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Steve Freed: This is Diabetes in Control. We’re here at AACE 2016 in Orlando, Florida. We have with us a special guest and a cardiologist, not an endocrinologist. It’s always great to get a different opinion. So maybe you can tell us a little bit about yourself, even where you went to school, where you’re practicing, what type of practice?
Dr. Taub: I am a cardiologist at University of California, San Diego. I’m an associate professor of medicine and I’m also a director of the cardiac wellness and rehab center at UC-San Diego. I did my medical school at Boston University. I did my Internal Medicine residency at University of Washington in Seattle and my cardiology fellowship at University of California, San Diego.
Steve Freed: So tell us a little bit about your practice? What do you do on a daily basis?
Dr. Taub: I see patients about 50% of the time. The other 50% of the time I’m engaged in research and administrative work. I have a very busy clinical practice. I see a lot of patients with various cardiac disease, from coronary disease to arrhythmias to valvular disease. But I would say patients with diabetes comprise over 75% of the patients that I see.
Steve: That’s interesting. You’re a cardiologist and you probably see more diabetic patients than an internist would.
Dr. Taub: Definitely.
Steve: Because, obviously most patients with diabetes have increased cardiovascular risk. In fact, if you think about it, most people with diabetes don’t die from diabetes.
Dr. Taub: They die from heart disease.
Steve: They die from heart disease. Obviously, the two are really interrelated and our newsletter basically focuses not just on diabetes, even things that are related like gum disease. It causes inflammation. It causes heart problems. Sometimes we don’t think of all these other things being involved. My personal feeling as a diabetes educator is that if a person has diabetes, and they’re not in control with their blood sugars, they’re at risk for every disease known to man, whether it be dry skin, amputation, blindness, colds and flus, yeast infections…. Every disease known to man because their resistance is open for infections. I’m sure you see a lot of the same thing, nobody comes to you just for their diabetes. Nobody comes to you just because they have hypertension. Really, you have to look at all those different things.
Dr. Taub: You have to manage everything aggressively. So, patients with diabetes that I typically see have often already had their first heart attack. So we focus a lot on their management of their cholesterol. We focus on their blood pressure. I work very closely with my endocrinology colleagues in managing their diabetes. Many times I will make suggestions based on drugs that have good cardiac data to the endocrinologist on what patients should be started on. And often, many times when patients don’t have an endocrinologist, I will often be the first one to start them on medication for their diabetes.
Steve: You work in a large institution. I always see that large institutions, you probably have at least a couple of dietitians that you work with. You probably have a couple of nurse diabetes educators that you work with. You probably have some pharmacists that you work with. So you have the luxury of having all these other people part of the diabetes team working with you as a real team, different from going to a family practitioner who has none of these people and has to send out, if he does, to all these other people. So your results should be a lot better than a family practitioner’s. You actually, I presume, you get graded in some way for lowering A1Cs, lowering blood pressure, meeting goals. Is that right?
Dr. Taub: Yes, we do. We are constantly being evaluated on how well we manage all of those parameters. One thing I will say. It’s not necessarily about having a large team. Sometimes patients just want the physician’s time and they want to be engaged with the physician. So a family practitioner that doesn’t have a lot of resources can still do an incredible job, as long as they’re engaged with the patient.
Steve: Just like every other profession, you’ve got the good, the bad and the ugly. To get it away from that subject, let’s talk about why you’re here. Are you presenting?
Dr. Taub: Yes, I did a presentation this morning on the use of a new category of drugs called PCSK9 inhibitors, which are used to treat elevated cholesterol.
Steve: Tell us a little bit about these drugs. It’s not a drug that you would give to 90% of your patients with diabetes with high cholesterol when there’s a generic drug out there that only costs cents per day. These new drugs are very expensive.
Dr. Taub: Yes, they’re very expensive and the FDA has only approved them for certain types of individuals. One of them are people that have familial heterozygous hypercholesterolemia. These are patients that have a genetic condition in which their LDL or bad cholesterol is really high, usually over 190. These patients often have a strong family history. That’s one category. The other category are patients who’ve had prior heart attacks, prior strokes, prior TIA, or have peripheral vascular disease, who need additional LDL lowering on top of the statin that they’re already on. That encompasses a lot of people with diabetes, because people with diabetes often have had a heart attack, a stroke, a TIA, and peripheral vascular disease as well. So very common in diabetics. So by that FDA indication, there are people with diabetes that are eligible for these drugs.
Steve: So, how low can the cholesterol be, or how high does it have to be, before they’ll even consider payment?
Dr. Taub: If a person falls into that category of having prior heart attack, prior stroke, and their LDL is over 100, technically, the insurance company should approve it based on the FDA indication. When they first came out last year, it was very difficult to get the drugs approved, but now it’s getting easier and easier. Most of the time I’m able to get the drugs approved if the patient has the appropriate indication.
Steve: How low have you seen this particular drug drop the LDL, from what to what?
Dr. Taub: I’ve seen in some of my patients that have really high LDLs, starting with 220. I’ve seen it drop to 80. Other patients that we’ve started at 130, I’ve seen it drop to 40s to 50s.
Steve: Drugs, particularly these drugs, have a lot of good effects. Like any other drug, including aspirin, there’s also some negative effects, you have to consider those. What are some of the negative possible effects from these drugs?
Dr. Taub: Well in the clinical trials, what they’ve seen is some injection site reaction. These drugs are an injection. You inject every two weeks. There’s some reactions around the injection site. Other side effects that they’ve seen in the clinical trials are muscle aches. In my practice the main problem that I’ve seen is the injection site reactions. With any drug, a lot of side effects don’t appear until you have a large number of patients that are exposed. For instance, with statins, we didn’t start seeing the signal of elevated blood glucose levels in some patients until 25 years after statins were on the market. It is going to take time to see some of the more subtle effects. Right now, the main side effects that I’ve seen are really related to the injection.
Steve: Do you ever have the opportunity to, for especially type 2s, to actually recommend, to actually change drugs for blood glucose? Or do you always go through their endo or internist?
Dr. Taub: Well, I would say that for the majority of the type 2 diabetics, if they’re on insulin then at that point I would definitely insist that they go to an endocrinologist. Many patients don’t have the time to be going to multiple doctors. A lot of patients that I’ve followed over a long period time, that I’ve actually made the diagnosis of type 2 diabetes, I typically start them on Metformin. If their blood sugars are well-controlled they’ll just continue with me. If it gets higher and I need some assistance from my endocrinology colleagues in managing it, then I’ll refer. Also anybody that needs insulin, I refer.
Steve: What about obesity? Most of your patients come in, they have high cholesterol, they have diabetes, and they’re going to be overweight at least. What do you do for those patients?
Dr. Taub: Start with the basics and work on lifestyle modification. After that, where I work at the University of California, San Diego, we actually have a weight management center that’s staffed by a board certified physician in bariatric medicine, who does a lot of consults for our patients who are overweight. There are 4 new drugs that are FDA approved for weight management. I’ll usually defer to him to start those. When I see a patient needs extra help, I refer to our weight management center. They have a lot of resources, including dietitians to work with the patients.
Steve: You’ve had successes with your patients, so what kind of things that you do that you found to benefit your patients that other medical professionals could do?
Dr. Taub: That’s a very good question. There’s a lot of things that I do that I think have been very important to my patients not having heart attacks and strokes and the preventative cardiologist. I focus very much on prevention and one of the ways I do that is by really looking at biomarkers. Those are blood tests that can give us a lot of insights into what’s going on. I have a standard set of blood tests that I check that’s a little bit different from what most people, a primary care physician, would do. I usually will do a panel called NMR Lipo-profile which has LDL particle number, which is particularly important in diabetics, because LDL levels can be normal or low, but the LDL particle number will come back high. It will push me to be much more aggressive with treatment. I also check for something called Lipoprotein(a) or LP(a), which is also an important biomarker to predict cardiovascular risk. I also check high sensitivity CRP. I’ll put all this together in determining how aggressive I need to be. I also believe in testing things like vitamin D that are very evidenced based because low vitamin D levels are associated with a lot of different metabolic derangements. The other thing that I also believe in is many of my patients have arrhythmias or palpitations, so I check a blood test called RBC magnesium. I don’t check blood tests frequently but the first time the patients see me, I’ll get some good standard set of labs to really risk stratify the patient. Is this somebody that needs to see me more often? Is this somebody that I need to be more aggressive with? Those blood tests help me with that. The other thing that I think I do a little bit differently is I do believe in dietary changes and lifestyle changes. I’m not a person to push the statin on immediately, I do go through a lot of other things. Many times those lifestyle changes are successful before instituting the medications. When I do start a medication, I always believe in doing the lowest possible dose and titrating it. A lot of times patients get put on a statin and they’re just basically kept on it for the rest of their life. If I see patients making good changes, I like to reduce medications. If patients are exercising more and their blood pressures are getting better, I will take the doses of blood pressure medications down by half. Those are all things that I like to do. I also screen very extensively for sleep apnea, because sleep apnea is associated with high blood pressure and a lot of patients with diabetes also have sleep apnea. Treating sleep apnea often allows you to reduce medications. That’s another important thing that I screen for. I think in terms of unique aspects of my practice, it’s really listening to the patient and understanding what their life is, what they want to get out of their life, and helping them get there through, whether it’s medications or through lifestyle modification.
Steve: So what about the calcium score? Is there any reason to check the calcium scores? Most doctors don’t do that. Is there a benefit to that?
Dr. Taub: Well, coronary calcium scoring has been shown in study after study to be very predictive of outcomes. It’s another test that you can use to risk stratify somebody. Somebody who has a high calcium score you want to be more aggressive with in managing their lipids versus somebody that does not. It’s another tool. Sometimes I’ll use it but usually the biomarkers that I check give me enough information.
Steve: So in the new drugs the PCSK9s, how do you start a patient on it? Do you just give them the first shot and they walk out the door, and they come back in two weeks?
Dr. Taub: That’s a good question, because they are relatively new drugs, you have to go through a pretty extensive approval process from the insurance company. You have to document the patients have tried different statins. What doses of statins, you have to document what their LDL is. Once the drug is approved by the insurance company, what we’ll typically do is we’ll ask the patient to come in for their first injection so our nurse can walk them through it. It’s actually very simple, the needle is a very small gauge needle. Most patients say they can’t even feel it. We do walk them through the first injection. The companies also provide nurses to come to the patient’s home to walk them through the first injection. After the first injection, patients usually feel very comfortable injecting themselves and it’s once every two weeks.
Steve: When can you expect to see results?
Dr. Taub: I’ve seen amazing results in 3 months, when I check their next lipid profile.
Steve: Now we have some drugs that are very interesting. If I was going to be a physician, I think this would be a good time to become a physician, because you have a lot more tools. From 1950 to 1995 we only had one oral drug to treat diabetes. Now we’ve got over 11,398 combination possibilities, makes it more confusing, but we certainly have the tools. There’s no reason why anyone should walk around with elevated blood sugars with all the knowledge that we have on diet and physical activity and all these new drugs. Plus we have insulin. You can always get someone’s blood sugar down with insulin. And yet, in this country if you add up all the people with and look at their blood sugars, you’ll probably come up with an A1C that’s over 9%, for those people including those that don’t go to doctors that have diabetes. And yet we have all these tools available to us. It blows my mind why so many people are not being treated properly. That’s one of the reasons we have our newsletter is to educate the physicians, take better care of their patients. Getting back to what I was saying is this is a very unique time because within the last 5 years we’ve found that certain drugs actually reduce your risk for cardiovascular disease at the same time lowering blood sugars. The SGLT-2s. Do you see a lot of those drugs? Do you recommend those type of things to your patients or do you feel secure using those drugs?
Dr. Taub: It’s a very exciting time because of a lot of the outcome data that has come out, especially the Empa-Reg study with the SGLT-2 inhibitor. It’s exciting because the reduction in cardiovascular mortality in hospitalizations, death from MI. It’s very significant. As cardiologists we have to pay attention to that data because those are all of our patients. The patients with diabetes, those are the ones that are having a significant amount of heart attacks. It’s an exciting time to be practicing medicine. We, as cardiologists definitely need to know the data. This data has actually pushed me to prescribe these medications that alter cardiovascular mortality to my patients.
Steve: I want to thank you for your time. Before I let you go, because you’re going to be talking on these new cholesterol medications, what information would you like to get out to the family practitioners? A lot of doctors are afraid to write for these new medications, until they’ve been out 5, 10, 20 years sometimes. What would you like to tell them as far as using these new drugs for cholesterol, for LDL? By the way, have you seen any rise in HDL?
Dr. Taub: I have seen about a 5-12% rise in HDL. I would say that the data for these new drugs is very compelling. There’s two PCSK9 inhibitors on the market, alirocumab and evolocumab. Both of these drugs in clinical studies have shown up to a 50 to 60% lowering of LDL cholesterol. We don’t have the outcome studies yet. We’ll have them hopefully next year. What I would say is for people that really have high LDL cholesterol that we are not able to get to a level less than 100, these are people we should really consider, especially people that have had a prior heart attack or stroke. We should consider these drugs. The other group of people that are very under-appreciated are the familial heterozygous hypercholesterolemia patients. Anybody that’s walking around with an LDL over 190 untreated, which I would say 5-10% of many people’s practice, need to be on these drugs.
Steve: You mentioned that one of the side effects of the PCSK9 inhibitors is the site irritation. How does that compare to site irritation with insulin?
Dr. Taub: That’s an interesting question. I think the site irritation here is a little bit more pronounced because sometimes patients at the site of the injection are actually complaining of a cramping, significant pain. One of the things about the site reactions is sometimes patients are not administering the drug properly. You’re supposed to wait for 30 minutes, leave the drug out at room temperature before injecting, because when you don’t it’s viscous. Some of the sight reactions might be due to patients not doing it properly. That’s why we spend a lot of time educating them and having the nurse show them how to inject, so that could be it. But I don’t think it’s the same magnitude of what we see with insulin.
Steve: Can a patient do their self-injection?
Dr. Taub: Yes they can.
Steve: So they can be sent home with the medication for a month or whatever and this is done every two weeks.