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Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Clinical Risk Assessment

Background:

  • Statins are the primary treatment for reducing atherosclerotic cardiovascular disease (ASCVD) risk.
  • Some patients continue to have elevated ASCVD risk even with maximal statin therapy.
  • Ezetimibe and PCSK9 monoclonal antibodies (mAbs) have demonstrated efficacy in reducing ASCVD events in clinical trials.

Purpose of the Study:

  • To evaluate the number-needed-to-treat (NNT) for ezetimibe and PCSK9 mAbs in patients with persistent high ASCVD risk.
  • To identify specific patient subgroups who may benefit from adding non-statin therapies to statin regimens.
  • To inform clinical decision-making regarding the use of advanced lipid-lowering therapies.

Main Methods:

  • Analysis of randomized trial data to calculate NNT for ASCVD event prevention.
  • Stratification of patient groups based on ASCVD risk level (extremely high, very high, high) and low-density lipoprotein cholesterol (LDL-C) levels.
  • Comparison of NNT values for PCSK9 mAbs and ezetimibe across different patient profiles.

Main Results:

  • PCSK9 mAbs may be cost-effective for extremely high-risk patients (e.g., those with familial hypercholesterolemia, polyvascular disease, recurrent events) with LDL-C ≥70 mg/dL (NNT <25).
  • Ezetimibe is a reasonable option for patient groups with NNTs <30, including extremely high-risk patients with LDL-C ≥130 mg/dL.
  • Specific LDL-C thresholds for initiating non-statin therapy are defined for various risk categories.

Conclusions:

  • NNT analysis provides a framework for selecting patients who will derive the greatest benefit from non-statin therapies.
  • Ezetimibe and PCSK9 mAbs are valuable additions to statin therapy for select high-risk ASCVD populations.
  • Personalized treatment strategies based on risk stratification and LDL-C levels are crucial for optimizing ASCVD prevention.