A Non-Statin Drug for Treating Cholesterol gets FDA’s Approval

The US Food and Drug Administration has approved a new drug that treats high cholesterol in patients. This drug is not a statin, in fact, it works better than statins. This medicine (Bempedoic acid) is made by “Esperion Therapeutics” by the commercial name “Nexletol”.

The patients are advised to use it once a day and the commercial However it requires the patient to follow a healthy diet and standard dosing only. Some previous studies show that medicines are helpful to reduce the low-density lipoprotein (LDL) called cholesterol. This LDL is labeled as the “bad” cholesterol and it often leads to cardiac issues i.e. heart failure or stroke.

This new FDA-approved medicine is designed to lower cholesterol levels of the body but its benefit in reducing the risk of heart problems is not completely clear. It is yet to show its efficacy against heart problems. After that, it could be recommended to people with heart conditions who otherwise cannot use statins for reducing high cholesterol.

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This new medicine Nexletol reduces LDL cholesterol by up to 28%, as the company promises. This company has also applied to the FDA for approving it to be used as a combination medicine therapy with another non-statin medicine called ezetimibe. This combination is thought to reduce cholesterol by up to 44% in patients with high cholesterol levels. However, this combination usage has not received the FDA’s approval yet. So, any comment on that would be untimely.

Typically, every 1 in 5 US citizens of age 40 to 75 takes a daily statin for preventing heart-related problems. But there are many people who can’t take statins for their side effects. Even with improved diet and physical activity, more than 15 million Americans cannot use the standard cholesterol medicines so they definitely need an alternative of statins.

This new drug has shown high tolerance levels during the clinical study phase, the company tells. It comes with warnings and precautions mentioned on its labels i.e. gout development, tendon rupture or hyperuricemia.

The common side effects that could hit a user include the following.

• Upper respiratory infection
• Muscular spasms
• Hyperuricemia
• Chronic back pain
• Abdominal distress and pain
• Bronchitis
• Anemia
• Liver problems

Tim Mayleben is the president and CEO of Esperion Therapeutics. He says in a press release that;

“Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals. Today’s approval provides them with a new medicine to go along with a healthy diet.”

A high cholesterol level is dangerous for health. It accumulates inside the blood arteries and narrows the passage for blood flow. It results in reduced blood circulation and oxygen supply to the heart, leading to certain heart conditions especially stroke.

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Nearly 102 million US citizens (adults) are living with considerably high cholesterol levels and 35 million are living with extremely high cholesterol level and they are at risk of heart problems.

Dr. Roger Blumenthal is the director of the Ciccarone Center for the Prevention of Cardiovascular Disease at John Hopkins and the author of cholesterol control guidelines for the American Heart Association.  He says; “I definitely think it will be another tool that we have to utilize.”

He believes doctors could use this non-statin treatment for patients of high cholesterol on which the standard statins are not a good option.