- An investigational drug called lerodalcibep lowered low-density lipoprotein (LDL) cholesterol, or “bad” cholesterol, by 50% or more, a new study showed.
- The one-year clinical trial included people who were unable to lower their LDL cholesterol sufficiently using statins.
- Lerodalcibep has not yet been approved by the FDA, but two other drugs in this class were approved by the agency in 2015.
An investigational drug lowered low-density lipoprotein (LDL) cholesterol, or “bad” cholesterol, in people who were unable to lower their LDL cholesterol enough using statins.
The researchers say the results support the use of lerodalcibep as a treatment for people with existing cardiovascular disease or who are at high or very high risk of cardiovascular disease.
Most people in the study who received lerodalcibep injections once a month were able to reduce their LDL cholesterol levels by 50% or more. They also reached target levels for LDL cholesterol recommended by current guidelines.
The results of the clinical trial were published on July 3 in
About 10% of American adults have high cholesterol, according to the
However, only about half of those who could benefit from a cholesterol-lowering drug are currently taking one, the agency said. This increases their risk of heart attack, stroke and other major cardiovascular problems.
Medications 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 in Fountain Valley. , California. “The result is a significant reduction in cholesterol levels.”
FDA
“[Approved PCSK9 inhibitors] work very well to lower cholesterol. Sometimes even better than the statins that we usually give to lower cholesterol,” Ni told Healthline.
Also, “patients don’t get many side effects from PCSK9 inhibitors,” he said. “The only downside is that they can be a little expensive for some patients, depending on insurance.”
PCSK9 inhibitors can be used for patients who have not been able to lower their cholesterol sufficiently using statins. In this case, a PCSK9 inhibitor will be prescribed along with a statin.
However, people who cannot tolerate the side effects of statins can only take a PCSK9 inhibitor, Ni said.
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 female. Overall, 88% of people completed the clinical trial.
People were randomly assigned to receive either monthly injections of lerodalcibep or an inactive placebo for 52 weeks.
After one year, 90% of people who took lerodalcibep reduced their LDL cholesterol by 50% or more and reached their recommended LDL cholesterol goals.
On average, people who took lerodalcibep lowered their 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 crucial, as high levels of apolipoprotein B and lipoprotein (a) are a significant risk factor for cardiovascular disease,” said Jacqueline Hollywood, MD, cardiologist at Hackensack University Medical Center, “and we currently have limited treatment options for lipoprotein a)”
The study results also show that lerodalcibep was well tolerated, with side effects similar to placebo.
The main difference was that injection site reactions 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 severity.
Given the benefits of FDA-approved PCSK9 inhibitors, Ni said it’s good to see a new drug that works in a similar way to them.
“In this trial, we can see that lerodalcibep lowers LDL cholesterol by a very similar amount. [as those other drugs]”, he said.
He noted that previous 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 additional long-term studies will be needed to show whether lerodalcibep has a similar effect on cardiovascular risk.
“Cholesterol-lowering drugs that were very promising have surprised us before,” Ni said. “So I think it’s really important that we continue to that next step [of additional studies].”
Hollywood pointed out that a limitation of the study is that it involved a relatively small number of participants. Despite this, the people in the study had “a wide range of risk factors for cardiovascular disease,” she told Healthline, “suggesting that the drug may benefit a different population.”
One group the drug may help are 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, the drug may prevent new plaques from forming, Hollywood said, although additional studies are needed to confirm this potential benefit.
“Overall, the study provides promising evidence for the potential of lerodalcibep in the treatment of cardiovascular disease,” she said.
In a one-year clinical trial, participants were randomly assigned to receive either the PCSK9 inhibitor lerodalcibep or an inactive placebo. The people in the study were unable to lower their LDL cholesterol, or bad cholesterol, using statins.
Most people who took lerodalcibep saw reductions in LDL cholesterol of 50% or more and reached LDL cholesterol goals set by the guidelines.
People who took lerodalcibep also saw reductions in triglycerides and other lipids linked to an increased risk of heart attack and stroke. Lerodalcibep was well tolerated, with side effects similar to placebo. The main side effects of the drug were those that occurred at the injection site.
