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International variation in characteristics and clinical outcomes of patients with type 2 diabetes and heart failure: Insights from TECOS - 02/12/19

Doi : 10.1016/j.ahj.2019.08.016 
Ankeet S. Bhatt, MD, MBA a, Nancy Luo, MD b, Nicole Solomon, MS b, Neha J. Pagidipati, MD, MPH b, Giuseppe Ambrosio, MD c, Jennifer B. Green, MD b, Darren K. McGuire, MD, MHSc d, Eberhard Standl, MD e, Jan H. Cornel, MD, PhD f, Sigrun Halvorsen, MD, PhD g, Renato D. Lopes, MD, PhD b, Harvey D. White, MB CHB, DSc h, Rury R. Holman, MB ChB i, Eric D. Peterson, MD, MPH b, Robert J. Mentz, MD b,
on behalf of the

TECOS Study Group

a Brigham and Women's Hospital, Harvard Medical School, Boston, MA 
b Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 
c Division of Cardiology, University of Perugia School of Medicine, Perugia, Italy 
d Division of Cardiology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX 
e Diabetes Research Group, Munich Helmholtz Center, Munich, Germany 
f Noordwest Ziekenhuisgroep, Department of Cardiology, Alkmaar, the Netherlands 
g Department of Cardiology, Oslo University Hospital, and University of Oslo, Oslo, Norway 
h Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand 
i Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom 

Reprint requests: Robert J. Mentz, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.Duke Clinical Research InstitutePO Box 17969DurhamNC27715

Background

International differences in management/outcomes among patients with type 2 diabetes and heart failure (HF) are not well characterized. We sought to evaluate geographic variation in treatment and outcomes among these patients.

Methods and results

Among 14,671 participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), those with HF at baseline and a documented ejection fraction (EF) (N = 1591; 10.8%) were categorized by enrollment region (North America, Latin America, Western Europe, Eastern Europe, and Asia Pacific). Cox models were used to examine the association between geographic region and the primary outcome of all-cause mortality (ACM) or hospitalization for HF (hHF) in addition to ACM alone. Analyses were stratified by those with EF <40% or EF ≥40%. The majority of participants with HF were enrolled in Eastern Europe (53%). Overall, 1,267 (79.6%) had EF ≥40%. β-Blocker (83%) and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (86%) use was high across all regions in patients with EF <40%. During a median follow-up of 2.9 years, Eastern European participants had lower rates of ACM/hHF compared with North Americans (adjusted hazard ratio: 0.45; 95% CI: 0.32-0.64). These differences were seen only in the EF ≥40% subgroup and not the EF <40% subgroup. ACM was similar among Eastern European and North American participants (adjusted hazard ratio: 0.79; 95% CI: 0.44-1.45).

Conclusions

Significant variation exists in the clinical features and outcomes of HF patients across regions in TECOS. Patients from Eastern Europe had lower risk-adjusted ACM/hHF than those in North America, driven by those with EF ≥40%. These data may inform the design of future international trials.

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 Matthew Aaron Cavender, MD, MPH, served as guest editor for this article
 Acknowledgments
R. R. H. is a National Institute for Health Research Senior Investigator. Peter Hoffmann, an employee of the Duke Clinical Research Institute, provided editorial support.
 Disclosures: A. S. B.: none; N. L.: none; N. S.: none; N. J. P. reports ownership in Freedom Health, Inc; Physician Partners, LLC; RXAdvance, LLC; and Florida Medical Associates, LLC; G. A. has served on an advisory board and speaker's bureau for Merck; J. B. G. has received grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Sanofi; personal fees from AstraZeneca, Merck, Boehringer-Ingelheim, and NovoNordisk; D. K. M. has received honoraria for clinical trial leadership from AstraZeneca, Sanofi Aventis, Janssen, Boehringer Ingelheim, Merck & Co, Novo Nordisk, Lexicon, and GlaxoSmithKline; and honoraria for consultancy from AstraZeneca, Sanofi Aventis, Lilly US, Boehringer Ingelheim, Merck & Co., Pfizer, Novo Nordisk, and Metavant; E. S. has received personal fees from Oxford Diabetes Trials Unit, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Menarini, Merck Serono, Excemed, Novartis, NovoNordisk, and Sanofi; J. H. C. has received personal fees from Merck, Eli Lilly, and AstraZeneca; S. H. has received speaker fees from Merck and Boehringer Ingelheim; R. D. L. has received research support from Bristol-Myers Squibb and GlaxoSmithKline, and personal fees from Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, and Portola; H. D. W. has received grants from Sanofi Aventis, Eli Lilly and Company, National Institute of Health, Merck Sharpe & Dohm, AstraZeneca, Omthera Pharmaceuticals, Pfizer, Elsai Inc, DalGen Products and Services, and personal fees from AstraZeneca; R. R. H. has received grants from AstraZeneca, Bayer AG, and Merck Sharp & Dohme, as well as personal fees from Amgen, Bayer AG, Boehringer Ingelheim, Novo Nordisk, and Servier. E. D. P. has received grants from Janssen, Merck, Sanofi, AstraZeneca, Genentech, and Amgen, and has consulting associations with Janssen, Bayer, Merck, and Sanofi; R. J. M. has received grants from AstraZeneca and GlaxoSmithKline and personal fees from Boehringer-Ingelheim.
 Clinical Trial Registration: ClinicalTrials.gov: NCT00790205


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Vol 218

P. 57-65 - décembre 2019 Retour au numéro
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