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Whether and Why Do We Need a Vaccine Against Atherosclerosis? Can We Expect It Anytime Soon?
Stanisław Surma1, Amirhossein Sahebkar2,3,4, Maciej Banach5,6,7
1Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, 40-752, Katowice, Poland.
Insights
An innovative anti-PCSK9 vaccine shows promise for long-term control of high LDL-C, a key factor in atherosclerotic cardiovascular disease. Further trials are needed to confirm its safety and efficacy as a novel lipid-lowering therapy.
Area of Science:
- Cardiovascular Medicine
- Immunology
- Pharmacology
Background:
- Atherosclerotic cardiovascular disease (ASCVD) is a major cause of premature death, significantly driven by lipid disorders like elevated low-density lipoprotein cholesterol (LDL-C).
- The cumulative exposure to high LDL-C (cholesterol-years) dictates ASCVD risk, emphasizing the need for early, aggressive, and sustained lipid-lowering strategies.
- Despite available treatments, achieving optimal lipid control remains challenging, highlighting the demand for novel therapeutic approaches and improved treatment adherence.
Purpose of the Study:
- To review the significance and current status of anti-PCSK9 vaccine development as a novel strategy for managing lipid disorders and reducing cardiovascular risk.
- To explore the potential of an anti-PCSK9 vaccine for long-term, adherence-independent control of LDL-C concentrations.
Main Methods:
- Review of experimental studies and existing clinical trial data on anti-PCSK9 vaccines.
- Assessment of immune response, lipid-lowering effects, anti-atherosclerotic properties, tolerability, and safety profiles.
Main Results:
- Experimental and preliminary clinical data indicate that anti-PCSK9 vaccines can induce a durable immune response, leading to sustained LDL-C reduction and anti-atherosclerotic effects.
- The vaccine candidates have demonstrated good tolerability and a satisfactory safety profile in initial investigations.
- Long-term efficacy and safety require confirmation through large-scale Phase 2, Phase 3, and cardiovascular outcome trials.
Conclusions:
- Anti-PCSK9 vaccines represent a promising novel therapeutic avenue for managing lipid disorders and potentially reducing ASCVD.
- Further clinical validation is essential to establish the role of anti-PCSK9 vaccines in the therapeutic armamentarium for cardiovascular disease prevention.
- Successful development could offer a long-term, potentially annual, treatment option for improving lipid management and patient outcomes.
Purpose Of Review:
Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of premature death. Lipid disorders, particularly elevated serum low-density lipoprotein cholesterol (LDL-C), contribute significantly to ASCVD. The risk of developing ASCVD is influenced by the duration of exposure to elevated LDL-C concentrations (cholesterol-years concept). Implementing lipid-lowering treatments based on the principles of "the earlier the better," "the lower the better," and "the longer the better" has been shown to reduce cardiovascular risk and significantly extend lifespan. Despite the availability of numerous lipid-lowering drugs, achieving satisfactory control of lipid disorders remains very challenging. Therefore, there is a need for novel approaches to improve treatment adherence.
Recent Findings:
One promising solution under investigation is the development of an anti-PCSK9 vaccine, which could be administered annually to provide long-term control over LDL-C concentrations. Experimental studies and the sole clinical trial conducted thus far have demonstrated that the anti-PCSK9 vaccine induces a durable immune response associated with lipid-lowering and anti-atherosclerotic effects. Furthermore, it has exhibited good tolerability and a satisfactory safety profile. However, we still need data from phase 2, 3, and cardiovascular outcome trial to confirm its safety and efficacy and add value in the armamentarium of available and perspective lipid-lowering drugs. This article highlights the significance of developing an anti-PCSK9 vaccine and provides an overview of the current knowledge on various anti-PCSK9 vaccines.
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