Evolocumab for Primary Prevention of Cardiovascular Events: Key Findings and Implications
1. Why is preventing a ‘first cardiovascular event’ important?
Myocardial infarction or ischemic stroke, once they occur, are not only difficult to fully recover from, but also greatly increase the risk of recurrence. Since these events are mostly the result of long-term atherosclerosis, strategies to lower risk before the disease occurs are paramount.
However, the effectiveness of potent lipid-lowering agents has often been demonstrated primarily in people who have already experienced cardiovascular disease (secondary prevention).
Therefore, confirming whether these drugs are also helpful for people who are at high risk but have not yet experienced cardiovascular disease is a clinically meaningful question.
2. What is evolocumab?
Evolocumab is an injectable medication in the PCSK9 inhibitor class. It has the following characteristics:
Administered every 2 or 4 weeks
Very effectively lowers LDL cholesterol
Useful in patients whose LDL does not reach target levels despite using high-intensity statins
Can also be used in patients with statin intolerance
As studies accumulate showing that the lower the LDL cholesterol, the lower the risk of cardiovascular disease, the role of this drug is gradually expanding.
* Evolocumab
- Most potent LDL-lowering ability
- Used when statins are not sufficient
* PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) protein
- Destroys LDL receptors in our body (making LDL removal difficult)
- Originally intended to prevent excessive increase of LDL receptors (energy metabolism, cell membrane composition, cholesterol homeostasis balance)
3. Who participated in this study?
This study is a large-scale clinical trial involving over 12,000 patients recruited from more than 30 countries worldwide.
All participants met the following criteria:
No prior history of myocardial infarction or stroke
High LDL cholesterol levels
High-risk group with one of the following:
Atherosclerosis confirmed in coronary, carotid, or peripheral arteries
Diabetes lasting more than 10 years or diabetes with complications
Additional risk factors such as older age, smoking, high non-HDL cholesterol
In other words, these were people at high risk of developing cardiovascular disease, even though they had not yet experienced a major event.
4. Summary of Key Results
The study found that evolocumab significantly reduced the first occurrence of cardiovascular disease in high-risk patients.
1) Reduced risk of myocardial infarction, ischemic stroke, and coronary artery death
The probability of these events occurring was significantly reduced in patients using evolocumab.
A relative risk reduction of about 25% was observed based on the study analysis.
2) Reduced need for revascularization procedures such as stent insertion
The incidence of procedures requiring cardiovascular revascularization was also reduced.
3) LDL cholesterol decreased by an average of over 50%
At 1 year after drug administration, the median LDL level dropped to about 45 mg/dL.
This is a very low level that meets the target for very high-risk groups presented in the latest guidelines.
4) Safety was consistent with previous reports
Serious side effects requiring drug discontinuation were similar to the placebo group.
5. Why is this study important?
This study is special for two reasons:
First, a clear effect was confirmed even in primary prevention patients
PCSK9 inhibitors have previously been proven effective mainly in people who have already had a myocardial infarction or stroke.
However, this study shows a clear preventive effect even in high-risk groups who have not yet experienced an event.
Second, it is a long-term (average of about 4.6 years) follow-up study
The preventive effect of cardiovascular disease tends to be more evident in long-term follow-up.
This study shows how meaningful a strategy of strongly lowering LDL in the long term is.
6. Which patients will benefit?
Evolocumab may be considered in clinical practice for patients such as:
Patients whose LDL is higher than target despite using statin + ezetimibe
Patients with long-standing diabetes or diabetic complications
Cases where atherosclerosis is confirmed by imaging
Familial hypercholesterolemia
Patients who cannot use a sufficient dose due to statin side effects
7. Tips for use in clinical practice
Clearly set LDL targets. Less than 55 mg/dL is recommended for high-risk groups.
Consider adding a PCSK9 inhibitor if existing treatment is not sufficient.
Although it is an injectable drug every 2-4 weeks, adherence is good due to the long dosing interval.
Cost and insurance coverage vary by country and situation, so consultation is necessary.
This study shows that aggressively lowering LDL cholesterol before high-risk patients experience a myocardial infarction or stroke can
significantly reduce the risk of disease.
Cardiovascular disease is much more important to prevent than to treat after it occurs.
Accurate LDL target setting and aggressive drug treatment strategies are key to protecting health.
Source :https://blog.naver.com/kidneyhelp/224088992657
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