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Development and Validation of Algorithms to Identify Statin Intolerance in a US Administrative Database.

Kathy L Schulman1, Lois E Lamerato2, Mehul R Dalal3

  • 1Outcomes Research Solutions, Inc., Waltham, MA, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|October 8, 2016
PubMed
Summary

Validated algorithms can now identify statin intolerance (SI) in administrative databases. These tools improve real-world research by accurately detecting SI, aiding clinical decision-making for patients with lipid disorders.

Keywords:
administrative datacardiovascular riskclaims dataelectronic medical recordhypercholesterolemiastatin intolerancevalidation

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Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Health Informatics

Background:

  • Statin intolerance (SI) poses a challenge in managing hyperlipidemia and cardiovascular disease.
  • Accurate identification of SI is crucial for effective patient management and research.

Purpose of the Study:

  • To develop and validate algorithms for defining statin intolerance (SI) within administrative databases.
  • To compare the performance of these algorithms against electronic medical records (EMRs) as a reference standard.

Main Methods:

  • One thousand adult patients with dyslipidemia and statin therapy changes were analyzed.
  • Data on statin use, comorbidities, adverse events, and lab results were extracted from administrative databases and EMRs.
  • Algorithms were developed to define absolute and titration intolerance, with performance assessed using concordance and accuracy metrics.

Main Results:

  • The developed algorithms demonstrated substantial concordance for identifying any SI (κ = 0.66) and titration intolerance (κ = 0.74).
  • The titration intolerance algorithm showed good sensitivity (85.4%) and positive predictive value (70.1%), particularly in high cardiovascular risk patients.
  • Performance varied by SI type, with absolute intolerance algorithms showing lower accuracy.

Conclusions:

  • Validated algorithms are now available for identifying statin intolerance in administrative databases.
  • These algorithms support real-world research and inform clinical decision-making for managing dyslipidemia.
  • This represents a significant advancement for utilizing administrative data in cardiovascular research.