New Guidance, New Data and New Targets for the Management of Hyperlipidemia - Episode 3

Real-World Data on Achieving LDL Thresholds

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Mary McGowan, MD, FNLA, discusses real-world data from the Family Heart Database on achieving LDL-C thresholds.

Keith C. Ferdinand, MD, FACC, FAHA, FNLA: Dr McGowan, I said you were going to show us some information, some real-world evidence of how [well] we’re doing or not doing in achieving LDL-C [low-density lipoprotein cholesterol] thresholds. What do you have?

Mary McGowan, MD, FNLA: Thanks very much, Keith. I have some data from the Family Heart Foundation that I’d like to share with everybody. As a Family Heart Foundation, we have a large database. And what we did was 2 analyses. And I’m going to share those with all of you. And I thank you for indulging me for this. And I think this is not news to anybody, but there are extensive clinical trial data that demonstrate that lowering LDL, as we’ve all just been talking about, reduces heart attacks, strokes, and the need for cardiovascular interventions. And the 2018 multidisciplinary guideline on the management of blood cholesterol called for the initiation and intensification of lipid-lowering therapies if the LDL [level] exceeds the various thresholds that we’ve talked about. So we wanted to assess the achievement of below-threshold LDL levels in patients at elevated risk using a real-world database, the Family Heart Database. This database is huge. It comprises diagnostic, procedural, prescription, and laboratory data on over 324 million individuals in the US from 2012 to 2021. Now, everybody isn’t in the database for all that time. What we’re going to look at in analysis 1 is a data set that includes over 38 million patients who had sufficient diagnostic, procedure, medication, [and] lab data and had LDL [levels] above the thresholds we were talking about, an LDL [level] over 100 mg/dL in high-risk primary prevention or over 70 mg/dL in secondary prevention. We did not use the over 55-mg/dL [threshold] because, as you can see, we go through only 2021 in terms of the data.

Most patients at elevated risk, that is 72%, never achieved their LDL below their LDL threshold. For those—[and] this was really surprising—for those achieving periods below the [thresholds], the mean duration was very [short]. It was 159 days. One of the prime reasons is that most health care providers, that is 80% of those taking care of these individuals, never prescribed combination therapy, even though the guidelines, as we know, provide direction and a rationale for doing so. Analysis 1 gives you sort of an example of some of the things we saw. The ideal would be the top row, as you can see here. [Patient] comes to their provider, they’re above the threshold, but they’re not on any lipid-lowering therapy. The provider initially, as Erin pointed out, puts them on a single agent, likely a statin. And then that does not do the trick. In very short order, 12 weeks or so, [patient] comes back, gets rechecked, and then they get placed on multiple lipid-lowering agents or a second lipid-lowering agent to achieve their goal. But what we see is in the real world, things are actually quite messy. The reality is the last 3 rows as you can see. First of all, you can see the white data. That means we have insufficient data to even look at these individuals. But most people are either above threshold with a single lipid-lowering agent [or] above threshold on multiple lipid-lowering agents, which means that the primary care provider is trying to put people on more than 1 agent. Then most common, or very common, is about 40% of people above threshold [are] on no lipid-lowering therapy. Our conclusion from this first analysis [of] the Family Heart Database was despite effective and safe lipid-lowering therapies, the real world finds that most patients remain above guideline-recommended thresholds, and those who do achieve levels of LDL below thresholds are doing so for only a short period of time. In the United States, we know there’s insufficient prescribing of combination lipid-lowering therapies. And often patients themselves don’t understand the importance of adhering to these lipid-lowering therapies, [thus] putting them at increased risk for atherosclerosis.

Transcript Edited for Clarity