their other decreasing scores for things like anxiety also were pretty mild. I have a problem, I think, here, which is that when I recall being a teenager it was just a really tough time of life where there were tons of transitions going on, and the notion that I would have made a decision particularly about GnRH agonists at that point, but also about these gender-affirming hormones, that would have been a durable and supportable decision for me later on, is something that I really question.

Rick: Right. In fact, the authors mentioned there is a group of individuals here that really don’t do any better at all. The assumption would be is their psychological dysfunction is related to their incongruence and if you fix that they would get better. But as a group, that’s really not true. The investigators say they have a bunch of work to do now. These are really significant because some of these were a one or two-point change on 100-point scale. Is it durable? Who should we not apply this to?

Elizabeth: No doubt there is more to come. Finally, let’s turn to JAMA Cardiology.

Rick: I tee this up as, “Can we effectively remotely monitor and treat blood pressure and cholesterol in populations using non-licensed health care providers?” We have a big push in identifying high blood pressure and high cholesterol, but half of the patients that we know that have one of these two conditions in the U.S., it’s not even adequately controlled.

What these investigators did was they decided to take about 10,000 patients enrolled in a comprehensive remote hypertension and cholesterol program. All these individuals received education. They all received a home blood pressure device and medication titration. It was done by non-licensed navigators and pharmacists who were supported by cardiovascular clinicians, coordinated care using standard algorithms, task management and automation software, and different ways of communicating depending on how the patient wanted to. It’s over a 3-year period.

They had over 400,000 blood pressure recordings and over 139 lab reports. For people that were involved with this particular program, about 40% of them stayed throughout the program and continued into a maintenance phase.

It lowered their systolic blood pressure by about 10 mm and their diastolic by about 5 mm. For individuals that just received the education and didn’t have all that other stuff, there was really no significant change in their blood pressure. It lowered the LDL cholesterol by about 35 points. It’s very effective. It doesn’t require more clinician time.

Elizabeth: We are experiencing nationally, and likely internationally as well, a huge shortage in clinicians, so trying to establish ways to effectively reach these populations — also, this was a very diverse population.

Rick: It really was. The average age was about 65 years. About 55% were female, 12% Black, and 11% Hispanic. It was effective regardless of your gender, regardless of your age, or regardless of your race. Somebody still has to manage these individuals, but it shows that it can be done if it’s done in a thoughtful way.

Elizabeth: I would ask you what your concerns are about putting more onus on the patient in order to manage these kinds of things.

Rick: Clearly, it requires a motivated patient. These patients actually like the convenience.

By the way, if there is any question about it, then it was kicked up to a physician or to a pharmacist that could provide additional support. But most of this can be driven by algorithms now. At a population level, you can take care of hundreds of thousands of patients.

Elizabeth: On that note, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.