New Pill May Reduce Cholesterol for Statin Users

Researchers recently revealed a new pill that could help lower artery-clogging cholesterol in individuals taking statins who remain at high risk for heart attacks.

This pill, dubbed Ensitide, is still in experimental phases but shows promise in eliminating cholesterol from the body—something that currently requires injectable medications. If the Food and Drug Administration, or FDA, approves it, it could be an easy solution for millions.

Statins are a common treatment, as they limit cholesterol production in the liver. Yet, many patients, even on the highest doses, often find their LDL, or “bad” cholesterol, still exceeds medical recommendations.

In a significant study, over 2,900 high-risk patients were randomly assigned to either take Ensitide tablets or a placebo along with their usual treatment. The findings, published in the New England Journal of Medicine, indicated that those who took Ensitide experienced up to a 60% decrease in LDL cholesterol over six months.

There are other medications available to complement statins, but according to Dr. Anne-Marie Navar, a cardiologist at UT Southwestern Medical Center, none manage to achieve the LDL reduction shown with Ensitide.

Researchers noted the drug’s effects diminished slightly over a year, but importantly, the safety profile remained consistent between those taking the drug and those on a placebo. A small catch? It has to be taken on an empty stomach.

Heart disease is a leading killer in the U.S., with high LDL cholesterol being the primary risk factor for heart attacks and strokes. An LDL level of 100 is generally safe, but if you have high cholesterol or heart disease, doctors recommend reducing it to at least 70—and even lower for those at very high risk.

Statin medications, like Lipitor and Crestor, are quite effective for lowering LDL cholesterol. Additionally, some injectable drugs target a liver protein called PCSK9, which hinders the removal of cholesterol from the bloodstream. However, only a small number of patients benefit from these PCSK9 inhibitors due to costs and the complexities involved in their administration.

The study, funded by Merck, provides crucial data needed to pursue FDA approval for Ensitide, which has now been fast-tracked by the agency.

Dr. William Borden from Boston University remarked on the compelling evidence that this new pill may be as effective as the PCSK9 injections. Still, he warned that proving it leads to fewer heart attacks, strokes, or deaths will require more time, with Merck conducting further studies involving over 14,000 patients.