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new experimental drug has been shown to lower low-density lipoprotein cholesterol or LDL – a major risk factor for heart disease by nearly 60 per cent, scientists said. Oral PCSK9 inhibitors – which include Enlicitide - are a newer option for lowering LDL-C without injections. Developed by Merck, Enlicitide, according to the early trial results, is highly effective and has a safety profile similar to the placebo group in the trial, though more post-market surveillance is needed. “Heterozygous familial hypercholesterolemia is a common genetic disorder that affects approximately 1 in 250 individuals and is characterized by elevated levels of LDL-C from birth,” the researchers wrote in their published paper.
How was the trial conducted?
According to researchers, nearly 300 participants with HeFH were recruited who were already taking cholesterol-lowering statins. However, none of them had any positive or desired effect from them. However, a once-daily Enlicitide decanoate pill was able to reduce LDL-C by an average of 58.2 per cent after 24 weeks. Those given a placebo instead actually saw a slight rise in the levels of LDL-C. “In adults with HeFH, enlicitide is an effective and well-tolerated treatment for lowering the level of LDL-C,” the study authors wrote.
How does Enlicitide work?
Enlicitide decanoate is a PCSK9 inhibitor, which means it limits the effectiveness of PCSK9 - a blood protein that interferes with your liver's efforts to clear away LDL-C, causing a buildup. The treatment is basically making sure the liver can do its cholesterol-clearing job properly. There are already PCSK9 inhibitors available, but they are administered through injection. Patients are more likely to stick to courses of drugs given in pill form, and here, 98 percent of the trial participants did. “Adherence with both the once-daily oral intervention and fasting instructions for dosing was notably high in both treatment groups," wrote the researchers. However, according to scientists, the drug still needs to get regulatory approval before it can be prescribed, but since the results of the phase 3 are encouraging, researchers say the steps ahead will be positive.
What is LDL cholesterol?
LDL cholesterol is often known as "bad" cholesterol because its high levels lead to a buildup of plaque in your arteries, which causes a higher risk of heart disease and stroke. While your body needs cholesterol to function, LDL is the type of cholesterol that deposits cholesterol throughout your body via lipoproteins, and when there is too much, it can accumulate on artery walls. LDL carries cholesterol from the liver to the rest of your body's cells. When there is too much of it in your blood, this cholesterol builds up on the walls of your arteries – leading to plaque, which narrows the arteries by restricting blood flow and leading to heart attack, stroke, or other cardiovascular problems.
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