II. Indications
- Obesity (BMI 27 to 40)
III. Contraindications
- Abnormal gastrointestinal motility
- Altered Gastrointestinal Anatomy (e.g. Esophageal Strictures)
- Pregnancy
- Caution in GERD and Peptic Ulcer Disease
IV. Mechanism
- Considered a medical device (lower efficacy threshold for approval than medications)
- Capsule contains thousands of cellulose hydrogel beads and citric acid
- Three capsule dose (taken with water) expands in Stomach and proximal Small Intestine
- Increased bulk reduces Stomach capacity for additional intake
- Increases satiety
- Particles are not absorbed (passed unchanged, unmetabolized into stool)
V. Dosing
- Plenity 3 capsules with 16 ounces water taken 20-30 min before lunch and before dinner
- Discontinue use if insignificant weight loss at 2 months
VI. Cost
- Estimated at $100 per month
VII. Adverse Effects
- Gastrointestinal (e.g. Flatulence, Abdominal Pain, Abdominal Bloating) in 40% of patients
VIII. Efficacy
- In 6 months of taking medication, results in 2% greater weight loss than Placebo
- Similar weight loss to Orlistat, but less weight loss than other medications (e.g. Phentermine, Qsymia)
IX. Drug Interactions
- May interfere with absorption of other medications
