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4/16/2016 Disclosures The Rapidly Changing Landscape Consulting of Diabetes Mellitus: What You Merck, Astra Zeneca, Novartis Need to Know Research BMS Joshua Beckman, MD Ownership Director, Section of Vascular Medicine


  1. 4/16/2016 Disclosures The Rapidly Changing Landscape • Consulting of Diabetes Mellitus: What You – Merck, Astra Zeneca, Novartis Need to Know • Research – BMS Joshua Beckman, MD • Ownership Director, Section of Vascular Medicine – Janacare, EMX Vanderbilt University 5-Year Risk of Developing Agenda Ischemic Ulceration • What we worry about N=1244 men with claudication 50 • What is happening now Risk of Ischemic DM Present DM Absent 40 Ulceration, % • Why the change 30 20 10 0 | | | | | | | | | | | 0.8 0.7 0.9 0.6 0.5 0.4 0.3 0.2 0.1 ABI Aquino R. J Vasc Surg. 2001;34:962-970. 1

  2. 4/16/2016 Diabetes and Insulin Resistance is Present in Patients with CAD: Incidence of Contralateral The Euro Heart Survey CLI in Diabetic Subjects A survey 110 centers in 25 countries of 4196 patients referred to Incidence of CLI and amputation of the contralateral limb in 533 diabetic a cardiologist for CAD (2107 acutely & 2854 electively). Patients without pts hospitalized because of CLI from 1999 to 2003 and followed-up until 2005. DM underwent oral glucose tolerance testing when stable. 1.00 Critical Limb Ischemia 0.75 0.50 0.25 0.00 0 2 4 6 8 Years Bartnik, M. Eur Heart J 2004; 25(21):1880 Faglia, E. Diabetes Res Clin Prac. 2007:77: 445–450 Annualized Rate of Diabetes The Presence of CVD and CKD Per 1000 Persons Strongly Predicts CVD Events Analysis of 29 clinical trials of patients with diabetes evaluating the impact of Trends in diabetes incidence in persons 40-55 years in Framingham Study participants. Baseline cardiovascular disease and proteinuria on event rates MI + Stroke (Events/1000 patient-years) Trials stratified by baseline CVD prevalence No CVD 10.6 Some CVD 24.6 All CVD 35.2 Trials stratified by baseline protienuria prevalence No proteinuria 6.5 Some proteinuria 19.1 All proteinuria 25.3 Preiss, D AHJ 2011;161:210-219 Abraham, TM. Diab Care 2015: 38(3): 482-7 2

  3. 4/16/2016 Number and Percentage of U.S. Population with Prevalence and Incidence Trends for Diagnosed Diagnosed Diabetes, 1958-2013 Diabetes Among Adults Aged 20 to 79 Years, United 8 25 States, 1980-2012 7 Percentage with Diabetes 20 In 1997, the diabetes diagnostic criteria for fasting plasma glucose was lowered from Number with Diabetes Number with Diabetes Percentage with Diabetes 6 140 mg/dL or more to 126 mg/dL or more; in 2010, hemoglobin A 1c was adopted for the diagnosis of diabetes. From the from the National Health Interview Survey (NHIS). 5 15 (Millions) 4 10 3 2 5 1 0 0 1958 62 66 70 74 78 82 86 90 94 98 02 06 10 13 Year CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes/statistics Geiss JAMA. 2014;312(12):1218-1226. Provincial distribution diabetes Prevalence of diabetes and per prevalence in China in the last decade capita GRP in China Zuo. Diabetes Research and Clinical Practice, 2014; 104:63–72 Zuo. Diabetes Research and Clinical Practice, 2014; 104:63–72 3

  4. 4/16/2016 Meta ‐ analysis of Diabetes and Prior MI on Coronary Revascularization During Risk of Fatal and Non-Fatal MI Hospitalization In Patients with Diabetes National Inpatient Sample, 2000–2010 Bulugahapitya, U. Diabet Med 2009; 26:142-8 Bina Ahmed et al. J Am Heart Assoc 2014;3:e001090 Decrease Mortality Rates by Sex In Trends in Age-Standardized Rates of Diabetes-Related Complications among Patients with Diabetes U.S. Adults, 1990–2010. National Inpatient Sample, 2000–2010 Data from the National Health Interview Survey, the National Hospital Discharge Survey, the U.S. Renal Data System, and the U.S. National Vital Statistics System Gregg EW et al. N Engl J Med 2014;370:1514-1523. Bina Ahmed et al. J Am Heart Assoc 2014;3:e001090 4

  5. 4/16/2016 Long-Term Outcomes in Diabetes Effect of CT Angio CAD Screening Mellitus Related to Prolonging in Diabetes Patients: DIAD 64 Clopidogrel After Coronary Stenting 900 pts, DM 3-5 yrs, randomized to CTA or not. 38% normal. 28,849 patients undergoing stenting in VHA Thukkani, AK. JACC, Volume 66, Issue 10, 2015, 1091–1101 Nuhlestein, J JAMA 2014;213:2234-43 Cardiovascular Outcomes and Death Incidence of CVD, MI, or stroke with from Any Cause in EMPA-REG OUTCOME vorapaxar vs placebo stratified by diabetic 7028 patients with CV disease and diet controlled DM randomized status. TRA-2P To empagliflozin 10 or 25 mg daily or placebo Matthew A. Cavender et al. Circulation. 2015;131:1047-1053 Zinman B et al. N Engl J Med 2015;373:2117-2128. 5

  6. 4/16/2016 Summary • Diabetes and cardiovascular disease are inextricably linked. • Standard therapies proved to reduce cardiovascular risk work in diabetes – Blood pressure control – Statin therapy – Antiplatelet therapy • Aggressive use of standard therapies would reduce the cardiovascular disease burden substantially 6

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