MANNHEIM More patients with high cardiovascular risk are reaching their LDL-cholesterol goals probably thanks to combination lipid-lowering therapy, but much work remains to be done, suggest data from a European registry.

More than 7200 patients with baseline and 1-year cholesterol measurements from the SANTORINI registry were included in the current analysis.

The results showed that the percentage of patients who met their LDL cholesterol target increased from 21% to 31%, with an average decrease in mean levels of 0.4 mmol/L in both the high and very high risk groups. .

The research was presented at the 91st Congress of the European Atherosclerosis Society (EAS) on May 23.

This decrease in LDL cholesterol levels “is largely driven, thankfully, by those people who are not on lipid-lowering medication who are on something, and also by many other patients switching to combination therapies,” such as a statin plus ezetimibe, said study presenter Kausik Ray, MD, PhD, professor of public health at Imperial College London, London, UK, and chair of EAS.

“However, at the population level, we are not bringing our population to the target because we are not putting enough patients on combination therapy. The mantra must be to move to combination therapy rather than monotherapy,” and this it starts with your own risk assessment,” Ray said.

He also admitted that the SANTORINI registry represents the “best case scenario” because it includes people willing to participate in the research.

Ray noted that when you look at electronic health record data, the picture is “worse than this.”

“Sad Work”

Asked for comment, session co-chair Andreas Zirlik, MD, PhD, described the results as “very disappointing.”

“We now have so many good tools to curb LDL cholesterol, and we’re still doing a terrible job,” Zirlik, Head of the Department of Cardiology and President of the University Heart Center Graz, LKH-University Hospital and Medical University of Graz, Graz, Austria, said heart.org | Medscape Cardiology.

Referring to the overall increase of 10% of patients in the registry who met the goal, he said: “It’s a little bit better, but is it really worth celebrating? No.”

Zirlik suggested that, with most studies showing only a “small fraction” of patients receiving combination therapy, “we need a recommendation, as we have now in blood pressure therapy, to start proactively with a combination “.

He also believes that while “the lower the better” and “the sooner the better” are “great slogans” for lipid management, “maybe we need a little more granularity in the higher-risk group because it’s like if anyone had a vascular phenotype it is higher risk.

“But there are definitely patients out there, for example those who have really had an event, who should have very strict and speedy recommendations for more aggressive therapy,” beyond just a combination, Zirlik said.

behavior over time

Ray began his presentation by noting that, normally, registries provide a snapshot of current care practices, but with the 1-year follow-up from the SANTORINI registry, they were able to observe physician behavior over time and ask some questions. key questions.

Note these include: What care do healthcare providers provide at each of the participating sites? What changed in that follow-up year? What did that change entail?

Ray also pointed out that SANTORINI is the first registry conducted in Europe by the updated 2019 ESC/EAS guidelines for the management of dyslipidemias. The guidelines “moved the goalposts” for three of the LDL cholesterol risk categories, with two of those hard to reach, he said.

In particular, the objectives have become:

  • High-risk: < 1.8 mmol/L (< 70 mg/dL)

  • Very high risk: < 1.4 mmol/L (< 55 mg/dL)

  • For both: 50% reduction in LDL cholesterol

“What we have forgotten to tell people is that the goalposts have shifted due to the use of combination therapy,” he said.

SANTORINI enrolled 9136 patients with high and very high cardiovascular risk between March 2020 and February 2021 in 623 centers in 14 European countries and followed them up to 31 May 2022.

For the current analysis, lipid management was assessed in 7120 patients who had available LDL cholesterol levels at both baseline and 1-year follow-up.

They had a mean age of 65 and 72.1% were men. “Not surprisingly, there are a lot of people with established cardiovascular disease, smoking, high blood pressure,” Ray noted, and the mean LDL cholesterol level was 2.42 mmol/L (93.53 mg/dL).

Overall, the mean LDL-cholesterol level dropped to 1.98 mmol/L, with the percentage of patients meeting the goal increasing from 21.5% to 32.1%, with similar results seen in both high- and very high-risk groups.

“Each group is moving about 0.4 mmol/L,” Ray said, “which translates into about 10 percent more people hitting the target.”

“So, the question now is: where did it come from? Who are the ones that are moving?”

It showed that, over the course of the study, the percentage of patients receiving no lipid-lowering therapy decreased from 21.6% to 3.0%.

There was a small increase in monotherapy use, from 50.9% to 55.4% of patients, which was largely due to the increase in statin use.

There was, however, a much larger increase in the proportion of patients receiving the combination therapy, from 27.5% to 41.7%. This was largely due to the increase in the use of a statin plus ezetimibe, with smaller increases for the proprotein convertase inhibitor subtilisin/kexin type 9 (PCSK9) combinations.

Again, similar patterns were seen in both the high- and very high-risk groups, albeit with a greater switch to combination therapies in the high-risk group, from 29.9% to 45.3%.

Turning to goal achievement, Ray showed that 28.2% of high-risk patients who achieved their baseline LDL cholesterol target were receiving monotherapy, with statin therapy being the most common, while 36, 6% had combination therapy.

The most used combination was PCSK9 inhibition plus another drug, in 52.1% of patients, while 32.7% took a statin plus ezetimibe. This pattern was mirrored in the high risk group.

The study was sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo company. Ray discloses relationships with Amgen, Sanofi, Regeneron, Daiichi Sankyo, Pfizer, Viatris, Abbott, AstraZeneca, Lilly, Kowa, Novo Nordisk, Boehringer Ingelheim, Esperion, Cargene, Resverlogix, SCRIBE, Novartis, Silence Therapeutics, CRISPR, Bayer, New Amsterdam Pharmaceuticals, BI, Vaxxinity, PEMI-31.

91st Congress of the European Atherosclerosis Society 2023. Presented on 23 May 2023. Abstract 1536

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