ESC/EAS Tightens Up Lipid Targets for Dyslipidemia With New Recommendations

ESC/EAS on Dyslipidemias

June 30, 2011

June 29, 2011 (Gothenburg, Sweden) — The European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have released new guidelines for the management of patients with dyslipidemia, providing up-to-date treatment recommendations for patients with the various lipid abnormalities. The new guidelines focus on the Systemic Coronary Risk Estimation (SCORE) for assessing individual patient risk, estimating the 10-year risk of a fatal atherosclerotic event, including MI, stroke, occlusive arterial disease, and sudden cardiac death.

"Previous guidelines in Europe were based only on global risk factors," Dr Alberico Catapano (University of Milan, Italy), the EAS task force chair, told heartwire . "We do acknowledge that a patient's risk is made up of several different factors, but we never had any specific guidance for the management of patients with dyslipidemia. This is important because dyslipidemia is one of the most significant risk factors contributing to cardiovascular disease."

Presenting the details of the ESC/EAS guidelines for the management of dyslipidemias during a plenary session here at European Atherosclerosis Society 2011 Congress, Catapano stressed that LDL cholesterol is still the primary target in the management of patients with dyslipidemia, but unlike the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines, the European task force provides less wiggle room for physicians.

For patients at very high risk of cardiovascular disease, the ESC/EAS writing committee states that LDL-cholesterol levels should be lowered to less than 70 mg/dL, a target that is not optional, as it is in the NCEP guidelines. If less than 70 mg/dL can't be achieved, physicians should aim for a >50% reduction in LDL cholesterol. The nonoptional target is given a class IA recommendation, meaning that there is evidence and/or general agreement that the therapy is beneficial or useful and is derived from multiple randomized clinical trials.

For patients at high risk, the target LDL goal is less than 100 mg/dL, again differing from the optional recommendation in the NCEP guidelines. Among those patients at moderate risk of cardiovascular disease, those with a SCORE level ranging from >1% to <5%, the new treatment target is less than 115 mg/dL, a level that is lower than the 130-mg/dL target recommended in the NCEP ATP III. For moderate-risk patients, the evidence is not as strong and is based on consensus opinion or a small number of studies, retrospective analyses, and registries.

"Several clinical trials published and presented over the past few years have shown clearly that lower LDL-cholesterol levels are better," said Catapano.

Treatment options

Regarding treatment options, Catapano told heartwire that they recommend physicians prescribe statin therapy up to the highest dose possible or the highest tolerable dose to reach the target LDL-cholesterol level. For patients with statin intolerance, they recommend bile-acid sequestrants or nicotinic acid. Based on weaker evidence, they also state that a cholesterol-absorption inhibitor, alone or in combination with bile-acid sequestrants or nicotinic acid, may be considered in these statin-intolerant patients.

In addition to recommending LDL cholesterol as the primary target, the ESC/EAS task force states that total cholesterol can be considered a treatment target if other lipid analyses are unavailable and that triglycerides should be analyzed during the treatment of dyslipidemias in patients with high triglyceride levels. Non-HDL cholesterol should be considered a secondary target in patients with combined hyperlipidemias, diabetes, metabolic syndrome, or chronic kidney disease, as should apolipoprotein B (apoB).

On the other hand, the guidelines do not suggest a specific target level for HDL cholesterol or for ratios of apoB/apoA1 and non-HDL cholesterol/HDL cholesterol. Catapano said that while the guidelines do not recommend a specific goal for HDL-cholesterol levels, this does not mean that they should be ignored. He pointed out that HDL cholesterol is a strong risk factor for cardiovascular disease, and it is recommended clinicians use it when estimating risk. Nicotinic acid is the most effective drug for raising HDL cholesterol and "should be considered," according to the ESC/EAS, while statins and fibrates can also raise HDL cholesterol.

As reported by heartwire , large morbidity and mortality trials designed to show a clinical benefit with drugs that increase HDL cholesterol have come up short. The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL Cholesterol/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) study of high-dose extended-release niacin (Niaspan, Abbott) given in addition to statin therapy in patients with a history of cardiovascular disease, high triglycerides (TG), and low levels of HDL cholesterol was halted prematurely because niacin offered no additional benefits in this patient population. The Heart Protection Study 2 Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) study, however, another large trial with niacin, is still ongoing. Torcetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, was stopped in its tracks when it was shown the drug increased the risk of death and cardiovascular events.

Fibrate trials have been just as disappointing, with the ACCORD-Lipid and FIELD studies both failing to show a benefit of using fenofibrate.

Women, the elderly, and those with inherited dyslipidemias

The new guidelines also provide direction on managing a range of patients, including women, the elderly, diabetics, and those with chronic kidney disease. The elderly derive similar benefit from LDL lowering as younger patients, according to the task force, and there is no reason to treat female patients any differently, either. Postmenopausal women, those with an elevated risk of cardiovascular disease, would derive particular benefit from LDL lowering.

In the new document, the task force also lays out the magnitude of effect various lifestyle interventions have on lipid levels, such as reductions in saturated and trans fat, as well as reductions in body weight. They provide differing definitions of obesity depending on ethnicity, with South Asians having a more rigid definition of central obesity compared with whites.

Catapano emphasized that clinicians should also be aware of patients with inherited dyslipidemias. "The familial forms, not only familial hypercholesterolemia but also familial combined, occur in 1.5% to 2.0% of the population," he said. "It's a large number of patients who are at very high risk of cardiovascular disease."

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