| Gelesis100 | |
|---|---|
| Other names | Plenity Oral superabsorbent hydrogel |
| [edit on Wikidata] | |
Gelesis100, sold under the brand name Plenity, is an oral hydrogel used to treat overweight and obesity. It absorbs water and expands in the stomach and small bowel thereby increasing feelings of fullness. Possible side effects include primarily gastrointestinal symptoms, such as diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence. It is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis. The US Food and Drug Administration approved it in 2019 as a medical device. Gelesis100 was developed by the company Gelesis.
History
The US Food and Drug Administration approved the use of Gelesis100 in April 2019 as a medical device. Gelesis100 is the first treatment of its kind for overweight and obesity. In 2022, the American Gastroenterology Association published a guideline for the management of obesity, which recommended the use of Gelesis100 be limited to clinical trials due to limited evidence.
Uses and effectiveness
Gelesis100 is used to treat obesity and overweight as an anti-obesity medication. Gelesis100 is taken as a pill before meals with water.
Gelesis100 has been criticized for its small impact on weight loss relative to side effects.
Mechanism and physiology
Gelesis100 is an oral superabsorbent hydrogel, which is produced from carboxymethylcellulose and citric acid. The cross-linked product forms a hydrophilic matrix, which absorbs water. Taken in capsule form by mouth, as Gelesis100 absorbs water, it expands in the stomach and small intestine. After absorbing water, a semisolid gel structure forms, which may promote satiety and result in weight loss via reduced caloric intake.
Contraindications
Gelesis100 is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.
Side effects
Side effects consist of minor gastrointestinal symptoms, including diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence. Gelesis100 is not associated with any severe adverse events. However, long-term safety data beyond 24 weeks is not available.
References
- ^ Pass, A; Bialonczyk, D; Chiquette, E; Goldman, JD (2020-12-21). "Oral Superabsorbent Hydrogel (Plenity) for Weight Management". The Annals of Pharmacotherapy. 55 (9): 1146–1152. doi:10.1177/1060028020983046. PMID 33348994. S2CID 229351539.
- ^ Kahan, S; Kumbhari, V (February 2019). "A Weight Loss Device That Looks Like a Pill". Obesity. 27 (2): 189. doi:10.1002/oby.22399. PMID 30677264. S2CID 59252036.
- ^ Lee, Bruce Y. (Apr 18, 2019). "Plenity Now Is FDA-Approved For Weight Management". Forbes.
- "De Novo request for classification of Plenity" (PDF). U.S. Food & Drug Administration.
- ^ Grunvald, E; Shah, R; Hernaez, R; Chandar, AK; Pickett-Blakely, O; Teigen, LM; Harindhanavudhi, T; Sultan, S; Singh, S; Davitkov, P; AGA Clinical Guidelines, Committee (November 2022). "AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity". Gastroenterology. 163 (5): 1198–1225. doi:10.1053/j.gastro.2022.08.045. PMID 36273831.
- ^ Umashanker, D; Igel, LI; Kumar, RB; Aronne, LJ (April 2017). "Current and Future Medical Treatment of Obesity". Gastrointestinal Endoscopy Clinics of North America. 27 (2): 181–190. doi:10.1016/j.giec.2016.12.008. PMID 28292399.
- Greenway, FL; Aronne, LJ; Raben, A; Astrup, A; Apovian, CM; Hill, JO; Kaplan, LM; Fujioka, K; Matejkova, E; Svacina, S; Luzi, L; Gnessi, L; Navas-Carretero, S; Alfredo Martinez, J; Still, CD; Sannino, A; Saponaro, C; Demitri, C; Urban, LE; Leider, H; Chiquette, E; Ron, ES; Zohar, Y; Heshmati, HM (February 2019). "A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss". Obesity. 27 (2): 205–216. doi:10.1002/oby.22347. PMC 6587502. PMID 30421844.
- Miller, LE; Bhattacharyya, R (September 2019). "Unclear Benefit of Gelesis100 for Body Weight Loss". Obesity. 27 (9): 1383. doi:10.1002/oby.22532. PMID 31264776. S2CID 195771241.
- Naguy, A; Alamiri, B (March 2020). "2019 FDA approved psychotherapeutic medications". Asian Journal of Psychiatry. 49: 101976. doi:10.1016/j.ajp.2020.101976. PMID 32120296. S2CID 211831891.
- Appleby, Julie (June 22, 2022). "New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results". Kaiser Health News.
- ^ Mechanick, JI; Apovian, C; Brethauer, S; Garvey, WT; Joffe, AM; Kim, J; Kushner, RF; Lindquist, R; Pessah-Pollack, R; Seger, J; Urman, RD; Adams, S; Cleek, JB; Correa, R; Figaro, MK; Flanders, K; Grams, J; Hurley, DL; Kothari, S; Seger, MV; Still, CD (December 2019). "Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures – 2019 Update". Endocrine Practice. 25 (12): 1346–1359. doi:10.4158/GL-2019-0406. PMID 31682518.