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Report of Specific Cardiovascular Outcomes of the ADVANTAGE Trial
TO THE EDITOR:
In their letter to the editor, Braunstein and Polis (1) address the omission of important cardiovascular safety results from a 2003 report on the ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness) trial (2). The 2003 article, authored by Lisse and colleagues (including Polis), reported no statistically significant differences for any cardiovascular end points in comparisons of Vioxx (rofecoxib, Merck & Co., Inc., Whitehouse Station, New Jersey) and naproxen in a 12-week clinical trial. In fact, almost 3 years earlier, Merck gave the U.S. Food and Drug Administration (FDA) a data table that showed a statistically significant relative risk of 7.0 for cardiac events among patients receiving Vioxx compared with those receiving naproxen in the ADVANTAGE trial. …
