A new experimental pill, named enlicitide, has shown significant promise in lowering artery-clogging cholesterol levels in patients at high risk of heart attacks, according to research published on March 15, 2023, in the New England Journal of Medicine. Despite the use of statins, many individuals struggle to achieve optimal cholesterol levels, making this new option potentially transformative for millions.
In a landmark study involving over 2,900 high-risk patients, participants were randomly assigned to either add a daily dose of enlicitide or a placebo to their existing treatment regimen. Results indicated that those taking enlicitide experienced a remarkable reduction in LDL, or “bad,” cholesterol, with levels dropping by as much as 60% over six months. This outcome was highlighted by study lead author Dr. Ann Marie Navar, a cardiologist at UT Southwestern Medical Center, who noted, “Other pills that patients can add to their statins exist, but none come close to the degree of LDL cholesterol lowering that we see with enlicitide.”
The study also revealed that the cholesterol-lowering benefits persisted with only a slight decline after a year. Importantly, researchers found no significant safety differences between those taking enlicitide and those receiving the placebo. However, it is crucial to note that the pill must be taken on an empty stomach to be effective.
Heart disease remains the leading cause of death globally, with high LDL cholesterol being a primary risk factor for heart attacks and strokes. Medical guidelines recommend that individuals with high cholesterol or heart disease aim for an LDL level below 70, a target that many patients currently struggle to meet, even when taking the highest doses of statins like Lipitor and Crestor.
While statins are effective, some patients require additional treatment options. Currently, some injectable drugs, known as PCSK9 inhibitors, work differently by blocking a liver protein that limits the body’s ability to clear cholesterol from the bloodstream. Despite their effectiveness, only a small fraction of eligible patients utilize these injections due to their complexity and cost. Although prices for these shots have recently decreased, the administration process can be cumbersome for many patients.
The study funded by Merck provides crucial data needed for the company to seek FDA approval for enlicitide. The FDA has included the drug in a program designed for expedited reviews. Dr. William Boden of Boston University and the VA New England Healthcare System, who was not involved in the study, commented in the journal that the research offers “compelling evidence” that the new pill can lower cholesterol levels comparably to PCSK9 injections.
Despite these promising results, Boden cautioned that further research is necessary to demonstrate whether the reduction in cholesterol translates into fewer heart attacks, strokes, or deaths. Such outcomes typically require longer studies to validate. Merck is currently conducting a study involving more than 14,000 patients to explore these critical questions.
As the healthcare landscape evolves, enlicitide could emerge as a vital new option for millions struggling with high cholesterol, potentially simplifying their treatment regimen and improving heart health outcomes worldwide.
