Lipid Management Suboptimal Despite High-Intensity Therapy

Liam Davenport

May 10, 2018

LISBON, Portugal — Less than 40% of patients receiving high-intensity lipid-lowering therapy after a cardiovascular disease (CVD)–related hospitalization are at target for their low-density lipoprotein (LDL) cholesterol levels, the results of a major European survey reveal. The survey also found large variations between countries.

The fifth EUROASPIRE survey of more than 8000 patients treated at over 130 centers in 27 European countries showed that, overall, 70% of patients were not at their LDL cholesterol target and almost 70% had below-guideline levels of high-density lipoprotein (HDL) cholesterol 1 year after hospitalization.

The findings, presented at the European Atherosclerosis Society (EAS) 2018 meeting, also showed that although 84% of patients across Europe took lipid-lowering therapy, only 32% had achieved the LDL cholesterol target of less than 1.8 mmol/L.

Among the 60% of patients who were taking high-intensity lipid-lowering therapy, only 36% met the target. Worryingly, a substantial proportion of patients had their lipid-lowering therapy downgraded between discharge and follow-up.

Asked to explain the apparent lack of impact of statin therapy on lipid levels, Guy De Backer, MD, PhD, emeritus professor of medicine, Ghent University, Belgium, said, "Of course, we as physicians always say it's the patient who is not taking the drug. That is the most easy response from a physician's point of view, but I don't agree with it."

He pointed out that the survey asked the patients about their adherence to therapy, "and 95% told us that they were taking the drug very, very regularly, almost every day, so I'm not sure. Compliance may be a very small explanation of it, but definitely not all of it."

While emphasizing that the results are an average of 8000 patients from all over Europe and therefore need to be interpreted with caution, De Backer said, "Still, it means that even more intensive treatments will be needed in a high proportion of our patients."

Another area highlighted by the survey was the intercenter variations within countries, which De Backer believes underlines the importance of the whole care package, not just in terms of lipid-lowering therapy.

He pointed to the overall and hypertension results from EUROASPIRE V, presented at EuroPrevent in Ljubljana, Slovenia, 2 weeks ago, which also revealed huge discrepancies between centers.

"We have to look into [that in] more detail, and I think we can learn from each other," he said."Those who are doing so well should tell what they are doing more than the centers where the results are very poor."

Guideline Implementation

De Backer began his presentation by noting that the objective of the EUROASPIRE surveys, which have been running since 1995, is to determine how the European guidelines on CVD are implemented in clinical practice in patients with coronary heart disease.

To that end, the researchers recruited men and women aged younger than 80 years who had been hospitalized between 6 months and 2 years before the survey interview for elective coronary artery bypass surgery, percutaneous coronary intervention, or acute coronary syndromes.

Trained technicians administered standardized interviews, and data were gathered on height, weight, waist circumference, blood pressure, and carbon monoxide levels in the breath.

In addition, fasting venous blood samples were taken to determine serum cholesterol levels, hemoglobin A1c, and creatinine levels, all analyzed in one central laboratory, alongside fasting glucose and oral glucose tolerance tests and calculation of the urine albumin-to-creatinine ratio.

Participants also completed self-report questionnaires on anxiety, depression, and quality of life.

For EUROASPIRE V, 131 centers in 27 countries took part, with 8261 patients interviewed in 2016-2017 from 16,208 identified, giving a participation rate of 56%.

The median time between the index hospitalization and the interview was 1.1 years. The mean age of the participants was 64 years, and 26% were female.

The results showed that, overall, 71% of patients were above the target LDL cholesterol level of 1.8 mmol/L (70 mg/dL), ranging from 44% in Finland to 90% in Lithuania and Kazakhstan.

Overall, 41% of patients had an HDL cholesterol level less than 1 mmol/L in men and less than 1.2 mmol/L in women, ranging from 25% in Germany to 84% in Egypt.

Fasting triglycerides were at least 1.7 mmol/L (150 mg/dL) in 31% of patients across Europe as a whole, ranging from 19% in Belgium to 51% in Bosnia Herzegovina.

Finally, non-HDL-cholesterol levels were at least 2.5 mmol/L (100 mg/dL) in 68% of patients overall, ranging from 43% in Finland to 89% in Kazakhstan.

Notably, the use of lipid-lowering drugs was high, at an average of 84% of patients, with most countries scoring at least 79%. These drugs were typically statins, taken by 81% of patients overall.

In contrast, only 15 patients in total across the whole of Europe took proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors during the survey period.

Among patients receiving lipid-lowering drugs, 32% overall had an LDL cholesterol level less than 1.8 mmol/L (70 mg/dL), ranging from 10% in Lithuania to 55% in Finland.

Interestingly, there were vast discrepancies even within countries, with two centers in the same country, for example, having rates of 24% and 41%, suggesting wide differences in practices and outcomes even within the same healthcare system.

When the researchers focused on the use of high-intensity lipid-lowering therapy, with the intention of achieving a change in LDL cholesterol levels of 50% or greater, they found that 60% of patients overall were given such treatment.

This resulted in 36% of patients achieving the target of an LDL cholesterol level less than 1.8 mmol/L. In comparison, 38% of patients receiving high-intensity treatment had an LDL cholesterol level of 1.8 to 2.5 mmol/L and 26% had a level of 2.5 mmol/L or greater.

Looking at change in lipid-lowering therapy between hospital discharge and the interview in 7811 patients, the team found that 68% stayed on the same treatment.

However, 12% increased from moderate-intensity to high-intensity lipid-lowering therapy, while 10% decreased from high-intensity to moderate-intensity therapy, and 10% went from high- or moderate-intensity to no lipid-lowering therapy.

De Backer concluded that 1 year after hospitalization, "most patients in the EUROASPIRE V survey had less than optimal management of LDL cholesterol levels, despite the use of statins."

Therefore, he said, "Concerted efforts are needed to use appropriate lipid-lowering therapies in combination with lifestyle interventions to achieve the evidence-based recommended LDL cholesterol target for secondary prevention."

Wakeup Call

Discussing the findings, S. Lale Tokgözoğlu, MD, PhD, EAS president and professor of cardiology, Hacettepe University, Ankara, Turkey, said that the EUROASPIRE surveys "have been very important because they were the wakeup call in Europe showing that most of the patients are not at goal."

In other words, the surveys "have shown us that there is a huge gap between guidelines and real life," she told theheart.org | Medscape Cardiology. "They have also shown us that, through time, risk factor control is not really getting better, [despite] increased medication use. There's also an alarming increased rate of obesity throughout Europe [and] smoking is still a problem, especially in females, and young people are taking up smoking."

Tokgözoğlu noted, however, that the number of patients not at their LDL cholesterol goal has improved between the EUROASPIRE IV and V surveys, falling from 80% to 70%, so "things have improved just a little bit."

De Backer urged a note of caution, however, over comparing EUROASPIRE IV and V because fewer centers in fewer countries took part in the earlier survey.

At the European Society of Cardiology (ESC) Annual Congress later this year, the team will present time trends restricted to only centers that took part in both EUROASPIRE IV and EUROASPIRE V.

"Now, just looking at V and what we have published in IV, there are indeed some improvements to a certain extent, but we should be more precise and more accurate in comparing apples with apples, and not apples with pears," De Backer said.

Tokgözoğlu nevertheless pointed out that the ESC published prevention guidelines between the EUROASPIRE IV and V surveys, "so you would have thought that, with that information, things would have got much better, but of course it's extremely difficult."

She emphasized that it's "not a matter that a physician, per se, can solve" but rather an issue for both the patient and the physician or healthcare provider together.

"We need a paradigm shift in our approach to implementation," Tokgözoğlu said. "Clearly, what we are doing now is not working."

The first step is to get patients to take responsibility for their own health, she said. "If you dictate to the patient and if you do not reach a consensus with the patient, nothing is going to happen. And you need to educate the patient."

This, however, takes time, and she said that because physicians are "extremely busy," a team-based approach involving the pharmacist and the nurse may help.

She also believes that sending reminders, such as shown in the Australian TEXTME study, may help with risk factor control, alongside keeping track of patient adherence patterns via electronic health records and prescriptions, all of which may be made more accessible through the explosion in health-related smartphone apps.

"So we need to be very original, and this is science in itself," Tokgözoğlu said. "There's a meta-analysis showing that 9% of all cardiovascular events in Europe could be prevented if patients adhered to medications. Nothing else."

She said that, overall, the EUROASPIRE V survey is "reminding us that we need to do more, and the classical approaches are not working."

"We need a longitudinal, multifaceted approach, which involves the patients, the team and probably should make use of the health information technologies that we have today."

The EUROASPIRE V survey was carried out under the auspices of the European Society of Cardiology, EURObservational Research Programme. The survey was supported through unrestricted research grants to the European Society of Cardiology from Amgen, Elli Lilly, Ferrer, NovoNordisk, Pfizer, and Sanofi. De Backer reports being a consultant for MSD. Tokgözoğ lu reports being a consultant for Merck, Abbott, Daiichi Sankyo, Amgen, and Sanofi and receiving honoraria from Abbott, Astra, Actelion, Merck, Servier, Recordati, Mylan, Amgen, Novartis, Sanofi, Pfizer, Bayer, Novo Nordisk, and Sanovel.

European Atherosclerosis Society (EAS) 2018. Presented May 7, 2018.

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