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A New COVID-19 Vaccine; Treating High Blood Pressure to Stave Off T2D

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 a new blood thinner, COVID and flu vaccines given together, a new COVID vaccine, blood pressure lowering and diabetes risk, and apoB for prediction of heart disease risk.

Program notes:

0:40 Flu and COVID shots together? And a new COVID vaccine

1:40 India creating its own vaccine

2:41 Flu and COVID vaccines together

3:41 Dual use reduces barriers to vaccination

4:00 Treating high blood pressure to reduce development of type 2 diabetes

5:00 ACE inhibitors and ARBs only

6:01 Follow-up when people start on diuretics

6:50 Prevention of venous thromboembolism with a new blood thinner

7:50 Less likely to cause bleeding

8:26 ApoB instead of LDL and triglycerides

9:30 Easy to measure

10:38 Just going to measure apoB

11:18 End

Transcript:

Elizabeth Tracey: Does managing high blood pressure reduce diabetes risk?

Rick Lange, MD: A new type of blood thinner.

Elizabeth: Is there a better way to assess someone’s heart disease risk?

Rick: And COVID vaccine, a new one, and should it be given with the flu vaccine?

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 Centre in El Paso. I am 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: Rick, we are treating two studies that are in The Lancet together today. One is that you served up as should we give the flu vaccine and the COVID vaccine simultaneously, and a new type of COVID vaccine.

Rick: Which one do you want to cover first?

Elizabeth: Whichever you’d like.

Rick: Well, let’s talk about the new vaccine first. The country of India has developed their own vaccine. It’s a whole-variant, inactivated virus vaccine. Almost 26,000 participants were randomly assigned in this double-blind study to receive either their vaccine called BBV152, or placebo, and they studied the efficacy.

It’s pretty effective. When they looked at the number of cases, 0.3% of those that received the vaccine developed COVID versus 1.2% of those that received placebo. That’s an efficacy of about 78%. The efficacy of preventing asymptomatic infection was about two thirds. By the way, it doesn’t require the extreme cold storage as some of the other vaccines.

Elizabeth: That’s great news. I think it’s also great news that India is creating its own vaccine. I think that we have a big problem with the limitations relative to the manufacturing of vaccines. I think the more countries that get into this game, the better we are all going to be.

Rick: Yeah. Kudos, by the way, for developing the vaccine and also proving in a very good trial that it is in fact effective, and just about as effective as the other vaccines available.

Elizabeth: I think the other thing that is going to be interesting to see is going to be the long-term immunogenicity, if you will, of this particular strategy.

Rick: I am glad you mentioned it, Elizabeth. Again, this is two doses. Many of the vaccines were tested prior to the Delta variant. This was effective not only in the non-Delta variants, but also in the Delta variants as well, and just as effective in older and younger people, and people that had comorbid conditions.

Not only is it effective, but it’s also safe. The percentage of individuals that had side effects with the vaccine is — there was placebo, by the way — and no serious side effects. We need to test it in millions.

Elizabeth: Which I don’t think you’re going to have any trouble doing. Let’s turn to this issue that’s a big domestic issue — I have heard lots of people talking about it — should you get your flu vaccine and a COVID vaccine at the same time?

Rick: This was a very well-conducted study that looked at two different vaccines: the adenoviral vaccine, an mRNA vaccine with three different types of flu shots. The flu shots in older individuals, they needed a higher flu dose, that’s a quadrivalent. They have the usual flu vaccine and there is also one that has something that’s supposed to make you more immunogenic called an adjuvant.

They tested in six different groups, over almost 700 individuals, the two COVID vaccines and these three different flu vaccines in various combinations to say, “Hey, is it safe?” In this group of individuals … six different groups, different combinations, with the flu [vaccine] given on the second dose of the COVID vaccine.

What they established is that it is safe. There are no more side effects associated with either of the COVID vaccines or any of the flu vaccines. They are also just as effective in producing an immune response. We don’t want to put up barriers. If individuals know that they can get the COVID vaccine and the flu vaccine at the same time, that takes the barrier out of the way.

Elizabeth: It sure does. It should facilitate lots of people being able to get in there and get it done.

Rick: Absolutely. What I would tell people is they should be given in different arms. Again, it’s safe and efficacious.

Elizabeth: Since we are talking about safe and efficacious, let’s turn — we are still in The Lancet — to something that is really quite interesting. This notion that if we treat high blood pressure we can actually stave off new onset of type 2 diabetes.

This is not a new idea, and this study is a meta-analysis — what they call a one-stage individual-participant data (IPD) meta-analysis, looking at this risk of new-onset type 2 diabetes in folks who are being treated for high blood pressure.

They had over 145,000 participants from 19 randomized trials. The median follow-up was 4 and a half years. What they basically found was systolic blood pressure reduction by 5 mm of mercury reduced the risk of type 2 diabetes across all these trials by 11%.

The two types of blood pressure meds that were able to do this were angiotensin-converting enzyme, or ACE inhibitors, and ARBs, angiotensin II receptor blockers. They both were able to reduce the risk of type 2 diabetes.

It turns out that calcium channel blockers, however, had no impact, and beta-blockers and thiazide diuretics — so first-line treatment for hypertension — actually increased the risk.

What’s this say to you?

Rick: There probably is some link between hypertension and development of type 2 diabetes. I know that hypertension increases the sympathetic nerve activity, it increases inflammation, and it may affect insulin resistance.

It’s also important to note that it is somewhat of a class effect targeting specific medications. Those people that are considered to be at risk for type 2 diabetes, targeting blood pressure medications that include ACE inhibitors or ARBs is important. Those that are a higher risk would probably want to avoid thiazides or beta-blockers.

The interesting thing is most individuals aren’t treated with just one blood pressure medicine. It’s oftentimes two or three. This study didn’t assess what the combination of those things would be.

Elizabeth: I guess the other thing I’d like to see would be following up with people who start on diuretics — which, as we know, is what most people start on — and see what happens to diabetes incidence when people start on that.

Rick: Yep. When one looks at individual classes of medications, thiazide diuretics are known to increase the risk of glucose intolerance or insulin resistance just a bit.

We do know, however, in a population that is elderly with systolic hypertension, they are tolerated well, they are effective, they lower the risk of cardiovascular events, there are fewer or few side effects, and so it’s oftentimes one of the first go-to medications in the older population. Those that aren’t considered to be a risk of diabetes, the thiazide diuretics can still be very useful, but oftentimes they are used with other medications.

Elizabeth: More to come, no doubt. Let’s turn to the New England Journal of Medicine, the prevention of a serious problem, venous thromboembolism.

Rick: We see venous thromboembolism in a lot of different conditions, but one of the ones we have seen is people that have had hip or knee surgery. This I represented as a new class of blood thinners. We know that individuals that are born with what’s called a factor XI deficiency have a decreased risk of having venous thromboembolism, but they don’t bleed very much. That natural occurrence said, “Well, gosh. Maybe if we made an inhibitor to factor XI we could get the same results. We need something that’s given orally.”

This is the study of a new factor XI inhibitor that can be given orally. They tested it in people that are having knee surgery versus a known medication that we already give that we know was effective.

In over 1,200 patients, they gave half of them this new factor XI inhibitor called milvexian. What they found out is it was just as effective in preventing clots. It was less likely to cause clinically relevant bleeding than the current anticoagulant or blood thinner that we are using.

Elizabeth: This is really good news. This was just a phase II trial, though, wasn’t it?

Rick: It was, and what they discovered is that there is dose-dependent efficacy. The higher the dose, the more effective. But the higher dose didn’t increase the risk of bleeding.

Elizabeth: No doubt. This is excellent news for all those folks who have to have these kinds of meds after they have joint replacement.

Rick: Yeah. Kudos to our scientists that aren’t resting on the laurels saying, “Gosh, we have enough blood thinners and they are fine.” We are always looking for a better one and a safer one.

Elizabeth: Finally, let’s turn to JAMA Cardiology. We should note that we have all of these publications relative to cardiovascular disease that are also being released because of the American Heart Association meeting.

As we know, when we are trying to manage somebody’s lipids, we rely on this low-density lipoprotein and to a lesser degree to triglycerides. What this study basically says is, wait a second, there is a better way to do this. Apparently, this has been an ongoing controversy of which I was unaware. Tell me, Rick, you must have been aware of this.

Rick: I was. We have known for a long time that cholesterol is associated with a higher risk of cardiovascular disease. But more importantly, it’s different types of cholesterol, the low-density lipoproteins (LDL) cholesterol associated with the increased risk. Evidently, a high-density lipoprotein, with a decreased risk. It’s not really the cholesterol; it’s what is attached to the lipoprotein. In this particular case it’s called an apoB lipoprotein.

We have known about this for years. Instead of measuring all these cholesterols, maybe what we need to do, because the number of cholesterols can kind of increase or decrease, but the number of apoB particles may be a little bit more predictive. By the way, it’s easy to measure, it’s easier to understand, and it looks like the apoB proteins go up and down with statin therapy or lifestyle, and things like that.

Elizabeth: They had two prospective cohort analyses that they had two large international clinical trials and a U.K.-based biobank. There were almost 400,000 folks in the primary prevention group and over 40,000 who were receiving statin treatment.

Basically, what they found out was that this measurement, apoB, was absolutely the thing to be looking at. I would note that clinical laboratory standards do show that it can be measured effectively and reliably.

Rick: It’s the apoB protein that actually gets trapped in the arteries that causes this atherosclerotic process. It’s all in the apoB protein. These authors have said, “Listen, we have been getting this data for a number of years in different ways. Now it’s time just to change how we think about things.” Finally, we ought to say, “Listen, we’re just going to measure your apoB.”

Elizabeth: Well, if you were a betting guy, how many years would you say it’s going to take before patients are going to be up to speed on apoB?

Rick: I think it’s probably going to be about 5 years. I would suggest if the physicians get on board we start teaching the medical students and we start reporting about what the apoB levels are and how they are lowered with statin.

Elizabeth: Okay. That’s a look then at this week’s medical headlines from Texas Tech. I am Elizabeth Tracey.

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

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