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Published on: August 28, 2018
An update on PCSK9 inhibitors- pharmacokinetics, drug interactions, and toxicity
Svetlana Moşteoru1, Dan Gaiţă1, Maciej Banach2
1Cardiology Department, "Victor Babeş" University of Medicine and Pharmacy Timişoara , Romania.
Introduction:
While atherosclerotic cardiovascular disease is affecting growing numbers of patients, lipid-lowering therapies have been continuously improving to achieve prevention of cardiovascular events. Thus, the appearance of a novel therapeutic class, PCSK9 inhibitors, has raised both high expectations as well as concern over possible adverse effects.
Areas Covered:
This current review aims to analyze adverse events of special interest linked to PCSK9 inhibitors and give recommendations regarding further conduct when dealing with patients on this therapy. The most stringent adverse effect, neurocognitive impairment has been investigated in several studies, concluding that PCSK9 inhibitors neither improved nor worsened cognitive function. While new onset diabetes mellitus has also been a cause of concern due to its possible association with lipid lowering therapies, studies conducted so far have dispelled this possibility by showing that PCSK9 inhibitors do not increase this risk. Also, statin-associated muscle symptoms have not been proven to arise after the use of PCSK9 inhibitors, even in statin-intolerant patients.
Expert Opinion:
In conclusion, it can be safely stated that so far, no compelling evidence links PCSK9 inhibitors to these adverse events; however, long-term trials are always welcome to further assess potential adverse effects.
Insights
PCSK9 inhibitors are a new class of lipid-lowering therapies. Current evidence shows no link between PCSK9 inhibitors and adverse effects like neurocognitive impairment or new-onset diabetes.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Atherosclerotic cardiovascular disease (ASCVD) is a growing global health concern.
- Lipid-lowering therapies are crucial for preventing cardiovascular events.
- PCSK9 inhibitors represent a novel therapeutic class with potential benefits and concerns.
Purpose of the Study:
- To review and analyze adverse events associated with PCSK9 inhibitors.
- To provide recommendations for managing patients on PCSK9 inhibitor therapy.
- To assess the safety profile of PCSK9 inhibitors regarding specific adverse events.
Main Methods:
- Literature review of studies investigating PCSK9 inhibitors and adverse events.
- Analysis of data on neurocognitive function, new-onset diabetes, and muscle symptoms.
- Evaluation of evidence from clinical trials and observational studies.
Main Results:
- PCSK9 inhibitors did not demonstrate a significant impact on cognitive function.
- Studies indicate PCSK9 inhibitors do not increase the risk of new-onset diabetes mellitus.
- No evidence links PCSK9 inhibitors to statin-associated muscle symptoms, even in statin-intolerant patients.
Conclusions:
- Current evidence suggests PCSK9 inhibitors are not linked to the investigated adverse events.
- Further long-term trials are recommended to comprehensively assess potential risks.
- PCSK9 inhibitors appear to be a safe option for lipid management in ASCVD patients.
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