In a major breakthrough, a significant trial of bempedoic acid, a cholesterol-reducing medication, has yielded promising outcomes. This drug demonstrated a 13% reduction in severe adverse cardiovascular events among patients who cannot endure statins. These findings underline bempedoic acid’s potential as a beneficial alternative to first-line statin treatments, although its cholesterol-reducing capacity is less robust.
This medication has effectively lowered LDL cholesterol and diminished the likelihood of critical cardiovascular complications in a large-scale trial.
According to research published in the New England Journal of Medicine and earlier presented at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology, the drug bempedoic acid reduced the combined rate of severe adverse cardiovascular incidents by 13% in a considerable study involving high-cholesterol patients who could not bear statins.
An excess of low-density lipoprotein (LDL) cholesterol in the bloodstream can result in artery blockage and increased risk of heart attacks, strokes, and other heart diseases. Statins are the conventional primary treatment for cholesterol reduction and heart disease risk mitigation. Bempedoic acid targets the same biological pathway as statins but gets activated only in the liver. This limitation restricts the drug’s impact on muscle, brain, and other tissues or organs, explaining its fewer reported side effects compared to statins. The U.S. Food and Drug Administration has approved it as an additional treatment for lowering cholesterol in patients who have high cholesterol even while on maximally tolerated statin therapy.
The trial, named CLEAR Outcomes, is the pioneer in evaluating whether bempedoic acid can reduce cardiovascular outcomes. The drug demonstrated significant reductions in the trial’s primary endpoint, a composite of cardiovascular death, heart attack, stroke, or coronary revascularization (a procedure to unblock arteries). An analysis of different types of cardiac events showed a 23% reduction in heart attacks and a 19% reduction in coronary revascularizations with bempedoic acid, both statistically significant. These benefits were observed in both people who had and had not previously experienced a cardiac event.
“We are quite pleased with the results,” stated Steven E. Nissen, MD, chief academic officer of the Heart Vascular & Thoracic Institute at Cleveland Clinic and chair of the study. “Patients who couldn’t tolerate a statin did tolerate bempedoic acid and had a very positive outcome. We’re delighted to have demonstrated this level of efficacy on outcomes that genuinely matter to patients.”
The study enrolled over 14,000 statin-intolerant patients from December 2016 to August 2019 at over 1,200 sites in 32 countries. Patients and their clinicians had to acknowledge in writing their understanding of the benefits of statins and confirm the patient’s inability to tolerate statin therapy. All participants had baseline LDL levels of 100 mg/dL or higher and either a previous cardiac event or other heart disease risk factors. On average, patients were 65 years old, nearly half were women (48%), and approximately 70% had experienced a previous cardiac event. Participants were randomly assigned to take 180 mg of bempedoic acid or a placebo daily and were followed for over three years, on average.
There was no significant difference in death rates between the two study arms. However, the combined rate of cardiovascular death, heart attack, stroke, or coronary revascularization occurred in 11.7% of participants taking bempedoic acid and 13.3% of those taking a placebo.
Participants taking bempedoic acid experienced an average LDL cholesterol reduction of 20%-
Frequently Asked Questions (FAQs) about Bempedoic Acid
What is bempedoic acid?
Bempedoic acid is a cholesterol-lowering drug that has shown promising results in a large clinical trial. It has reduced major adverse cardiovascular events by 13% in patients unable to tolerate statins, making it a potential beneficial alternative for those who cannot use first-line statin treatments.
How does bempedoic acid work?
Bempedoic acid targets the same biological pathway as statins, but it is not activated until it reaches the liver. This limitation restricts the drug’s impact on muscle, brain, and other tissues or organs, which is why it does not have the same side effects reported with statins.
Who can benefit from bempedoic acid?
Patients who cannot tolerate statins, yet have high cholesterol levels and are at risk of cardiovascular diseases, may benefit from bempedoic acid.
How effective is bempedoic acid compared to statins?
While bempedoic acid has shown to reduce LDL cholesterol levels and cardiovascular risks, it’s not as potent as statins. In the CLEAR Outcomes trial, bempedoic acid led to a 20%-25% reduction in LDL cholesterol, compared to the typical 40%-50% reductions achieved with statins.
Are there any side effects associated with bempedoic acid?
Patients taking bempedoic acid have reported higher rates of several adverse events than those taking a placebo, including renal impairment, gout, gallstones, and elevated hepatic enzymes, likely due to the drug’s activity in the liver. However, these side effects did not lead to a higher rate of drug discontinuation.
More about Bempedoic Acid
- New England Journal of Medicine Publication
- American College of Cardiology’s Annual Scientific Session
- U.S. Food and Drug Administration
- Cleveland Clinic Heart Vascular & Thoracic Institute
- Esperion Therapeutics