A novel cholesterol-lowering pill, known as enlicitide, has demonstrated significant potential in reducing artery-clogging cholesterol levels among individuals at high risk for heart attacks, according to research published on March 15, 2023, in the New England Journal of Medicine. This experimental medication offers a new option for patients who are unable to adequately lower their low-density lipoprotein (LDL) cholesterol despite using traditional statin therapies.
Currently, statins are the standard treatment for high cholesterol, functioning by inhibiting the liver’s production of cholesterol. However, many patients still struggle to achieve optimal LDL levels, even at the highest doses of statins. The latest study involved over 2,900 high-risk participants who were randomly assigned to receive either a daily enlicitide pill or a placebo alongside their usual treatment. Participants taking enlicitide experienced a remarkable reduction in LDL cholesterol by as much as 60% over a six-month period.
Dr. Ann Marie Navar, a cardiologist at UT Southwestern Medical Center and the study’s lead author, emphasized the effectiveness of enlicitide, stating, “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 cholesterol-lowering effect persisted with only a slight decline over a year, and researchers found no significant safety concerns between the groups taking the pill and those receiving the placebo.
Despite its promising results, enlicitide comes with a requirement: it must be taken on an empty stomach. Heart disease remains a leading cause of mortality globally, with high LDL cholesterol being a primary risk factor for heart attacks and strokes. Medical guidelines recommend maintaining an LDL level of less than 100 for healthy individuals and less than 70 for those with high cholesterol or heart disease.
Statins, such as Lipitor and Crestor, are highly effective at lowering LDL cholesterol. For patients needing further assistance, injectable drugs that inhibit a liver protein called PCSK9 have emerged as alternatives. However, these injections are less commonly utilized due to their complexity and cost, despite recent price reductions. Dr. Navar noted that the injection route is often less appealing to patients and more complicated for healthcare providers to prescribe.
The research, funded by Merck, provides crucial data that may pave the way for FDA approval of enlicitide. The FDA has included the drug in a program that promises expedited reviews. Dr. William Boden of Boston University and the VA New England Healthcare System, who was not involved in the study, described the findings as “compelling evidence” that enlicitide could lower cholesterol levels similarly to PCSK9 inhibitors.
Boden did caution that the current study does not yet demonstrate that the pill’s cholesterol-lowering capabilities will translate into reductions in heart attacks, strokes, or mortality, as such outcomes typically require longer-term studies to establish. Merck is currently conducting a larger trial involving over 14,000 patients to further assess the long-term effects of enlicitide.
As the medical community awaits further data, the introduction of enlicitide illustrates a significant advancement in the ongoing battle against high cholesterol and its associated health risks.
