II. Indications

  1. Obesity (BMI 27 to 40)

III. Contraindications

  1. Abnormal gastrointestinal motility
  2. Altered Gastrointestinal Anatomy (e.g. Esophageal Strictures)
  3. Pregnancy
  4. Caution in GERD and Peptic Ulcer Disease

IV. Mechanism

  1. Considered a medical device (lower efficacy threshold for approval than medications)
  2. Capsule contains thousands of cellulose hydrogel beads and citric acid
  3. Three capsule dose (taken with water) expands in Stomach and proximal Small Intestine
    1. Increased bulk reduces Stomach capacity for additional intake
    2. Increases satiety
  4. Particles are not absorbed (passed unchanged, unmetabolized into stool)

V. Dosing

  1. Plenity 3 capsules with 16 ounces water taken 20-30 min before lunch and before dinner
  2. Discontinue use if insignificant weight loss at 2 months

VI. Cost

  1. Estimated at $100 per month

VII. Adverse Effects

  1. Gastrointestinal (e.g. Flatulence, Abdominal Pain, Abdominal Bloating) in 40% of patients

VIII. Efficacy

  1. In 6 months of taking medication, results in 2% greater weight loss than Placebo
  2. Similar weight loss to Orlistat, but less weight loss than other medications (e.g. Phentermine, Qsymia)

IX. Drug Interactions

  1. May interfere with absorption of other medications

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