28 Mar Study Finds No Increased Risk of Heart Failure From Incretin-Based Diabetes Drugs
MedicalResearch.com Interview with:
Kristian B. Filion, Ph.D., FAHA
Assistant Professor of Medicine, Division of Clinical Epidemiology, McGill University
Principal Investigator, Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital
Associate Member, Department of Epidemiology, Biostatistics, and Occupational Health, McGill University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Filion: Concerns regarding the cardiovascular safety of the antidiabetic incretin-based drugs arose following the unexpected finding of an increased risk of heart failure in the SAVOR-TIMI 53 trial of the DPP-4 inhibitor saxagliptin. Although subsequent trials did not find an increased risk of heart failure with these drugs, concerns regarding their heart failure effects remained due to the conflicting available evidence. Furthermore, with their highly-selected patient populations, the applicability of the results of these clinical trials to patients seen in a real world setting is unclear.
We therefore examined the risk of hospitalization for heart failure associated with incretin-based drugs in patients with type 2 diabetes in a real world setting using the health records of over 1.4 million patients from six jurisdictions (four Canadian provinces, the United Kingdom, and the United States). We used a common protocol in each database and statistically combined results across databases to obtain one overall estimate. We found that there was no evidence of an increased risk, a finding that was consistent in separate analyses for patients with and without a history of heart failure.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Filion: This study provides reassurance regarding concerns about the potential risk of heart failure with the use of incretin-based drugs compared with the use of combinations of oral antidiabetic drugs such as metformin and sulfonylureas.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Filion: It would be helpful to do additional analyses by individual incretin-based drug (i.e., by molecule), which could explain some of the heterogeneity observed in some of the clinical trials in this area.
In addition, many of the patients included in our study had a relatively short history of diabetes. In secondary analyses, we checked if the association differed by duration of treated diabetes and, although we found that it did not, it would be helpful to revisit this question in a few years as additional information becomes available.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Filion: This study was conducted by the Canadian Network for Observational Drug Effect Studies (CNODES), a pan-Canadian network funded by Health Canada and the Canadian Institutes of Health Research to study emerging drug safety issues. CNODES has the ability to analyze a vast amount of de-identified data to efficiently respond to drug safety issues that arise after a drug is already on the market.
In this case, we were able to analyze the health records of over 1.4 million patients who were prescribed an antidiabetic medication in Canada, the United Kingdom, and the United States.
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A Multicenter Observational Study of Incretin-based Drugs and Heart Failure
Kristian B. Filion, Ph.D., Laurent Azoulay, Ph.D., Robert W. Platt, Ph.D., Matthew Dahl, B.Sc., Colin R. Dormuth, Sc.D., Kristin K. Clemens, M.D., Nianping Hu, M.D., Ph.D., J. Michael Paterson, M.Sc., Laura Targownik, M.D., M.S.H.S., Tanvir C. Turin, M.D., Ph.D., Jacob A. Udell, M.D., M.P.H., and Pierre Ernst, M.D., for the CNODES Investigators*
N Engl J Med 2016; 374:1145-1154
March 24, 2016 DOI: 10.1056/NEJMoa1506115
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Kristian B. Filion, Ph.D., FAHA (2016). Study Finds No Increased Risk of Heart Failure From Incretin-Based Diabetes Drugs MedicalResearch.com