title: Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association.
abstract: The US Food and Drug Administration's Sentinel system has developed the capability to conduct active safety surveillance of marketed medical products in a large network of electronic healthcare databases. We assessed the extent to which the newly developed, semiautomated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol-driven assessment, which found an adjusted hazard ratio (HR) of 3.04 (95% confidence interval [CI], 2.81-3.27) comparing angioedema in patients initiating angiotensin-converting enzyme (ACE) inhibitors vs. beta-blockers. Using data from 13 Data Partners between 1 January 2008, and 30 September 2013, the PSM tool identified 2,211,215 eligible ACE inhibitor and 1,673,682 eligible beta-blocker initiators. The tool produced an HR of 3.14 (95% CI, 2.86-3.44). This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol-driven assessment.
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. jgagne1@partners.org.
authors.forename: J J
authors.initials: JJ
authors.lastname: Gagne
authors.affiliation: Center for Pharmacoepidemiology Research and Training, Center for Clinical Epidemiology and Biostatistics, and Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
authors.forename: X
authors.initials: X
authors.lastname: Han
authors.affiliation: Center for Pharmacoepidemiology Research and Training, Center for Clinical Epidemiology and Biostatistics, and Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
authors.forename: S
authors.initials: S
authors.lastname: Hennessy
authors.affiliation: Center for Pharmacoepidemiology Research and Training, Center for Clinical Epidemiology and Biostatistics, and Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
authors.forename: C E
authors.initials: CE
authors.lastname: Leonard
authors.affiliation: Department of Epidemiology, University of Iowa College of Public Health, Iowa City, Iowa, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Chrischilles
authors.affiliation: Department of Epidemiology, University of Iowa College of Public Health, Iowa City, Iowa, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Carnahan
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: S V
authors.initials: SV
authors.lastname: Wang
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
authors.forename: C
authors.initials: C
authors.lastname: Fuller
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
authors.forename: A
authors.initials: A
authors.lastname: Iyer
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
authors.forename: H
authors.initials: H
authors.lastname: Katcoff
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
authors.forename: T S
authors.initials: TS
authors.lastname: Woodworth
authors.affiliation: Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: P
authors.initials: P
authors.lastname: Archdeacon
authors.affiliation: Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: T E
authors.initials: TE
authors.lastname: Meyer
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: S
authors.initials: S
authors.lastname: Schneeweiss
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
authors.forename: S
authors.initials: S
authors.lastname: Toh
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000009:adverse effects*; D000799:Angioedema / Q000139:chemically induced*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects*; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015233:Models, Statistical; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors