Nav: Home

Statin add-on may offer new/another option for reducing LDL-C in high-risk patients

March 18, 2019

New Orleans, LA (Mar 18, 2019) - Patients at high risk for a heart attack or stroke who took an investigational drug in addition to a statin had significantly lower LDL, or "bad" cholesterol, after 12 weeks compared to similar patients who took a placebo in addition to statin therapy, according to research presented at the American College of Cardiology's 68th Annual Scientific Session.

LDL cholesterol levels in patients who received the investigational drug, known as bempedoic acid, were reduced by 17.4 percent after 12 weeks of treatment and the reduction was sustained at 52 weeks of treatment, compared with patients who received a placebo, with no differences in overall adverse effects, including serious adverse events and muscle-related side effects, said Anne C. Goldberg, MD, professor of medicine at Washington University School of Medicine in St. Louis and lead author of the study.

"These findings--taken together with other recently reported results of large randomized trials of bempedoic acid--indicate that this agent may add to the armamentarium of treatment options for high-risk patients with atherosclerotic cardiovascular disease whose LDL cholesterol remains uncontrolled despite taking a maximally tolerated statin," Goldberg said.

Studies have shown statins to be highly effective at lowering cholesterol levels and reducing the risk of a heart attack or stroke. These drugs work primarily by blocking an enzyme that the liver uses to make cholesterol, but they also inhibit cholesterol production in muscles. Some patients develop muscle pain and must limit the statin dose they take, or in some cases, discontinue taking a statin to avoid this side effect. About 10 percent of patients taking high-dose statins experience muscle pain as a side effect, Goldberg said.

The Blood Cholesterol Guideline published in 2018 by the ACC and the American Heart Association recommends treating patients with atherosclerotic cardiovascular disease (ASCVD) with the highest tolerated dose of a statin, with the goal of reducing LDL cholesterol levels by at least 50 percent.

Bempedoic acid also blocks the liver from making cholesterol, but unlike statins it does not block cholesterol production in muscles. For this reason, Goldberg said, researchers think that bempedoic acid may be less likely than statins to cause muscle pain and thus may promote further reduction of LDL cholesterol levels in patients who must limit their statin doses or not take a statin at all because of this adverse effect.

A total of 779 patients were enrolled in the study. Their average age was 64 years and more than 60 percent were men. At study entry, all patients had LDL cholesterol levels of at least 100 mg/dL and were already taking the highest tolerated dose of a statin. A subset of 77 patients was not able to tolerate any dose of a statin.

In addition to ASCVD, 80 percent of the patients had high blood pressure and 30 percent had diabetes. Six percent had an inherited condition, familial hypercholesterolemia, which causes high LDL cholesterol and elevates risk for a heart attack from an early age.

Patients were randomly assigned to take either bempedoic acid 180 mg tablet once a day or an identical placebo tablet once a day as an add-on to the statin they were already taking. Because this was a double-blind study, neither the patients nor their doctors knew which one they received. Two-thirds of the patients received the study drug and one-third took the placebo.

The study's primary endpoint was the percentage change in LDL cholesterol levels after 12 weeks. Patients continued to take the study medications for a year so that researchers could monitor the safety of bempedoic acid and the durability of treatment effects.

At 12 weeks, LDL cholesterol levels had declined to 97.6 mg/dL from an average of 119.4 mg/dL at study entry for patients taking bempedoic acid. Over the same period, LDL cholesterol levels among patients in the placebo group were essentially unchanged (122.8 mg/dL at 12 weeks vs 122.4 at study entry). In the subgroup of patients who were not taking a statin at study entry, LDL cholesterol levels were reduced by 22 percent at 12 weeks.

At one year, patients in the bempedoic acid group had an average LDL cholesterol level of 99.6 mg/dL, while for those in the placebo group the average was 116.9 mg/dL. Major adjudicated cardiovascular events (5-point MACE) were reported by 6.1 percent of patients taking bempedoic acid and by 8.2 percent of those taking the placebo, a non-statistically significant difference, Goldberg said. Rates of worsening diabetes were similar in the two groups.

"The effect of bempedoic acid was durable at one year and we observed no increase in adverse effects from the addition of bempedoic acid to statin therapy," Goldberg said.

Results of a randomized, double-blinded trial involving 2,230 patients, announced in May 2018, found that bempedoic acid reduced LDL cholesterol by 18.1 percent on top of maximally tolerated statin therapy at 12 weeks with no increase in adverse events compared with the placebo arm.
-end-
A global randomized, double-blinded, placebo-controlled trial is now underway to determine whether treatment with bempedoic acid decreases the risk of heart attacks, strokes and death from heart or blood-vessel disease in patients who can tolerate less than the lowest approved daily starting dose of a statin. This trial, which will enroll an estimated 12,600 patients in about 30 countries, is expected to be completed in 2022.

Esperion Therapeutics, Inc., the manufacturer of bempedoic acid, announced in February that it submitted an application to the U.S. Food and Drug Administration for the approval of bempedoic acid for reducing LDL cholesterol.

This study was funded by Esperion Therapeutics, Inc.

The ACC's Annual Scientific Session will take place March 16-18, 2019, in New Orleans, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter and #ACC19 for the latest news from the meeting.

The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.

American College of Cardiology

Related Heart Attack Articles:

Where you live could determine risk of heart attack, stroke or dying of heart disease
People living in parts of Ontario with better access to preventive health care had lower rates of cardiac events compared to residents of regions with less access, found a new study published in CMAJ (Canadian Medical Association Journal).
Activated T-cells drive post-heart attack heart failure
Chronic inflammation after a heart attack can promote heart failure and death.
ICU care for COPD, heart failure and heart attack may not be better
Does a stay in the intensive care unit give patients a better chance of surviving a chronic obstructive pulmonary disease (COPD) or heart failure flare-up or even a heart attack, compared with care in another type of hospital unit?
Heart attack treatment might be in your face
Researchers at the University of Cincinnati have received $2.4 million in federal funding to pursue research on a novel cell therapy that would repair heart damage using modified cells taken from the patient's own facial muscle.
Tissue engineering advance reduces heart failure in model of heart attack
Researchers have grown heart tissue by seeding a mix of human cells onto a 1-micron-resolution scaffold made with a 3-D printer.
Study shows functional effects of human stem cell delivery to heart muscle after heart attack
Researchers delivered human stem cells seeded in biological sutures to the damaged heart muscles of rats following induced acute myocardial infarction and assessed the effects on cardiac function one week later.
Younger heart attack survivors may face premature heart disease death
For patients age 50 and younger, the risk of premature death after a heart attack has dropped significantly, but their risk is still almost twice as high when compared to the general population, largely due to heart disease and other smoking-related diseases The risk of heart attack can be greatly reduced by quitting smoking, exercising and following a healthy diet.
After the heart attack: Injectable gels could prevent future heart failure (video)
During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells in the heart.
Heart failure after first heart attack may increase cancer risk
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared to first-time heart attack survivors without heart failure, according to a study today in the Journal of the American College of Cardiology.
1 in 4 patients develop heart failure within 4 years of first heart attack
One in four patients develop heart failure within four years of a first heart attack, according to a study in nearly 25,000 patients presented today at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure by Dr.

Related Heart Attack Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Digital Manipulation
Technology has reshaped our lives in amazing ways. But at what cost? This hour, TED speakers reveal how what we see, read, believe — even how we vote — can be manipulated by the technology we use. Guests include journalist Carole Cadwalladr, consumer advocate Finn Myrstad, writer and marketing professor Scott Galloway, behavioral designer Nir Eyal, and computer graphics researcher Doug Roble.
Now Playing: Science for the People

#529 Do You Really Want to Find Out Who's Your Daddy?
At least some of you by now have probably spit into a tube and mailed it off to find out who your closest relatives are, where you might be from, and what terrible diseases might await you. But what exactly did you find out? And what did you give away? In this live panel at Awesome Con we bring in science writer Tina Saey to talk about all her DNA testing, and bioethicist Debra Mathews, to determine whether Tina should have done it at all. Related links: What FamilyTreeDNA sharing genetic data with police means for you Crime solvers embraced...