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New Diabetes Medications

New Diabetes Medications. Sniffy Insulin and Lizard Spit. Hilary Suzawa Med/Peds August 2006. Money! Money! Money!. Diabetic drug market $15 billion today Expected to be $25 billion in 2011 Cost $1500-2000 per year per patient for the new medications. Pathophysiology.

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New Diabetes Medications

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  1. New Diabetes Medications Sniffy Insulin and Lizard Spit Hilary Suzawa Med/Peds August 2006

  2. Money! Money! Money! • Diabetic drug market $15 billion today • Expected to be $25 billion in 2011 • Cost $1500-2000 per year per patient for the new medications

  3. Pathophysiology • It’s more than just insulin • An oral glucose load stimulates higher insulin secretion than an equal or higher IV glucose load • Something in the GI tract stimulates insulin • Incretin hormones are peptide hormones secreted by enteroendocrine cells that line the GI tract

  4. Other Hormones • GI secreted –Incretins • Gastric inhibitory peptide aka glucose-dependent insulinotropic peptide (GIP) • Glucagon-like peptide-1 and -2 (GLP-1, GLP-2) • In DM type II • GIP levels are normal but peptide loses its ability to stimulate insulin secretion (function) • GLP-1 levels are decreased (quantity) • GLP-1 is rapidly inactivated by enzyme dipeptidyl peptidase-IV (DPP-IV) • Islet cell secreted—Amylin

  5. Incretins • Stimulate glucose-dependent insulin secretion • Increase insulin in response to meals • Lower risk of hypoglycemia • Suppresses inappropriate glucagon secretion • Increases Beta cell growth and replication • Slows gastric emptying • May decrease food intake (satiety)

  6. Amylin • Suppresses glucagon secretion • especially postprandial • Decreases postprandial hepatic GLC production • Decreases postprandial GLC levels • Reduces gastric emptying time • Centrally-mediated induction of satiety • In DM type II, Amylin secretion delayed and decreased (quantity)

  7. New Kids on the Block

  8. Flew Under the Radar • Pramlintide (Symlin) • Amylin mimic • FDA approved 3/2005

  9. Exenatide (Byetta): GLP-1 mimic • Approved 6/2004 • Synthetic version of exendin-4 (isolated from the venom of the Gila monster) • Mechanism: Binds to GLP-1 receptor (mimic) • Resistant to DPP-IV and so has increased half-life

  10. Exenatide (Byetta) • Injection (subcutaneous) • Pre-filled pen; 250 mcg/ml • Dose • 5 mcg BID within 60 minutes prior to a meal • After one month may increase to 10 mcg BID • Currently BID but may soon have a weekly formulation (Exenatide LAR)

  11. Exenatide (Byetta) • Most common side effect: Nausea • Benefits • Weight loss • Low risk of hypoglycemia • Animal studies—may help pancreas re-grow cells • Efficacy • When added to sulfonylureas or metformin additional lowering of HbA1c by 0.5-1% • Renal excretion

  12. Inhaled Insulin (Exubera) • FDA approved 1/2006 • Inhaled • Dose • 0.05 mg/kg (round down) TID within 10 minutes of a meal • 1 mg and 3 mg blisters • Three 1 mg blisters gives higher level than one 3 mg blister • Give two 1 mg blisters instead of one 3 mg blister if need to substitute

  13. Inhaled Insulin (Exubera) • Side Effects • Respiratory sx, decreases in PFTs (baseline recommended) • Chest pain • Hypoglycemia • Xerostomia and Rash • Otitis media and ear pain (pediatrics) • If current smoker or quit within past 6 months then increased absorption may lead to increased risk of hypoglycemia • Renal excretion

  14. Gliptins (DPP-IV inhibitor) • (Vildagliptin) Galvus & (Sitagliptin) Januvia • Inhibits the destruction of GLP-1 (DPP-IV inhibitor; dipeptidyl peptidase IV inhibitor) • Raise levels of the hormone GLP-1 • Causes the pancreas to produce more insulin • Not as efficacious as metformin • Use as adjunct instead of sulfonylureas (avoid hypoglycemia and weight gain)

  15. Vildagliptin (Galvus) • Dose • 50 mg po daily or 50 mg po BID • Increased GLP-1 and GIP in DM type I and DM type II • Decrease triglycerides • Improved insulin sensitivity • Most common side effect: • Mild hypoglycemia

  16. Sitagliptin (Januvia) • Dose • 100 mg po daily or 200 mg po daily • Renal excretion

  17. Pramlintide (Symlin) • Synthetic analog of human amylin • Mechanism: Supresses glucagon • Adjunctive therapy • Decrease insulin dose by 50% when add Symlin • Dose • Type I: 15 mcg immediately before meals, increase to target 30-60 mcg • Type II: 60 mcg immediately before meals, increase to target 120 mcg

  18. Pramlintide (Symlin) • Side effects • Hypoglycemia (*boxed warning) • Nausea • Headache • Benefits • Weight loss

  19. Key Points • New medications are adjuncts and do not replace insulin or glucophage (Metformin) as mainstays of treatment • Many of the medications are given with meals • Exenatide (Byetta) may help with weight loss • Inhaled insulin (Exubera) may cause respiratory sx and must check baseline PFTs • Vildagliptin (Galvus) and Sitagliptin (Januvia) not yet on the market • Must decrease insulin dose 50% if add Pramlintide (Symlin) because of hypoglycemia

  20. Bibliography • Berenson, A. 4 Diabetes Drugs are Seen Raising Hope and Profit. New York Times June 22, 2006. • Jeha G and Heptulla R. Newer therapeutic options for children with diabetes mellitus: theoretical and practical considerations. Pediatric Diabetes 2006: 7: 122-138. • Trujillo J. Incretin hormones in the treatment of type 2 diabetes. Formulary March 2006: 41: 130-141 • Up to Date • http://www.glucagon.com

  21. The End

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