Carola P. Friedman, MD, FACC

5/22/02


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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

Author: villat