New Light on Treatments for High Cholesterol

A new PCSK9 inhibitor (recaticimab) injected every one to three months may work safely and provide more flexible dosing to lower cholesterol, according to late-breaking science presented today at the American Heart Association’s Scientific Sessions 2023. 

American Heart Association guidelines indicate a cholesterol target of less than 100 mg/dl in most adults and less than 70 mg/dl in high-risk people who have already had a heart attack, or stroke or have genetic forms of high cholesterol. When cholesterol-lowering statin medications and other treatments are not effective in reducing bad cholesterol to target levels, physicians may often add a PCSK9 inhibitor. The medication binds to and inactivates a protein on cells found in the liver to lower bad cholesterol. Current FDA approved PCSK9 inhibitors include alirocumab and evolocumab, which are injected every 2-4 weeks.

This multicenter study in China involved 689 participants with abnormally high levels of bad cholesterol despite ongoing moderate or high intensity statin therapy. Participants were divided into three groups: one received either 150 mg of recaticimab or a placebo injection every 4 weeks; one group received 300 mg of recaticimab or placebo injection every 8 weeks; and one group was given 450 mg of recaticimab or placebo injection every 12 weeks.

The study found:

• At every dosage/interval, participants who received recaticimab had lower bad cholesterol levels at 24 weeks than those receiving a placebo.
• In the 4-week injection group, bad cholesterol was reduced 62% among those taking recaticimab vs. 0% among those in the placebo group; in the 8-week injection group, bad cholesterol was reduced 59% vs. +0.4% respectively; and in the 12-week injection group bad cholesterol was reduced 51% vs. +2% respectively.
• At every dosage/interval, recaticimab lowered their bad cholesterol to the target by 24 weeks compared to the placebo and these levels were maintained at 48 weeks.
• At 24 weeks, 90% of the 4-week injection group reached goal compared to 16% of the placebo group; while the percentage was 95% vs. 14% respectively in the 8-week injection group; and 86% vs. 16% respectively in the 12-week injection group.
• A similar amount of injection site reactions were common during the 48 weeks, such as: redness and soreness was 84% for those on recaticimab and 83% for those on placebo; injection site reaction was 3.9% in the recaticimab and 1.3% in the placebo groups.

“Since all the doses and frequencies had similar effectiveness and safety, this may someday provide patients and physicians with more flexible options,” Du said.

In the study’s secondary findings, other types of lipids associated with atherosclerotic heart disease were also reduced significantly in the recaticimab groups compared to the placebo groups, including:

• Lipoprotein(a), or Lp(a), a type of cholesterol inherited from family that is a common independent risk factor for heart disease, dropped 29% — 40% in the recaticimab groups versus decreases of 0.1% — 9.5% in the placebo groups;

• Apolipoprotein B, a component of proteins of very low-, low-density and intermediate-density lipoproteins, were down 42% — 53% in the recaticimab groups versus increases of 0.3% — 2.5% in the placebo groups; and
• A measure of all cholesterol content — except the “good cholesterol” known as high-density lipoprotein cholesterol — were down 44% — 55% in the recaticimab groups versus increases of 1% — 4% in the placebo groups.

“Recaticimab reduced these key lipid parameters by a similar magnitude to other PCSK9 inhibitors, providing further evidence of profound benefits with the treatment despite less frequent dosing,” Du said.

Sources:

American Heart Association. “New medication given every 1-3 months may slash stubborn high cholesterol.” ScienceDaily. ScienceDaily, 13 November 2023. <www.sciencedaily.com/releases/2023/11/231113111821.htm>.

Materials provided by American Heart Association. Note: Content may be edited for style and length.

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Photo by Karolina Grabowska

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