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A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent

  1. Bruce Fireman1,*,
  2. Sengwee Toh2,
  3. Melissa G. Butler3,
  4. Alan S. Go1,
  5. Hylton V. Joffe4,
  6. David J. Graham4,
  7. Jennifer C. Nelson5,
  8. Gregory W. Daniel6,
  9. Joe V. Selby1

Article first published online: 19 JAN 2012

DOI: 10.1002/pds.2337

Issue

Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology and Drug Safety

Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program

Volume 21, Issue Supplement S1, pages 282–290, January 2012

Additional Information

How to Cite

Fireman, B., Toh, S., Butler, M. G., Go, A. S., Joffe, H. V., Graham, D. J., Nelson, J. C., Daniel, G. W. and Selby, J. V. (2012), A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent. Pharmacoepidem. Drug Safe., 21: 282–290. doi: 10.1002/pds.2337

Author Information

  1. 1

    Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA

  2. 2

    Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA

  3. 3

    Center for Health Research Southeast, Kaiser Permanente Georgia, Atlanta, GA, USA

  4. 4

    Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

  5. 5

    Group Health Research Institute, Group Health Cooperative, Seattle, WA, USA

  6. 6

    Government and Academic Research, HealthCore, Inc., Alexandria, VA, USA

*B. Fireman, Division of Research, Kaiser Permanente, 2000 Broadway, Oakland, CA 94612, USA. E-mail: bruce.fireman@kp.org

Publication History

  1. Issue published online: 19 JAN 2012
  2. Article first published online: 19 JAN 2012

Funded by

  • FDA through the Department of Health and Human Services. Grant Number: HHSF223200910006I

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Keywords:

  • acute myocardial infarction;
  • diabetes mellitus;
  • drug safety;
  • drug surveillance;
  • saxagliptin

ABSTRACT

Purpose

To describe a protocol for active surveillance of acute myocardial infarction (AMI) in users of a recently approved oral antidiabetic medication, saxagliptin, and to provide the rationale for decisions made in drafting the protocol.

Methods

A new-user cohort design is planned for evaluating data from at least four Mini-Sentinel data partners from 1 August 2009 (following US Food and Drug Administration's approval of saxagliptin) through mid-2013. New users of saxagliptin will be compared in separate analyses with new users of sitagliptin, pioglitazone, long-acting insulins, and second-generation sulfonylureas. Two approaches to controlling for confounding will be evaluated: matching by exposure propensity score and stratification by AMI risk score. The primary analyses will use Cox regression models specified in a way that does not require pooling of patient-level data from the data partners. The Cox models are fit to summarized data on risk sets composed of saxagliptin users and similar comparator users at the time of an AMI. Secondary analyses will use alternative methods including Poisson regression and will explore whether further adjustment for covariates available only at some data partners (e.g., blood pressure) modifies results.

Results

The results of this study are pending.

Conclusions

The proposed protocol describes a design for surveillance to evaluate the safety of a newly marketed agent as postmarket experience accrues. It uses data from multiple partner organizations without requiring sharing of patient-level data and compares alternative approaches to controlling for confounding. It is hoped that this initial active surveillance project of the Mini-Sentinel will provide insights that inform future population-based surveillance of medical product safety. Copyright © 2012 John Wiley & Sons, Ltd.

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