New European Lipid Guidelines Take Aggressive Approach
September 01, 2019
“We also recommend that patients should be treated aggressively with high-dose statins and with the option of adding ezetimibe and PCSK9 [proprotein convertase subtilisin/kexin type] inhibitors to achieve these targets. This is another big change from the previous guidelines,” co-chair, François Mach, Geneva University Hospital, Switzerland, said.
“We wanted to go beyond what the US has done — we felt the evidence supported a more aggressive approach, although more evidence has become available since the last US guidelines were issued,” Mach commented.
“The US approach of ‘fire and forget’ is not good enough,” he added. “We need to keep reviewing the patient and keep measuring LDL levels to get them down as low as possible. Without this approach, patients tend to stop taking their statins.”
“The new 1.4 mmol/L target for very high-risk patients is easy to justify using data from the latest meta-analyses and trials with high dose statins and PCSK9 inhibitors,” Baigent noted. “The vast majority of patients can get to this level with high-dose statin plus ezetimibe. This is a cheap and safe combination. PCSK9 inhibitors will only need to be used in a very small proportion of patients.”
No Distinction Between Primary and Secondary Prevention
The other major change in the new guidelines is the removal of the distinction between primary and secondary prevention.
“What we’ve done is to make sure the recommendations are similar for a similar level of risk regardless of whether a patient has had a previous event,” Baigent explained. “We have not distinguished between primary and secondary prevention; rather, risk is calculated the same way in both settings.
“While secondary prevention patients will normally be at higher risk, a primary prevention patient could still be at high risk if they have multiple risk factors, and data show that the benefits of statins do not differ between primary and secondary prevention per se — rather, it is the level of risk that is important,” he said.
The one exception to this is in the elderly. “While we have strengthened the recommendation for use of statins in the elderly in general, we have given a slightly weaker recommendation for primary prevention patients those aged over 75,” he noted.
Emphasis on Statin Safety
The document has a new section emphasizing the safety of aggressive LDL lowering and of the statins. “There are no known adverse effects of very low LDL concentrations,” it states.
On the statins, it says: “While statins rarely cause serious muscle damage (myopathy, or rhabdomyolysis in the most severe cases), there is much public concern that statins may commonly cause less serious muscle symptoms. Such statin ‘intolerance’ is frequently encountered by practitioners and may be difficult to manage. However, placebo-controlled randomized trials have shown very clearly that true statin intolerance is rare, and that it is generally possible to institute some form of statin therapy (e.g. by changing the statin or reducing the dose) in the overwhelming majority of patients.”
“We want to send a strong message to patients and physicians on this to try to keep patients on statins in the vast majority of cases,” Mach said.
Calcium Scores, Lp(a), ApoB for Risk Stratification
The guidelines also recommend for the first time the use of new tests to help identify higher-risk patients. These include both coronary artery calcium (CAC) imaging and biomarker tests.
“CAC score assessment with CT may be helpful in reaching decisions about treatment in people who are at moderate risk of atherosclerotic cardiovascular disease,” the document notes. “Obtaining such a score may assist in discussions about treatment strategies in patients where the LDL-C goal is not achieved with lifestyle intervention alone and there is a question of whether to institute LDL-C-lowering treatment.”