FDA Approves New Non-Statin Drug to Fight ‘Bad’ Cholesterol

A new drug that can treat high cholesterol differently and more efficiently as compared to the currently prescribed cholesterol lowering statins has been approved by the US Food and Drug Administration (FDA). Bempedoic acid, a once-a-day oral medication which will commercially be known as Nexletol, will be used to treat heart problems in patients who cannot tolerate statins.

According to Esperion Therapeutics, the company that produced the drug, Nexletol can effectively lower low-density lipoprotein cholesterol, more commonly known as LDL or ‘bad’ cholesterol, which is a key cause of heart problems and strokes. Further studies are being conducted to establish whether the drug can also lower the risk of the above mentioned health complications.

High Cholesterol and Heart Disease – Worrisome Facts

Cholesterol, a waxy and fatty substance found mainly in greasy and oily foods, is essential for the body to function. However, excessive amounts can build up in arteries and restrict the passage of blood and oxygen to and from the heart, resulting in heart complications and the risk of having a stroke.

Heart disease is the leading cause of death worldwide, with the death toll likely to increase because of the rise of the obesity epidemic. More than 102 million US adults have higher than normal cholesterol levels, and 35 million have levels that put them at a risk for heart disease. Despite following a healthy diet, exercising and taking statins, it is estimated that almost 15 million heart patients in the US cannot lower their cholesterol levels to the recommended range.

Heart diseases are expensive to manage and treat – about $1 billion a day are spent in medical costs attributed to heart-related issues in the US alone. The most common medications for preventing heart attacks and strokes are statins. It is estimated that more than 1 in 5 Americans aged 40 to 75 years take a statin. However, some individuals simply cannot tolerate the drugs or cannot take a high dose, since they experience severe adverse side effects such as muscle aches and stomach problems.

“I definitely think it will be another tool that we have to utilize and it will be good to have another medication that can help patients,” claimed Dr. Roger Blumenthal, director of Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease.

Nexletol – A New Hope for Managing Heart Disease

Nexletol acts by inhibiting the production of cholesterol. According to Esperion Therapeutics, it can lower LDL levels by up to 28 percent. Moreover, studies have shown that using the drug in combination with another non-statin drug Ezetimibe lowered LDL cholesterol between 38-44 percent.

Clinical studies have shown the drug to be well-tolerated. Precautions and label warnings include hyperuricemia (excess of uric acid in the blood), increased tendon injury or rupture and development of gout. Most common adverse reactions were muscle spasms, upper respiratory infection, back pain, abdominal discomfort, anaemia, bronchitis and raised levels of liver enzymes.

In a press release, Tim Mayleben, president and chief executive officer of Esperion, stated that even while taking maximally tolerated strains of statins, or no statins at all, some patients cannot achieve their LDL-C goals. “Today’s approval provides them with a new medicine to go along with a healthy diet.”

However, Blumenthal reminded patients to not simply rely on drugs and to also focus on making healthy lifestyle changes. He stressed that a balanced diet and regular exercise will help prevent heart disease and further complications in life.

“It’s always important to remember: good lifestyle habits are the cornerstone of prevention.”

Leave A Reply

Your email address will not be published.