Gelesis100 Explained
Gelesis100 |
Synonyms: | Plenity Oral superabsorbent hydrogel |
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.[1] 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.
Uses and effectiveness
Gelesis100 is used to treat obesity and overweight as an anti-obesity medication.[3] Gelesis100 is taken as a pill before meals with water.[4] [5]
Gelesis100 has been criticized for its small impact on weight loss relative to side effects.[6]
Mechanism and physiology
Gelesis100 is an oral superabsorbent hydrogel, which is produced from carboxymethylcellulose and citric acid.[7] The cross-linked product forms a hydrophilic matrix, which absorbs water. Taken in capsule form by mouth,[8] as Gelesis100 absorbs water, it expands in the stomach and small intestine.[9] After absorbing water, a semisolid gel structure forms, which may promote satiety and result in weight loss via reduced caloric intake.[10]
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.[11] However, long-term safety data beyond 24 weeks is not available.
External links
Notes and References
- Web site: De Novo request for classification of Plenity . U.S. Food & Drug Administration.
- Kahan . S . Kumbhari . V . A Weight Loss Device That Looks Like a Pill. . Obesity . February 2019 . 27 . 2 . 189 . 10.1002/oby.22399 . 30677264. 59252036 . free .
- Pass . A . Bialonczyk . D . Chiquette . E . Goldman . JD . Oral Superabsorbent Hydrogel (Plenity) for Weight Management. . The Annals of Pharmacotherapy . 2020-12-21 . 55 . 1146–1152 . 9 . 10.1177/1060028020983046 . 33348994. 229351539 .
- Umashanker . D . Igel . LI . Kumar . RB . Aronne . LJ . Current and Future Medical Treatment of Obesity. . Gastrointestinal Endoscopy Clinics of North America . April 2017 . 27 . 2 . 181–190 . 10.1016/j.giec.2016.12.008 . 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 . A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. . Obesity . February 2019 . 27 . 2 . 205–216 . 10.1002/oby.22347 . 30421844. 6587502 .
- Miller . LE . Bhattacharyya . R . Unclear Benefit of Gelesis100 for Body Weight Loss. . Obesity . September 2019 . 27 . 9 . 1383 . 10.1002/oby.22532 . 31264776. 195771241 .
- Naguy . A . Alamiri . B . 2019 FDA approved psychotherapeutic medications. . Asian Journal of Psychiatry . March 2020 . 49 . 101976 . 10.1016/j.ajp.2020.101976 . 32120296. 211831891 .
- News: Appleby . Julie . New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results . Kaiser Health News . June 22, 2022.
- News: Lee . Bruce Y. . Plenity Now Is FDA-Approved For Weight Management . Forbes . Apr 18, 2019.
- 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 . AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity. . Gastroenterology . November 2022 . 163 . 5 . 1198–1225 . 10.1053/j.gastro.2022.08.045 . 36273831. free .
- 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 . Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures – 2019 Update . Endocrine Practice . December 2019 . 25 . 12 . 1346–1359 . 10.4158/GL-2019-0406 . 31682518. free .