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Related Experiment Videos

Model-based development of gemcabene, a new lipid-altering agent.

Jaap W Mandema1, David Hermann, Wenping Wang

  • 1Pharsight Corporation, Mountain View, CA 94040, USA. jmandema@wequantify.com

The AAPS Journal
|December 16, 2005
PubMed
Summary

Model-based decision making guided gemcabene development, revealing distinct LDL-C lowering interactions compared to ezetimibe. This analysis led to the early termination of gemcabene

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Area of Science:

  • Pharmacometrics and Quantitative Pharmacology
  • Drug Development and Decision Analysis
  • Cardiovascular Disease Therapeutics

Background:

  • Gemcabene is a novel lipid-altering agent.
  • Statins and ezetimibe are existing lipid-lowering therapies.
  • Comparative efficacy and safety data are crucial for drug development.

Purpose of the Study:

  • To evaluate the value of model-based, quantitative decision-making in gemcabene development.
  • To compare the clinical profile of gemcabene with statins and ezetimibe.
  • To inform critical decisions regarding gemcabene's further development.

Main Methods:

  • Developed dose-response models for lipid effects, adverse events, and cardiovascular risk reduction.
  • Integrated public and proprietary patient-level data from nearly 10,000 patients.

Related Experiment Videos

  • Utilized Pharsight Drug Model Explorer for model accessibility and visualization.

    • Main Results:

    • Gemcabene demonstrated a significantly different LDL-C lowering interaction with statins compared to ezetimibe.
    • Ezetimibe showed an independent additive LDL-C effect across the statin dose range.
    • Gemcabene's additive LDL-C effect diminished at higher statin doses, despite a notable effect alone or with low-dose statins.

    Conclusions:

    • Model-based decision-making enhanced understanding of gemcabene's clinical profile.
    • The distinct interaction profile of gemcabene with statins influenced development decisions.
    • Early availability and exploration of the model facilitated a rapid decision to halt gemcabene development.