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Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial
Open accessAbstract
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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“In the RECORD 112 and the PROactive trials, 183 patients randomized to TZDs, rosiglitazone and pioglitazone, respectively, had more HF events than those on placebo.”
From Type 2 diabetes mellitus and heart failure: A position statement from the Heart Failure Association of the European Society of Cardiology (2018) · cites this paper as [112]
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Brenner, B. M., Cooper, M. E., de Zeeuw, D., Keane, W. F., Mitch, W. E., Parving, H.-H., Remuzzi, G., Snapinn, S. M., Zhang, Z., & Shahinfar, S. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa011161 · Cited by 7,493
Lewis, E. J., Hunsicker, L. G., Clarke, W. R., Berl, T., Pohl, M. A., Lewis, J. B., Ritz, E., Atkins, R. C., Rohde, R., & Raz, I. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa011303 · Cited by 5,987
Dormandy, J. A., Charbonnel, B., Eckland, D. J., Erdmann, E., Massi-Benedetti, M., Moules, I. K., Skene, A. M., Tan, M. H., Lefèbvre, P. J., Murray, G. D., et al. (2005) · The Lancet · doi:10.1016/s0140-6736(05)67528-9 · Cited by 4,129
Guidelines for the diagnosis and treatment of chronic heart failure
Remme, W. J. (2001) · European Heart Journal · doi:10.1053/euhj.2001.2783 · Cited by 1,595
Home, P. D., Pocock, S. J., Beck-Nielsen, H., Curtis, P. S., Gomis, R., Hanefeld, M., Jones, N. P., Komajda, M., & McMurray, J. J. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60953-3 · Cited by 1,393
Thiazolidinedione Use, Fluid Retention, and Congestive Heart Failure
Nesto, R. W., Bell, D. S. H., Bonow, R. O., Fonseca, V. A., Grundy, S. M., Horton, E. S., Winter, M. L., Porte, D., Semenkovich, C. F., Smith, S. E., et al. (2003) · Circulation · doi:10.1161/01.cir.0000103683.99399.7e · Cited by 831
Lago, R. M., Singh, P. P., & Nesto, R. W. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61514-1 · Cited by 710
Glycemic Control and Heart Failure Among Adult Patients With Diabetes
Iribarren, C., Karter, A. J., Go, A. S., Ferrara, A. M., Liu, J. Y., Sidney, S., & Selby, J. V. (2001) · Circulation · doi:10.1161/01.cir.103.22.2668 · Cited by 709
Guan, Y., Hao, C., Cha, D. R., Rao, R., Lu, W., Kohan, D. E., Magnuson, M. A., Redha, R., Zhang, Y., & Breyer, M. D. (2005) · Nature Medicine · doi:10.1038/nm1278 · Cited by 608
Research works printed but not linked: 1
- 2001, Diabetes Care, 24, 614
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McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O. D., et al. (2021) · PubMed · doi:10.1093/eurheartj/ehab670 · Cited by 20,604
2013 ACCF/AHA Guideline for the Management of Heart Failure
Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Drazner, M. H., Fonarow, G. C., Geraci, S. A., Horwich, T., Januzzi, J. L., et al. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.05.019 · Cited by 12,536
Self-citation2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
Ponikowski, P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., Falk, V., González-Juanatey, J. R., Harjola, V.-P., Jankowska, E. A., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw128 · Cited by 11,429
2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure
Ponikowski, P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., Falk, V., González-Juanatey, J. R., Harjola, V.-P., Jankowska, E. A., et al. (2016) · European Journal of Heart Failure · doi:10.1002/ejhf.592 · Cited by 5,866
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Circulation · doi:10.1161/cir.0000000000001063 · Cited by 4,922
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)
- 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
- 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
- hybrid
- doi.org
- 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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