Statins not enough? New pill expected to lower cholesterol

Cardiologists can soon prescribe a new pill expected to lower cholesterol beyond levels achieved by statins.  The daily pill, enlicitide (brand name Lipfendra), was approved in July by the U.S. Food and Drug Administration. It was expected to become available to U.S. patients this month. 

The pill is primarily intended for patients whose cholesterol is not reduced sufficiently by high-intensity statins, said Dr. Ninel Hovnanians (pronounced nee-NEL hove-NAH-nee-ins). She is a cardiologist with the UW Medicine Heart Institute in Seattle.  

“Many patients will think this medication is a replacement for their statin. These medications are meant to be an add-on to a statin and not a replacement for statins,” Hovnanians said.  

Enlicitide is a PCSK9 inhibitor, a drug class whose mechanism of action differs from that of statins. These drugs affect the PCSK9 protein and help the liver clear low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood. By contrast, statins work by halting the liver’s production of cholesterol.  

LDL-lowering PCSK9 inhibitors have been available as injectables administered once or twice a month. But some patients are averse to giving themselves a shot or find it burdensome to keep injectors refrigerated, especially during travel, Hovnanians said.  

“Some patients in general are more nervous and anxious about injectable medications, and they prefer a medication that could potentially be out of their system quicker. I think having a daily oral pill will be more accessible,” she said. 

Statins, depending on their intensity, predictably lower LDL cholesterol between 20% and 50%. Two randomized, double-blind clinical trials (1, 2) of enlicitide provided evidence of its safety and efficacy in adults with high levels of LDL cholesterol. In each trial, the drug lowered LDL cholesterol by more than 55%.  

PCSK9 inhibitors are much more expensive than statins. Enlicitide’s listed cost is $315 per month. Before a health insurer would commit to cover the new drug, Hovnanians said, it likely would require evidence that statins, in concert with diet and exercise, have not lowered LDL cholesterol to the clinical target level. 

“The American Heart Association/American College of Cardiology still identify statins as the first-line of therapy for atherosclerosis. So I think a patient would have to fail statins before we even prescribe this new medication,” she said. “We may have an easier time getting the oral medication covered (by insurance) because it is less costly than an injectable, but that remains to be seen.” 

PCSK9 inhibitors may be prescribed as a first-line therapy if a patient has a medical condition that makes statins intolerable, she added.  

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