Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis

Home, Philip D.; Pocock, Stuart J.; Beck-Nielsen, Henning; Gomis, Ramón; Hanefeld, Markolf; Jones, Nigel P.; Komajda, Michel; McMurray, John J.V.

doi:10.1056/nejmoa073394

Cited by 761Diabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and LipoproteinsPeroxisome Proliferator-Activated Receptors

Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis

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Home, Philip D., Pocock, Stuart J., Beck-Nielsen, Henning, Gomis, Ramón, Hanefeld, Markolf, Jones, Nigel P., Komajda, Michel, McMurray, John J.V.·2007·New England Journal of Medicine

DOI 10.1056/nejmoa073394

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Abstract

BACKGROUND: A recent meta-analysis raised concern regarding an increased risk of myocardial infarction and death from cardiovascular causes associated with rosiglitazone treatment of type 2 diabetes. METHODS: We conducted an unplanned interim analysis of a randomized, multicenter, open-label, noninferiority trial involving 4447 patients with type 2 diabetes who had inadequate glycemic control while receiving metformin or sulfonylurea, in which 2220 patients were assigned to receive add-on rosiglitazone (rosiglitazone group), and 2227 to receive a combination of metformin plus sulfonylurea (control group). The primary end point was hospitalization or death from cardiovascular causes. RESULTS: Because the mean follow-up was only 3.75 years, our interim analysis had limited statistical power to detect treatment differences. A total of 217 patients in the rosiglitazone group and 202 patients in the control group had the adjudicated primary end point (hazard ratio, 1.08; 95% confidence interval [CI], 0.89 to 1.31). After the inclusion of end points pending adjudication, the hazard ratio was 1.11 (95% CI, 0.93 to 1.32). There were no statistically significant differences between the rosiglitazone group and the control group regarding myocardial infarction and death from cardiovascular causes or any cause. There were more patients with heart failure in the rosiglitazone group than in the control group (hazard ratio, 2.15; 95% CI, 1.30 to 3.57). CONCLUSIONS: Our interim findings from this ongoing study were inconclusive regarding the effect of rosiglitazone on the overall risk of hospitalization or death from cardiovascular causes. There was no evidence of any increase in death from either cardiovascular causes or all causes. Rosiglitazone was associated with an increased risk of heart failure. The data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction. (ClinicalTrials.gov number, NCT00379769 [ClinicalTrials.gov].).

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Authors: Home, P. D., Pocock, S. J., Beck-Nielsen, H., Gomis, R., Hanefeld, M., Jones, N. P., Komajda, M., & McMurray, J. J. V.
Affiliations: Newcastle University (GB)
London School of Hygiene & Tropical Medicine (GB)
Hospital Clínic de Barcelona (ES)
GlaxoSmithKline (United Kingdom) (GB)
ORCID: Pocock, Stuart J.
Gomis, Ramón
McMurray, John J.V.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2007-07-05
Volume: 357
Issue: 1
Pages: 28-38
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa073394
OpenAlex: W1972136146
Cited by: 761
References: 18
Citations by year: 2026: 1 · 2025: 6 · 2024: 6 · 2023: 7 · 2022: 16 · 2021: 10 · 2020: 13 · 2019: 10 · 2018: 14 · 2017: 17 · 2016: 19 · 2015: 13 · 2014: 27 · 2013: 25 · 2012: 29
FWCI: 122.76
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Newcastle University ePrints (Newcastle Univesity)
Funders: Amgen
Eli Lilly and Company
Pfizer
GlaxoSmithKline
Sanofi
Newcastle University
Novo Nordisk
Servier
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
Keywords: rosiglitazone, type 2 diabetes, cardiovascular outcomes, myocardial infarction, cardiovascular mortality, heart failure, metformin, sulfonylureas, adjunctive therapy, glycemic control
MeSH terms: Rosiglitazone, Adult, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Myocardial Infarction, Risk, Sulfonylurea Compounds, Thiazolidinediones, Kaplan-Meier Estimate

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Rosiglitazone Evaluated for Cardiovascular Outcomes — An Interim Analysis

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