@article{b9c2c92aff5f4ffcafa574237016b0f3,
title = "International variation in characteristics and clinical outcomes of patients with type 2 diabetes and heart failure: Insights from TECOS",
abstract = "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.",
author = "{TECOS Study Group} and Bhatt, {Ankeet S.} and Nancy Luo and Nicole Solomon and Pagidipati, {Neha J.} and Giuseppe Ambrosio and Green, {Jennifer B.} and McGuire, {Darren K.} and Eberhard Standl and Cornel, {Jan H.} and Sigrun Halvorsen and Lopes, {Renato D.} and White, {Harvey D.} and Holman, {Rury R.} and Peterson, {Eric D.} and Mentz, {Robert J.}",
note = "Funding Information: The TECOS trial was funded by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ. The study was designed and run independently by the Duke Clinical Research Institute and the University of Oxford Diabetes Trials Unit in an academic collaboration with the sponsor. All analyses were performed by Duke Clinical Research Institute and the University of Oxford Diabetes Trials Unit, independent of the sponsor. The authors are solely responsible for the design and conduct of this study, all analyses, the drafting and editing of the paper, and its final contents. All authors agreed to submit the report for publication; the funder had no role in this decision. 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. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc.",
year = "2019",
month = dec,
doi = "10.1016/j.ahj.2019.08.016",
language = "English (US)",
volume = "218",
pages = "57--65",
journal = "American heart journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
}