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Achieving Diabetes Targets Where are we, and how can we do better?

Achieving Diabetes Targets Where are we, and how can we do better?. Robert E. Ratner, MD MedStar Research Institute Georgetown University Medical School Washington, DC. EVERY 24 HOURS. New Cases – 4,100 Amputations – 230 (60% of non-traumatic amputations annually)

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Achieving Diabetes Targets Where are we, and how can we do better?

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  1. Achieving Diabetes TargetsWhere are we, and how can we do better? Robert E. Ratner, MD MedStar Research Institute Georgetown University Medical School Washington, DC

  2. EVERY 24 HOURS • New Cases – 4,100 • Amputations – 230 (60% of non-traumatic amputations annually) • Blindness – 55 (#1 cause) • Kidney Failure – 120 (#1 cause) • Deaths – 810 - >60% due to CVD Derived from NIDDK, National Diabetes Statistics fact sheet. HHS, NIH, 2005.

  3. $132 Billion for Total Excess U.S. Cost Attributable to Diabetes in 2002 Costs in Millions of Dollars Indirect Costs Institutional Care Medication and Supplies Outpatient Care American Diabetes Association. Diabetes Care 2003;26:917-932.

  4. Projected impact of changing demographic characteristics on the national cost of diabetes: 2002–2020 (in 2002 billions of dollars) Source: Economic Costs of Diabetes in the U.S. in 2002, Lewin Group, Inc., for the American Diabetes Association, 2002. (http://care.diabetesjournals.org/cgi/content/full/26/3/9617)

  5. Number of Persons Initiating Treatment for End-Stage Renal Disease Related to Diabetes, United States, 1984–2002 Source: National Diabetes Surveillance System – CDC website (http://www.cdc.gov/diabetes/statistics/index.htm)

  6. Adjusted ESRD incident rates, by primary diagnosis, & diabetes in the general population Incident ESRD patients; rates adjusted for age, gender, & race. USRDS, accessed July 13, 2007

  7. Adjusted ESRD incident rates of ESRD due to diabetes illi illi lla lla Incident ESRD patients; adjusted for age, gender, & race. USRDS, accessed July 13, 2007

  8. Prevalence of Visual Impairment per 100 Adults with Diabetes, by Age, United States, 1997–2003 Source: National Diabetes Surveillance System – CDC website (http://www.cdc.gov/diabetes/statistics/index.htm)

  9. Hospital Discharge Rates forNontraumatic Lower Extremity Amputation per 1,000 Diabetic Population, by Age, United States, 1980–2003 Source: National Diabetes Surveillance System – CDC website (http://www.cdc.gov/diabetes/statistics/index.htm)

  10. 1 5 p<0.0001 1 0 Hazard ratio 1 37% decrease per 1% decrement in HbA1c 0 . 5 0 5 6 7 8 9 1 0 1 1 Updated mean HbA1c UKPDS 35. BMJ 2000; 321: 405-12 Microvascular Endpoints

  11. 5 p<0.0001 Hazard ratio 1 14% decrease per 1% decrement in HbA1c 0 . 5 0 5 6 7 8 9 1 0 1 1 Updated mean HbA1c UKPDS 35. BMJ 2000; 321: 405-12 Fatal and Non-Fatal Myocardial Infarction

  12. 5 p=0.035 Hazard ratio 1 12% decrease per 1% decrement in HbA1c 0 . 5 0 5 6 7 8 9 1 0 1 1 Updated mean HbA1c UKPDS 35. BMJ 2000; 321: 405-12 Fatal and Non-Fatal Stroke

  13. Microvasculardisease Incidence per1000 patient-years Myocardialinfarction Updated mean HbA1c (%) Myocardial Infarction and Microvascular Disease UKPDS 35. BMJ 2000; 321: 405-12

  14. A1c is a good biologic correlate to microvascular disease complications A1c is a less powerful correlate to macrovascular disease due to the multi-factorial nature of the CVD

  15. Percent of Patients (n=122,453) (n=62,252) (n=35,472) (n=20,688) (n=29,893) Aggressive Control of Type 2 Diabetes is a Challenge • 76% of patients surveyed had an A1C level recorded in the chart in the previous 12 months Distribution of A1C (%) Among Patients with Recorded Test Results (n=270,758) in Community Practice Graham, et al. Diabetes 2002;51(Suppl 2):A274.

  16. Lessons from the DCCT and UKPDS:Sustained Intensification of Therapy is Difficult DCCT EDIC (Type 1) UKPDS (Type 2),Insulin Group 10 8 9.0 8.1 7.9 8 7.3 HbA1c (%) HbA1c (%) 7 Baseline 6 6 Normal 4 0 0 6.5 + 4 + 6 yrs 0 2 4 6 8 10 yrs DCCT EDIC UK Prospective Diabetes Study Group (UKPDS) 33:Lancet.1998;352:837–853. DCCT/EDIC Research Group. New Engl J Med. 2000; 342: 381-389. Steffes et al. Diabetes. 2001 (suppl. 2) 50: A63.

  17. Progress in Achieving A1C Goal % of adult patients with Diabetes Physician Recognition Program, average performance of applicants, 1997-2003 data. * Lower is better for this measure. www.ncqa.org

  18. Secondary endpoint : HbA1c Treatment difference (95% CI) Rosiglitazone vs metformin, -0.13 (-0.22 to -0.05); P=0.002 Rosiglitazone vs glyburide, -0.42 (-0.50 to -0.33); P<0.001 8.0 7.6 7.2 Glycated Hemoglobin (%) 6.8 Annualized slope (95% CI) 6.4 Rosiglitazone, 0.07 (0.06 to 0.09) Metformin, 0.14 (0.13 to 0.16)* Glyburide, 0.24 (0.23 to 0.26)* 6.0 0 0 1 2 3 4 5 Years No. of Patients 4012 3308 2991 2583 2197 822 *Significant difference rosiglitazone vs other treatment groups with Hochberg adjustment. Kahn SE, et al. N Engl J Med 2006;355:2427–2443.

  19. Clinical Inertia: Failure to Advance Therapy When Required Percentage of Subjects advancing when HbA1C >8% • At Insulin Initiation, the average patient had: • 5 years with HbA1C >8% • 10 years with HbA1C >7% 100 80 66.6% 60 % Age of Subjects 44.6% 40 35.3% 18.6% 20 0 Diet Sulfonylurea Metformin Combination 1Brown et al. The Burden of Treatment Failure in Type 2 Diabetes. Diabetes Care 27. 1535-1540, 2004

  20. Severe Adverse EffectsSubstantiated in Published Clinical Trials Hypoglycemia Lactic acidosis CV InsulinYesNo No SulfonylureasYesYes? No MetforminNoNoYes -Glucosidase inhibitors No No No Glitazones (TZDs) No Yes(CHF) No Repaglinide, nateglinide*Yes No No Incretin Mimetics/Enhancers No No No * Recently available agents with few trials documenting long-term outcomes CV=cardiovascular; CHF=congestive heart failure

  21. Weight Gain is a Common Side Effect of Most Oral Agents for Type 2 Diabetes • Oral antidiabetic agent* • Weight change (kg) -3.8-0.5 • Metformin1-3 -0.2-4.3 • SUs1-4 0.9-4.6 • TZDs4-6 0.3-3.0 • Meglitinides4,7,8 -0.3-1.9 • Metformin + SU1-3 0.8-2.1 • Metformin + TZD5,6,9 -5 -4 -3 -2 -1 0 1 2 3 4 5 • 1. Bristol-Myers Squibb. Glucophage® Full prescribing Information. 2004. • 2. Bristol-Myers Squibb. Glucovance® Full prescribing Information. 2004. • 3. Bristol-Myers Squibb. Metaglip® Full Prescribing Information. 2002. • 4. Malone M. Ann Pharmacother. 2005;39:2046-2055. • 5. Eli Lilly. Actos® Full Prescribing Information. 2004. • 6. GlaxoSmithKline. Avandia® Full Prescribing Information. 2005. • 7. Novartis. Starlix® Full Prescribing Information. 2004. • 8. Novo Nordisk. Prandin® Full Prescribing Information. 2004. • 9. GlaxoSmithKline. Avandamet® Full Prescribing Information. 2005. *Data are not from head-to-head studies

  22. Adherence to Prescribed Drugs in Patients with Type 2 Diabetes Mateo JF et al. Int J Clin Pract. 2006;60:422-428.

  23. Diabetes Care. 2004 May 1; 27(5):1218-1224 Insulin adherence among patients with type 2 diabetes was 62-64%

  24. Medical BenefitsSubstantiated in Published Clinical Trials Microvascular Cardiovascular InsulinYes Yes? SulfonylureasYesNo MetforminYes Yes? -Glucosidase inhibitorsNoYes? Glitazones (TZDs) No No Repaglinide, nateglinide* No NoIncretin Mimetics/Enhancers* No No * Recently available agents with few trials documenting long-term outcomes

  25. Does Treatment of Diabetes impact Mortality? Kahler KH, et al. Diabetes Care 30:1689, 2007

  26. Why do we need new therapies for Type 2 Diabetes? • The epidemic of diabetes and its complications will soon swamp our medical delivery system • A1c is a well validated short term target • We are not currently achieving our glycemic targets • Current therapies have either limited efficacy, marked complexity, or unacceptable side effects • Therapies must be acceptable to patients and health care providers – They must be utilized!

  27. What should drive diabetes drug development and approval? • Safety (Hepatic, CVD, Hypoglycemia – While realizing that diabetes is a serious disease!) • Efficacy (glycemic control, risk factor reduction) • Side Effects (weight gain) • Patient acceptability

  28. 50000 45000 40000 35000 30000 25000 20000 15000 10000 5000 0 DM + DM + DM + HTN DM HD HTN + HD Only The Business Case for a Comprehensive Approach MEAN CUMULATIVE 3-YEAR MEDICAL CHARGES FOR DIABETES PATIENTS BY CO-MORBIDITIES AND GLYCEMIC CONTROL $ HbA1c 10% HbA1c 9% HbA1c 8% HbA1c 7% HbA1c 6% DM = Diabetes; HTN = Hypertension; HD = Heart Disease Gilmer, et al. Diab. Care, 1997; 20:1847-1853

  29. Cost/ QALY lifetime follow-upUS cohort >=25 years Glycemia Hypertension Lipid Intervention type CDC JAMA 2002

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