Enlicitide demonstrated a 60% reduction in LDL cholesterol levels compared to placebo in a phase 3 randomized controlled trial, marking the first successful oral formulation of PCSK9 inhibition technology. The compound achieved therapeutic effects comparable to existing injectable PCSK9 inhibitors like evolocumab and alirocumab, while offering the convenience of daily oral dosing. This represents a significant advancement in lipid management, as current PCSK9 inhibitors require subcutaneous injection every two weeks, creating barriers to patient adherence and broader clinical adoption. The oral route could democratize access to this powerful cholesterol-lowering mechanism, particularly for patients who struggle with injectable therapies or require long-term cardiovascular risk reduction. However, the durability of these effects and real-world cardiovascular outcomes remain to be established through longer-term studies. The technology also faces the challenge of demonstrating cost-effectiveness compared to established statins and the existing injectable PCSK9 inhibitors. If approved, enlicitide could reshape the treatment paradigm for patients with familial hypercholesterolemia and those at high cardiovascular risk who cannot achieve target LDL levels with conventional therapy.
First Oral PCSK9 Inhibitor Enlicitide Reduces LDL Cholesterol 60%
📄 Based on research published in New England Journal of Medicine
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