Table of Contents
Carola P. Friedman, MD, FACC
Pravachol 10 OTC Program
The OTC Population
Points to Consider with OTC Availability of a Lipid Lowering Medication
Consumer Use Program
Consumer Use Trials: Objectives
Label Comprehension: People Understood the Label
Comparison of Label Tested and Proposed OTC Label
PREDICT Objectives
PREDICT Advertising Designed to Capture Broad Spectrum of the Population
PREDICT Participant Disposition
PREDICT Retail Site Characteristics
Participant Behavior Choices Throughout the Course of PREDICT
PREDICT Results: Baseline Characteristics of Participants Responding to Advertisement
PREDICT Participants Responding to Advertisement Demographics (Randomized Population n=3,872)
PREDICT Participants Responding to Advertisement Health Care Status / Cholesterol Action (Randomized Population n=3,872)
PREDICT Subsequent Evaluations
PREDICT Results: OTC Consumer Behavior
PREDICT Disposition of OTC Participants
PREDICT Characteristics of the OTC Purchase Population
PREDICT Behavior to Consult a Physician (OTC Purchase Population n=720)
PREDICT Profile of Participants Who Took Without Consulting (n=72)
PREDICT OTC Availability Did Not Distract from Physician Involvement (Qualified Population)
PREDICT Utilization of Health Care System Maintained
PPT Slide
PREDICT Dialogue Served as Gateway into Healthcare System
PREDICT Safety Profile Maintained
PREDICT Tolerability of Pravachol 10 mg Is Similar in OTC and Rx Environments (Qualified and Treated Population)
OTC Pravachol 10 mg: Percent Reduction in LDL-C (mg/dl) ± SE Maintained in OTC Environment
PREDICT Extension: OTC Compliance Maintained at 1 Year
PREDICT Extension Reduction in LDL-C Maintained at 1 Year (Extension Population)
PPT Slide
Summary of PREDICT OTC Behavior
OTC Pravachol Trial In an Observed Naturalistic Setting (OPTIONS)
OPTIONS Study Design and Objectives
OPTIONS Advertising and Pharmacy Site Characteristics
OPTIONS Exclusion Criteria
OPTIONS Results: Baseline Characteristics of Participants Responding to Advertisement
OPTIONS Participant Disposition
OPTIONS Participants Responding to Advertisement Demographics (Enrolled Population n=782)
OPTIONS Participants Responding to Advertisement Health Care Status / Cholesterol Action (Enrolled Population n=782)
OPTIONS Physician Office Activities
OPTIONS Results: Consumer Behavior
OPTIONS Purchase Population was Appropriate
OPTIONS Behaviors of Purchase Population (n=404)
OPTIONS Profile of Participants Who Took Without Consulting (n=157)
OPTIONS Safety
Summary of the Pravachol Consumer Use Program
Characteristics of OTC Purchase Population Are Consistent Across Studies
Summary of Results
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