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“New Cholesterol-Lowering Drugs: Are They Safe?

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New Cholesterol-Lowering Drugs: Are They Safe?

High cholesterol is a well-established risk factor for heart disease, the leading cause of death worldwide. For decades, statins have been the cornerstone of cholesterol-lowering therapy, effectively reducing LDL cholesterol ("bad" cholesterol) and lowering the risk of heart attacks and strokes. However, statins are not without their limitations. Some individuals cannot tolerate them due to side effects, while others may not achieve sufficient cholesterol reduction even at the highest doses.

In recent years, new classes of cholesterol-lowering drugs have emerged, offering hope for those who cannot tolerate statins or need additional cholesterol reduction. These new drugs work through different mechanisms than statins, providing alternative or complementary approaches to managing cholesterol levels. However, with any new medication, questions about safety and long-term effects are paramount. This article will explore the landscape of new cholesterol-lowering drugs, examining their mechanisms of action, efficacy, and, most importantly, their safety profiles.

The Need for New Cholesterol-Lowering Drugs

Before delving into the specifics of new cholesterol-lowering drugs, it’s essential to understand why they are needed. Statins, while effective, have limitations:

• Side Effects: Statins can cause side effects such as muscle pain, liver problems, and an increased risk of diabetes in some individuals. These side effects can lead to non-adherence to statin therapy, reducing their effectiveness.
• Insufficient LDL-C Reduction: Some individuals, particularly those with familial hypercholesterolemia (FH), may not achieve sufficient LDL-C reduction with statins alone, even at the highest tolerated doses.
• Statin Intolerance: A significant portion of the population experiences statin intolerance, making it difficult or impossible for them to take statins at all.

These limitations have spurred the development of new cholesterol-lowering drugs that can overcome these challenges and provide additional options for managing cholesterol levels.

New Classes of Cholesterol-Lowering Drugs

Several new classes of cholesterol-lowering drugs have emerged in recent years, each with its unique mechanism of action:

1. PCSK9 Inhibitors:

• Mechanism of Action: PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that reduces the number of LDL receptors on liver cells. LDL receptors are responsible for removing LDL cholesterol from the bloodstream. PCSK9 inhibitors block the action of PCSK9, increasing the number of LDL receptors and lowering LDL cholesterol levels.
• Examples: Alirocumab (Praluent) and evolocumab (Repatha) are two PCSK9 inhibitors approved by the FDA.
• Efficacy: PCSK9 inhibitors can lower LDL cholesterol levels by an additional 50-60% when added to statin therapy. They have also been shown to reduce the risk of heart attacks, strokes, and other cardiovascular events.
• Safety: PCSK9 inhibitors are generally well-tolerated. The most common side effects are injection site reactions, such as redness, itching, or pain. Some studies have suggested a possible increased risk of neurocognitive events, but further research is needed to confirm this.
• Administration: PCSK9 inhibitors are administered as subcutaneous injections, typically every two weeks or once a month.

2. Bempedoic Acid:

• Mechanism of Action: Bempedoic acid is an ATP citrate lyase (ACL) inhibitor. ACL is an enzyme involved in cholesterol synthesis in the liver. Bempedoic acid blocks ACL, reducing cholesterol production and lowering LDL cholesterol levels.
• Examples: Bempedoic acid (Nexletol) is approved by the FDA.
• Efficacy: Bempedoic acid can lower LDL cholesterol levels by about 15-25% when added to statin therapy. It has also been shown to reduce the risk of cardiovascular events in individuals with established heart disease or at high risk for heart disease.
• Safety: Bempedoic acid is generally well-tolerated. The most common side effects are muscle spasms, back pain, and elevated uric acid levels.
• Administration: Bempedoic acid is taken orally once daily.

3. Inclisiran:

• Mechanism of Action: Inclisiran is a small interfering RNA (siRNA) that targets PCSK9 mRNA in the liver. By silencing PCSK9 mRNA, inclisiran reduces the production of PCSK9 protein, leading to an increase in LDL receptors and a decrease in LDL cholesterol levels.
• Examples: Inclisiran (Leqvio) is approved by the FDA.
• Efficacy: Inclisiran can lower LDL cholesterol levels by about 50% when added to statin therapy.
• Safety: Inclisiran is generally well-tolerated. The most common side effects are injection site reactions.
• Administration: Inclisiran is administered as a subcutaneous injection, initially given twice, three months apart, and then every six months.

4. Evinacumab:

• Mechanism of Action: Evinacumab is a fully human monoclonal antibody that inhibits angiopoietin-like 3 (ANGPTL3). ANGPTL3 is a protein that inhibits lipoprotein lipase (LPL), an enzyme that breaks down triglycerides. By inhibiting ANGPTL3, evinacumab increases LPL activity, leading to lower triglyceride levels and lower LDL cholesterol levels.
• Examples: Evinacumab (Evkeeza) is approved by the FDA for homozygous familial hypercholesterolemia (HoFH).
• Efficacy: Evinacumab can significantly lower LDL cholesterol levels in individuals with HoFH, a rare genetic disorder that causes extremely high cholesterol levels.
• Safety: Evinacumab is generally well-tolerated. The most common side effects are upper respiratory tract infections and influenza-like illness.
• Administration: Evinacumab is administered as an intravenous infusion once a month.

Safety Considerations

While the new cholesterol-lowering drugs offer promising benefits, it’s essential to consider their safety profiles. As with any medication, potential side effects and long-term risks must be carefully evaluated.

• Short-Term Side Effects: The new cholesterol-lowering drugs have generally been well-tolerated in clinical trials. The most common side effects are injection site reactions (for PCSK9 inhibitors and inclisiran), muscle spasms, back pain, and elevated uric acid levels (for bempedoic acid), and upper respiratory tract infections and influenza-like illness (for evinacumab).
• Long-Term Safety: Long-term safety data for the new cholesterol-lowering drugs are still being collected. While initial studies have been reassuring, ongoing monitoring and post-market surveillance are crucial to identify any potential long-term risks.
• Neurocognitive Effects: Some studies have suggested a possible increased risk of neurocognitive events with PCSK9 inhibitors. However, other studies have not found this association. Further research is needed to clarify the potential impact of PCSK9 inhibitors on cognitive function.
• Combination Therapy: The safety of combining multiple cholesterol-lowering drugs is also an important consideration. While combination therapy can be effective in achieving significant cholesterol reduction, it may also increase the risk of side effects.
• Patient-Specific Factors: The safety of cholesterol-lowering drugs can also be influenced by patient-specific factors, such as age, gender, race, and underlying medical conditions. It’s essential for healthcare providers to consider these factors when prescribing cholesterol-lowering medications.

Conclusion

The new cholesterol-lowering drugs represent a significant advancement in the management of high cholesterol. They offer alternative or complementary approaches to statins, providing hope for those who cannot tolerate statins or need additional cholesterol reduction. PCSK9 inhibitors, bempedoic acid, inclisiran, and evinacumab have demonstrated efficacy in lowering LDL cholesterol levels and reducing the risk of cardiovascular events.

While these new drugs have generally been well-tolerated in clinical trials, it’s essential to consider their safety profiles. Short-term side effects have been relatively mild, but long-term safety data are still being collected. Ongoing monitoring and post-market surveillance are crucial to identify any potential long-term risks.

The decision to use new cholesterol-lowering drugs should be made on an individual basis, considering the patient’s risk factors, cholesterol levels, tolerance to statins, and overall health status. Healthcare providers should carefully weigh the potential benefits and risks of these drugs before prescribing them.

As research continues and more long-term data become available, our understanding of the safety and efficacy of the new cholesterol-lowering drugs will continue to evolve. These advancements hold the promise of further reducing the burden of heart disease and improving the health of individuals with high cholesterol.