How Can Leqvio Help Manage Cholesterol Effectively?

 Effects of Cholesterol on a Patient’s Life

Cholesterol is a waxy, fat-like substance essential for the body’s normal function. However, excessive levels of low-density lipoprotein (LDL), commonly known as 'bad cholesterol,' can lead to severe health issues. High cholesterol significantly increases the risk of cardiovascular diseases (CVDs), including heart attacks and strokes.1

Individuals with high cholesterol often experience complications such as atherosclerosis, where plaque builds up in the arteries, restricting blood flow.2 This condition can lead to chest pain (angina), peripheral artery disease, and even chronic kidney disease due to reduced blood supply.3

Cardiovascular diseases account for nearly one-third of all deaths worldwide, making cholesterol management crucial.4 Elevated LDL cholesterol contributes to the formation of plaques that can rupture, causing life-threatening complications. Managing cholesterol effectively through lifestyle modifications, dietary changes, and medications can significantly reduce CVD-related mortality and morbidity.1

Symptoms of an underlying Cardiac Disease:5

It can be rather tricky to self-diagnose or know when one has a cardiac condition, there maybe no specific symptoms. A heart attack or stroke may be the first sign of underlying disease. Symptoms of a heart attack include:

  • Pain/feeling uneasy in the centre of the chest; and/or

  • Pain/discomfort in the arms, the left shoulder, elbows, jaw, or even the back.

Moreover, the person may experience difficulty in breathing, nausea or vomiting, light-headedness, have a cold sweat and turn pale. Women are more likely than men to have most of the symptoms. 1

Atherosclerosis: In this, the arteries become narrowed due to the buildup of fatty deposits such as cholesterol, and other substances, forming “plaque” on the artery walls. Over time, these plaques restrict blood flow, leading to a higher risk of heart attack, stroke, and other cardiovascular problems. As the plaque grows, it can rupture, causing blood clots that further block blood flow. 2

Familial hypercholesterolemia (FH): A genetic disorder that results in high levels of low-density lipoprotein (LDL) cholesterol in the blood, increasing the risk of cardiovascular diseases. It is caused by mutations in genes involved in cholesterol metabolism, typically the LDLR gene, leading to reduced ability to remove LDL cholesterol, commonly referred to as “bad cholesterol” from the blood circulation. FH can be inherited in an autosomal dominant manner, meaning one copy of the defective gene is enough to cause the condition.  Familial hypercholesterolemia affects an estimated 1 in 200 to 1 in 250 people in most countries and is thought to be the most common inherited condition affecting the heart and blood vessels. 

Why are Indian Medicines Not Enough?

In India, statins are the most widely prescribed medications for lowering cholesterol. While they effectively reduce LDL cholesterol levels, they may not work sufficiently for all patients, particularly those with familial hypercholesterolemia (FH) or statin intolerance. Some patients also tend to discontinue statins due to their side-effects.7,10,11. 

What are Statins? Statins are a class of drugs that inhibit HMG-CoA reductase, an enzyme essential for cholesterol synthesis in the liver. Commonly prescribed statins include atorvastatin, rosuvastatin, and simvastatin.10  While they effectively lower LDL cholesterol, some patients experience side effects such as muscle pain, liver dysfunction, and an increased risk of diabetes.12

Moreover, despite being the first-line therapy, statins alone do not always achieve optimal LDL reduction, especially in high-risk individuals. This has led to a growing demand for alternative therapies that offer better cholesterol control with minimal side effects.9,10

Introducing Medicines Approved Outside India

Beyond statins, several cholesterol-lowering therapies have been approved globally but remain unavailable in India. Among them, PCSK9 inhibitors and small interfering RNA (siRNA) therapies like inclisiran (Leqvio) have demonstrated significant LDL-lowering effects.9 These advanced treatments offer promising solutions for patients who do not respond well to conventional statins.

How Can Leqvio Help?

Leqvio (inclisiran) is a novel cholesterol-lowering drug that utilizes small interfering RNA (siRNA) technology to target PCSK9, a protein responsible for degrading LDL receptors in the liver. By inhibiting PCSK9, Leqvio increases LDL receptor activity, significantly reducing LDL cholesterol levels.12

Unlike daily statins, Leqvio is administered as an injection twice a year, providing sustained LDL reduction with fewer compliance issues.13  Clinical trials have shown that Leqvio can lower LDL cholesterol by up to 50% when combined with statins, offering an effective solution for patients requiring additional cholesterol management.14

Maximizing medication benefits: 17

Leqvio is best used in combination with a healthy diet and other lifestyle changes to manage cholesterol levels effectively. 

It is particularly suitable for individuals who need additional help managing their cholesterol levels despite other treatments.

  • Dietary changes: Eating a fibre-rich diet, including omega-3 rich foods & reducing trans fat.

  • Managing weight: Regular exercising to manage weight. 

  • Quitting bad habits: Avoid smoking and alcohol. 

  • Other medications: Your doctor may prescribe Leqvio with another medication or supplements to maximize its benefits, Leqvio is commonly combined with statins. Other medicines may include Ezetimibe, Fibrates, Omega-3 supplements or another PCSK9 inhibitor.

Who Can Take Leqvio?

Leqvio is recommended for individuals with:

  • Familial hypercholesterolemia (FH), a genetic disorder leading to high cholesterol levels.15

  • Atherosclerotic cardiovascular disease (ASCVD) requiring aggressive LDL management.16

  • Patients intolerant to statins or those needing adjunctive therapy to achieve target LDL levels.17

However, Leqvio is not yet widely available n India. It is accessible through special import programs like Rx4U Named Patient Purchase.18

Possible Side Effects

Leqvio is generally well-tolerated, but some patients may experience mild side effects, including:

  • Injection site reactions such as redness, swelling, or pain.19

  • Flu-like symptoms, including fatigue and muscle pain.20

  • Liver enzyme elevations in rare cases.21

Conclusion

Managing cholesterol effectively is crucial for preventing life-threatening cardiovascular diseases. While statins remain the standard treatment, many patients require alternative options like Leqvio for optimal LDL control. Leqvio’s innovative siRNA mechanism, biannual dosing schedule, and proven efficacy make it a game-changer for cholesterol management. 

Rx4u making treatments accessible

Although Leqvio is not yet available in India, patients can still access this advanced cholesterol-lowering therapy through global supply programs like Rx4U. Rx4u under Name Patient Program act as a bridge, streamlining the complex process of procurement while navigating regulatory and logistical challenges. 

By ensuring that life-changing treatments reach those who need them most, Rx4U offers more than just medication—it provides a lifeline of hope for better health and a brighter future.



References

  1. CDC. "Managing cholesterol levels." https://www.cdc.gov/cholesterol/index.htm 

  2. NIH. "Atherosclerosis and cardiovascular risks." https://www.ncbi.nlm.nih.gov/books/NBK343489/ 

  3. MedlinePlus. "Cholesterol" https://medlineplus.gov/cholesterol.html#:~:text=What%20other%20health%20problems%20can,stroke%2C%20and%20peripheral%20arterial%20disease. 

  4.  https://world-heart-federation.org/wp-content/uploads/World-Heart-Report-2023.pdf 

  5. ->World Health Organization. "Cardiovascular diseases." https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

  6. https://medlineplus.gov/genetics/condition/familial-hypercholesterolemia/#resources

  7.  https://pmc.ncbi.nlm.nih.gov/articles/PMC3872714/ 

  8. European Society of Cardiology. "LDL management guidelines." https://www.escardio.org/Guidelines

  9. PubMed. "PCSK9 inhibitors in cholesterol management." https://pubmed.ncbi.nlm.nih.gov/29203548/

  10. Mayo Clinic. "Statins and cholesterol." https://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statins/art-20045772

  11. American College of Cardiology. "Statin side effects and risks." https://www.acc.org/latest-in-cardiology/articles/2021/06/28/12/42/statin-intolerance

  12. New England Journal of Medicine. "Inclisiran and LDL cholesterol." https://www.nejm.org/doi/full/10.1056/NEJMoa1912387

  13. JAMA. "Efficacy of biannual Leqvio injections." https://jamanetwork.com/journals/jama/fullarticle/2762808

  14. Circulation Journal. "LDL reduction with Leqvio." https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050437

  15. National Lipid Association. "Familial hypercholesterolemia treatment." https://www.lipid.org/nla/treatment-fh

  16. PubMed. "ASCVD and LDL targets." https://pubmed.ncbi.nlm.nih.gov/31735717/

  17. BMJ. "Adjunctive therapies for cholesterol management." https://www.bmj.com/content/368/bmj.m389

  18. https://www.rx4u.com

  19. FDA. "Leqvio safety and side effects." https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/leqvio-inclisiran

  20. NIH. "Inclisiran clinical trials." https://clinicaltrials.gov/ct2/show/NCT03400800

  21. MedlinePlus. "Potential risks of siRNA therapies." https://medlineplus.gov/genetics/understanding/therapy/sirna/

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