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Mar 28, 2017

New Cholesterol-Lowering Drug Shows Promise for Patients with Heart Disease

PCSK9 inhibitors lower LDL and risk for heart complications, but access to the drug is an issue for many.

A new cholesterol-lowering drug called evolocumab shows great promise for patients with heart disease, based on research linking the drug to a 59% reduction in “bad” cholesterol and reduced risk of heart attack and stroke.

Recently published in the New England Journal of Medicine and presented at the American College of Cardiology’s 66th Annual Scientific Session, this study tested the safety and efficacy of evolocumab in patients with existing heart disease. Evolocumab is a new type of drug called a PCSK9 inhibitor, which helps reduce low-density lipoprotein (LDL) cholesterol, often referred to as “bad” cholesterol.

The study included more than 27,500 patients with heart disease who were already on cholesterol-lowering statins. To qualify, participants had to have a minimum LDL cholesterol level of 70 mg/dL, which is still below the recommended target of 100 mg/dL. However, studies suggest that patients with heart disease can benefit from lowering their cholesterol beyond current targets, given their increased risk for heart events.

Half of participants were randomly assigned to evolocumab, in addition to their regular statin therapy, while the other half received a placebo with no active ingredients. The drugs were administered by needle 1-2 times a month and participants were followed for over two years.

Over the course of the study, researchers found that overall LDL levels dropped from 92 mg/dL to 30 mg/dL among participants taking evolocumab. This translated to a 59% greater reduction in LDL cholesterol than the placebo drug.

Researchers also found that compared to placebo, evolocumab reduced risk for heart-related complications by 15%. These complications included heart attack, stroke, revascularization, hospitalization for chest pain and heart-related death. A second set of analyses also showed that evolocumab reduced risk for heart attack, stroke and heart-related death by 20%.

There were no significant differences in serious adverse events among either group, although patients taking evolocumab were more likely to have a skin reaction where the drug was injected. Researchers also note that based on a smaller group of patients that underwent cognitive testing, evolocumab was not associated with changes in brain function.

Findings suggest that evolocumab, in combination with statin therapy, significantly lowers bad cholesterol and risk for heart events in patients with heart disease. The new drug also appears safe, as it did not increase risk for serious adverse events.

These findings come on the heels of similar study called the SPIRE 1 and SPIRE 2 trials, which were also presented at the American College of Cardiology’s Annual Scientific Sessions and published in the New England Journal of Medicine. The trials tested the safety and efficacy of bococizumab—a similar type of PCSK9 inhibitor that helps lower LDL cholesterol. Analysis showed that bococizumab helped reduced risk of heart events in high-risk patients, but had no significant benefit in low-risk patients. However, the study was stopped early because many patients developed antibodies to the drug, which lessened its cholesterol-lowering benefits. Fortunately, similar issues were not observed with evolocumab, which is encouraging for the millions of Americans living with heart disease.

Increasing access to this new class of drugs since its approval by the U.S. Food and Drug Administration has already proven a challenge

In another study also presented at the conference, researchers analyzed data from more than 45,000 patients prescribed a PCSK9 inhibitor between August 2015 and July 2016. Overall, the prescription was initially rejected by insurance companies for 79% of patients, and in the end, less than one-third of patients actually received the drug after it was prescribed. Researchers also noted that 35% of patients never picked up their prescriptions after being approved.

The take-home message, according to experts, is that while the new class of cholesterol-lowering drugs is promising, there’s still work to be done. Experts hope that with future research, we can help identify which patients stand to benefit most from this added cholesterol-lowering therapy. In the meantime, experts must help address barriers that prevent patients from getting the medicine prescribed by their providers.

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