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

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

Clin Pharmacol Ther. 2016 Nov;100(5):558-564. doi: 10.1002/cpt.429. Epub 2016 Aug 22.

Authors

J J Gagne¹, X Han², S Hennessy², C E Leonard², E A Chrischilles³, R M Carnahan³, S V Wang⁴, C Fuller⁵, A Iyer⁵, H Katcoff⁵, T S Woodworth⁵, P Archdeacon⁶, T E Meyer⁷, S Schneeweiss⁴, S Toh⁵

Affiliations

¹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. [email protected].
² 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.
³ Department of Epidemiology, University of Iowa College of Public Health, Iowa City, Iowa, USA.
⁴ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
⁵ Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
⁶ Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
⁷ Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 27416001
PMCID: PMC6736515
DOI: 10.1002/cpt.429

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.

Publication types

Comparative Study

MeSH terms

Adrenergic beta-Antagonists / adverse effects*
Angioedema / chemically induced*
Angiotensin-Converting Enzyme Inhibitors / adverse effects*
Databases, Factual
Drug-Related Side Effects and Adverse Reactions*
Humans
Models, Statistical
Product Surveillance, Postmarketing / statistics & numerical data*
United States
United States Food and Drug Administration

Substances

Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors

Abstract

Publication types

MeSH terms

Substances

Grants and funding