Medicine:Gelesis100
| Gelesis100 | |
|---|---|
| Other names | Plenity Oral superabsorbent hydrogel |
Gelesis100, sold under the brand name Plenity, is an oral hydrogel used to treat overweight and obesity.[1] It absorbs water and expands in the stomach and small bowel thereby increasing feelings of fullness. Possible side effects include primarily gastrointestinal symptoms,[2] such as diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence.[3] It is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.[1] 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.[4] Gelesis100 is the first treatment of its kind for overweight and obesity.[2] 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.[5]
Uses and effectiveness
Gelesis100 is used to treat obesity and overweight as an anti-obesity medication.[1] Gelesis100 is taken as a pill before meals with water.[6][7]
Gelesis100 has been criticized for its small impact on weight loss relative to side effects.[8]
Mechanism and physiology
Gelesis100 is an oral superabsorbent hydrogel, which is produced from carboxymethylcellulose and citric acid.[1][9] The cross-linked product forms a hydrophilic matrix, which absorbs water.[1] Taken in capsule form by mouth,[10] as Gelesis100 absorbs water, it expands in the stomach and small intestine.[3][6] After absorbing water, a semisolid gel structure forms, which may promote satiety and result in weight loss[1] via reduced caloric intake.[5]
Contraindications
Gelesis100 is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.[1]
Side effects
Side effects consist of minor gastrointestinal symptoms,[2] including diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence.[3] Gelesis100 is not associated with any severe adverse events.[11] However, long-term safety data beyond 24 weeks is not available.[11]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 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.
- ↑ 2.0 2.1 2.2 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.
- ↑ 3.0 3.1 3.2 Lee, Bruce Y. (Apr 18, 2019). "Plenity Now Is FDA-Approved For Weight Management". Forbes. https://www.forbes.com/sites/brucelee/2019/04/18/plenity-now-is-fda-approved-for-weight-management/?sh=3beed8b312a8.
- ↑ "De Novo request for classification of Plenity". U.S. Food & Drug Administration. https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180060.pdf.
- ↑ 5.0 5.1 Grunvald, E; Shah, R; Hernaez, R; Chandar, AK; Pickett-Blakely, O; Teigen, LM; Harindhanavudhi, T; Sultan, S et al. (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.
- ↑ 6.0 6.1 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 et al. (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. 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.
- ↑ 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.
- ↑ Appleby, Julie (June 22, 2022). "New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results". Kaiser Health News. https://khn.org/news/article/new-weight-loss-treatment-is-marked-by-heavy-marketing-and-modest-results/.
- ↑ 11.0 11.1 Mechanick, JI; Apovian, C; Brethauer, S; Garvey, WT; Joffe, AM; Kim, J; Kushner, RF; Lindquist, R et al. (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.
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