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 a new agent to help prevent kidney transplant rejection, more effective medications to reduce kidney disease and CVD in people with diabetes, use of nicotine pouches nationally, and acceptability of hospital at home.
Program notes:
0:40 Hospital-at-home care
1:40 Recover faster at home
2:41 Nicotine pouch use nationally
3:41 Assessed smoking status
4:41 Mouth lesions possible
5:32 Medication to mitigate multiple diseases in people with diabetes
6:33 Reduced death by cardiac causes by 30%
7:33 Few patients received both medications
8:08 A monoclonal antibody to help kidney transplant rejection
9:08 Nine infusions of the antibody
10:08 Might have to take over the long haul
11:08 More precise antibody possible
12:24 End
Transcript:
Elizabeth: Is there hope for treating rejection of kidney transplants?
Rick: Medication to minimize the risk of kidney disease and death in patients with diabetes.
Elizabeth: Use of nicotine pouches nationally.
Rick: And do people buy into hospital-at-home care?
Elizabeth: That’s what we’re talking about this week on TT HealthWatch, 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: 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: I’m going to toss the ball to you, sir. Which one would you like to start with?
Rick: Elizabeth, let’s talk about hospital-at-home care. This is an article in JAMA that talks about providing hospital-level care for patients with low to moderate acuity actually in the home. In this setting, the family members actually provide low-level care for the patients such as managing the medications.
There are currently 322 hospitals across 37 states that are already approved to provide hospital-at-home care. The studies have shown that hospital-at-home care can actually reduce readmissions, it can lower the costs, and there is a better experience compared with the traditional hospital care. Knowing this, if you just took a random sampling across people in the U.S., is it acceptable?
To answer that, there were 1,233 people who were randomly selected. This is from a panel of about 13,000 different adults aged 20 or more that were in what’s called the Understanding America Study. The survey asked them about four different domains. Was hospital-at-home care acceptable? Was it considered to be effective, safe, and convenient?
About two-thirds of the individuals agreed or strongly agreed that people actually recover faster at home. With regard to hospital safety, about 60% of Americans felt that it was safer. With regard to the convenience, about 50% agreed that it was more convenient, and the patients were more comfortable if treated at home, and then a combined 82% agreed that they could manage medications, and 41% said that they could even change feeding tubes.
Elizabeth: This is really an interesting snapshot, isn’t it? I wonder what it predicts with regard to more of these kinds of services being provided at home.
Rick: From a medical standpoint, the studies show, again, reduced readmissions, low cost, and better experiences to the patient. But here the family member said, “Yeah. We agree with that. By the way, we would be willing to participate as well.” I think this could signal an increased uptake or increased use of hospital-at-home care.
Elizabeth: And expansion into all 50 states, I suspect. I also suspect that it will be reimbursed by big third-party payers because it’s less expensive.
Rick: No downsides to this as far as I can tell.
Elizabeth: Remaining in JAMA, then, in a research letter, let’s take a look at the prevalence of nicotine pouch use among U.S. adults. I have to admit that I was unfamiliar with these particular devices and I look askance at them. I will say right away, in my editorial way, that it appears like one more thing that’s developed by big tobacco in order to maintain a market share when there is so much regulation and social disapproval of cigarette smoking and vaping.
These things are single-use microfiber sachets that are prefilled with a nicotine microcrystalline powder and some other constituents. Sales of these things — this is an astonishing figure — between 2019 and 2022 have increased 641%.
They used the Current Population Survey to assess how many people are using them and what are the characteristics of these folks. They assessed their smoking status, whether they were never-smokers, current smokers, or are they trying to quit cigarette smoking — could that be why they are actually using these things?
This is a pretty representative sample, about half women, 17% Hispanic, and 12%, non-Hispanic Black. Overall, they found that just shy of 3% of all their participants reported ever nicotine pouch use and about 0.4% reported current use. Their smoking status was associated with this. Some of the participants said that they were trying to use them in lieu of actual cigarette smoking.
What we know, of course, about trying to use these kinds of things — just using nicotine substitution for cigarette smoking cessation — is that it doesn’t really work out very well. These pouches are probably not going to end up being efficacious in that regard. Pouch use can be associated still, though, with nicotine dependence. It can also cause mouth lesions and we know that in the presence of HPV, for example, those things could result in an increased preponderance of oropharyngeal cancers. I’m sorry that their use is increasing so much and I do not see an upside.
Rick: Yeah. Elizabeth, I agree with you. Fortunately, very few individuals currently use them. It obviously does avoid respiratory exposure of smoke and some of the toxins. Previous studies they asked, does the pouch actually relieve the cigarette cravings for those that are smoking daily and would it help people get off cigarettes?
It really doesn’t. In this particular study, there was a higher reported pouch use in younger age groups, particularly males and whites, than in older individuals, those that have been smoking for a long period of time. I don’t see any value because it can foster nicotine dependence. I see a lot of downside.
Elizabeth: Yet one more crazy device out there. Let’s turn to the New England Journal of Medicine.
Rick: A medication that can help mitigate the progression of chronic kidney disease and actually prevent cardiovascular death and death in diabetics. We have another weight loss medication, the GLP-1 agonists — the glucagon-like protein-1 agonists. These are medications like semaglutide that we know that they reduce weight in individuals who have diabetes and a lot of individuals are receiving injections of these medications. Do they also extend benefits like the other medications?
They took over 3,500 individuals who were randomized to receive either placebo or semaglutide and followed them up for about 3½ years. The study was supposed to go a bit longer, but they stopped it because there was already a benefit. The question was, does it slow down or prevent chronic kidney disease? Does it affect the death rate from either kidney-related disease or cardiovascular disease?
For those who received the semaglutide, it looks like it reduced the overall outcome by about 24%. The kidney-specific components of the primary outcome decreased it by about 21% and deaths from cardiovascular causes reduced it by about 30%. These are again clinically important outcomes in diabetics. Semaglutide and probably the GLP-1 agonists as a group can be beneficial in diabetics with regard to kidney disease and preventing death.
Elizabeth: Also, there is emerging evidence that they might have even more of a global impact on other stuff like cancer.
It’s sounding like, of course, that these are pretty persuasive. Let’s talk about a cost-benefit analysis. What are the downsides of this and has this specifically been compared with other agents that work by different mechanisms?
Rick: The first thing is there was no mention of what the cost-benefit was in this particular study. To reduce the primary outcome by 24% after 3½ years, from a medical standpoint that’s pretty persuasive. With regard to comparison with the other medications I mentioned, or more importantly, could they be additive — let’s say someone is on an SGLT2 and also a GLP-1 agonist — is there additional benefit from adding those two?
Unfortunately, in this particular trial there were very few patients in whom they received both medications and so we can’t answer that. But I think either comparison studies [or] additive studies will be important for defining which medication or medications we choose first, which combinations we use.
Elizabeth: I think all of this, of course, is a short-term fix, because ultimately prevention of obesity and sedentary lifestyle is going to reduce the incidence of type 2 diabetes a lot and may obviate the need for all of these strategies to short-circuit the long-term impact.
Rick: You’re right, Elizabeth. If we could prevent them rather than treating them, we’d be much better off.
Elizabeth: Remaining in the New England Journal of Medicine, let’s talk about a monoclonal antibody that’s called felzartamab. This is a phase II trial where they are taking a look at this antibody-mediated rejection of transplanted kidneys. That is actually a leading cause of kidney transplant failure. Interestingly, it’s kind of a long-term problem that develops in this study anyway, years after the kidney has been transplanted.
They target in this a receptor that’s called CD38 to inhibit graft injury that’s caused by alloantibodies and natural killer cells. This is a double-blind, randomized, placebo-controlled trial with a total of 22 patients who underwent randomization and one person ended up with kidney rejection, so they dropped out. These folks all had antibody-mediated rejection that occurred at least 180 days after transplantation, but in fact was considerably longer than that.
They would receive either nine infusions of this CD38 monoclonal antibody or not. They did that over a period of 6 months and then they followed that with a 6-month observation period, clearly looking at the safety and the side effect profile of felzartamab, but they also had these key secondary outcomes that in my mind are really important outcomes: renal biopsy results at 24 and 52 weeks, donor-specific antibody levels — are we making a bunch of antibodies against this kidney? — their peripheral natural killer cell counts, and donor-derived, cell-free DNA levels that indicate that there has been damage to the transplanted organ.
All of these measures were improved in the folks who received the antibody, and that was at the expense — or not at much expense at all — with regard to any kind of adverse side effects. The big thing was that after they stopped receiving the antibody, a lot of these markers started to go back up again, indicating that you may end up having to take this stuff over the long haul.
Rick: Whenever you see a study of just 22 patients published in the New England Journal of Medicine, you have to ask yourself why, in the early phase of this, is this so important? That’s because, as you mentioned, antibodies attacking the donated kidney are a leading cause of kidney failure months and years after the kidney has been transplanted. Today, they have tried a number of different things — different antibodies to different things, different inhibitors — and nothing has worked.
This particular antibody that attacks the cells that makes antibodies to try to deplete them clearly has a signal that is beneficial. It’s a small study. It’s a fairly short duration. When they stopped it, the benefits went away. But it’s at least a signal that they are addressing the right thing and can receive a benefit. It’s exciting because we have tried four or five or six other different things that weren’t beneficial. This one at least can be. We need to confirm that in larger studies of longer duration.
Elizabeth: And very well may point the way toward modification of this antibody so that it’s even more precise than it is right now. Having said that, I would also say another benefit was there was concern about depletion of the natural killer (NK) cell population and whether that was going to result in significant infection risks. It turned out that this antibody did not completely ablate the whole population of NK cells and in using this antibody in patients with multiple myeloma that was also an observation they made, that those folks did not end up more prone to infections, even though this subpopulation of NK cells was depleted.
Rick: It’s really hard to make any conclusions about whether there are very many serious side effects and whether they may be related to infections. Whenever you disturb the immune system, you run the possibility you increase the risk of cancers as well. With just 11 patients, the only thing we can say is it does show some promise.
Elizabeth: More studies coming undoubtedly. On that note then, 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.
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