Gone are the recommended LDL- and non-HDL–cholesterol targets, specifically those that ask physicians to treat patients with cardiovascular disease to less than 100 mg/dL or the optional goal of less than 70 mg/dL.
According to the expert panel, there is simply no evidence from randomized, controlled clinical trials to support treatment to a specific target. As a result, the new guidelines make no recommendations for specific LDL-cholesterol or non-HDL targets for the primary and secondary prevention of atherosclerotic cardiovascular disease.
Instead, the new guidelines identify four groups of primary- and secondary-prevention patients in whom physicians should focus their efforts to reduce cardiovascular disease events.
And in these four patient groups, the new guidelines make recommendations regarding the appropriate "intensity" of statin therapy in order to achieve relative reductions in LDL cholesterol.
No Evidence for Treating to Specific Targets
Dr Neil Stone (Northwestern University Feinberg School of Medicine, Chicago, IL), the chair of the expert panel who wrote the guidelines, spoke with the media during a conference call and said there were some problems with treating to goal, specifically in patients who were treated close but not exactly to target.
"In secondary prevention, what if your patient is on high-intensity statin therapy and gets an LDL-cholesterol level of 78 [mg/dL] and is adhering to an excellent lifestyle?" said Stone. "From our point of view, there is a large body of evidence that says he's actually doing as good a job as he can possibly do. If he has to get to an optional goal of under 70 [mg/dL] as some would advocate, it means adding on medicines for which there is not proven benefit."
In addition, the panel said that the use of LDL-cholesterol targets might result in the overtreatment of patients with nonstatin drugs. These other agents have not been shown to reduce the risk of atherosclerotic cardiovascular disease.
Dr Donald Lloyd-Jones (Northwestern University Feinberg School of Medicine), the cochair of the guidelines on the assessment of cardiovascular risk, which were also released today along with guidelines for the management and treatment of obesity and guidelines for lifestyle management, said the evidence for treating to target simply isn't there, but that doesn't mean repeated measurements of LDL cholesterol won't be needed.
"There have been no clinical trials in which they've taken an approach where they've titrated medication dosing to achieve a certain LDL level," said Lloyd-Jones. "We just haven't had those trials designed or performed yet. So we just couldn't endorse that kind of approach. And yet, we're not abandoning the measurement of LDL cholesterol, because it's perhaps our best marker of understanding whether patients are going to achieve as much benefit as they can for the dose of statin they can tolerate. For the clinician, it's also a very important marker of adherence."
Stone acknowledged that the old targets might be part of the "mind-set" of physicians but said the new recommendations actually simplify treatment in that doctors won't have to fuss around with additional means to lower LDL cholesterol if the patient has been treated with an appropriate dose of statin therapy.
The Four Major Statin Groups
The four major primary- and secondary-prevention patient groups who should be treated with statins were identified on the basis of randomized, controlled clinical trials showing that the benefit of treatment outweighed the risk of adverse events.
The four treatment groups include:
According to the expert panel, there is simply no evidence from randomized, controlled clinical trials to support treatment to a specific target. As a result, the new guidelines make no recommendations for specific LDL-cholesterol or non-HDL targets for the primary and secondary prevention of atherosclerotic cardiovascular disease.
Instead, the new guidelines identify four groups of primary- and secondary-prevention patients in whom physicians should focus their efforts to reduce cardiovascular disease events.
And in these four patient groups, the new guidelines make recommendations regarding the appropriate "intensity" of statin therapy in order to achieve relative reductions in LDL cholesterol.
No Evidence for Treating to Specific Targets
Dr Neil Stone (Northwestern University Feinberg School of Medicine, Chicago, IL), the chair of the expert panel who wrote the guidelines, spoke with the media during a conference call and said there were some problems with treating to goal, specifically in patients who were treated close but not exactly to target.
"In secondary prevention, what if your patient is on high-intensity statin therapy and gets an LDL-cholesterol level of 78 [mg/dL] and is adhering to an excellent lifestyle?" said Stone. "From our point of view, there is a large body of evidence that says he's actually doing as good a job as he can possibly do. If he has to get to an optional goal of under 70 [mg/dL] as some would advocate, it means adding on medicines for which there is not proven benefit."
In addition, the panel said that the use of LDL-cholesterol targets might result in the overtreatment of patients with nonstatin drugs. These other agents have not been shown to reduce the risk of atherosclerotic cardiovascular disease.
Dr Donald Lloyd-Jones (Northwestern University Feinberg School of Medicine), the cochair of the guidelines on the assessment of cardiovascular risk, which were also released today along with guidelines for the management and treatment of obesity and guidelines for lifestyle management, said the evidence for treating to target simply isn't there, but that doesn't mean repeated measurements of LDL cholesterol won't be needed.
"There have been no clinical trials in which they've taken an approach where they've titrated medication dosing to achieve a certain LDL level," said Lloyd-Jones. "We just haven't had those trials designed or performed yet. So we just couldn't endorse that kind of approach. And yet, we're not abandoning the measurement of LDL cholesterol, because it's perhaps our best marker of understanding whether patients are going to achieve as much benefit as they can for the dose of statin they can tolerate. For the clinician, it's also a very important marker of adherence."
Stone acknowledged that the old targets might be part of the "mind-set" of physicians but said the new recommendations actually simplify treatment in that doctors won't have to fuss around with additional means to lower LDL cholesterol if the patient has been treated with an appropriate dose of statin therapy.
The Four Major Statin Groups
The four major primary- and secondary-prevention patient groups who should be treated with statins were identified on the basis of randomized, controlled clinical trials showing that the benefit of treatment outweighed the risk of adverse events.
The four treatment groups include:
- Individuals with clinical atherosclerotic cardiovascular disease.
- Individuals with LDL-cholesterol levels >190 mg/dL, such as those with familial hypercholesterolemia.
- Individuals with diabetes aged 40 to 75 years old with LDL-cholesterol levels between 70 and 189 mg/dL and without evidence of atherosclerotic cardiovascular disease.
- Individuals without evidence of cardiovascular disease or diabetes but who have LDL-cholesterol levels between 70 and 189 mg/dL and a 10-year risk of atherosclerotic cardiovascular disease>7.5%.