What blood tests are required when renewing Praluent (alirocumab) in patients with hypercholesterolemia and cardiovascular disease?

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Blood Monitoring When Renewing Praluent (Alirocumab)

No routine blood monitoring is required for Praluent (alirocumab) itself, but lipid panels should be checked to assess treatment response and achievement of LDL-C goals. 1

Primary Monitoring: Lipid Panel

  • Check a lipid panel (LDL-C, total cholesterol, non-HDL-C, apolipoprotein B) at renewal to assess treatment efficacy and goal achievement. 2, 3

  • The American College of Cardiology recommends follow-up lipid testing within 4-12 weeks after initiating or changing PCSK9 inhibitor therapy, then at least annually for patients on stable therapy. 2, 3

  • Target LDL-C goals are <70 mg/dL (<1.8 mmol/L) for very high-risk patients or <100 mg/dL (<2.6 mmol/L) for high-risk patients. 2

  • Non-HDL-C and apolipoprotein B are also important treatment targets, with goals of <100 mg/dL (or <130 mg/dL for high-risk) and <80 mg/dL respectively. 2, 4

No Hepatic or Muscle Enzyme Monitoring Required

  • Unlike statins, PCSK9 inhibitors (alirocumab and evolocumab) do not require routine monitoring of hepatic transaminases (ALT/AST) or creatine kinase (CK). 1

  • The 2022 ACC Expert Consensus states that alirocumab has no warnings or precautions requiring routine laboratory monitoring for hepatotoxicity or myopathy. 1

  • The FDA label for Praluent does not mandate any baseline or ongoing laboratory monitoring beyond lipid assessment. 5

Clinical Context for Monitoring

  • If the patient is on concomitant statin therapy, continue monitoring hepatic transaminases and CK according to statin-specific guidelines (typically every 3-4 months in the first year, then every 6 months). 1

  • When ezetimibe is used in combination with statins, monitor hepatic transaminases before and during treatment based on statin monitoring recommendations. 1

Practical Monitoring Schedule

  • At renewal (typically every 3-6 months initially): Obtain lipid panel to verify LDL-C reduction and goal achievement. 2, 3

  • Once stable on therapy: Annual lipid panels are sufficient for ongoing monitoring. 2, 3

  • Dose adjustment consideration: If LDL-C remains ≥70 mg/dL after 8 weeks on alirocumab 75 mg every 2 weeks, consider up-titration to 150 mg every 2 weeks. 1, 5

Common Pitfalls to Avoid

  • Do not order routine liver function tests or CK levels for Praluent monitoring—these are unnecessary and not indicated by guidelines or the FDA label. 1, 5

  • Do not confuse PCSK9 inhibitor monitoring with statin monitoring requirements—they have distinctly different safety profiles. 1

  • Ensure adequate follow-up of lipid values to verify treatment effectiveness, not just prescription renewal without outcome assessment. 2, 6

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Lipid Management and Cardiovascular Risk Assessment

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Repeating Lipid Profile After 3 Months is Appropriate

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Laboratory Tests for Well Child Visits

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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