Statin alternative shown to lower cholesterol, improve heart health

NEW YORK: The first drug designed for lowering cholesterol levels among people with statin-intolerance has shown to reduce serious cardiovascular events, according to a global study of nearly 14,000 patients.

Statins have been the standard first-line treatment for the prevention of cardiovascular disease that works by lowering cholesterol levels in the blood. However, in some people, it causes side effects such as muscle pain or leads to bad interactions with other medications, and these people then refuse to follow the treatment.

Researchers, from Cleveland Clinic in the US, led a clinical trial to show that the statin-intolerant patients who used bempedoic acid not only had a decrease in lowered low-density lipoproetin (LDL) or bad cholesterol but also had reduced heart attacks and coronary procedures.

Approved by the US Food and Drug Administration (FDA), Bempedoic acid is made by the US pharmaceutical company Esperion Therapeutics (which also funded the study). It is sold under the brand name Nexletol.

Bempedoic acid differs from statins by not activating until it reaches the liver. This limits the drug's effects on muscle, or other tissues or organs, reducing the likelihood of side effects reported with statins.

"Until now, there have not been any drugs designed specifically for statin-intolerant patients," said lead author Steven E. Nissen, chief academic officer of the Heart Vascular & Thoracic Institute at Cleveland Clinic.

"While statins remain the cornerstone of risk reduction in patients with elevated LDL cholesterol, this is a major step forward for a population who need statins but suffer troublesome side-effects," he added.

The findings were presented at the American College of Cardiology's 72nd Annual Scientific Session in New Orleans and also published in the New England Journal of Medicine.

The study enrolled 13,970 statin-intolerant patients between December 2016 and August 2019 in 32 countries.

All participants had LDL-c levels of 100 mg/dL or higher and either a previous cardiac event or other risk factors for heart disease. Participants were randomly assigned to take 180 mg of bempedoic acid or a placebo daily and followed for an average of over three years.

The results showed that bempedoic acid treatment reduced the risk of cardiovascular death, heart attack, stroke or coronary revascularizations (a procedure to open blocked arteries) by 13 per cent.

Bempedoic acid also reduced heart attacks by 23 per cent and coronary revascularisations by 19 per cent.

Researchers noted that the 20-25 per cent reduction in LDL cholesterol reported for bempedoic acid is less than the 40-50 per cent reductions typically achieved with statins.