Rapid Identification of Myocardial Infarction Risk Associated With Diabetes Medications Using Electronic Medical Records
- John S. Brownstein, PHD1,2,3,
- Shawn N. Murphy, MD, PHD4,5,
- Allison B. Goldfine, MD5,6,
- Richard W. Grant, MD7,8,
- Margarita Sordo, PHD4,5,
- Vivian Gainer, MS5,
- Judith A. Colecchi, MS5,
- Anil Dubey, MD4,5,
- David M. Nathan, MD8,9,
- John P. Glaser, PHD5 and
- Isaac S. Kohane, MD, PHD1,5,10
- 1Children's Hospital Informatics Program at the Harvard–MIT Division of Health Sciences and Technology, Boston, Massachusetts;
- 2Division of Emergency Medicine, Children's Hospital Boston, Boston, Massachusetts;
- 3Department of Pediatrics, Harvard Medical School, Boston, Massachusetts;
- 4Laboratory of Computer Science, Massachusetts General Hospital, Boston, Massachusetts;
- 5Partners Healthcare, Boston, Massachusetts;
- 6Joslin Diabetes Center, Boston, Massachusetts;
- 7Division of General Medicine, Massachusetts General Hospital, Boston, Massachusetts;
- 8Department of Medicine, Harvard Medical School, Boston, Massachusetts;
- 9Diabetes Center, Massachusetts General Hospital, Boston, Massachusetts;
- 10Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
- Corresponding author: John S. Brownstein, john_brownstein{at}harvard.edu.
-
J.S.B. and S.N.M. contributed equally to the work.
Abstract
OBJECTIVE To assess the ability to identify potential association(s) of diabetes medications with myocardial infarction using usual care clinical data obtained from the electronic medical record.
RESEARCH DESIGN AND METHODS We defined a retrospective cohort of patients (n = 34,253) treated with a sulfonylurea, metformin, rosiglitazone, or pioglitazone in a single academic health care network. All patients were aged >18 years with at least one prescription for one of the medications between 1 January 2000 and 31 December 2006. The study outcome was acute myocardial infarction requiring hospitalization. We used a cumulative temporal approach to ascertain the calendar date for earliest identifiable risk associated with rosiglitazone compared with that for other therapies.
RESULTS Sulfonylurea, metformin, rosiglitazone, or pioglitazone therapy was prescribed for 11,200, 12,490, 1,879, and 806 patients, respectively. A total of 1,343 myocardial infarctions were identified. After adjustment for potential myocardial infarction risk factors, the relative risk for myocardial infarction with rosiglitazone was 1.3 (95% CI 1.1–1.6) compared with sulfonylurea, 2.2 (1.6–3.1) compared with metformin, and 2.2 (1.5–3.4) compared with pioglitazone. Prospective surveillance using these data would have identified increased risk for myocardial infarction with rosiglitazone compared with metformin within 18 months of its introduction with a risk ratio of 2.1 (95% CI 1.2–3.8).
CONCLUSIONS Our results are consistent with a relative adverse cardiovascular risk profile for rosiglitazone. Our use of usual care electronic data sources from a large hospital network represents an innovative approach to rapid safety signal detection that may enable more effective postmarketing drug surveillance.
Footnotes
-
The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
-
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
-
- Received August 13, 2009.
- Accepted December 2, 2009.
- © 2010 by the American Diabetes Association.
