New drug can lower cholesterol without a statin

A new drug shows promise of reducing LDL blood cholesterol without the muscle aches and weakness that can happen with statins.

A recent study called the CLEAR Outcomes trial reported in The New England Journal of Medicine shows that the drug, bempedoic acid, reduces low-density LDL cholesterol without the muscle aches.

About two in five adults in the United States have high cholesterol, defined as a total blood cholesterol level of 200 mg/dL or higher, according to the federal Centers for Disease Control (CDC). High cholesterol has no signs or symptoms, but it puts people at greater risk for heart attacks and strokes.

Doctors’ first line of treatment is to put patients with high cholesterol on prescription statins. Unfortunately, about 15 percent of people who try statins experience muscle aches, pains and weakness. Many of those people simply stop taking the medication, which leaves them dangerously unprotected.

“It’s the most common side effect,” said cardiologist Kenneth Spector, MD at the Cape Cod Cardiovascular Centers in Falmouth and Sandwich. “There are other side effects, like liver insufficiency, but it’s the muscle achiness that’s the biggest problem with using these statin medications.”

For the CLEAR Outcomes study, a total of 13,970 patients were randomly assigned to either the bempedoic acid group or the placebo group. After close to 40 weeks of follow up, bempedoic acid was shown to reduce LDL cholesterol by 21 percent.

More recent news was even better. A subgroup analysis from the trial confirmed that bempedoic acid prevented cardiovascular events in high-risk, statin-intolerant patients who had not yet had an event. In the patients in the subgroup, bempedoic acid was associated with a large decrease in the risk of major cardiovascular events compared with a placebo.

Statins Still the First Choice

But, Dr. Spector explained, despite the success of bempedoic acid, statins are still the first line of treatment.

“Statins do something a little less defined that lowers morbidity and mortality beyond just lowering the cholesterol,” he said. “The important thing is not really just lowering the cholesterol. It’s whether that lowering translates into an improvement in morbidity and mortality – illness and death.”

Statins are HMG CoA reductase inhibitors, which is part of the bound chemical pathway to make cholesterol, Dr. Spector said. The drugs work in the liver to prevent cholesterol from forming, according to the American Heart Association. This reduces the amount of cholesterol circulating in the blood. Statins are most effective at lowering the LDL (bad) cholesterol, but they also help lower triglycerides and raise HDL (good) cholesterol.

If a patient has side effects from statins, the first thing Dr. Spector does is lower their dose or add a second medication like Zetia. PCSK9 inhibitors are another choice, but they come with drawbacks.

“PCSK9 inhibitors are expensive and injectable and a lot of people don’t like having to take injections, so certainly in that group of people, I would recommend maybe a lower dose of the statin in combination with this newer drug,” he said. “Not everyone can tolerate the first line drug so it is good to have some adjunct therapy.”

Lifestyle Changes

In addition to taking medication, patients should also make lifestyle changes to lower their cholesterol. The CDC offers the following lifestyle tips to prevent or treat high cholesterol:

• Eat a healthy diet. That includes limiting foods that are high in saturated fats. Instead choose foods that are high in fiber and low in saturated fat, trans fat, sodium and added sugars.
• Maintain a healthy weight.
• Exercise regularly. The Surgeon General recommends 150 minutes of moderate-intensity exercise per week.
• Quit smoking.
• Limit alcohol.

“You should try to lower cholesterol with diet and exercise and then lower it the rest of they way with medication, typically statins,” Dr. Spector said. “The exception is if you’ve had an acute coronary syndrome. It you’ve actually had an acute coronary syndrome, we still want you to have good diet and exercise but even if your cholesterol was low, we still want you on a statin.”