Myocarditis After COVID Vax; Cigar Sales in Convenience Stores

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TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, 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 best oral anticoagulant, managing immune-modulating drugs in those with autoimmune disease, myocarditis and pericarditis after COVID vaccination, and cigar sales in convenience stores in the U.S.

Program notes:

0:37 Myocarditis and pericarditis after COVID vaccination

1:35 Most under age 40 and second dose

2:33 Rare side effects will emerge

2:50 Autoimmune disease treatment management

3:50 Use of infliximab (Avsola) in a range of autoimmune conditions

4:50 TDM helps maintain infliximab efficacy

5:50 Insurance requires preauthorization

6:50 Anticoagulant therapy in atrial fibrillation

7:50 Rivaroxaban (Xarelto) more likely to have strokes

8:50 Missing a dose leaves people uncovered

9:26 Cigar sales in convenience stores

10:26 Flavored sales increased

11:03 Two to three cigars sold together

12:05 FDA proposed a ban

13:03 End

Transcript:

Elizabeth Tracey: Will those tobacco manufacturers ever give up?

Rick Lange, MD: Myocarditis and pericarditis after COVID vaccination.

Elizabeth: If we are managing somebody with immunomodulatory drugs, if we do that more carefully, is that helpful?

Rick: And is one anticoagulant better than the other with people with atrial fibrillation?

Elizabeth: That’s what we are 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: 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: Rick, let’s turn right to the BMJ and our COVID material for this week.

Rick: So Elizabeth, there has been a lot of concern about the incidence of myocarditis or pericarditis — that’s inflammation of the heart or inflammation of the surrounding tissue around the heart — after COVID vaccination. They have never had a good population-based study, so that’s exactly what this is.

These authors reviewed data from all 5 million residents of Denmark, aged 12 or older, 4 million of whom had received one of the two mRNA vaccines over a course of a year. All cases of myocarditis or pericarditis were identified in these individuals. They compared the risk with each of the mRNA vaccines for the first 28 days after vaccination.

For those that received the Pfizer vaccine, 3.5 million individuals, only 48 developed myocarditis or pericarditis within the first 28 days. The vaccine was associated with myocarditis and pericarditis only in females.

When they went to the Moderna, however, the incidence was about three times higher. Most of this occurred in individuals under the age of 40. It seemed to occur primarily with the second dose, but most importantly, all of the cases were mild, all the individuals did well. The incidence is low. It’s much lower than having heart complications related to getting COVID infection.

Elizabeth: Now, the Moderna vaccine, was that disproportionately affecting men?

Rick: No, the Moderna vaccine affected both men and women.

Elizabeth: Clearly, there are lots of emerging data. We know that with the warning relative to the J&J vaccine about what are the side effects and especially the rare ones that occur with vaccination with all these different vaccines.

Rick: Again, Elizabeth, I want to point out these are very rare complications. The complications are really much lower than associated lung or heart abnormalities, or long COVID symptoms that people can experience.

Elizabeth: There is no question in my mind, and I’m sure in yours also, that as these other vaccines start emerging and being employed we are going to see a full constellation of rare side effects that are going to emerge.

Rick: As long as the benefit outweighs the risk of these vaccinations, and for the mRNA vaccines that’s certainly true, individuals should be getting vaccinated and those that have been vaccinated fully should be getting boosters, especially with the onset of the Omicron variant.

Elizabeth: Exactly. Let’s turn to JAMA. We have all become more excruciatingly aware, I would say, of just the sheer number of people who have immune-mediated inflammatory diseases. It’s huge. And we have taken a look at whether COVID is more severe in these folks, whether they have a higher risk of death.

So in this case, it’s nothing to do with COVID. But it has to do with if we are using a specific immunomodulatory medication that’s called infliximab on a range of these folks with inflammatory diseases, can we employ something that’s called therapeutic drug monitoring and render this more flexible, I would say? Because what happens when these immunomodulatory agents are used, particularly this one in these people, over time they can produce antibodies against it, and it can also result in a huge loss in efficacy. Then they end up with all kinds of flares. Clearly, that has long-term damage relative to organ damage as well as a really dramatically reduced quality of life.

This was one where they used infliximab in 20 Norwegian hospitals among a range of autoimmune conditions, including rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, or psoriasis. Really a full range, although the end was kind of low for all of them.

They randomized patients 1:1 to what they call this proactive therapeutic disease monitoring — or we’re going to abbreviate it TDM. Then they had also scheduled monitoring of serum drug levels and anti-drug antibodies in that group that was in the TDM randomization.

They followed these folks for a year, a full year, which I think is really impressive. What they found out was that those patients who were in the TDM group had sustained disease control without disease worsening in about 74%. While those that were in the standard treatment group, it was about 56%. It’s sure looking like, in order to maintain the efficacy of these agents, this therapeutic drug monitoring is a really good idea.

Rick: As you mentioned, these are immune-mediated inflammatory diseases. Infliximab is what’s known as a biologic disease-modifying drug. That is, it just doesn’t hide symptoms. It actually modifies the disease. It decreases the inflammation.

For those individuals in which it’s initiated over the course of about a year or so, about 50% of them have a relapse thought to be due to either low drug levels or the development of antibodies to this therapy. Therapeutic disease monitoring actually measures the serum level in individuals. If it was too low, they increased the dose. Or if they develop antibodies to it, they backed off. As you noticed, when they did that, it significantly improved the outcome, compared to just giving routine doses to everybody. This is really an important way to treat individuals.

Now, here are the barriers to it. Insurance companies, because these drugs are expensive, actually require pre-authorization to increase the drug doses. Then to do this kind of therapeutic monitoring takes additional nurses, physician assistants, and pharmacists to help monitor these patients, so the cost effectiveness really hasn’t been studied yet today.

Elizabeth: They also note — the editorialists — that it’s still not clear whether these kinds of results will apply to other drugs that work by this mechanism. They also note that usually medications such as methotrexate are recommended, even during infliximab therapy, to try to modulate that antibody development.

Rick: Certainly, this specific agent, yes. Regarding this class of agents, I think we really do need to study it because the results are different with each of these different antibody disease-modifying drugs.

Elizabeth: But could be really good news for all of those folks who have these autoimmune diseases.

Rick: Certainly worthy of study.

Elizabeth: Yeah. Staying in JAMA, then, on to you.

Rick: I want to talk about this study because it helps inform the choice of anticoagulant therapy in patients with atrial fibrillation. This is an irregular heart rhythm that’s associated with stroke. The way to prevent this is to put people in anticoagulant therapy.

Beginning in 2010, we have had more direct-acting oral anticoagulants, called DOACs. We now have a total of four of those, but two of them are primarily used in the U.S., one called apixaban given twice a day and one called rivaroxaban given once a day. But they have never been compared to one another. What these authors tried to do is to find out among these two, is one preferred over the other?

Now, about 70% of patients with atrial fibrillation are put on one of these two medications. They compared rivaroxaban with apixaban for more than 580,000 Medicare beneficiaries with atrial fibrillation — these are individuals over the age of 65 — up to 4 years of follow-up. About two-thirds of these patients received apixaban and about one-third received rivaroxaban.

What they discovered was that the patients that received rivaroxaban were more likely to have ischemic events — strokes — than those that received apixaban. They were also more likely to have hemorrhagic events. [Over a] thousand patient-years of treatment, patients who received rivaroxaban had about 2.7 additional strokes and 21 additional non-fatal bleeding events compared to patients who received apixaban.

Elizabeth: This is one of those studies that, as you know, I’m happy to refer to as a “duh” study. Why didn’t anybody ever look at this before?

Rick: To do this kind of a study where you are comparing two of these agents, first of all, both companies have to agree. It would take about 85,000 patients to be followed for 5 years just to detect a 10% difference — a very large, lengthy, and expensive study.

Elizabeth: OK. Based on this study, what are you going to be doing with your patients?

Rick: Well, it’s funny. We had already seen that apixaban was better, and so I tend to use it. Now, the downside is you have to take it twice a day instead of once a day. Part of the issue with rivaroxaban is if you miss a dose, you’re really uncovered for a longer period of time and that’s probably why the higher incidence of stroke.

The higher incidences of bleeding is probably because it has higher peak levels than the apixaban. In general, I encourage my patients to make sure they are very fastidious about taking it twice a day, and I prefer apixaban over rivaroxaban.

Elizabeth: What about the cost differential?

Rick: First of all, they are both expensive. The apixaban is about to be generic and that’s going to lower the costs significantly. Some are included on the insurance program and others are not. I do have some patients that receive rivaroxaban primarily because that’s the one that their insurer prefers.

Elizabeth: Ummm. Staying in JAMA, then, let’s turn to this issue of I said are these tobacco manufacturers ever going to give up? If I could, I would take away all tobacco products right now. I am convinced it might be good as an insecticide, but other than that, there just shouldn’t be anything out there.

This is a research letter that’s taking a look at cigar sales in convenience stores in the U.S. between 2009 and 2020. Those cigar manufacturers, what they are doing is honing in on flavors that turn out to be really attractive. They also are trying to manipulate pack sizes.

It took a look at a bunch of different flavors that these things come in: sweet flavors, fruit, wine, and mint and menthol, and something that they call concept flavors — which I don’t really get, maybe you do — which they identify as ambiguous descriptors. They also take a look at, well, they were selling them, in what kinds of packs, how many of them came together.

What they found is that flavored cigar sales significantly increased, but the non-flavored ones did not change. There were shifts in the flavor types. So fruit flavors lost interest, but the sweet and candy flavors increased and then kind of stabilized. The wine flavors declined, and the concept flavors increased and then increased at a slightly lower pace. Also, this pack size issue — about 77% in 2009 in these five-pack kind of things. Now the shifts have occurred with sales of two to three cigars increasing more rapidly than others.

What they point out — and if you look at the graphs it’s really distressing — is that these inexpensive, small-pack sizes and those that are flavored hold appeal, and even where they are sold, hold appeal for young people, and may facilitate their experimentation and ultimately with their addiction to a tobacco product.

Rick: Just to piggyback on one of the things you mentioned: these concept flavors are things called sweets, or green sweets, or black, or diamond, or jazz. It’s not a real flavor; that’s why it’s called concept. You’re right — they are targeting these flavored cigars in small packs so they are more affordable to younger individuals. Ninety-one percent of all cigar sales in 2020 occurred in convenience stores. I was not aware of that. This is a tobacco retail outlet that’s obviously very popular among youths, so this is really distressing.

The article does mention that in 2021 the FDA proposed a ban on flavored cigars. Implementing this policy may take years, and it’s likely to be delayed because of litigation from the industry as well that needs to be addressed.

Elizabeth: Yeah. This gateway kind of thing, trying to get people addicted to nicotine so that then they go on to other habits, is just something that I think really needs to be interrupted. I tend to think the FDA isn’t exerting its full authority and here is the place where I feel like they ought to do a better job of that.

Rick: The FDA can propose a ban, but they can’t actually institute it. It has to get executive or legislative approval. But even then, when this happens, the industry delays implementation just by litigation. This is clearly not in the best interest of our youths.

Elizabeth: Exactly. 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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