New Oral Medication Significantly Lowers Bad Cholesterol Levels
A recent clinical trial has shown promising findings for a new oral medication that significantly reduces levels of bad cholesterol (LDL) in adults diagnosed with heterozygous familial hypercholesterolemia (HeFH), a prevalent inherited lipid disorder.
The medication, named "Enlicitide", developed by the American pharmaceutical firm "Merck", is part of a new class of PCSK9 inhibitors. Unlike traditional treatments that require injections, this drug is administered as a daily oral tablet, which may enhance patient adherence to treatment.
* Mechanism of Action
The mechanism of "Enlicitide" involves inhibiting the PCSK9 protein, which typically leads to the degradation of liver receptors that remove bad cholesterol from the bloodstream. By blocking this protein, the number of liver receptors increases, facilitating the removal of higher amounts of LDL and reducing the risk of fat buildup in arteries, thereby lowering the chances of heart disease and early strokes.
* Clinical Trial Results
The phase three trial involved 303 adults from 17 countries, all of whom were already on statins or other lipid-lowering treatments. Participants were randomly assigned to two groups:
_ Group One: Received 20 mg of "Enlicitide" daily.
_ Group Two: Received a placebo.
After 24 weeks, the group taking the active drug experienced an average 58.2% reduction in LDL cholesterol, while the placebo group showed no significant change. By week 52, the average reduction in LDL among those on "Enlicitide" stabilized at 55.3%, while the placebo group saw an increase of 8.7% in LDL levels.
The drug also positively impacted other heart disease-related markers:
• Reduction in apolipoprotein B (ApoB) by approximately 48.2%
• Reduction in lipoprotein (a) by 24.7%
* Safety and Side Effects
"Enlicitide" was generally well tolerated, with 77.7% of users reporting at least one side effect, compared to 76.2% in the placebo group. Only 2% of participants discontinued treatment due to side effects, versus 3% in the placebo group.
* Conclusion:
Researchers regard "Enlicitide" as an effective and well-tolerated option for reducing bad cholesterol in patients with HeFH, with the notable benefit of oral administration. However, a critical question remains:
Will this significant reduction in bad cholesterol lead to a decrease in heart attacks, strokes, and mortality rates?
Further trials are ongoing to address this question and to evaluate the drug in broader high-risk patient populations beyond those with the inherited condition.
Until long-term efficacy is established, "Enlicitide" is viewed as a promising addition to the range of cholesterol-lowering treatments, particularly due to its convenient oral form.
