Safety of saxagliptin: rationale for and design of a series of postmarketing observational studies

ABSTRACT Purpose To describe the design and rationale of a series of postmarketing studies to examine the safety of saxagliptin, an oral dipeptidyl peptidase‐4 inhibitor for the treatment of type 2 diabetes mellitus, in real‐world settings. Methods We are conducting a series of retrospective cohort...

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Published in:	Pharmacoepidemiology and drug safety Vol. 21; no. 11; pp. 1202 - 1215
Main Authors:	Lo Re III, Vincent, Haynes, Kevin, Ming, Eileen E., Wood Ives, Jennifer, Horne, Laura N., Fortier, Kimberly, Carbonari, Dena M., Hennessy, Sean, Cardillo, Serena, Reese, Peter P., Reddy, K. Rajender, Margolis, David, Apter, Andrea, Kimmel, Stephen E., Roy, Jason, Freeman, Cristin P., Razzaghi, Hanieh, Holick, Crystal N., Esposito, Daina B., Van Staa, Tjeerd-Pieter, Bhullar, Harshvinder, Strom, Brian L.
Format:	Journal Article
Language:	English
Published:	England Blackwell Publishing Ltd 01-11-2012 Wiley Subscription Services, Inc
Subjects:	Adamantane - adverse effects Adamantane - analogs & derivatives Adverse Drug Reaction Reporting Systems - organization & administration Adverse Drug Reaction Reporting Systems - statistics & numerical data adverse event Algorithms Cohort Studies Consumer Product Safety Databases, Factual Diabetes diabetes mellitus Dipeptides - adverse effects dipeptidyl peptidase-4 inhibitor Dipeptidyl-Peptidase IV Inhibitors - adverse effects Drug therapy Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology Endpoint Determination Epidemiologic Research Design Humans pharmacoepidemiology Pharmacoepidemiology - methods Pharmacology Retrospective Studies Safety saxagliptin United Kingdom
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Summary:	ABSTRACT Purpose To describe the design and rationale of a series of postmarketing studies to examine the safety of saxagliptin, an oral dipeptidyl peptidase‐4 inhibitor for the treatment of type 2 diabetes mellitus, in real‐world settings. Methods We are conducting a series of retrospective cohort studies using two UK (General Practice Research Database, and The Health Improvement Network) and two US (Medicare, HealthCore Integrated Research DatabaseSM) data sources. The primary outcomes of interest will include (i) hospitalization with acute liver failure, (ii) hospitalization for acute kidney injury, (iii) hospitalization for severe hypersensitivity reactions, (iv) hospitalization for severe infections, (v) hospitalization with infections associated with T‐lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or nontuberculous mycobacteria), and (vi) major cardiovascular events. Diagnosis codes for the outcomes of interest will be validated by medical record review within each data source. Projected use and estimated incidence rates of outcomes of interest suggest there will be at least 80% statistical power to detect a minimum hazard ratio of 1.5 for major cardiovascular events, 2.0 for acute kidney injury and severe infections, 2.4 for acute liver failure, and 4.0 for severe hypersensitivity reactions. Results Forthcoming. Conclusions This postmarketing safety assessment will provide important information regarding the safety of saxagliptin and could potentially identify important dipeptidyl peptidase‐4 inhibitor class effects. The methods described may be useful to others planning similar evaluations. Copyright © 2012 John Wiley & Sons, Ltd.
Bibliography:	istex:9562E3231F36B36F3CA99CB516BA2D0E471482FD ArticleID:PDS3318 ark:/67375/WNG-W6QBZT8Z-D ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1053-8569 1099-1557
DOI:	10.1002/pds.3318