New Pill May Lower Cholesterol for High-Risk Patients

WASHINGTON – A new type of pill has shown promise in significantly lowering artery-clogging cholesterol in individuals at high risk for heart attacks, even if they’re already on statins, researchers reported. Although still in the experimental phase, this pill, called enlicitide, could potentially provide an easier alternative for many patients, as current options for similar results typically require injections.

Statins are the primary treatment for high cholesterol, working by blocking some of the liver’s cholesterol production. However, even at maximum doses, many individuals find they still need extra help to reduce their LDL, or “bad,” cholesterol to meet medical recommendations.

In a comprehensive study involving over 2,900 high-risk participants, some were given a daily enlicitide pill while others received a placebo. Those taking enlicitide experienced reductions in LDL cholesterol of up to 60 percent over six months. The findings were published in the New England Journal of Medicine.

Dr. Ann Marie Navar, a cardiologist at UT Southwestern Medical Center and the study’s lead author, noted that while there are other medications available to complement statins, none have matched the cholesterol-lowering effectiveness of enlicitide.

The benefits appear to persist, with only a slight decrease over a year, and no notable safety concerns were found between the enlicitide users and those on placebo. However, the pill must be taken on an empty stomach, which some may find inconvenient.

Heart disease remains the leading cause of death in the U.S., with high LDL cholesterol being a major contributing factor for heart attacks and strokes. For healthy individuals, an LDL level of around 100 is acceptable, but doctors generally recommend lower levels for those with heart disease or high cholesterol—typically aiming for at least 70, particularly in high-risk patients.

Standard statins like Lipitor and Crestor effectively lower LDL levels, but other more powerful injectable drugs also exist. These work by inhibiting a liver protein called 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. While the costs for these shots have decreased recently, patients often find injections cumbersome, and they present additional complexities for doctors when prescribing.

Merck, which funded the study, is gathering the final data required to seek FDA approval for enlicitide. The FDA has now placed the drug in a fast-track review program.

Dr. William Boden, affiliated with Boston University and the VA New England Healthcare System and not part of the research team, described the evidence as “compelling.” It suggests that the pill may reduce cholesterol levels similarly to PCSK9 injections.

However, he pointed out that it’s too early to determine whether the pill’s cholesterol-lowering effects will lead to fewer heart attacks, strokes, or deaths, as such outcomes require far longer to study. Merck is currently conducting research involving more than 14,000 patients to address this question.