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Published on: August 28, 2018
Safety Issues Associated With the Clinical Application of PCSK9 Inhibitors: Current Findings
1From the Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China.
Abstract:
Reduction in low-density lipoprotein cholesterol levels is the cornerstone of treatment and prevention of atherosclerotic cardiovascular diseases. Currently, high-intensity statins are being used as the first-line therapy to lower low-density lipoprotein cholesterol levels, as they improve the prognosis of patients with atherosclerotic cardiovascular disease and those in high-risk groups. However, in some patients, the expected reduction in cholesterol is not achieved despite aggressive treatment with statins. Moreover, some patients cannot tolerate the dosage or show poor response or compliance to statins. Therefore, combination therapies with statins and other medications should be considered. Recently, several clinical trials have shown that the use of proprotein convertase subtilisin/kexin type 9 inhibitors with or without statins and/or other lipid-lowering drugs can significantly reduce low-density lipoprotein cholesterol levels, sometimes to extremely low levels. Therefore, to facilitate appropriate prescription of these new lipid-lowering drugs, we systemically evaluated the safety issues associated with these inhibitors and extremely low low-density lipoprotein cholesterol levels.
Insights
High-intensity statins are first-line for atherosclerotic cardiovascular disease, but some patients need alternatives. Proprotein convertase subtilisin/kexin type 9 inhibitors offer significant low-density lipoprotein cholesterol reduction, with safety evaluated here.
Area of Science:
- Cardiology
- Pharmacology
- Biochemistry
Background:
- Low-density lipoprotein cholesterol (LDL-C) reduction is crucial for preventing atherosclerotic cardiovascular diseases (ASCVD).
- High-intensity statins are the primary therapy, but suboptimal response and intolerance occur.
- Alternative and combination therapies are needed for effective LDL-C management.
Purpose of the Study:
- To evaluate the safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
- To assess safety concerns related to achieving extremely low LDL-C levels.
- To inform the appropriate prescription of novel lipid-lowering agents.
Main Methods:
- Systematic evaluation of clinical trial data.
- Analysis of safety profiles for PCSK9 inhibitors.
- Review of outcomes associated with very low LDL-C levels.
Main Results:
- PCSK9 inhibitors significantly reduce LDL-C, often to very low levels.
- Combination therapy with statins and PCSK9 inhibitors shows efficacy.
- Safety data on PCSK9 inhibitors and extreme LDL-C reduction were analyzed.
Conclusions:
- PCSK9 inhibitors represent a valuable therapeutic option for managing hyperlipidemia.
- Understanding safety is paramount for utilizing PCSK9 inhibitors and achieving target LDL-C.
- Further research and clinical guidance are needed for optimal use of these agents.
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