Gelesis100

Last updated
Gelesis100
Other namesPlenity
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.

Contents

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]

Related Research Articles

<span class="mw-page-title-main">Obesity</span> Medical condition in which excess body fat harms health

Obesity is a medical condition, sometimes considered a disease, in which excess body fat has accumulated to such an extent that it can potentially have negative affects on health. People are classified as obese when their body mass index (BMI)—a person's weight divided by the square of the person's height—is over 30 kg/m2; the range 25–30 kg/m2 is defined as overweight. Some East Asian countries use lower values to calculate obesity. Obesity is a major cause of disability and is correlated with various diseases and conditions, particularly cardiovascular diseases, type 2 diabetes, obstructive sleep apnea, certain types of cancer, and osteoarthritis.

<span class="mw-page-title-main">Irritable bowel syndrome</span> Functional gastrointestinal disorder

Irritable bowel syndrome (IBS) is a "disorder of gut-brain interaction" characterized by a group of symptoms that commonly include abdominal pain, abdominal bloating and changes in the consistency of bowel movements. These symptoms may occur over a long time, sometimes for years. IBS can negatively affect quality of life and may result in missed school or work or reduced productivity at work. Disorders such as anxiety, major depression, and chronic fatigue syndrome are common among people with IBS.

<span class="mw-page-title-main">Weight loss</span> Reduction of the total body mass

Weight loss, in the context of medicine, health, or physical fitness, refers to a reduction of the total body mass, by a mean loss of fluid, body fat, or lean mass. Weight loss can either occur unintentionally because of malnourishment or an underlying disease, or from a conscious effort to improve an actual or perceived overweight or obese state. "Unexplained" weight loss that is not caused by reduction in calorific intake or increase in exercise is called cachexia and may be a symptom of a serious medical condition.

<span class="mw-page-title-main">Gastric bypass surgery</span> Type of bariatric surgery

Gastric bypass surgery refers to a technique in which the stomach is divided into a small upper pouch and a much larger lower "remnant" pouch and then the small intestine is rearranged to connect to both. Surgeons have developed several different ways to reconnect the intestine, thus leading to several different gastric bypass procedures (GBP). Any GBP leads to a marked reduction in the functional volume of the stomach, accompanied by an altered physiological and physical response to food.

<span class="mw-page-title-main">Malabsorption</span> Medical condition

Malabsorption is a state arising from abnormality in absorption of food nutrients across the gastrointestinal (GI) tract. Impairment can be of single or multiple nutrients depending on the abnormality. This may lead to malnutrition and a variety of anaemias.

<span class="mw-page-title-main">Anti-obesity medication</span> Class of pharmacological agents

Anti-obesity medication or weight loss medications are pharmacological agents that reduce or control excess body fat. These medications alter one of the fundamental processes of the human body, weight regulation, by reducing appetite and consequently energy intake, increasing energy expenditure, redirecting nutrients from adipose to lean tissue, or interfering with the absorption of calories.

<span class="mw-page-title-main">Small intestinal bacterial overgrowth</span> Medical condition

Small intestinal bacterial overgrowth (SIBO), also termed bacterial overgrowth, or small bowel bacterial overgrowth syndrome (SBBOS), is a disorder of excessive bacterial growth in the small intestine. Unlike the colon, which is rich with bacteria, the small bowel usually has fewer than 100,000 organisms per millilitre. Patients with bacterial overgrowth typically develop symptoms which may include nausea, bloating, vomiting, diarrhea, malnutrition, weight loss and malabsorption, which is caused by a number of mechanisms.

Bariatrics is the branch of medicine that deals with the causes, prevention, and treatment of obesity.

<span class="mw-page-title-main">Colestyramine</span> Pharmaceutical drug

Colestyramine (INN) or cholestyramine (USAN) is a bile acid sequestrant, which binds bile in the gastrointestinal tract to prevent its reabsorption. It is a strong ion exchange resin, which means it can exchange its chloride anions with anionic bile acids in the gastrointestinal tract and bind them strongly in the resin matrix. The functional group of the anion exchange resin is a quaternary ammonium group attached to an inert styrene-divinylbenzene copolymer.

Necrotizing enterocolitis (NEC) is a devastating intestinal disease that affects premature or very low birth weight infants. Symptoms may include poor feeding, bloating, decreased activity, blood in the stool, vomiting of bile, bowel death, multiorgan failure, and even death.

<span class="mw-page-title-main">Blind loop syndrome</span> Medical condition

Blind loop syndrome, also known as stagnant loop syndrome, is a state that occurs when the normal bacterial flora of the small intestine proliferates to numbers that cause significant derangement to the normal physiological processes of digestion and absorption. In some cases of blind loop syndrome, overgrowth of pathogenic non-commensal bacteria has also been noted. It has long been understood that from birth, and throughout life, large amounts of bacteria reside symbiotically within animal gastrointestinal tracts such as the human gastrointestinal tract. The understanding of this gut flora has even led to novel treatments for bowel irregularity that utilize so called "probiotics" or good bacteria that aid in normal digestion. The problem of blind loop syndrome arises when the bacterial colonies residing in the upper gastrointestinal tract begin to grow out of control or are altered in their makeup thereby creating a burden on the normal physiological processes occurring in the small intestine. This results in problems, among others, of: vitamin B12 deficiency, fat malabsorption and steatorrhea, fat-soluble vitamin deficiencies and intestinal wall injury.

<span class="mw-page-title-main">Exocrine pancreatic insufficiency</span> Human disease

Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack or reduction of digestive enzymes made by the pancreas. EPI can occur in humans and is prevalent in many conditions such as cystic fibrosis, Shwachman–Diamond syndrome, different types of pancreatitis, multiple types of diabetes mellitus, advanced renal disease, older adults, celiac disease, IBS-D, IBD, HIV, alcohol-related liver disease, Sjogren syndrome, tobacco use, and use of somatostatin analogues.

Radiation enteropathy is a syndrome that may develop following abdominal or pelvic radiation therapy for cancer. Many affected people are cancer survivors who had treatment for cervical cancer or prostate cancer; it has also been termed pelvic radiation disease with radiation proctitis being one of the principal features.

<span class="mw-page-title-main">SeHCAT</span> Chemical compound

SeHCAT is a drug used in a clinical test to diagnose bile acid malabsorption.

Chronic diarrheaof infancy, also called toddler's diarrhea, is a common condition typically affecting up to 1.7 billion children between ages 6–30 months worldwide every year, usually resolving by age 4. According to the World Health Organization (WHO), diarrheal disease is the second greatest cause of death in children 5 years and younger. Diarrheal disease takes the lives of 525,000 or more children per year. Diarrhea is characterized as the condition of passing of three or more loose or watery bowel movements within a day sometimes with undigested food visible. Diarrhea is separated into three clinical categories; acute diarrhea may last multiple hours or days, acute bloody diarrhea, also known as dysentery, and finally, chronic or persistent diarrhea which lasts 2–4 weeks or more. There is normal growth with no evidence of malnutrition in the child experiencing persistent diarrhea. In chronic diarrhea there is no evidence of blood in the stool and there is no sign of infection. The condition may be related to irritable bowel syndrome. There are various tests that can be performed to rule out other causes of diarrhea that don't fall under the chronic criteria, including blood test, colonoscopy, and even genetic testing. Most acute or severe cases of diarrhea have treatment guidelines revolving around prescription or non prescription medications based on the cause, but the treatment protocols for chronic diarrhea focus on replenishing the body with lost fluids and electrolytes, because there typically isn't a treatable cause.

Management of obesity can include lifestyle changes, medications, or surgery. Although many studies have sought effective interventions, there is currently no evidence-based, well-defined, and efficient intervention to prevent obesity.

Bile acid malabsorption (BAM), known also as bile acid diarrhea, is a cause of several gut-related problems, the main one being chronic diarrhea. It has also been called bile acid-induced diarrhea, cholerheic or choleretic enteropathy, bile salt diarrhea or bile salt malabsorption. It can result from malabsorption secondary to gastrointestinal disease, or be a primary disorder, associated with excessive bile acid production. Treatment with bile acid sequestrants is often effective. It is recognised as a disability in the United Kingdom under the Equality Act 2010

Semaglutide is an antidiabetic medication used for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management. It was developed by Novo Nordisk It was approved for use in the US in 2017. It is a peptide similar to the hormone glucagon-like peptide-1 (GLP-1), modified with a side chain. It can be administered by subcutaneous injection or taken orally. It is sold under the brand names Ozempic (injectable) and Rybelsus (pill) for diabetes, and under the brand name Wegovy for weight loss.

In medicine, endoscopic sleeve gastroplasty (ESG) is a minimally-invasive, non-surgical (incisionless), endoscopic weight loss procedure that is part of the field of endoscopic bariatric therapies. To perform ESG, a physician sutures a patient’s stomach into a narrower, smaller tube-like configuration. The result is a more restricted stomach that forces patients to feel fuller sooner, eating fewer calories, which facilitates weight loss.

Intestinal bypass is a bariatric surgery performed on patients with morbid obesity to create an irreversible weight loss, when implementing harsh restrictions on the diets have failed. Jejunocolic anastomosis was firstly employed. Nonetheless, it led to some unexpected complications such as severe electrolyte imbalance and liver failure. It was then modified to jejunoileal techniques. Viewed as a novel form of treatment for obesity, many intestinal bypass operations were carried out in the 1960s and 1980s. Significant weight loss was observed in patients, but this surgery also resulted in several complications, for instance, nutritional deficiencies and metabolic problems. Due to the presence of surgical alternatives and anti-obesity medications, intestinal bypass is now rarely used.

References

  1. 1 2 3 4 5 6 7 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.
  2. 1 2 3 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.
  3. 1 2 3 Lee, Bruce Y. (Apr 18, 2019). "Plenity Now Is FDA-Approved For Weight Management". Forbes.
  4. "De Novo request for classification of Plenity" (PDF). U.S. Food & Drug Administration.
  5. 1 2 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.
  6. 1 2 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.
  7. 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.
  8. 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.
  9. 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.
  10. Appleby, Julie (June 22, 2022). "New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results". Kaiser Health News.
  11. 1 2 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.