The New Statin? Monthly Injection Lowers “Bad” Cholesterol by 50%

About 10% of American adults have high cholesterol, according to Centers for Disease Control and Prevention.

However, only about half of those who could benefit from a cholesterol-lowering drug are still taking it, the agency said. This increases their risk of heart disease, stroke and other major heart problems.

Medicines available to treat high cholesterol include statins, which have been available since the 1980s, and newer PCSK9 inhibitors.

PCSK9 inhibitors target a protein in the liver called proprotein convertase subtilisin kexin 9, or PCSK9.

“PCSK9 inhibitors improve your liver’s ability to take cholesterol particles from the blood and process them,” said Yu-Ming Ni, MD, cardiologist and lipidologist at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center. Fountain Valley, Calif. “The result is a significant reduction in cholesterol.”

FDA accepted Two PCSK9 inhibitors in 2015: alirocumab (Praluent) and evolocumab (Repatha). Both are given by injection under the skin, every two to four weeks. Lerodalcibep has not been approved by the FDA.

“[Approved PCSK9 inhibitors] very effective in lowering cholesterol. “Sometimes it’s better than the statins that we usually prescribe for lowering cholesterol,” Ni told Healthline.

Also, “patients don’t experience many side effects from PCSK9 inhibitors,” he said. “The only downside is that they can be expensive for some patients, depending on insurance.”

PCSK9 inhibitors can be used in patients who have not been able to lower their cholesterol adequately using statins. In this case, a PCSK9 inhibitor would be prescribed along with a statin.

However, people who cannot tolerate the side effects of statins can simply take a PCSK9 inhibitor, said Ni.

The new study included 922 adults who were taking the highest dose of a statin they could tolerate, but still had not lowered their LDL cholesterol to the target level recommended by the guidelines.

The average age of the participants was 65 years and 45% were women. Overall, 88% of people completed the clinical trial.

People were randomly assigned to receive monthly injections of lerodalcibep or an inactive placebo for 52 weeks.

After one year, 90% of people who received lerodalcibep reduced their LDL cholesterol by 50% or more, and met recommended LDL cholesterol goals.

On average, people who received lerodalcibep reduced LDL cholesterol by 56% after 52 weeks and 69.5% after 60 weeks. They also saw reductions in apolipoprotein B, apolipoprotein(a) and triglycerides.

“This is important, since high levels of apolipoprotein B and high lipoprotein (a) are a major risk factor for heart disease,” said Jacqueline Hollywood, MD, a cardiologist at Hackensack University Medical Center, “and currently we have limited treatment options for lipoprotein a).

The study results also show that lerodalcibep was well tolerated, with adverse events similar to placebo.

The main difference was that reactions at the injection site occurred more often in people who received lerodalcibep (6.9%) compared to those in the placebo group (0.3%). These reactions were mild or moderate in intensity.

Given the benefits of FDA-approved PCSK9 inhibitors, Ni said it’s good to see a new drug that works in the same way.

“In this trial, we see that lorodalcibep lowers LDL cholesterol to a very similar extent [as those other drugs],” he said.

He pointed out that the first studies of FDA-approved PCSK9 inhibitors show that these drugs can also reduce the risk of cardiovascular events such as heart attack and stroke.

However, he cautions that more long-term studies will be needed to show whether lerodalcibep has the same effect on cardiovascular risk.

“Cholesterol-lowering drugs that were very comforting have surprised us before,” said Ni. So I think it’s very important that we move on to the next step [of additional studies].”

Hollywood pointed out that another limitation of the study was that it involved a small number of participants. However, the people in this study had “a wide range of heart disease risks,” he told Healthline, “suggesting that this drug may benefit different people.”

Another group that this drug can help is people with atherosclerosis, a condition in which plaque builds up in the arteries, which can increase the risk of heart attack and stroke.

By lowering cholesterol and inflammation, drugs can prevent the formation of new plaques, said Hollywood, although more studies are needed to confirm this potential benefit.

“Overall, the study provides promising evidence for the potential of lerodalcibep in the treatment of heart disease,” he said.

In the year-long trial, participants were assigned to receive the PCSK9 inhibitor lerodalcibep or an inactive placebo. People in the study were unable to lower their LDL cholesterol, or bad cholesterol, using statins.

The majority of people who received rodalcibep saw a reduction in their LDL cholesterol of 50% or more, and reached the LDL cholesterol goals set by the guidelines.

People who received rodalcibep also saw reductions in triglycerides and other lipids associated with an increased risk of heart disease and stroke. Lerodalcibep was well tolerated, with placebo-like effects. The main side effects of the drug were those that occurred at the injection site.