Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

J J Gagne; X Han; S Hennessy; C E Leonard; E A Chrischilles; R M Carnahan; S V Wang; C Fuller; A Iyer; H Katcoff; T S Woodworth; P Archdeacon; T E Meyer; S Schneeweiss; S Toh

doi:10.1002/cpt.429

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Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

Journal article

Peer reviewed

Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

J J Gagne, X Han, S Hennessy, C E Leonard, E A Chrischilles, R M Carnahan, S V Wang, C Fuller, A Iyer, H Katcoff, …

Clinical pharmacology and therapeutics, Vol.100(5), pp.558-564

11/2016

DOI: 10.1002/cpt.429

PMCID: PMC6736515

PMID: 27416001

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https://www.ncbi.nlm.nih.gov/pmc/articles/6736515View

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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.

United States

Product Surveillance, Postmarketing - statistics & numerical data

Drug-Related Side Effects and Adverse Reactions

Humans

Angiotensin-Converting Enzyme Inhibitors - adverse effects

Adrenergic beta-Antagonists - adverse effects

Angioedema - chemically induced

Models, Statistical

United States Food and Drug Administration

Databases, Factual

Details

Title: Subtitle: Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association
Creators: J J Gagne - Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. jgagne1@partners.org
X Han - 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
S Hennessy - 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
C E Leonard - 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
E A Chrischilles - Department of Epidemiology, University of Iowa College of Public Health, Iowa City, Iowa, USA
R M Carnahan - Department of Epidemiology, University of Iowa College of Public Health, Iowa City, Iowa, USA
S V Wang - Brigham and Women's Hospital
C Fuller - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA
A Iyer - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA
H Katcoff - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA
T S Woodworth - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA
P Archdeacon - Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
T E Meyer - Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
S Schneeweiss - Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA
S Toh - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA
Resource Type: Journal article
Publication Details: Clinical pharmacology and therapeutics, Vol.100(5), pp.558-564
DOI: 10.1002/cpt.429
PMID: 27416001
PMCID: PMC6736515
NLM abbreviation: Clin Pharmacol Ther
ISSN: 1532-6535
eISSN: 1532-6535
Publisher: United States
Grant note: R00 HS022193 / AHRQ HHS HHSF223200910006I / FDA HHS
Language: English
Date published: 11/2016
Academic Unit: Pharmacy; Epidemiology; Injury Prevention Research Center
Record Identifier: 9983995164902771

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