Although the relationship between type 2 diabetes mellitus (T2DM) and risk of microvascular and macrovascular complications is well established, data in a broad US population is limited. This study described the long-term trajectory for rates of vascular disease and mortality among individuals with incident T2DM using real-world data to better inform targeting and timing of treatment interventions.
Claims and mortality data from a national US commercially insured/Medicare Advantage population were used to identify individuals with incident T2DM and non-T2DM controls who had continuous health plan eligibility for ≥10 years or who died during the study period (1/1/06-12/31/15). Individuals with T2DM were identified using T2DM diagnosis and DM medication codes in 2007; the date of the earliest such claim was assigned as the index date. Controls had no claims for DM during the same study period. Incident T2DM individuals were 1:1 matched to controls on age, gender and health plan/insurance type. Outcomes assessed were incidence, period prevalence, time to first diagnosis of vascular disease and all-cause mortality.
The study cohort comprised of 13,883 matched incident T2DM and non-T2DM pairs (mean age 63.6 years; 49.5% female). The incident T2DM group developed vascular disease at twice the rate as the non-DM group, 197 vs. 98 per 1,000 person-years (PY). The median time to vascular disease was shorter among the incident T2DM group as compared to the non-DM group [1,043 vs. 2,507 days, hazard ratio (HR): 1.89, P<0.001]. Vascular disease incidence rates increased with age in the T2DM/non-T2DM groups [18-44 years: 107.1/28.2 per 1,000-PY, HR: 3.60, P<0.001; 45-64 years: 166.3/70.3 per 1000 1,000-PY, HR: 2.23, P<0.001; and ≥65 years: 391.0/199.7 per 1,000-PY, HR: 1.81, P<0.001], respectively. Cumulative 10-year all-cause mortality was higher in the T2DM group (27.5%) compared to non-T2DM group (19.6%). While annual prevalence of vascular disease increased drastically from baseline to end of follow-up (42.5% to 81.1% T2DM/29.0% to 61.0% non-T2DM), the largest increase was observed between the baseline year and the first year of follow-up (42.5% to 60.5% T2DM/29.0% to 38.3% non-T2DM).
Discussion : T2DM is associated with a rapid and substantial increase in microvascular and macrovascular disease across all age groups, with an overall increase in mortality. Younger individuals with T2DM demonstrated the highest relative difference in vascular disease rates vs. those without T2DM.
Early diagnosis and aggressive treatment of T2DM, especially in younger individuals, may have the greatest potential for impact on morbidity and mortality over the long term.
Jay Visaria– Associate Director, HealthCore, Inc., Wilmington, Delaware
Neeraj Iyer– Senior Manager, Value Evidence & Outcomes, Novo Nordisk Inc., Bordentown, New Jersey
Amit Raval– Associate Director, Merck and Co. , Inc.
Sheldon Kong– Independent, Independent, Belle Mead, New Jersey
Todd Hobbs– Vice President, CMO, Novo Nordisk Inc, Plainsboro, New Jersey
Jonathan Bouchard– Senior Director, Health Economics and Value Assessment, Sanofi
David Kern– Director, Epidemiology, Janssen Research & Development
Vincent Willey– Principal Scientist, HealthCore, Wilmington, Delaware
Jay Visaria is Research Manager, Life Sciences HealthCore, Inc. He has worked in this capacity for over four years, with earlier experience conducting health outcomes research in the PBM and academic setting. Jay has a doctorate in Pharmaceutical Administration and a Masters in Public Health (Epidemiology).
Senior Manager, Value Evidence & Outcomes
Novo Nordisk Inc.
Bordentown, New Jersey
Neeraj N. Iyer, PhD is an experienced health economist and health outcomes researcher. He currently serves as Senior Manager, Value Evidence & Outcomes (VEO) for Novo Nordisk Inc. He is responsible for designing, conducting, and communicating disease-state as well as product-specific research, focused on capturing the economic, clinical, and humanistic outcomes of patients with hemophilia and other rare bleeding disorders, growth hormone disorder, diabetes and obesity, through research collaborations and partnerships with channel partners. Dr. Iyer is a pharmacist by training (Pune University, India) and received his MS and PhD in Health Economics & Outcomes Research from Purdue University in West Lafayette, IN.
Merck and Co. , Inc.
I am an Experience Health Economics and Outcomes Professional, currently working at Merck and Co, Inc.
Vice President, CMO
Novo Nordisk Inc
Plainsboro, New Jersey
Todd Hobbs, MD, is vice president and chief medical officer for Novo Nordisk in North America, where he leads the organization’s focus on the implications of diabetes for the patient, healthcare system and healthcare professionals.
Dr. Hobbs provides overall medical guidance to Novo Nordisk’s diabetes, cardiovascular, and obesity-related projects. He provides input into the clinical development and life-cycle management strategies for all approved products, as well as medical input into the R&D pipeline. He is involved with the optimization of relationships with top key opinion leaders and medical societies, and provides guidance to and participates in consultant advisory boards and key patient and professional association relationships.
He currently serves as a member of the board for the American Medical Group Association Foundation, the research foundation arm of the American Medical Group Association (AMGA).
Prior to working at Novo Nordisk, Dr. Hobbs had established a clinical practice based in Louisville, Kentucky, focusing on the intensive management of patients with diabetes of all ages, and served as chairman of the Medicine Department for a large Regional Medical Center in Kentucky. During this 10-year clinical career, he cared for more than 2,500 adults and children with diabetes, including outpatient and inpatient care, as well as intensive care.
Senior Director, Health Economics and Value Assessment
Senior Director, HEOR at Novo Nordisk at time of study
Janssen Research & Development
Dr. Kern is a director of Epidemiology at Janssen, and a member of the Epidemiology Analtyics team. His main responsibility is a therapeutic area epidemiologist for neuroscience, conducting research in Parkinson's disease and multiple sclerosis, utilizing insurance claims, registries and other data sources to support Janssen's neuroscience portfolio. Dave is also involved in the Observational Health Data Sciences and Informatics (OHDSI) group, a collaboration of researchers from various institutions and industries across the globe. Prior to joining Janssen in 2017, Dave spent seven years at HealthCore where he led a team of researchers performing health economic and outcomes research studies for various pharmaceutical and device companies utilizing administrative claims data, physician and patient surveys, and medical chart reviews. Dr. Kern received his PhD in Epidemiology from Drexel University and his Master of Science in Biostatistics from Columbia University.
Vincent J. Willey, PharmD, BCACP is a Principal Scientist for HealthCore. He is responsible for the overall scientific integrity for specific health economics and outcomes research and health services research projects as well as our late phase studies with a particular emphasis on pragmatic clinical trials. His focus is on assuring that HealthCore’s studies are sound from a clinical, research methodology and health care system perspective. From 2014 to 2017, Dr. Willey served as the Staff Vice President, Life Sciences Research (LSR) for HealthCore. Prior to this position, Dr. Willey was an Associate Professor of Pharmacy and Vice Chair at the Philadelphia College of Pharmacy within the University of the Sciences. He received his Bachelor of Pharmacy degree from the Philadelphia College of Pharmacy and Science and his Doctor of Pharmacy degree from the Philadelphia College of Pharmacy at the University of the Sciences.
Dr. Willey’s pharmacy practice experience spans 25+ years in the areas of community pharmacy, long-term care consulting, home infusion, and ambulatory care clinical services. From 2009 to 2014, he developed and implemented a pharmacist-managed program to assist a primary care physician group practice in the management of patients with diabetes (DM), cardiovascular disease (CVD), and respiratory disease within a patient-centered medical home (PCMH). Within the DM and CVD program, he provided services that included collection of detailed medical and medication histories, assessment of cardiovascular risk, providing physician recommendations, and on applicable patients, medication care plans, insulin initiation training, medication and disease state education, and therapeutic lifestyle modification counseling. Within the respiratory program, Dr. Willey performed detailed pulmonary histories, medication reconciliation, spirometry assessments and evaluation, as well as recommended and implemented comprehensive treatment plans. He currently maintains his credentials as a Board Certified Ambulatory Care pharmacist in addition to his pharmacy licensure.
Dr. Willey has published over 50 original research manuscripts in peer reviewed journals and presented at numerous medical, pharmacy and health-economic research national meetings. He has published and presented on a variety of topics, including DM, CVD, respiratory disease, mental health and cancer. His original research interests have focused on the outcomes associated with medication therapy in the “real-world” setting of clinical practice, the therapeutic area of dyslipidemia and diabetes management and the pharmacist within the patient-centered medical home concept. He has also served as a peer reviewer for multiple medical and pharmacy journals and is currently a member of the Editorial Board of the American Health and Drug Benefits journal and formally a member of the Journal of Managed Care Pharmacy’s Editorial Advisory Board. Dr. Willey served as the Chair of the Advisory Group for the American Pharmacists Association that was responsible for the content of their Pharmacy-Based Cardiovascular Disease Risk Management Certificate Training Program, a Member of the Agency for Healthcare Research and Quality’s Comparative Effectiveness Research (CER) Pharmacy Workgroup, had been selected as a stakeholder reviewer for the Patient-Centered Outcomes Research Institute (PCORI), and was previously a member of the Institutional Review Board at the University of Pennsylvania.