David S. Egilman, MD, MPH; Amos H. Presler, BS
Potential Financial Conflicts of Interest: Expert testimony: Dr. Egilman has served as an expert witness in Vioxx litigation. Mr. Presler is employed by Dr. Egilman.
Egilman D., Presler A.; Report of Specific Cardiovascular Outcomes of the ADVANTAGE Trial. Ann Intern Med. 2006;144:781. doi: 10.7326/0003-4819-144-10-200605160-00016
Download citation file:
Published: Ann Intern Med. 2006;144(10):781.
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. The Merck data table is included in a 3-page letter (3) that was written in 2001 in response to the FDA's request for additional information regarding the ADVANTAGE trial; it shows 7 serious adverse cardiac events in patients receiving Vioxx (6 events adjudicated as myocardial infarction and 1 event adjudicated as a “sudden/unknown” death) and 1 adjudicated myocardial infarction in a patient receiving naproxen. In addition, another event that was “reported as hypertensive heart disease and death by Merck” was reclassified by the FDA in November 2001 as a “sudden/unknown” death, pushing the cardiac events for Vioxx to 8 (4).
to gain full access to the content and tools.
Learn more about subscription options.
Register Now for a free account.
Copyright © 2016 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use
This PDF is available to Subscribers Only