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What We Know About Semaglutide Opposed Occasions and Gastroparesis: Half I

Semaglutide-containing drugs bought underneath the model names Ozempic® and Wegovy® have made headlines after being linked to gastroparesis. Each drugs belong to a category of medication referred to as glucagon-like peptide-1 (GLP-1) receptor agonists. GLP-1 is a regulator of urge for food and caloric consumption and is understood to have numerous drug interactions attributable to delayed gastric emptying on account of remedy.

In a 2-year research (ClinicalTrials.gov Identifier: NCT03693430) of semaglutide use in sufferers with obese or weight problems, researchers discovered that 82.2% of sufferers taking semaglutide skilled gentle to average gastrointestinal (GI) adversarial occasions in contrast with 53.9% within the placebo group. There have been no experiences of gastroparesis within the research.1

Whereas semaglutide and different GLP-1 agonists trigger adversarial occasions, similar to nausea, vomiting, diarrhea, and a variety of different GI signs, these results of delayed gastric emptying are reported to be decreased after 20 weeks of use. 2


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What Are Different Causes of Gastroparesis?

Diabetes is the commonest underlying reason behind gastroparesis and may injury the vagus nerve, resulting in impaired muscular operate within the abdomen and small gut.3 Research present that the 10-year cumulative incidence of diabetic gastroparesis is estimated to be 5.2% amongst sufferers with sort 1 diabetes and 1% in sufferers with sort 2 diabetes.4

Different recognized causes of gastroparesis embrace celiac illness, neurological problems similar to Parkinson illness and central nervous system tumors, collagen vascular problems similar to scleroderma and systemic lupus erythematosus, hypothyroidism, and drugs.5

Drugs that can lead to delayed gastric emptying resulting in gastroparesis embrace proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, opioid analgesics, progesterone, lithium, cyclosporin, and levodopa.5

Analysis on semaglutide-induced gastroparesis is proscribed, however affected person experiences have been rising.

Case Research of GLP-1-Induced Gastroparesis

1. A 52-year-old lady with a 10-year historical past of diabetes offered with a 7-month historical past of postprandial epigastric ache with concomitant fullness, bloating, and nausea that was unrelieved after proton pump inhibitors and antispasmodics. She was initiated on weekly semaglutide subcutaneous injection 1 month previous to symptom onset, and her diabetes is presently well-managed (A1c, 5.7%). A 4-hour scintigraphic gastric emptying (SGE) check indicated delayed gastric emptying. Semaglutide was held for six weeks, resulting in symptom decision.6

2. A 57-year-old lady with a 16-year historical past of diabetes offered with a yr historical past of belly bloating, nausea, and vomiting. The affected person was initiated on dulaglutide subcutaneous weekly injection 15 months prior and has an A1c of 8.2%. A SGE confirmed delayed gastric emptying. Dulaglutide was held for 4 weeks, leading to a gradual decision of signs.6

3. A 52-year-old man with a historical past of diabetes, hypertension, and hyperlipidemia offered with a 1-week historical past of nausea, belly distension, and ache. The affected person was receiving day by day liraglutide for glycemic management (A1c, 7%). After non permanent discontinuation of liraglutide, dietary modification, and a brief course of antiemetics and metoclopramide, the person’s signs resolved.7

Semaglutide and Gastroparesis within the Information

In July 2023, 3 girls informed CNN that they developed extreme GI signs after receiving remedy with semaglutide injections. Two of the ladies had been recognized with extreme gastroparesis.8

Then, in early August 2023, a girl sued Novo Nordisk and Eli Lilly, the producers of semaglutide and tirzepatide injections, alleging that the businesses did not warn sufferers of extreme GI signs. The girl reported abdomen ache, extreme vomiting, GI burning, hospitalization attributable to abdomen points, and a lack of enamel attributable to extreme vomiting.9

Whereas each treatment package deal inserts state that delayed gastric emptying is feasible with the treatment and will have an effect on drug absorption, they don’t particularly state that gastroparesis is a possible danger.10 The GI adversarial occasions listed on the semaglutide package deal inserts look like gentle to average, together with nausea, abdomen ache, bloating, constipation, diarrhea, and vomiting.10-12

As the recognition of those drugs will increase, consultants count on a rise in GI adversarial occasion experiences sooner or later. The US Meals and Drug Administration (FDA) informed CNN in a press release that they’ve “received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report.”8

Nevertheless, the FDA additionally informed CNN that they’re unable to verify if the drugs straight prompted gastroparesis or another etiology.8

Lively IngredientModel TitleFDA-Permitted Indication10-15Formulation10-15
SemaglutideWegovy; OzempicDiabetes: Adjunct to weight loss program and train to enhance glycemic management in adults   Continual Weight Administration: Adjunct to a decreased caloric weight loss program and elevated train in adultsSubcutaneous injection
SemaglutideRybelsusDiabetes: Adjunct to weight loss program and train to enhance glycemic management in adultsOral pill
DulaglutideTrulicityDiabetes: Adjunct to weight loss program and train to enhance glycemic management in sufferers 10 years and older and cut back danger for main adversarial cardiovascular occasionsSubcutaneous injection
LiraglutideSaxenda; VictozaDiabetes: Adjunct to weight loss program and train to enhance glycemic management in adults   Continual Weight Administration: Adjunct to a decreased caloric weight loss program and elevated train in kids and adultsSubcutaneous injection
Desk 2. GLP-1 Agonists Permitted by the US Meals and Drug Administration

Clinician Pointers for Managing Gastroparesis

Clinicians don’t suggest semaglutide for sufferers who expertise signs of gastroparesis.4 An SGE over a length of three hours is advisable when evaluating for gastroparesis in sufferers with higher GI signs. If an SGE evaluation will not be possible, wi-fi motility capsule or a secure isotope breath check is an inexpensive various.16

Dietary modifications with small-particle, low-fat, nondigestible meals are advisable to offer symptom aid and improve gastric emptying. Metoclopramide, domperidone, or 5-HT4 agonists are advisable to enhance gastric emptying. Antiemetics are prompt for symptom management however don’t enhance gastric emptying. Central neuromodulators, ghrelin agonists, and haloperidol aren’t advisable in remedy.19

There may be restricted analysis on the administration of medication- or drug-induced gastroparesis. Primarily based on present case research, administration consists of discontinuation of the treatment, symptom management with antiemetics and prokinetic brokers per tips, dietary help, and dietary modification.7 Additional analysis is warranted to determine subsequent steps for sufferers who develop gastroparesis after semaglutide use, and whether or not reinitiation of remedy is feasible after dialogue of profit vs danger with their well being care supplier.

References

  1. Garvey WT, Batterham, RL Bhatta M, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Night time With. 2022;28: 2083–2091. doi:10.1038/s41591-022-02026-4
  2. Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. Printed on-line December 2, 2020. doi:10.1111/dom.14280
  3. Signs & Causes of Gastroparesis. Nationwide Institute of Diabetes and Digestive and Kidney Illnesses. Final up to date January 2018. Accessed August 4, 2023. https://www.niddk.nih.gov/health-information/digestive-diseases/gastroparesis/symptoms-causes
  4. Younger CF, Moussa M, Shubrook JH. Diabetic gastroparesis: a review. Diabetes Spectr. 2020;33(3):290–297. doi:10.2337/ds19-0062
  5. Parkman HP, Hasler WL, Fisher RS. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004; 127(5):1592-1622. doi:1053/j.gastro.2004.09.055
  6. Ammar Class M, Galura GM, McCallum RW. Medication-induced gastroparesis: a case report. J Investig Med Excessive Influence Case Rep. Printed on-line October 18, 2021. doi:10.1177/23247096211051919
  7. Rai P, Madi MY, Dickstein A. Liraglutide-induced acute gastroparesis. Cureus. Printed on-line December 28, 2018. doi:10.7759/cureus.3791
  8. Goodman B. They took blockbuster medication for weight reduction and diabetes. Now their stomachs are paralyzed. CNN. Printed July 25, 2023. Up to date August 29, 2023. Accessed August 29, 2023. https://www.cnn.com/2023/07/25/health/weight-loss-diabetes-drugs-gastroparesis/index.html
  9. Shapero J. Ozempic, Mounjaro producers sued over danger of abdomen paralysis. The Hill. Printed on-line August 2, 2023. Accessed August 10, 2023. https://thehill.com/policy/healthcare/4134614-ozempic-mounjaro-sued-stomach-paralysis/
  10. Meals and Drug Administration. Wegovy Prescribing Data. Up to date June 2021. Accessed August 10, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf
  11. Meals and Drug Administration. Ozempic Prescribing Data. Up to date December 2017. Accessed August 10, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
  12. Meals and Drug Administration. Rybelsus Prescribing Data. Up to date September 2019. Accessed August 10, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf
  13. Meals and Drug Administration. Trulicity Prescribing Data. Up to date November 2022. Accessed August 29, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf
  14. Meals and Drug Administration. Saxenda Prescribing Data. Up to date April 2023. Accessed August 29, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206321s016lbl.pdf
  15. Meals and Drug Administration. Victoza Prescribing Data. Up to date July 2023. Accessed August 29, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf
  16. Camilleri M, Kuo B, Nguyen L, et al. ACG clinical guideline: gastroparesis. Am J Gastroenterol. 117(8):1197-1220 . doi:10.14309/ajg.00000000000001874
That is the primary article in a 2-part sequence on gastroparesis. The second article Clinician Insights on Learn how to Handle Semaglutide-Induced Gastroparesis: Half II is accessible here.

This text initially appeared on Gastroenterology Advisor

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