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AHRQ’s Effective Health Care Program: Applying Existing Evidence to Diabetes Care

AHRQ’s Effective Health Care Program: Applying Existing Evidence to Diabetes Care. Tuesday, December 14, 2010 CALL-IN TELEPHONE NUMBER: (888) 632-5065 ACCESS CODE: 25848872#. Questions. To submit a question: Press the “Ask Question” button located at the bottom of the screen.

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AHRQ’s Effective Health Care Program: Applying Existing Evidence to Diabetes Care

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  1. AHRQ’s Effective Health Care Program: Applying Existing Evidence to Diabetes Care Tuesday, December 14, 2010 CALL-IN TELEPHONE NUMBER: (888) 632-5065 ACCESS CODE: 25848872#

  2. Questions To submit a question: • Press the “Ask Question” button located at the bottom of the screen. • When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. • Once completed, press the “Submit” button. CALL-IN NUMBER: (888) 632-5065 ACCESS CODE: 25848872# 2

  3. Agenda • Brief Overview of Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program- Sonia Nagda, moderator • Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults With Type 2 Diabetes- Rehan Qayyum, M.D., M.H.S. • Q&A from Audience CALL-IN NUMBER: (888) 632-5065 ACCESS CODE: 25848872# 3

  4. Questions To submit a question: Press the “Ask Question” button located at the bottom of the screen. When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. Once completed, press the “Submit” button. 4

  5. Patient-Centered Outcomes Research and AHRQ’s Effective Health Care Program Sonia Nagda, M.D., M.P.H. AHRQ’s Office of Communications and Knowledge Transfer 5

  6. Patient-Centered Outcomes Research • Also known as comparative effectiveness research • Unbiased and practical, evidence-based information • Compares drugs, devices, tests and surgeries, and approaches to health care • Benefits and harms • What is known and what isn’t • Descriptive, not prescriptive Harms Benefits 6

  7. A Framework for Patient-Centered Outcomes Research Evidence Generation Strategies Interventions Conditions Populations Improvements in Health Care Horizon Scanning Evidence Need Identification Dissemination Translation Evidence Synthesis Research Platform Infrastructure – Methods Development – Training 7

  8. Research Focus: 14 Priority Conditions Arthritis and nontraumatic joint disorders Cancer Cardiovascular disease, including stroke and hypertension Dementia, including Alzheimer’s disease Depression and other mental health disorders Developmental delays, ADHD and autism Diabetes mellitus Functional limitations and disability Infectious diseases, including HIV/AIDS Obesity Peptic ulcer disease and dyspepsia Pregnancy including preterm birth Pulmonary disease/asthma Substance abuse 8

  9. Effective Health Care Program Translation Products Patient Decision Aid (available soon) Executive Summary Web Site Systematic Review Report Clinician Guide Faculty Slides Consumer Guide Interactive Case Study Policymaker Summary 9 CE Modules

  10. Diabetes Resources 10

  11. Public Involvement Report Translation & Dissemination Topic Generation Topic Refinement Research Review Research Needs Development Topic Development During the Research Process Disseminating the Findings • Nominate topics using the online form • Participate in key question refinement • Comment via the web on draft key questions and reports Web links Newsletter blurbs Articles or commentaries Web conferences Continuing Education 11

  12. Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults with Type 2 Diabetes Rehan Qayyum, M.D., M.H.S. Prepared for: Agency for Healthcare Research and Quality Contract No. #290-02-0018 Prepared by: Evidence-based Practice Center, The Johns Hopkins University 12

  13. Insulin Analogues Insulin analogues are altered forms of human insulin with minor structural changes without affecting glycemic control These structural changes impart pharmacokinetic properties that allow better control of the onset and duration of insulinlike activity. These analogues are produced using recombinant DNA technology. 13

  14. Insulin Analogues 14

  15. Premixed Insulin Analogues Mixture of rapid-acting and intermediate-acting insulin analogues Intermediate-acting insulin is prepared by mixing insulin analogues with protamine sulfate 15

  16. Key Questions In adults (age ≥ 18 years) with type 2 diabetes, what is the effectiveness of premixed insulin analogues (insulin aspart 70/30, insulin lispro 75/25, insulin lispro 50/50) in achieving optimal glycemic control, as compared to insulin regimens including, but not necessarily limited to, the following preparations? Premixed human insulin preparations (neutral protamine Hagedorn [NPH]/regular 70/30, NPH/regular 50/50) Long-acting insulin analogues (insulin detemir, insulin glargine) administered alone Intermediate-acting human insulin (NPH insulin) administered alone Short-acting human insulin (regular insulin) administered prandially Rapid-acting insulin analogues (insulin aspart, insulin glulisine, insulin lispro) administered separately (prandially) with a long-acting insulin analogue (insulin detemir, insulin glargine) For adults with type 2 diabetes, do premixed insulin analogues differ from other commonly used insulin preparations with regard to safety, adverse effects, or adherence? The adverse effects of interest include, but are not limited to, hypoglycemia (nocturnal and daytime), weight gain, and interactions with other medications. 16

  17. Key Questions (cont.) 3. Does the effectiveness or safety of the new premixed insulin analogue regimens vary across the following subpopulations of patients with type 2 diabetes • The elderly (≥ 65 years), very elderly (≥ 85 years) • Other demographic groups (ethnic or racial groups, genders) • Individuals with comorbid medical conditions • Individuals with limited life expectancy • Individuals with disabilities 4. What is the effectiveness and safety of the new premixed insulin analogue regimens in individuals on oral antidiabetic agents and individuals with different blood glucose patterns (such as fasting hyperglycemia or postprandial hyperglycemia) or types of control (such as tight control, usual control, good fasting or postprandial control)? 17

  18. Methods Search Strategy Electronic database (February 2008) Hand search of literature and Web sites Scientific information submitted by the pharmacy industry Study Inclusion Criteria Clinical trials and observational studies Two reviewers independently selected studies Data Abstraction For relevant outcomes Crossover studies excluded from progressive outcomes 18

  19. Statistical Methods Intermediate outcomes (Fasting and postprandial glucose, A1c) Random effects model Adverse Effects (Hypoglycemia, weight change) Random effects model Clinical Outcomes (rare-event data) Fixed effects model (Mantel-Haenszel) Sensitivity analysis with Peto’s method and Bayesian random-effects model 19

  20. Results 20 Qayyum et al. Ann Intern Med. 2008; 21:549-559

  21. Results- Fasting Glucose - 21 Qayyum et al. Ann Intern Med. 2008; 21:549-559

  22. Results- Postprandial Glucose - 22 Qayyum et al. Ann Intern Med. 2008; 21:549-559

  23. Results- Hemoglobin A1C - 23 Qayyum et al. Ann Intern Med. 2008; 21:549-559

  24. Results- Hypoglycemia - 24 Qayyum et al. Ann Intern Med. 2008; 21:549-559

  25. Results- Weight Change - 25

  26. Results- Other Comparisons - No or scant data for other comparisons 26

  27. Results- Clinical Outcomes - 27 Qayyum et al. Ann Intern Med. 2008; 21:549-559

  28. Results- Quality of Life - Six studies evaluated this outcome. In four studies using validated measurement tools, only one of six quality of life outcomes (psychological distress) showed a statistically significant difference, in favor of premixed insulin analogues over other antidiabetic agents. 28

  29. Results- in combination with oral agents - Fasting glucose, Postprandial glucose, and Hypoglycemia 3 studies; no significant difference Hemoglobin A1c 3 studies, combination better than premixed analogues alone Weight change and Clinical outcomes 2 studies, no significant difference 29

  30. Results No evidence for adherence to treatment regimen effectiveness and safety in subpopulations of interest different intensity of glucose control targeting fasting versus postprandial glucose control 30

  31. Case Study 1 50-year-old obese diabetic male comes in for his regular clinic visit HbA1C = 8.7 Fasting glucose = 160-190 On glipizide 10 mg twice daily and metformin XL 1000mg twice daily 31

  32. Case Study 2 56-year-old diabetic female comes in for her regular clinic visit HbA1C = 7.4 Fasting glucose = 120-140 Postprandial glucose = 180-220 On glyburide/metformin 5/500 BID and sitagliptin 100mg QD 32

  33. Summary 33

  34. Questions To submit a question: Press the “Ask Question” button located at the bottom of the screen. When you click on the button, a box will appear at the bottom of your screen requesting that you enter your question. Once completed, press the “Submit” button. 34

  35. For more information about… • AHRQ’s Effective Health Care Program: www.effectivehealthcare.ahrq.gov. • Accessing these FREE resources through AHRQ’s Publications Clearinghouse: (800) 358-9295. • E-mail notices: http://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/. • If you have a question about utilizing AHRQ resources please e-mail us at: EHC_Clinicians@ahrq.hhs.gov. 35

  36. Thank you! • Thank you for joining us today! • Please take a moment to provide us feedback at the end of this event. • A recording and transcript for today’s event will be available on AHRQ’s Web site. 36

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