JSM 2005 - Toronto

Abstract #304882

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 371
Type: Other
Date/Time: Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor: ASA
Abstract - #304882
Title: Chronology of Clinically Important Cardiovascular (CV) Event Data in the Rofecoxib (VIOXX) Development Program
Author(s): Raymond Bain*+
Companies: Merck & Co., Inc.
Address: Sumneytown Pike, BL3-3, West Point, PA, 19486,
Keywords:
Abstract:

The chronology begins with a summary of CV data included in the original 1998 New Drug Application (NDA) filing followed by CV results from VIGOR (a gastrointestinal outcomes trial) which showed increased CV risk for rofecoxib in comparison to naproxen. After this observation, a series of analyses were carried out to provide context for interpretation of the VIGOR CV results, i.e., comparison to placebo and to non-naproxen NSAIDs (non-steroidal anti-inflammatory drugs). These include interim and final CV results from large placebo-controlled trials in Alzheimer's Disease patients and a series of combined analyses of CV events from Merck clinical trials of rofecoxib. Finally, the CV results from the APPROVe study (a colon polyp prevention trial) which led to the voluntary withdrawal of VIOXX will be reviewed. The presentation will highlight issues regarding the potential for evolving interpretation of early trial data as subsequent trial results accumulate.

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Revised March 2005