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Newer Diabetes Medications, TZDs, and Combinations Final Original Report February 2011

Methods. PopulationsAdults and children with type 2 diabetes for all included drugsAdults and children with type 1 diabetes for pramlintideInterventionsNewer Diabetes MedicationsAmylin Agonists: pramlintideDPP-4 Inhibitors: sitagliptin, saxagliptinGLP-1 Agonists: exenatide, liraglutide. 2. M

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Newer Diabetes Medications, TZDs, and Combinations Final Original Report February 2011

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    2. Methods Populations Adults and children with type 2 diabetes for all included drugs Adults and children with type 1 diabetes for pramlintide Interventions Newer Diabetes Medications Amylin Agonists: pramlintide DPP-4 Inhibitors: sitagliptin, saxagliptin GLP-1 Agonists: exenatide, liraglutide 2

    3. Methods (continued) Interventions (continued) Thiazolidinediones (TZDs) Rosiglitazone Pioglitazone Fixed dose combination products and dual therapy Avandamet® (rosiglitazone + metformin) Avandaryl® (rosiglitazone + glimepiride) Actoplus Met® (pioglitazone + metformin) Duetact® (pioglitazone + glimepiride) Janumet® (sitagliptin + metformin) 3

    4. Methods (continued) Electronic database searches through July 2010 Pharmaceutical company submissions six pharmaceutical companies submitted dossiers for all included drugs except pramlintide 4

    5. Evidence in children: All key questions and all included medications For children, the strength of evidence was insufficient to make conclusions for all included medications The remaining slides address evidence in adults 5

    6. Key Question 1 What is the comparative efficacy and effectiveness of newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? 6

    7. Health Outcomes Some studies of these medications reported some health outcomes such as all-cause mortality or number of people with macrovascular disease among secondary outcomes or among adverse events, but overall evidence was insufficient to determine how the newer diabetes medications and combinations compare with other treatments for their impact on health outcomes.

    8. Pramlintide, T1 DM 8

    9. Pramlintide, T2 DM 9

    10. Sitagliptin 10

    11. Sitagliptin 11

    12. Saxagliptin 12

    13. Exenatide 13

    14. Exenatide 14

    15. Exenatide 15

    16. Liraglutide 16

    17. Liraglutide 17

    18. Liraglutide 18

    19. Pioglitazone 19

    20. Rosiglitazone 20

    21. FDCPs and Dual Therapy 21

    22. Key Question 2 What is the comparative tolerability and frequency of adverse events for newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? 22

    23. Pramlintide, T1 DM 23

    24. Pramlintide, T2 DM 24

    25. Sitagliptin 25

    26. Sitagliptin 26

    27. Saxagliptin 27

    28. Exenatide 28

    29. Exenatide 29

    30. Exenatide 30

    31. Liraglutide 31

    32. Liraglutide 32

    33. Rosiglitazone and Pioglitazone 33

    34. Rosiglitazone and Pioglitazone 34

    35. FDCPs and Dual Therapy: Avandamet® or dual therapy with metformin plus rosiglitazone 35

    36. FDCPs and Dual Therapy: Avandaryl® or dual therapy with rosiglitazone and glimepiride 36

    37. FDCPs and Dual Therapy: Actoplus Met® or dual therapy with pioglitazone and metformin 37 -Evidence was limited to one large trial (N=600) comparing Actoplus Met® with component monotherapies and a 15 month trial comparing dual therapy with pioglitazone and metformin to monotherapy with either that reported very little harms information.-Evidence was limited to one large trial (N=600) comparing Actoplus Met® with component monotherapies and a 15 month trial comparing dual therapy with pioglitazone and metformin to monotherapy with either that reported very little harms information.

    38. FDCPs and Dual Therapy: Janumet® or dual therapy with sitagliptin and metformin 38

    39. Key Question 3 Are there subgroups of patients based on demographics (age, racial groups, gender), comorbidities (drug-disease interactions, obesity), or other medications (drug-drug interactions) for which newer diabetes medications, TZDs, and drug combinations (administered as combination products or dual therapy) differ in efficacy/effectiveness or frequency of adverse events? 39

    40. Key Question 3 40

    41. Conclusions All of the included medications were efficacious for reducing HbA1c and none of the newer medications appear to cause weight gain. Little data were available to evaluate the long-term effectiveness of the newer medications compared with more established treatments, limiting our ability to determine how to best incorporate newer medications into clinical practice. 41

    42. The information in this slide show is based on the drug class review report written by Daniel E. Jonas, MD, MPH Erin Van Scoyoc, MD, MPH Kate Gerrald, PharmD, BCPS Roberta Wines, MPH Halle Amick, MSPH Matthew Triplette, MPH Thomas Runge, MPH RTI-UNC Evidence-based Practice Center 42

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