Nexlizet is a once-daily oral combination medication (Bempedoic Acid + Ezetimibe) used to aggressively lower high levels of LDL-C ("bad cholesterol").
Crucially, it is one of the few non-statin drugs FDA-approved to reduce the risk of heart attack and coronary revascularization (heart procedures), particularly in patients who cannot tolerate statins or whose cholesterol remains too high despite maximum statin therapy. We detail its dual mechanism, its unique role for statin-intolerant patients, and key safety considerations.
6 Key Facts and Clinical Insights on Nexlizet
Dual Mechanism of Action (Double Blockade): Nexlizet combines two active ingredients:
Bempedoic Acid: Blocks the ATP-citrate lyase (ACL) enzyme in the liver, interrupting the body's natural cholesterol production pathway (working differently and upstream from statins).
Ezetimibe: Blocks the absorption of dietary cholesterol in the small intestine.
FDA Approval for CV Risk Reduction: Based on data from the large CLEAR Outcomes Trial, the Bempedoic Acid component of Nexlizet is approved to reduce the risk of myocardial infarction (heart attack) and coronary revascularization (procedures like stent placement or bypass surgery).
Target Patient Group: Statin Intolerance: The medication is a vital treatment option for adults who are unable to take recommended statin therapy (often due to muscle-related side effects, or myalgia) or whose LDL-C levels remain dangerously high even while taking a statin.
Significant LDL-C Reduction: In clinical trials, Nexlizet demonstrated a powerful ability to lower LDL-C, with reductions often nearing 40% when used in combination with other lipid-lowering therapies, helping patients reach aggressive cholesterol targets.
Key Safety Concerns (Gout and Tendons): While generally well-tolerated, serious side effects include an increased risk of hyperuricemia (high uric acid levels, which can lead to gout) and, less commonly, tendon rupture or injury. Patients over 60, those with kidney issues, or those taking steroids/fluoroquinolones are at higher risk.
Unique Non-Statin Oral Option: Nexlizet is one of the only oral, non-statin medications with direct FDA approval for cardiovascular risk reduction, offering a convenient alternative to injectable therapies like PCSK9 inhibitors for patients needing intensive cholesterol lowering.
Summary: Nexlizet is a crucial oral combination drug approved to reduce heart attack risk, primarily serving patients who cannot tolerate or achieve their LDL goals with statins alone. Its dual mechanism effectively lowers bad cholesterol, but patients must be monitored for serious side effects like gout and tendon issues.