Analysis of U.S.A. Multicenter Trial Results

5/16/02


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Table of Contents

Analysis of U.S.A. Multicenter Trial Results

PPT Slide

Objectives of the U.S.A. Multicenter Trial

Objectives of the U.S.A. Multicenter Trial (continued)

Approach to Understanding Efficacy in the U.S.A. Trial

Pivotal European and U.S.A. Study Methods

Drinking Data Collection Methods in Pivotal European and U.S.A. Trials

One Standard Drink Equals 12 Grams of Pure Alcohol

Drinking Data Collection Methods in Pivotal European and U.S.A. Trials (continued)

Drinking Data Obtained in Pivotal European and U.S.A. Trials

Timeline Follow Back Method

U.S.A. Multicenter Study Schema

Manual-Guided Brief Intervention and Medication Compliance Procedures

Acamprosate U.S.A. Multicenter Trial 21 Investigational Sites

Acamprosate U.S.A. Multicenter Trial Patient Characteristics

Acamprosate U.S.A. Multicenter Trial Baseline Clinical Characteristics

Acamprosate U.S.A. Multicenter Trial Baseline Abstinence Parameters

Acamprosate U.S.A. Multicenter Trial Lifetime Baseline Substance Use

Acamprosate U.S.A. Multicenter Trial Baseline Consumption of Cigarettes and Marijuana

Acamprosate U.S.A. Multicenter Trial Patient Disposition and Treatment Participation - Safety Population

U.S.A. Primary Efficacy Results (ITT Population) for Originally Planned Analyses

Baseline Factors Reliably Associated with Alcoholism Treatment Outcome

Baseline Factors Reliably Associated with Alcoholism Treatment Outcome (continued)

Acamprosate U.S.A. Multicenter Trial Covariates Applied Uniformly Across Outcome Measures

Acamprosate U.S.A. Multicenter Trial Case Report Form Question for Treatment Goal

U.S.A. Trial Patient Subgroups

Cumulative Abstinence Duration (%) with Covariates

Cumulative Abstinence Duration (%) with Covariates Treatment + Follow-up Phase

Odds Ratios with Covariates of Good Response (CAD ? 90%) and Poor Response (CAD ? 10%)

Odds Ratios with Covariates of Complete Abstinence During the Last Visit (Treatment Phase) Interval [LOCF]

Percent Reduction (Relative to Baseline) in Drinks per Week on Study with Covariates

Change from Baseline GGT at Treatment Phase Endpoint

Acamprosate U.S.A. Multicenter Trial Overall Summary

Acamprosate U.S.A. Multicenter Trial Overall Summary

Conclusions from Acamprosate U.S.A. and European Pivotal Trials

Conclusions from Acamprosate U.S.A. and European Pivotal Trials

Conclusions from Acamprosate U.S.A. and European Pivotal Trials

Author: Maureen Galie