II. Indications

  1. Type I and II Diabetes Mellitus
    1. Adjunct to Insulin therapy
    2. Third-line measure due to Hypoglycemia risk and cost

III. Contraindications

  1. Gastroparesis
  2. Hypoglycemia history (esp. if patient unaware of episodes)

IV. Mechanism

  1. Pramlintide is a synthetic analogue of human Amylin
  2. Amylin is secreted with Insulin from the Pancreas
  3. Amylin lowers post-prandial Blood Sugars
    1. Delays gastric emptying
    2. Inhibits Glucagon release

V. Precautions

  1. Switch to new pen device which replaces the vials and prevents dosing errors
    1. Warning: Pen concentration is different than vial concentration
  2. Dosing errors are common with the vials
    1. Dosing is typically listed in mcg, but is drawn up in Insulin syringes marked with units
    2. A patient who mistakes their 30 mcg dose for 30 units is accidentally taking 180 mcg

VI. Medications

  1. Pramlintide (SymlinPen) 1000 mcg/ml pen injector: 1.5 or 2.7 ml
    1. Pen replaces the older vials that required a 100 unit 0.3 ml syringe
  2. Store unopened vials in refrigerator
    1. Once opened, may be kept at room Temperature for up to 28 days

VII. Dosing

  1. Protocol
    1. Reduce short and mixed-acting Insulin dose by 50%
    2. Take with at least 250 calories (>30 g Carbohydrate)
    3. Inject SQ into Abdomen or thigh
  2. Type I Diabetes Mellitus
    1. Start: 15 mcg (2.5 U) SQ three times daily immediately before meals
    2. Titrated in 15 mcg increments every 3-7 days if tolerated (without significant Nausea, Vomiting)
    3. Target: 30 to 60 mcg (5-10 units) SQ three times daily before meals
    4. Discontinue or lower dose to 30 mcg if significant Nausea
  3. Type II Diabetes Mellitus
    1. Start: 60 mcg (10 U) SQ three times daily immediately before meals
    2. Target: 60 to 120 mcg (10-20 units) SQ three times daily before meals
    3. Discontinue or lower dose to 60 mcg if significant Nausea

VIII. Adverse effects

  1. Nausea (28%) or Vomiting (8%): Especically Type I DM (related to Delayed Gastric Emptying)
    1. Contraindicated in Gastroparesis
  2. Headache (13%)
  3. Anorexia (9%)
  4. Abdominal Pain (8%)
  5. Severe Hypoglycemia (4.7%)
    1. Occurs 3 hours after Insulin and Pramlintide dose (higher risk in Type 1 Diabetes Mellitus)
    2. FDA Black box warning (decrease Insulin dose before starting)

IX. Safety

  1. Pregnancy Category C
  2. Unknown safety in Lactation

X. Efficacy

  1. Drops Hemoglobin A1C 0.5 to 0.6% (contrast with Placebo: 0.25% )
  2. No good longterm outcome data (other agents with better longterm efficacy are preferred)
  3. Lowers weight 3 lb or 1.4 kg (Placebo: 0.6 kg gained)

XI. Drug Interactions

  1. Gastrointestinal motility medications
    1. Avoid with Pramlintide
  2. Alpha glucosidase Inhibitors
    1. Avoid with Pramlintide
  3. Drugs that require rapid onset
    1. Take rapid onset medications 1 hour prior to, or 2 hours after Pramlintide

Images: Related links to external sites (from Bing)

Related Studies