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Cited by 234Diabetes Treatment and ManagementHeart Failure Treatment and ManagementCardiovascular Function and Risk Factors

The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.

Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial

Open access
Komajda, M., McMurray, J. J.V., Beck-Nielsen, H., Gomis, R., Hanefeld, M., Pocock, S. J., Curtis, P. S., Jones, N. P., Home, P. D.·2010·European Heart Journal
DOI 10.1093/eurheartj/ehp604PMC PMC2848325
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Abstract

AIMS: Thiazolidinediones are insulin sensitizers, and are associated with fluid retention and increased risk of heart failure (HF) in people with type 2 diabetes. We assessed fatal and non-fatal HF events and their outcome, and identified HF predictors in the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes) trial population. METHODS AND RESULTS: In a multicentre, open-label study, we randomized 4447 people with type 2 diabetes on metformin or sulfonylurea monotherapy with a mean HbA(1c) of 7.9% to add-on rosiglitazone (n = 2220) or to a combination of metformin and sulfonylurea (n = 2227) and followed them over 5.5 years on average. Heart failure hospitalizations and deaths were adjudicated by a Clinical Endpoint Committee using pre-specified criteria. Independent predictors of HF events were identified out of a group of 30 pre-specified clinical, demographic, and biological variables. In the rosiglitazone group, the risk of HF death or hospitalization was doubled: HR = 2.10 (95% CI, 1.35-3.27): the excess HF event rate was 2.6 (1.1-4.1) per 1000 person-years. An excess in HF deaths was observed (10 vs. two), including four HF deaths as first HF events. By contrast, there was no increase in cardiovascular mortality or hospitalization (HR = 0.99, 95% CI, 0.85-1.16) or in cardiovascular deaths (60 vs. 71). Independent predictors of HF were rosiglitazone assignment, age, urinary albumin : creatinine ratio, body mass index, and systolic blood pressure at baseline. A history of previous cardiovascular disease was not predictive of HF. Duration of HF hospitalization and rate of HF re-hospitalization were similar in the two groups. CONCLUSION: These findings confirm the increased risk of HF events in people treated with rosiglitazone and support the recommendation that this agent should not continue to be used in people developing symptomatic HF while using the medication. Close follow-up for the risk of HF should be offered to elderly people, people with markedly increased body mass index, people with microalbuminuria/proteinuria, and people with increased systolic blood pressure.

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Figure 1 Study design of the RECORD trial.
Figure 1 Study design of the RECORD trial.CC BY-NC · PubMed Central
Figure 2 Kaplan–Meier plots of time to heart failure (fatal or non-fatal) in the RECORD study (yellow, rosiglitazone group, blue, active control group). (A) Intent-to-treat analysis and (B) per-protocol +30 days analysis.
Figure 2 Kaplan–Meier plots of time to heart failure (fatal or non-fatal) in the RECORD study (yellow, rosiglitazone group, blue, active control group). (A) Intent-to-treat analysis and (B) per-protocol +30 days analysis.CC BY-NC · PubMed Central

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  1. 2001, Diabetes Care, 24, 614

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Metadata

Authors
Komajda, M., McMurray, J. J. V., Beck-Nielsen, H., Gomis, R., Hanefeld, M., Pocock, S. J., Curtis, P. S., Jones, N. P., & Home, P. D.
Affiliations
  • University of Glasgow (GB)
  • Universitat de Barcelona (ES)
  • London School of Hygiene & Tropical Medicine (GB)
  • GlaxoSmithKline (United Kingdom) (GB)
  • Newcastle University (GB)
ORCID
Venue
European Heart Journal
Publisher
Oxford University Press (OUP)
Published
2010-01-29
Volume
31
Issue
7
Pages
824-831
ISSN
  • 0195-668X (ISSN-L)
  • 1522-9645
DOI
10.1093/eurheartj/ehp604
PMC
PMC2848325
OpenAlex
W2115360698
Cited by
234
References
27
Citations by year
2026: 7 · 2025: 5 · 2024: 7 · 2023: 6 · 2022: 10 · 2021: 15 · 2020: 24 · 2019: 17 · 2018: 14 · 2017: 19 · 2016: 16 · 2015: 20 · 2014: 19 · 2013: 10 · 2012: 17
FWCI
13.07
Type
journal article
Language
en
Open access
Licence
other-oa
Locations
  • European Heart Journal (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
  • Newcastle University ePrints (Newcastle Univesity)
Funders
GlaxoSmithKline
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
Keywords
rosiglitazone, heart failure, type 2 diabetes, thiazolidinediones, heart failure hospitalization, heart failure mortality, risk factors, metformin, sulfonylureas, urinary albumin-creatinine ratio, body mass index, systolic blood pressure, cardiovascular mortality, RECORD trial, insulin sensitizers, fluid retention, microalbuminuria
MeSH terms
Rosiglitazone, Adult, Aged, Diabetes Mellitus, Type 2, Female, Heart Failure, Humans, Hypoglycemic Agents, Male, Middle Aged, Risk Factors, Thiazolidinediones, Kaplan-Meier Estimate

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