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.

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Citation

Published Version (Please cite this version)

10.1016/j.ahj.2019.08.016

Publication Info

Bhatt, Ankeet S, Nancy Luo, Nicole Solomon, Neha J Pagidipati, Giuseppe Ambrosio, Jennifer B Green, Darren K McGuire, Eberhard Standl, et al. (2019). International variation in characteristics and clinical outcomes of patients with type 2 diabetes and heart failure: Insights from TECOS. American heart journal, 218. pp. 57–65. 10.1016/j.ahj.2019.08.016 Retrieved from https://hdl.handle.net/10161/31141.

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Scholars@Duke

Solomon

Nicole Solomon

Biostatistician, Senior
Pagidipati

Neha Pagidipati

Associate Professor of Medicine

Neha J. Pagidipati, MD, MPH, is an Assistant Professor of Medicine and cardiovascular disease prevention specialist.  Since 2011, she has conducted research on cardiometabolic disease prevention, lifestyle modification and weight management.  She is currently an NIH K12 scholar in Implementation and Dissemination Science. 

Dr. Pagidipati is building the Duke Cardiometabolic Disease Prevention Program, which focuses on behavior change and risk factor management in patients with high risk of cardiovascular and metabolic diseases such as diabetes and obesity.  The program’s multi-disciplinary team of cardiologists, endocrinologists, nephrologists, and hepatologists will work together to provide coordinated, team-based care to the most high-risk and complex patients in the health system. 

Dr. Pagidipati’s research grants include the COORDINATE-Diabetes Trial, to improve the quality of care for patients with diabetes and cardiovascular disease across the U.S., and QuBBD:  Deep Poisson Methods for Biomedical Time-to-Event and Longitudinal Data.  She served as a study clinician on the large, longitudinal EXSCEL (Exenatide Study of Cardiovascular Event Lowering) trial.  She is currently conducting a nation-wide study of obesity management using real-world data sources, and is a site investigator for the Baseline Health Study in collaboration with Verily Life Sciences. In addition, she is leading a large study within the Duke Health System to study heterogeneity within cardiovascular disease risk and response to weight loss interventions among individuals with obesity. 

Dr. Pagidipati graduated from Harvard College and Harvard Medical School.  She completed her internal medicine residency at Brigham and Women’s Hospital.  During a two-year research fellowship in Global Women’s Health at the Brigham, she obtained an MPH from the Harvard School of Public Health and studied cardiovascular disease prevention in women in India.  Dr. Pagidipati completed a four-year cardiology fellowship at the Duke University School of Medicine and served as Chief Research Fellow at the Duke Clinical Research Institute.  In 2017, she became a faculty member of the Duke University School of Medicine School. 

Green

Jennifer Brigitte Green

Professor of Medicine

Diabetes Mellitus: Prevention strategies, predictors, treatment effects; kidney and other complications including cardiovascular outcomes. Utilization of EHR data to construct tools to improve the care of diabetes and comorbid conditions.

Mentz

Robert John Mentz

Associate Professor of Medicine

I am a cardiologist with a clinical and research interest in heart failure (going from Failure to Function), including advanced therapies such as cardiac transplantation and mechanical assist devices or “heart pumps."

I serve our group as Chief of the Heart Failure Section.

I became a heart failure cardiologist in order to help patients manage their chronic disease over many months and years. I consider myself strongly committed to compassionate patient care with a focus on quality of life and patient preference.

I am the Editor in Chief of the Journal of Cardiac Failure - The official journal of the Heart Failure Society of America.

My research interests are focused on treating co-morbid diseases in heart failure patients and improving outcomes across the cardiovascular spectrum through clinical trials and outcomes research. Below, you will find my specific research interests:

  •     Cardiometabolic disease
  •     Co-morbidity characterization (diabetes, sleep apnea, renal failure) in heart failure
  •     Phenotypic characterization and risk prognostication of patients with heart failure
  •     Role of surrogate and nonfatal endpoints in clinical heart failure trials
  •     Biomarkers in heart failure
  •     Novel pharmacological and non-pharmacological approaches to heart failure
  •     Improving site-based heart failure research

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