Key result
Concomitant PPI and clopidogrel use shows unclear adverse risks after multilevel propensity adjustment.
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Editorials16 March 2010Propensity Score Adjustment With Multilevel Data: Setting Your Sites on Decreasing Selection BiasMichael E. Griswold, PhD, A. Russell Localio, PhD, and Cynthia Mulrow, MD, MSc, Senior Deputy EditorMichael E. Griswold, PhDFrom Center of Biostatistics, University of Mississippi Medical Center, Jackson, MS 39216; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA 19104; and American College of Physicians, Philadelphia, PA 19106., A. Russell Localio, PhDFrom Center of Biostatistics, University of Mississippi Medical Center, Jackson, MS 39216; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA 19104; and American College of Physicians, Philadelphia, PA 19106., and Cynthia Mulrow, MD, MSc, Senior Deputy EditorFrom Center of Biostatistics, University of Mississippi Medical Center, Jackson, MS 39216; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA 19104; and American College of Physicians, Philadelphia, PA 19106.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-152-6-201003160-00010 SectionsSupplemental MaterialAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Decision makers often rely on large, multisite observational studies to evaluate the benefits and harms of therapies. An important example is in this issue—a study from Ray and colleagues (1) adds to the debate about the potential harms of concurrent use of proton-pump inhibitors (PPIs) and clopidogrel. These drugs are frequently coprescribed, and the U.S. Food and Drug Administration, primarily on the basis of evidence from multisite observational studies, recently warned against concomitant use of one PPI, omeprazole, and clopidogrel (2). Ray and colleagues' analysis suggests that adverse consequences of concomitant PPI and clopidogrel use are not that clear. In ...References1. Ray WA, Murray KT, Griffin MR, Chung CP, Smalley WE, Hall K, et al. Outcomes with concurrent use of clopidogrel and proton-pump inhibitors. A cohort study. Ann Intern Med. 2010;152:337-45. LinkGoogle Scholar2. U.S. Food and Drug Administration. FDA announces new warning on Plavix: avoid use with Prilosec/Prilosec OTC [news release]. 18 November 2009. Silver Spring, MD: U.S. Food and Drug Administration; 2009. Accessed at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm 8 February 2010. Google Scholar3. Braitman LE, Rosenbaum PR. Rare outcomes, common treatments: analytic strategies using propensity scores [Editorial]. Ann Intern Med. 2002;137:693-5. [PMID: 12379071] LinkGoogle Scholar4. D'Agostino RB. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med. 1998;17:2265-81. [PMID: 9802183] CrossrefMedlineGoogle Scholar5. Austin PC, Mamdani MM. A comparison of propensity score methods: a case-study estimating the effectiveness of post-AMI statin use. Stat Med. 2006;25:2084-106. [PMID: 16220490] CrossrefMedlineGoogle Scholar6. Heagerty PJ, Zeger SL. Marginalized multilevel models and likelihood inference. Stat Sci. 2000;15:1-26. CrossrefGoogle Scholar7. Kang JDY, Schafer JL. Demystifying double robustness: a comparison of alternative strategies for estimating a population mean from incomplete data. Stat Sci. 2007;22:523-39. CrossrefGoogle Scholar8. Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009;180:713-8. [PMID: 19176635] CrossrefMedlineGoogle Scholar9. Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301:937-44. [PMID: 19258584] CrossrefMedlineGoogle Scholar10. O'Donoghue ML, Braunwald E, Antman EM, Murphy SA, Bates ER, Rozenman Y, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet. 2009;374:989-97. [PMID: 19726078] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Center of Biostatistics, University of Mississippi Medical Center, Jackson, MS 39216; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA 19104; and American College of Physicians, Philadelphia, PA 19106.Acknowledgment: The authors thank Ray and colleagues for providing their analytic data set and assistance in obtaining permission from the State of Tennessee Bureau of TennCare and Department of Health for its use.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-0315.Corresponding Author: Michael E. Griswold, PhD, Center of Biostatistics, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216; e-mail, [email protected]umsmed.edu.Current Author Addresses: Dr. Griswold: Center of Biostatistics, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216.Dr. Localio: Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, 606 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.Dr. Mulrow: Annals of Internal Medicine, 190 N. Independence Mall West, Philadelphia, PA 19106. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoOutcomes With Concurrent Use of Clopidogrel and Proton-Pump Inhibitors Wayne A. Ray , Katherine T. Murray , Marie R. Griffin , Cecilia P. Chung , Walter E. Smalley , Kathi Hall , James R. Daugherty , Lisa A. Kaltenbach , and C. 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Michael Griswold (2010) reported an editorial. Concomitant proton-pump inhibitor and clopidogrel use was evaluated. Concomitant proton-pump inhibitor and clopidogrel use in multisite observational studies has unclear adverse consequences when evaluated with propensity score adjustment for multilevel data.
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