New Pill Shows Promise in Reducing Cholesterol
WASHINGTON — A recently developed pill has significantly lowered cholesterol levels linked to artery blockage in individuals still at high risk for heart attacks, even when they are already using statins, researchers reported on Wednesday.
This pill, known as enlicitide, is still in the experimental stage. It effectively helps eliminate cholesterol from the body in a manner currently only achievable through injectable medications. If the Food and Drug Administration gives it the green light, enlicitide could simplify treatment for millions of patients.
Statins, which inhibit cholesterol production in the liver, form the foundation of cholesterol management. However, many patients, even those on the highest statin doses, still require additional support to sufficiently reduce their LDL, or “bad,” cholesterol to adhere to medical recommendations.
In a comprehensive study involving over 2,900 high-risk participants, subjects were randomly assigned to either take a daily enlicitide pill or a placebo alongside their usual treatment. Results highlighted that those using enlicitide experienced a reduction in LDL cholesterol by up to 60% within six months, as reported in the New England Journal of Medicine.
While there are other pills available to complement statin therapy, none have shown the same level of LDL cholesterol reduction as enlicitide, noted Dr. Ann Marie Navar, the study’s lead author and a cardiologist at UT Southwestern Medical Center.
The benefits of enlicitide slightly decreased over the course of a year. However, safety comparisons between those taking the drug and those on a placebo revealed no significant differences. One important note is that this pill must be taken while fasting.
Heart disease remains the leading cause of death in the U.S., with high LDL cholesterol being a significant risk factor for heart attacks and strokes. Doctors typically recommend maintaining an LDL level below 70 for individuals who have developed high cholesterol or heart disease, and an even lower target for those at very high risk.
Common statins such as Lipitor and Crestor effectively lower LDL levels. Additionally, some potent injectable medications operate differently by obstructing a liver protein named PCSK9, which restricts the body’s ability to clear cholesterol from the bloodstream. Unfortunately, only a small percentage of those who could benefit from PCSK9 inhibitors actually use them. Although prices for these injections have decreased recently, patients often find the shots cumbersome, and they pose more complications for physicians when prescribing.
Merck sponsored the study reported Wednesday, providing crucial data necessary for seeking FDA approval of enlicitide. The FDA has placed the drug in a program for expedited evaluation.
According to Dr. William Boden from Boston University, who wasn’t part of the study, the research presents “compelling evidence” that the new pill reduces cholesterol to a degree comparable to PCSK9 injections. However, he cautioned that there is currently no evidence indicating whether the cholesterol reduction from this pill leads to fewer heart attacks, strokes, or deaths—a determination that typically requires more extended studies. Merck is conducting a trial involving more than 14,000 patients to gather such data.
