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Comment & Response |

A Methodological Appraisal of Recent Real-World Data Publications on Dabigatran

Kristina Zint, PhD1; Jörg Kreuzer, MD1
[+] Author Affiliations
1Boehringer Ingelheim GmbH & Co KG, Ingelheim am Rhein, Germany
JAMA Intern Med. 2015;175(7):1244. doi:10.1001/jamainternmed.2015.1280.
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To the Editor Hernandez et al1 presented a study comparing the bleeding risk from a 5% random sample of Medicare patients treated with dabigatran etexilate or warfarin who were newly diagnosed as having atrial fibrillation. It is important to put their results into perspective with the very different results of the recently published study by Graham et al2 involving a 1-year–longer study period and a more than 50-fold–larger dabigatran population of Medicare patients compared with those in the study by Hernandez et al1 (67 207 vs 1302). Some of those data2 had been published in May 20143 but were not discussed by Hernandez et al.1 To better understand the discrepant results of the 2 studies, some open questions have to be considered.

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Correspondence

July 1, 2015
Marta A. Miyares, PharmD, BCPS (AQ Cardiology), CACP
1Pharmacy Department, Jackson Memorial Hospital, Miami, Florida
JAMA Intern Med. 2015;175(7):1242-1243. doi:10.1001/jamainternmed.2015.1271.
July 1, 2015
Deborah L. Horjus, MD; Gert A. van Montfrans, MD, PhD; Lizzy M. Brewster, MD, PhD
1Department of Vascular, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
2Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
JAMA Intern Med. 2015;175(7):1243. doi:10.1001/jamainternmed.2015.1274.
July 1, 2015
Adi Klil-Drori, MD; Laurent Azoulay, PhD
1Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Canada2Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada
1Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Canada3Department of Oncology, McGill University, Montreal, Quebec, Canada
JAMA Intern Med. 2015;175(7):1243-1244. doi:10.1001/jamainternmed.2015.1277.
July 1, 2015
Siyao Liu, BSc; Cherub O. Kim, MSc; Scott N. Lucyk, MD
1New York University School of Medicine, New York
2Division of Medical Toxicology, New York University School of Medicine, New York
JAMA Intern Med. 2015;175(7):1244-1245. doi:10.1001/jamainternmed.2015.1286.
July 1, 2015
Daniel Pilsgaard Henriksen, MD, PhD; Morten Rix Hansen, MD; Per Damkier, MD, PhD
1Department of Clinical Chemistry and Pharmacology, Odense University Hospital, Odense, Denmark
2Research Unit of Clinical Pharmacology, Department of Public Health, University of Southern Denmark, Odense, Denmark
JAMA Intern Med. 2015;175(7):1245. doi:10.1001/jamainternmed.2015.1289.
July 1, 2015
Inmaculada Hernandez, PharmD; Yuting Zhang, PhD
1Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA Intern Med. 2015;175(7):1245-1247. doi:10.1001/jamainternmed.2015.1299.
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