When to Start or Stop Statins in Older Adults: Tim Anderson, Rita Redberg, Mike Rich

Eric 00:30

Welcome to the GeriPal Podcast. This is Eric Widera.

Alex 00:35

This is Alex Smith.

Eric 00:36

And Alex, we’re going to be talking about starting and stopping statins in older adults. Who do we have with us?

Alex 00:42

We are delighted to welcome Rita Redberg, who’s a cardiologist at UCSF. Rita was editor at JAMA Internal Medicine from 2009 to 2023, where she spearheaded a focus on less is more medicine. Rita, welcome to the GeriPal Podcast. GeriPal Podcast.

Rita 00:59

Great to be here. Thanks.

Alex 01:01

We’re delighted to welcome back Tim Anderson, who is a general internist and health services researcher at the University of Pittsburgh. Tim, welcome back to GeriPal.

Tim 01:10

I can’t believe you let me back. (laughter)

Alex 01:18

And we’re also delighted to welcome back Mike Rich, who’s a cardiologist and professor emeritus at Washington University in St. Louis. And is a JAGS associate editor. Mike, welcome back to the GeriPal Podcast.

Mike 01:35

Thanks. Pleasure to be here. Looking forward to it.

Eric 01:38

So there’s a lot of news, new guidelines on when and who to start statins on, uh, with a section on older adults, which we’ll be talking about, and then when should we stop them. But before we do, we always start off with a song request. Tim, I heard you have a song for Alex.

Tim 01:53

Yeah, I thought since we were, you know, talking statins and talking heart attacks, we could start with Achy Breaky Heart.

Alex 02:00

All right, here’s a little bit.

Alex 02:07

(singing)

Eric 02:59

That was wonderful.

Alex 02:59

Yeah.

Alex 03:00

But will it kill this man? Hmm. What is an MI? What is a stroke?

Eric 03:05

We’ve got so much to talk about.

Alex 03:07

Right? There are more linkages there. Okay.

Rita 03:09

Yeah.

Alex 03:10

Good choice, Tim.

Eric 03:10

All right, Tim, I’m gonna start off with you. You wrote a wonderful article on the implications of new guidelines for statin use in – is it adults? There’s a pediatric section too, isn’t there?

Tim 03:25

There is.

Eric 03:25

New statin guidelines, and then you looked at eligibility for that. I’m wondering just from big picture, from your perspective, why did you get interested in this as a subject?

Tim 03:37

So I think asking questions about when is the right treatment for the right patient is something I learned from many geriatrician mentors, including some of your officemates at UCSF. But as an internist, I think applies across the lifespan.

And so cardiovascular decisions in particular, I think are probably the topic that we talk about almost every single patient. I see in clinic, in primary care, it’s, it’s some part of that conversation. And so statins, blood pressure meds, things like that are always hot, hot on my list.

Mike 04:07

Yeah.

Eric 04:08

And, and Rita, from your perspective, I don’t know, where do you think statins fall in big picture? Less is more. And how do you think about them? Because, you know, some people advocate that they should be over the counter.

Rita 04:21

Well, that’s not me. Unlike Most cardiologists, and definitely unlike the new guidelines, I think statins have basically no role in primary prevention. I think they distract us from things that are important, and I think the data is incredibly flawed and very weak for any benefit to patients.

Eric 04:41

Oh, oh, we got a lot to talk about.

Alex 04:43

We have stuff to talk about.

Tim 04:45

Yeah.

Alex 04:45

Mike, where do you fall on this?

Mike 04:48

So, as somewhat traditional cardiologist, I think the The data for statins for secondary prevention for sure, and also for primary prevention up to the age of 75, it’s pretty convincing. I think it lowers cardiovascular events and mortality. I think that the real question is the people over 75, and I think I agree with Rita on that, that the data are very weak.

We really don’t have any high-quality randomized trials, at least prior to STAREE, which we’ll talk about. His ongoing preventative trial, which I think is gonna give us some good insight into the use of statins in people over 75. I think with respect to Tim’s article, which showed that the new guidelines, which really lower the bar for prescribing statins, the implication of that is that there’s some 21 million, I think it is, additional adults in the United States who would be eligible for statins. based on the new guidelines compared to the prior guidelines.

Most of those are younger, low-risk people, though. It’s not so much the older people who, even with the prior guidelines, would meet criteria for scans, at least up to the age of 75.

Eric 05:58

Tim, I had a chance to read the guidelines. I saw your name on the guidelines.

Tim 06:02

Indeed, I was the American Geriatric Society representative in the multi-specialty guidelines, the rare non-cardiologist in the group, I would say.

Eric 06:11

I read your article and Honestly, the guidelines were very, very dense, a little bit hard to read, but your article had a beautiful table on the difference between the old guidelines and the new guidelines. Can you just give us, like our listeners, an overview what’s changed, especially in the realm for older adults in the new guidelines?

Tim 06:31

So I think the biggest initial change is a switch in how to calculate cardiovascular risk from the pooled cohort equations, which had been kind of around since around 2013. To the PREVENT equations, which are both a similar idea of estimating 10-year risk of heart attack and stroke for your patients, but incorporate slightly different inputs. For example, they have things like kidney function in there.

They take out things like race, and they also use or based on more modern or contemporary populations that have been followed. Still many cohorts from the 1970s and ’80s and ’90s, but some more recent. And the key thing about those cohorts is they lower everyone’s risk. So, you know, across the board, these new calculators drop estimated risk by about 50%.

How telling everyone they have lower risk then translates into even more statins for everyone is like a slightly more complicated picture we can get into. But if that’s kind of step 1, step 2 –

Eric 07:28

Wait, before you move to step 1, can I ask about Prevent, especially when we talk to older adults? I tried doing it for an 81-year-old. Apparently you can’t be 81. I was – the max age is 79 in PREVENT.

Tim 07:41

It is. The max age for the pooled cohorts was 75. So we added 4 years of older adults. But yes, that is one of the limitations.

Alex 07:50

And not to get too researchy, but Matthew Groudon, who’s a geriatrician in our group focused on deprescribing, he kind of did a deep dive into what went into the PREVENT atherosclerotic cardiovascular disease calculator. And it sounds like the data come from Optum datasets and included people, you know, maybe a few people who died of like heart attack and stroke, but it’s hard to tell. You can’t tell the exact numbers. The majority of them are probably people who had, you know, everything from a troponin leak to a serious, serious symptomatic event.

Rita 08:26

I will say when I trained in cardiology and my first 20 years in cardiology, we used the Framingham risk score, which as you know, is still It’s been around since right after World War II. It has many generations, has the most data. You know, the move to the pooled cohort equation was very controversial at the time because it was clearly recognized to overestimate risk and was not validated in multiple studies and populations.

So I agree that it’s good to get off of the pooled cohort, and PREVENT is better. I, I still use Framingham Risk in the office if I want a risk calculator. It works really well. But I think it was a sleight of hand, would be the nicest way I could say, to go from saying your risk is lower, but you need more statins. And there was definitely no evidence for that.

And the former AHA president basically said, well, if we have to go with PREVENT, which they kind of have to do because it was an AHA-sanctioned risk calculator, we’re just going to drop eligibility, because the goal seemed to be to get as many people onto statins as possible, and if that means telling people with a ridiculously low 2%, 3% score that they’re still needing to take a drug to lower their cholesterol for the rest of their life, then that’s what we’re going to do.

Eric 09:40

And that 3% –

Rita 09:41

there wasn’t any evidence to support that change.

Eric 09:44

3% of what happening over how, what period of time?

Rita 09:48

10-year risk is usually what they’re using.

Mike 09:51

So just to put some numbers on that. Yeah. So the new guidelines using PREVENT equations recommend consideration of statins for those at borderline risk, which they consider 3% to 5%. Intermediate risk or moderate risk is 5% to 10%, and high risk is 10% or more. That’s roughly half for each category of what was recommended in the prior set of guidelines. And so, as Tim has pointed out in his article, that has been one factor that’s greatly increased the eligibility for statins in the U.S. adult population, including older individuals.

Now, You can think about 3% risk in pretty much any American in their 70s. Their likelihood of having a cardiovascular event in 10 years is greater than 3%. So essentially means that everybody over age 70 in the U.S. is potentially eligible for a stent. And I agree with Rita’s point that there’s really little justification, particularly beyond the age of 79, data to support that, at least as of now.

Eric 10:53

Tim, we’ve talked about your article. What did you find for older adults? How many of them are eligible?

Tim 11:00

So it’s, it’s well over 90%, even if we start with just age 60 and over. And I think approaching 95% if you go with age 70 and over. I think the one group that doesn’t get a statin recommendation is folks whose LDL is less than 70 naturally. And so there’s that subpopulation of people whose LDL isn’t just low, but is super low. for whom there’s not a statin recommendation in the guidelines.

Eric 11:25

Except if you have chronic kidney disease or HIV.

Tim 11:29

Even then you get carved out, I think.

Eric 11:31

You get carved out.

Mike 11:32

Okay.

Tim 11:32

Yeah. As long as you haven’t had a heart attack or stroke, and then we, you know, push it even lower.

Eric 11:36

But in this one, CKD stage 3 is kind of autostatin.

Mike 11:42

Yep.

Tim 11:43

Diabetes and CKD and HIV are all functionally autostatin. Again, some carve out for a A perfectly low LDL naturally, which is fairly rare.

Eric 11:54

All right. I’d love your thoughts. So it’s interesting. So what I’m hearing is we have a new calculator that we should be using. All of our risks for cardiovascular outcomes have actually decreased over 10 years using this new calculator, but somehow all of our expectations to start a statin now have actually also increased.

More people are eligible for it. Now, I want to, I’m going to get back to that, but we got to actually also acknowledge we actually have now a study of older adults starting a statin coming out of Australia called the STAREE trial, which is, you know, we’ve been waiting for this trial to come out for many years to try to figure out who should start a statin. Rita, what do you remember as far as the eligibility and the population in this STAREE trial?

Rita 12:46

So it was for, as you said, people over age 70. It was 10,000 healthy patients, but they, the thing that made them a bit unusual was somehow they got to age 70 having never been started on a statin. So they had to be statin naive in their…

Eric 13:01

Statin naive for their entire life? Like not just in the last year?

Rita 13:04

Probably. Yeah, it was at least the last 5, but I thought it said statin naive for their Forever.

Eric 13:11

Okay.

Rita 13:11

So a different group. And I will say the trial did, this was positive, enrolled 52% women, which you almost never see in a cardiology trial. I mean, certainly makes sense cuz in the older population, as you know, it, it is mostly women, I think 58% once you get to be over 65. So.

Tim 13:30

Yeah.

Eric 13:31

And then what was the big finding from this study? My recollection, correct me if I’m wrong. Is it decreased major adverse cardiovascular events, but it didn’t change mortality or other patient-related outcomes like function.

Rita 13:49

So they did exactly, they had 2 composite primary endpoints. And I have to say, I remember when Sanket and I turned in our first paper 20 years ago with 2 primary endpoints, the reviewer said, what’s wrong with you? A primary endpoint means one, but Evidently, commonly it means 2, and it often means a composite. But what I think the headline from the study is that there was absolutely no benefit on anything that matters to patients.

There was no benefit on disability-adjusted life years, no benefit on dementia, and no benefit on longevity. There was an increase in serious adverse events related to musculoskeletal issues and hepatobiliary issues and increase in diabetes, which are all known to be associated with And so you could start a medicine and you would not feel, you know, have any reduction in disability, dementia, or death. So to me, that’s a no-brainer. Why would you recommend that, taking that medicine?

I think it’s a little peculiar and a very subjective endpoint because what drove that major adverse cardiac events wasn’t even cardiovascular death, and it definitely wasn’t all-cause death. It was very subjective things like coronary revascularization. Again, that was in a population that was asymptomatic. Why were they getting revascularization? Even if they got chest pain, they could have been managed medically. So I didn’t understand the how, and that’s what drove the endpoint, that and non-fatal MIs, which again is a bit subjective.

Eric 15:18

And can I ask, how are those subjective? Like, it seems like you’re like, you know who got the revascularization and who didn’t. Like there are procedures.

Rita 15:26

But who decided to get the revascularization, right? The cardio – these were all followed in their clinic. So the doctor decided, oh, you’re not on a statin, you have a, you know, some chest pain. I’ll have to assume they had some chest pain. They didn’t present any of that data. You’re getting a PCI.

Mike 15:42

Yeah. So I have a slightly different take on the interpretation. I think that, I disagree that there was no benefit to the patients. I think that most patients would say a reduction, 25% reduction, basically 25% reduction in cardiovascular events is a meaningful benefit. It means less hospitalizations, maybe better function. I agree that the second co-primary endpoint, which was disability-adjusted life years and mortality, did not differ, but it wasn’t worse either, so it wasn’t as if the statin treatment was harmful. It was non-inferior with respect to that. outcome, so to speak, with benefit in terms of reducing cardiovascular events, which is, I think, a real benefit from –

Rita 16:33

But Mike, there was no benefit on disability-adjusted life here, so I don’t think you could say that they were living better, and you could do less PCI by simply not doing a PCI. Nobody who’s not having a – if you’re not having a STEMI, you just don’t need a PCI, so that, you know, you could achieve that without starting statins.

Alex 16:53

Tim, any thoughts from you about this?

Tim 16:55

I mean, I guess I take it a little bit as if you have a patient in front of you who’s 75 and not facing multimorbidity or polypharmacy or other things and says, you know, a heart attack or a revascularization doesn’t sound like something I particularly want to do. What can I do to reduce that risk? I mean, I think this trial supports that idea that in someone who’s preference sensitive, you know, really doesn’t want to have to be in the hospital for a heart-related reason.

Sure. On the other hand, like the population of folks who have 5 other health problems that might be bigger fish to fry, I think I, I’m not, you know, strikingly compelled that starting a primary prevention statin in somebody with other health concerns in their mid to late 70s, that this trial supports me that move strongly. And that’s right, that balance just between mortality matters if you have a lot of things going on. Do I have to have a revascularization mostly matters if you’re not worried about other health concerns coming up first.

Mike 17:53

Yeah.

Eric 17:54

Mike, I got a question for you. You’re gonna be my representative cardiologist. Why do cardiologists love these composite endpoints that include a pretty diverse set of outcomes? Yeah. Some of ’em I think we all agree on. Mortality seems really important. Some of ’em, like whether or not you have a troponin leak or there’s a positive troponin, maybe.

Mike 18:16

I think that, I think that the, the main answer to that question is a statistical one. By having a composite endpoint, you increase the number of events, and so you greatly increase the power of the analysis, and that enables smaller sample sizes and so forth. So, it’s – I think it’s principally a power issue.

There is, of course, a lot of controversy about the composite endpoints and should they be weighted, mortality obviously being more important than more frequent angina, for example. And, and so that’s an ongoing concern, but I think the rationale for the composite endpoint is primarily statistical and power related.

Eric 18:55

Yeah.

Rita 18:55

Definitely not done for patient interests because the composite endpoint is always driven by its weakest link, which is in this case the PCI and non-fatal MI, which are often troponin leaks.

Alex 19:08

Yeah. Yeah. And that this, this kind of cuts across The different studies we’re talking about today. I mean, even as I mentioned at the beginning, the Prevent ASCVD calculator seems to be based on a dataset that included a whole range of atherosclerotic cardiovascular events from death, you know, stroke to, you know, non-fatal MI, troponin leak, et cetera. Tim, any comment on using Like, how confident do you feel in that calculator and the data in which it’s based on?

Tim 19:43

So I think it’s important to point out that they, they did use a lot of the traditional prospective cohorts that have been, you know, patients followed not by health records, but by phone interviews with trained staff and adjudicated by clinicians. The same things like the Framingham cohort that kind of launched this sort of risk prediction many, many years ago.

And so these PREVENT models worked in a, you know, host of 10 or 15 different prospective cohorts representative of older adults, younger adults, men, women, adults from different racial and ethnic backgrounds. And then they also used Optum, um, or other, you know, EHR data. And I think there’s a lot of fair critiques of the, that use of these non-adjudicated datasets, but I wouldn’t dismiss the idea that it was still kind of validated in the same sets of cohorts that have kind of the highest quality standards.

Rita 20:35

Mm-hmm.

Tim 20:36

If anything, the challenge there is partly a recency question of if we’re gonna criticize all these cohorts like Framingham from being from the 1960s, well, if you wanna look at data from 5 years ago, the only way to do it is through, um, some of these EHR cohorts. So it’s a little bit of a balance of one weakness versus the other.

Rita 20:53

And I don’t believe that PREVENT was compared to Framingham, was it, when it was developed? It has, there’s, I haven’t seen any comparisons of PREVENT to Framingham in performance.

Tim 21:03

But like the risk scores, I haven’t seen, mostly I’ve seen pooled cohorts and PREVENT.

Rita 21:08

Right. Because the advantage of Framingham is, well, you need lipids, but you don’t need all those other like GFR and things that I don’t routinely test.

Mike 21:17

There’ve been comparisons of PREVENT and the PCE pooled cohorts in populations that weren’t involved in the development of them. And in general, the PREVENT outperforms. the PCE, including in other populations such as Asian populations and so forth. It’s not perfect, but relative to the observed versus predicted by PREVENT is pretty well calibrated in other populations.

Rita 21:47

I agree, Mike, and I think that was the selling point for PREVENT was that it was a more diverse population than PCE. I don’t think any of us think PCE was a good risk calculator.

Eric 21:57

I’m just You know, well, let me ask you this.

Rita 22:00

Better. But for me, I just wanted to say one point too, because Tim was saying earlier about the healthy people, but there’s a lot more decrement on quality of life to take a healthy person and put them on a drug when they feel perfectly fine. I mean, to me, to put them, someone on a drug for the rest of their life, no matter how many more years they have, you have to have a really good reason either to help them feel better or to live longer.

And nobody has ever told me they felt better when starting a statin, and they don’t live longer. And so it’s – I still think even in healthy people over 75, I cannot recommend starting a statin. And not based on the data. I think it’s very interesting. Before the STAREE and SACACITE trial, we had ALLHAT lipid-lowering trial, which was the only trial that included older persons in lipid lowering, and it showed increased mortality. In the statin arm for people over 70.

Eric 22:54

So Rita, ’cause I’m going to bring it back to something you said in the beginning. I actually started a statin after a trial of a year of trying to do diet and exercise to lower my LDL. I started a statin and funny thing is like I was pretty, eating pretty healthy. I started statin. I’m all, huh, maybe I can have a cheeseburger now.

Alex 23:12

There you go. It’s statin chaser.

Eric 23:15

I’m protected by a statin.

Rita 23:18

Definitely run into people at the cheeseburger line. It’s okay. I’m on a statin. I mean, so that’s, and you know, we did publish a study in JAMA Internal Medicine where they compared statin users over 10 years to non-statin users, and there was increased obesity, increased weight gain, and decreased physical activity in the statin users. So you’re not the only one, it appears, that thinks that.

Eric 23:42

Yeah.

Rita 23:43

But the thing is, Eric, what I tell my patients is we don’t even need to check your lipids because I’m, what I’m gonna recommend is healthy lifestyle, like what you were doing, diet and exercise. It’s really not gonna, but focusing on your LDL is just the wrong focus.

Eric 23:57

Yeah.

Rita 23:57

It’s a very small part of cardiac risk, and mostly it just gets people worried or to take statins, but it doesn’t really help you have a healthier lifestyle, which is really what’s gonna help you to feel better, prevent heart attacks, and live longer.

Eric 24:11

Well, let me ask you this, Mike. Tim, I’d love your thoughts too. If 90-something percent of older adults are being recommended for a statin, why even bother with the prevent? Why bother checking an LDL? You’re just gonna recommend it anyways.

Mike 24:29

So I think it’s not so much a recommendation. I mean, the guidelines after age 80, they recommend consistently a conversation, basically, shared decision-making, decide whether to start a statin or not. I personally think that it is useful to have a lipid profile in those patients because it does influence the risk. In other words, I think that if I have an 80-year-old patient whose PREVENT calculation comes out to 3.5%, that’s a lot different than somebody that comes out at 22%.

And I think that that’s something you talk about with the patient, so the 22%, you say, well, you have about a 1 out of 5 chance of having a cardiovascular event over the next 10 years.

Eric 25:16

Yeah.

Mike 25:17

And so that, you know, still is not like tomorrow, it’s spread out over a long period of time, and the person may not even live that long, but I think that it’s part of the conversation in discussing whether to consider starting a statin or not, and in my experience, I suspect It’s the same for Reed and Tim, that some patients will say, well, I’m not going to start a statin, I don’t care, and then in those patients, yeah, it probably doesn’t make much sense to even get a lipid profile, and other patients are more amenable to it if it’s going to reduce their risk of having a heart attack or stroke.

Eric 25:53

Let me ask you, Tim, so imagine there’s a 77-year-old coming into your clinic, you’re going to talk to them about statin, You do a PREVENT and they have a risk score of 3.8%. How do you counsel them about starting or stopping a statin based on what we know, the STAREE trial, these guidelines?

Tim 26:15

I’m not sure that there’s actually any 77-year-olds who could have a PREVENT score that low.

Speaker 6 26:20

Okay.

Tim 26:21

But that’s a, that’s a, you know, a feature.

Eric 26:24

I actually tried to do a 79-year-old and I was struggling. Like I, everything was healthy. I was, Like everybody was coming up with a statin.

Tim 26:33

So I think that in those cases, I, I do think as this gets to Mike’s point about not just what that one numeric score is, but you know, what are the other risk factors? You know, if somebody’s blood pressure is 170 and their cholesterol is fine, I’m not going to start them on a statin. I’m going to treat their blood pressure. And both of those, you know, are risk-reducing strategies.

On the other hand, somebody who I, I think of this more in younger adults than older adults, but somebody who, you know, reports a strong family history to me and says, I’m really scared of these things, and they’re otherwise perfectly healthy, that’s the person who, you know, from their preferences and priorities may be more open to being on that statin at a risk of 3.5%. I think though, in older adults, that gets to Rita’s point is it’s pretty hard to find somebody who’s in their mid to late 70s who kind of wants to be on a statin who hasn’t found a doctor to prescribe it for them already, right?

Mike 27:25

Yeah.

Tim 27:25

Like if your, if your values are you really want to avoid these things, you already could have. It’s not like statins are hard to find or at this point cost prohibitive for most folks. So I don’t know that I focus on, you know, trying to batter down somebody’s preferences if they’re this sort of borderline risk category. Yeah.

Alex 27:44

Quickly to interject here, the statin guidelines, the new 2026 statin guidelines do contain like a tip sheet for geriatricians that Tim authored. I think it’s terrific and it does talk about this individual counseling prevent, you know, decisions should be based on more than age alone and it should account for other factors including goals, function, et cetera. So we’ll include a link to that in our show notes. Thank you, Tim.

Eric 28:12

Thank you. I guess I’m still confused. Like if, again, if you just look at the STAREE trial, like how am I supposed to counsel them? Like it, Okay. It won’t help potentially with your function. It may reduce revascular events and MI, but there’s no evidence that it reduces mortality. Is that a summary of what we –

Rita 28:34

Or improves disability-adjusted life years? And again, you can reduce the revascularizations by just not choosing one and choosing medical management, which is first line.

Eric 28:46

Mike, how do you think about it?

Mike 28:48

I think that, again, it’s really a shared decision-making. I think taking the full picture into account, not just what their lipids are, what are their other risk factors?

Eric 29:00

Yeah.

Mike 29:00

And what the patient’s preferences are. If they don’t want to take a statin or they don’t want any more medications, they feel fine, they don’t want to rock the boat in that regard, I’m fine with that. And On the other hand, if they’re at high risk and they’re amenable to starting a statin, or they want to start a statin to reduce their cardiovascular risk, I’m fine with that as well.

Eric 29:22

All right, Mike, another question for you. Back to the question, going back to if most older adults are already on a statin, I think 50% are somewhere around there, and these guidelines are saying 90-something percent probably should be. Based on Tim’s paper, which we’ll have a link to in our show notes. When do you think about stopping a statin?

Mike 29:44

Yeah, so just a clarification, the guidelines talk about eligibility for statins, and so people over 75 are eligible for statins. The guidelines don’t say that everybody over 75 should be starting on a statin. It says that there should be a conversation.

Eric 29:59

Well, I just wanted to mention one thing because it also reminded me of, there was an editorial that Tim Anderson paper along with the other papers in that group. And the argument was, look how bad we’re doing right now because this number of people are eligible for it, but this number of people are taking it. So we have to really push harder for more people to be taking statins. And if you look at the news outlets, because I did for, for the STAREE trial, it’s basically another win for statins, even in older adults. It’s never too late. is the messaging.

Mike 30:32

Yeah. Well, the STAREE trial, just one more comment about the STAREE trial. So it was 70 and older. The mean age was 74.7. So about half the patients were 75 and older. And they did the usual subgroup analysis by age over 75. And as far as the reduction in cardiovascular events, there was really no difference between the 70 to 75 and the over 75. But for the other primary, co-primary outcome, the over-75 group, there was a tendency for them to actually benefit from the statin. It was not – the interaction term was not statistically significant, but it was in a favorable trend for the over-75 group. I don’t know how to interpret that, but again, at least it didn’t look like the people were doing worse on a statin with respect to that coprimary endpoint. And then getting back to the –

Eric 31:22

Yeah, stopping.

Rita 31:24

Eric, I think it’s an important point about this eligibility, because I’ve yet to meet the person who wasn’t considered eligible for statins. I mean, I’ve had, you know, and they have it in these guidelines, you know, 25-year-olds who are eligible for statins. There is absolutely no data of any benefit, you know, on reduction of any kind of events or lengthening life in that age group. And certainly in the older age group, I’ve yet to meet the patient who wanted to take a medicine, including a statin, just for the sake of taking it.

I mean, they take it because they have this inaccurate idea that it’s going to prolong their life, which isn’t going to happen. or have some significant reduction in heart attack or in benefit on quality of life, which also isn’t going to happen. And so unfortunately, I’m sure in your offices, shared decision-making with actual data is occurring, but it’s not occurring for most patients. And it’s definitely – they’re getting it from those ads you saw and from drug company, you know, information. And –

Eric 32:23

Well, I want to make sure we have a little bit of time to talk about when to stop. So, Mike, I’ll start off with you. How do you think about when to stop a statin?

Mike 32:32

So I think we need more evidence, first of all, but I, in the end, I think it’s also a shared decision-making situation. I think we now do have a fair-sized randomized trial, the SAGA/CITE trial that was published recently in Lancet, in which 1,160 patients who were on primary prevention statin for at least a year, no history of any cardiovascular events, were randomized to discontinuing the statin or continuing the statin, and it was a non-inferiority trial. The idea was, is discontinuing the statin non-inferior to continuing it?

And the results were, the primary endpoint was mortality, and there was no difference. Mortality was actually slightly lower. In the discontinuation group, but not significantly so, and so it clearly met the non-inferiority criteria. They also looked at cardiovascular event rates, which were not significantly different between the 2 groups. There was a slightly higher, numerically higher number of MIs and strokes in the discontinuation group, but it was a small difference and not statistically significant, and so The conclusion of the trial was that it was safe to discontinue statins for primary prevention in people over age 75.

Follow-up was 3 years. The mortality in the continuation group was 7.9%, so relatively low-risk population, and one would like to see additional follow-up, at least another 2 years, to make sure that the results hold up over longer-term follow-up, but I think that that study at least supports the rationale for shared decision-making process in older people, primary prevention, who are potentially interested in coming off of a statin.

Eric 34:31

Do you feel better about stopping a statin based on the results of that study?

Mike 34:35

I’d say I feel more comfortable based on the results of that study.

Eric 34:39

All right, Tim, how about you? How did you think about SAGA?

Tim 34:43

Yeah, I think I share Mike’s point of view. I can’t say that I so frequently face a clinical scenario where somebody comes in who’s, you know, been taking a statin for 20 years and is just like, hey doc, I’m just like sick of this pill. And so it’s a little bit hard for me to know where that slots into the sort of like routine primary care as opposed to, right, someone who’s coming in with a change in their health, you know, a serious diagnosis.

Mike 35:10

Yeah.

Tim 35:10

In a different bucket or something else. And so from that standpoint, it’s both reassuring and yet it doesn’t tell me like I should go out and find every patient of mine who’s 75 and offer them to be off this med because if they’ve been on it for years and it’s not bothering them, I don’t know that the SAGACITE trial has convinced me kind of in the opposite way of STAREE that it, it’s somehow harming the patients to continue on it if they’ve already tolerated the meds just fine.

Eric 35:36

Okay. And, and Rita, I’m gonna go to you. The, The word on the street from people who are very pro-statins would argue that the, you know, this, this SAGA trial confidence intervals for mortality were wide. There’s no difference in quality of life. So taking a statin doesn’t seem to be bothering them and stopping it doesn’t improve their quality of life. Why not just continue it if they’ve been on it? Like Tim says, like, like, do we have to break up our day and then talk to the patient, shared decision about starting a, stopping a statin or just continue? If it’s working, don’t break it.

Rita 36:10

You know, if someone wants to continue taking a medicine that’s not helping them at all, you know, not certainly improving their quality of life or longevity, they’re certainly welcome to do that. But I think, as Mike and Tim both said, SALGA should make everyone feel very comfortable stopping a statin. And, you know, patients are generally delighted to be on less medicines. As, you know, one of the other changes I’ve seen in medicine in my last 35 years in medicine is that even healthy older people are on 5 to 7 drugs.

And I routinely will review all of their medications because it’s very burdensome to take a pill every day, including a statin. And, you know, there are other things with statins besides the diabetes. There have been a lot of reports, and they really need further study, of mild cognitive impairment that occurs with statins. I mean, there’s a lot of data suggesting you need cholesterol in your blood-brain, to keep the neurologic system working well. And when we keep, you know, going lower is better, it’s not good for people’s neurologic symptoms. And there have been FDA safety letters on mild cognitive impairment with statins.

And it, I think it’s shocking that we’ve had a drug out for like 40 years now, and there’s so little data on adverse effects. I mean, 20 years ago, I asked the Cholesterol Treatment Trialists to share the data on adverse events for statins. They don’t. They say they’re only holding the data for the drug companies, but it’s proprietary data and they can’t share the data. It’s industry’s data. So there just isn’t, you know, and it’s released very selectively, mostly from their group and very selective analyses. And so that’s not a good argument to me to keep someone on a medicine.

Mike 37:58

Yeah. I think that it’s a common problem on deprescribing That I encountered with my patients. The patients are hesitant to stop a medication that they’ve been on for a long time when they’re feeling fine. And it comes up with aspirin, for example. I think deprescribing of aspirin for primary prevention went through this same issue a few years ago. And many of my patients really said, well, I feel fine. I’m taking half a baby aspirin a day, and it’s not causing me any bleeding or anything else. So – I’m really a little hesitant to stop it. And same thing with statins.

Rita 38:35

I’ll say, when I was on MedPAC, just quick story, a few years ago, you know, we have dinner together and occasionally we talk about statins.

Alex 38:45

And just for our listeners, MedPAC is?

Rita 38:48

So MedPAC is a group of about 18 people that advise Congress on Medicare payment policies. So you go to Washington once a month for a 2-day public meeting and Talk about Medicare payment policy. And because it’s Thursday and Friday, we’d often have dinner together Thursday night, and statins came up at some of those dinners. And a few months after that, one of my colleagues said to me, you know, Rita, I didn’t think that I had any side effects from my statin, but I forgot it on a recent business trip. And after not taking it for a week, I realized I felt much clearer and my brain fog lifted, and I’m not going back.

Eric 39:28

So yeah, kind of need more research on this.

Speaker 6 39:31

Yeah.

Alex 39:32

I have a patient, I’m on service now. A patient in his late 90s who’s having terrible body pain said, this is worse than death. Let me die. They stopped the statin and he feels much better. Right. Yeah. That’s anecdotal. And, you know, many of us have stories.

Eric 39:48

And again, the STAREE trial, 5,000 people taking statins, no difference in dementia, no real quality of life issues.

Rita 39:56

It’s hard to say that people would be happier taking more medicines. I, yeah, people are generally delighted to be on no meds or very few.

Mike 40:04

Okay.

Eric 40:04

Lightning round, ’cause we have 4 minutes left.

Mike 40:07

Just, just to clarify or add additional comment on this cognitive function issue is it’s been a concern about statins for a long time. There’s some pretty small non-randomized studies suggesting that at least in some people may have an adverse effect on cognitive function, but in the large trials, This has been looked at extensively. There’s really no convincing evidence that on a population basis that statins have an adverse effect on cognitive function. Some studies suggesting they might even improve cognitive function by reducing CNS events. But I don’t know if any data from STAREE has been presented on this or not yet. Maybe Rita knows.

Rita 40:48

No, I asked them. I went to the STAREE presentation. It was a hotline at the European Society of Cardiology and asked them about it, and they did collect the data. data, but they haven’t released that yet. I will say it’s notable that both STAREE and SAGACITE were non-US trials. You know, all of the US statin studies that have not looked at cognitive effects were industry-sponsored, and they do not share their results or their data.

Mike 41:12

However, the PREVENTABLE trial, which is ongoing and is a US study, is looking carefully at geriatric outcomes, including cognitive function, physical function disability and so forth. So although it’s going to be some years before we get the results of PREVENTABLE, I think we will have some good data from that study when it’s completed.

Eric 41:32

And the SAGE study showed no difference in cognition between continuing or stopping a statin. Okay, lightning round.

Alex 41:39

Now we’re down to 2 minutes.

Eric 41:40

Lightning round. For older adults, is there a group of people that you would probably push more to start, for primary prevention, a statin? Rita, is there anybody that you would recommend? 75 and older, healthy diet and physical activity, healthy diet and physical act –

Rita 41:58

Mediterranean diet, physical activity, no statins.

Eric 42:02

No statins. So I, I should stop my cheeseburgers and stop my statin at the same time. All right, Tim.

Tim 42:10

I think that especially folks with not just the elevated risk score, but an actual elevated LDL and other risk factors as an older adult is certainly somebody I’d recommend.

Eric 42:20

How elevated? Over 70?

Tim 42:25

Certainly, you know, the over the 100 range, but I think more importantly, you know, things like the 10-year risk score is greater than 10%, things that put people not in these borderline risk categories, but in closer to high-risk categories.

Eric 42:37

Maybe not the borderline. Where do you fall in, Mike?

Mike 42:40

So, um, absolutely agree with, uh, diet and exercise. For a person over 80 who’s in the high-risk category, has high lipid panel, I would initiate a, uh, discussion, the pros and cons of starting a statin, and, uh, shared decision-making, decide whether or not to actually do it.

Eric 42:58

And what’s a high LDL for you?

Mike 43:01

Uh, over 100.

Eric 43:02

Over 100.

Rita 43:03

Mike, what was it when we started training? It was over 160. I mean, the goalposts move and not the – there was no data.

Mike 43:10

The goalposts did move. Getting down, down to 55 for the highest risk patients.

Rita 43:13

So yeah, it wasn’t based on any studies.

Eric 43:16

This is breaking my achy breaky heart.

Alex 43:18

Oh, there you go.

Mike 43:20

But there’s pretty con – there’s pretty clear, I think, and convincing evidence that lower is better if you’re going to treat. Lower LDL is better.

Rita 43:29

I don’t think there is. And they took it out of one set of guidelines, right? The 2018 took it out and then that wasn’t popular.

Eric 43:36

Well, we could do another hour, but maybe we can end with a little bit more of the song.

Alex 43:47

(singing)

Eric 44:39

Mike, Rita, Tim, thanks for being on this podcast.

Rita 44:43

Absolutely.

Mike 44:43

Thanks.

Tim 44:43

Thanks for having us.

Eric 44:44

And to all our listeners, we’re going to have links to all of these articles in our show notes. And thank you for your continued support.

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