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FDA Analysis of Cardiac Valvular Dysfunction with Use of Appetite Suppressants

9/17/97

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Table of Contents

  1. FDA Analysis of Cardiac Valvular Dysfunction with Use of Appetite Suppressants

  2. Data from Case Reports

  3. Summary of Case Reports (I)

  4. Summary of Case Reports (II)

  5. Echocardiographic “Research” Case Definition for Valvulopathy with Appetite Suppressants

  6. Summary of CARDIA Study*

  7. Summary of Case Reports (III)

  8. Data from Echocardiographic Screening of Asymptomatic Patients

  9. Overview of Surveys with Fenfluramine-Phentermine

  10. Counts of Subjects and Cases from Echo-Prevalence Surveys

  11. Absolute Risk of Valvulopathy from Echo-Prevalence Surveys

  12. Absolute Risk of Valvulopathy from Echo-Based Prevalence Surveys

  13. Relative Risk of Valvulopathy from Echo-Based Prevalence Surveys; CARDIA as Reference

  14. Relative Risk of Aortic Valvulopathy from Echo-Based Prevalence Surveys; CARDIA as Reference

  15. Epidemiologic Study of Valvulopathy with Fenfluramine Use in an HMO

  16. Summary of Echo Data on Obese Subjects - Obtained Prior to Suppressant Therapy

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