A recent study has shown that an experimental drug called lerodalcibep successfully lowered low-density lipoprotein (LDL) cholesterol, often referred to as “bad” cholesterol, by 50% or more in individuals who were unable to lower their LDL cholesterol levels sufficiently using statins. The study, which was published in JAMA Cardiology, supports the use of lerodalcibep as a potential treatment for individuals with existing cardiovascular disease or those at high or very high risk of cardiovascular disease.
The clinical trial involved 922 adults who were taking the maximum tolerable dose of a statin but still hadn’t reached the target LDL cholesterol level recommended by guidelines. The majority of participants finished the trial, and 90% of those who received lerodalcibep reduced their LDL cholesterol by 50% or more, meeting the recommended LDL cholesterol targets. On average, people who received lerodalcibep reduced their LDL cholesterol by 56% after 52 weeks and 69.5% after 60 weeks.
Lerodalcibep is not yet approved by the FDA, but two other drugs in the same class were approved by the agency in 2015. These drugs, alirocumab (Praluent) and evolocumab (Repatha), are given by injection under the skin every 2 to 4 weeks.
Statins and other cholesterol-lowering medications are commonly used to treat high cholesterol. However, only about half of the American adults who could benefit from these medications are currently taking them, according to the Centers for Disease Control and Prevention. This increases their risk of heart attack, stroke, and other major cardiovascular problems.
PCSK9 inhibitors, a newer class of cholesterol-lowering drugs, target a protein in the liver called proprotein convertase subtilisin kexin 9 (PCSK9). These drugs improve the liver’s ability to take up cholesterol particles from the blood and process them, resulting in a significant reduction in cholesterol levels. The FDA approved two PCSK9 inhibitors in 2015, and they may be used for patients who have been unable to lower their cholesterol enough using statins.
The study results also showed that lerodalcibep was well tolerated, with similar adverse events as the placebo. The main difference was that reactions at the injection site occurred more frequently in people who received lerodalcibep (6.9%) compared to those in the placebo group (0.3%). These reactions were mild or moderate in severity.
While the benefits of lerodalcibep are promising, additional longer-term studies would be needed to show whether it has a similar effect on cardiovascular risk. The study included a relatively small number of participants, but people in the study had a wide range of cardiovascular disease risk factors, suggesting that the drug could benefit a diverse population. One group that may particularly benefit from lerodalcibep are individuals with atherosclerosis, a condition in which plaques build up in the arteries, increasing the risk of heart attack and stroke. By lowering cholesterol and inflammation, the drug may prevent the formation of new plaques.
