Report of Specific Cardiovascular Outcomes of the ADVANTAGE Trial
Authors: David S. Egilman, Amos H. Presler
Journal: Annals of Internal Medicine (2006)

Letters16 May 2006Report of Specific Cardiovascular Outcomes of the ADVANTAGE TrialDavid S. Egilman, MD, MPH and Amos H. Presler, BSDavid S. Egilman, MD, MPHFrom Brown University, Attleboro, MA 02703.Search for more papers by this author and Amos H. Presler, BSFrom Brown University, Attleboro, MA 02703.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-144-10-200605160-00016 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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 ...References1. Braunstein N, Polis A. Report of specific cardiovascular outcomes of the ADVANTAGE trial [Letter]. Ann Intern Med. 2005;143:158-9. [PMID: 15968005] LinkGoogle Scholar2. Lisse JR, Perlman M, Johansson G, Shoemaker JR, Schechtman J, Skalky CS, et al. Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial. Ann Intern Med. 2003;139:539-46. [PMID: 14530224] LinkGoogle Scholar3. Silverman RE. Merck Research Laboratories letter to FDA, Center for Drug Evaluation and Research: NDA 21-042/S-007: Vioxx (rofecoxib tablets). Response to FDA request for information; 2001. Presented in evidence in Cona v. Merck, 2006. Google Scholar4. Villalba ML. Medical officer review, NDA 21-042 and NDA 21-052 (rofecoxib tablets and rofecoxib oral solution). Re: Complete response to approvable letter for 21-042/S 007 and 21-052/S 004. U.S. Food and Drug Administration; 2001. Google Scholar5. Smith B. Communication to J. Webb re: Vioxx seeding study selection. 8 January 1999. Bates no. MRK-AFB0001598. Presented in evidence in Humeston v. Merck, 2005. Google Scholar6. Weiner JD. E-mail to K. Lindemann, C. Fanelle, and R. Higbee. Subject: ADVANTAGE ideas. 19 March 1999. Bates nos. MRK-ADI0024344-MRKADI0024346. Presented in evidence in Humeston v. Merck, 2005. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Brown University, Attleboro, MA 02703.Disclosures: Expert testimony: Dr. Egilman has served as an expert witness in Vioxx litigation. Mr. Presler is employed by Dr. Egilman. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoGastrointestinal Tolerability and Effectiveness of Rofecoxib versus Naproxen in the Treatment of Osteoarthritis Jeffrey R. Lisse , Monica Perlman , Gunnar Johansson , James R. Shoemaker , Joy Schechtman , Carol S. Skalky , Mary E. Dixon , Adam B. Polis , Arthur J. Mollen , Gregory P. Geba , and Report of Specific Cardiovascular Outcomes of the ADVANTAGE Trial Ned Braunstein and Adam Polis Correction: Report of Specific Cardiovascular Outcomes of the ADVANTAGE TrialADVANTAGE: Merck Does Say No Jonathan M. Edelman Metrics Cited ByDust diseases and the legacy of corporate manipulation of science and lawADVANTAGE: Merck Does Say NoJonathan M. Edelman, MDThe ADVANTAGE Seeding Trial: A Review of Internal DocumentsKevin P. Hill, MD, MHS, Joseph S. Ross, MD, MHS, David S. Egilman, MD, MPH, and Harlan M. Krumholz, MD, SMSeeding Trials: Just Say “No”Harold C. Sox, MD, Editor and Drummond Rennie, MDCorrection: Report of Specific Cardiovascular Outcomes of the ADVANTAGE Trial 16 May 2006Volume 144, Issue 10Page: 781KeywordsCardiovascular therapyClinical trial reportingDrug safetyDrugsHeart diseasesMyocardial infarctionSafetyStatistical dataSudden cardiac death ePublished: 16 May 2006 Issue Published: 16 May 2006 CopyrightCopyright © 2006 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...