Although the target values for plasma lipid concentrations have been revised and reduced, there is no consensus as to whether or not low density lipoprotein cholesterol (LDL-C) levels should be treated according to target values.1,2
The American Heart Association/American College of Cardiology guidelines published in 20143 recommended a “shoot and forget” strategy in which the strength of the statin selected was more in line with the patients’ cardiovascular risk (CVR) than with their final target.
In the European Society of Cardiology guidelines published on 31 August 2019, the recommended LDL-C level for the low-risk population (score, <1%) is <116mg/dL.4 This recommendation was already present in the previous guidelines of 2016,5 but with a huge difference: At that time, the recommendation specified “lifestyle recommendations” (no intervention on lipids) when LDL-C concentration was 155 to 190mg/dL and the CVR was <1%, whereas now it indicates “Lifestyle intervention, consider adding drug if uncontrolled” when LDL-C is between 116 and 190 mg/dL at the same CVR (see table 5 in both guidelines).4,5
Then I wondered, how many of my patients, regardless of their CVR, had LDL-C values <116mg/dL without receiving treatment, and how many had those values with treatment? I reviewed the analysis requests for the past week and found that more than 70% of patients had values >116mg/dL; that is, they would need drug treatment. Looking at a larger database6 and without taking diabetes or CVR into consideration, a similar percentage of patients would have to be treated.
In light of the possibility of a huge increase in lipid-lowering treatments, I delved more deeply into the recent recommendations (p. 22).4 The LDL-C value of <116 in low-risk individuals is based on reference 36, from 2012, by Mihaylova et al.7 (also an author of the 2019 guidelines4). Hence, the current guidelines used an article from 2012 to support recommendations for 2019.
The study by Mihaylova did not propose any LDL-C target goal, much less 116. It was focused on avoidable events in populations with different CVR levels by decreasing LDL-C by 1 mmol (38 mg/dL), which, parenthetically, yielded a nonnegligible number of patients that would have to be treated.7
Where did the authors of the current guidelines get this value of 116? Is there a reference for the article from 2012 in the 2016 guidelines by the same authors? Remember, in 2016 the recommendation was not to intervene if the LDL-C concentration was between 155 and 190 mg/dL (p. 13, Table 5).5 As the article states: “Low-risk people should be given advice to help them maintain this status” (references 61-71). Furthermore, on page 17 the text says: “… the task force accepts that the choice of any given target goal for LDL-C may be open to debate… (references 65 and 66).
As it turns out, reference 66, which contributes to sustaining these 2 statements, is the same as reference 36 in the 2019 guidelines: the study by Mihylova et al.7
In summary, the 2019 European guidelines4 cite a study from 20127 to recommend LDL-C target goals for low-risk patients, but in 20165 they use the same reference to support very different recommendations.
What does this mean? And if it were really appropriate to attempt a goal of <116 mg/dL in low-risk patients, which would imply medicating around 70% of the population, could any health system sustain it?
.