Current and emerging pharmacotherapy for the treatment of gastroparesis

References

• Camilleri M, Sanders KM. Gastroparesis. Gastroenterology. 2022;162(1):68–87.e1. doi: 10.1053/j.gastro.2021.10.028
   PubMed Web of Science ®Google Scholar
• Parkman HP, Hallinan EK, Hasler WL, et al. Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis. Neurogastroenterol Motil. 2016;28(12):1902–1914. doi: 10.1111/nmo.12893
   PubMed Web of Science ®Google Scholar
• Camilleri M, Chedid V, Ford AC, et al. Gastroparesis. Nat Rev Dis Primers. 2018 [Published 2018 Nov 1];4(1):41. doi: 10.1038/s41572-018-0038-z
   PubMed Web of Science ®Google Scholar
• Ye Y, Jiang B, Manne S, et al. Epidemiology and outcomes of gastroparesis, as documented in general practice records, in the United Kingdom. Gut. 2021;70(4):644–653. doi: 10.1136/gutjnl-2020-321277
   PubMed Web of Science ®Google Scholar
• Syed AR, Wolfe MM, Calles-Escandon J. Epidemiology and diagnosis of gastroparesis in the United States: a population-based study. J Clin Gastroenterol. 2020;54(1):50–54. doi: 10.1097/MCG.0000000000001231
   PubMed Web of Science ®Google Scholar
• Jung HK, Choung RS, Locke GR 3rd, et al. The incidence, prevalence, and outcomes of patients with Gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009;136(4):1225–1233.
   PubMed Web of Science ®Google Scholar
• Hasler WL. Symptomatic management for Gastroparesis: antiemetics, analgesics, and symptom modulators. Gastroenterol Clin North Am. 2015;44(1):113–126. doi: 10.1016/j.gtc.2014.11.009
   PubMed Web of Science ®Google Scholar
• Homko CJ, Duffy F, Friedenberg FK, et al. Effect of dietary fat and food consistency on gastroparesis symptoms in patients with gastroparesis. Neurogastroenterol Motil. 2015;27(4):501–508. doi: 10.1111/nmo.12519
   PubMed Web of Science ®Google Scholar
• Usai-Satta P, Bellini M, Morelli O, et al. Gastroparesis: new insights into an old disease. World J Gastroenterol. 2020;26(19):2333–2348. doi: 10.3748/wjg.v26.i19.2333
   PubMed Web of Science ®Google Scholar
• Tack J, Camilleri M, Chang L, et al. Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders. Aliment Pharmacol Ther. 2012;35(7):745–767.
   PubMed Web of Science ®Google Scholar
• Sayuk GS, Tack J. Tegaserod: What’s old is new again. Clin Gastroenterol Hepatol. 2022;20(10):2175–84.e19. doi: 10.1016/j.cgh.2022.01.024
   PubMed Web of Science ®Google Scholar
• Lacy BE, Pimentel M, Brenner DM, et al. ACG clinical guideline: management of irritable bowel syndrome. Am J Gastroenterol. 2021;116(1):17–44. doi: 10.14309/ajg.0000000000001036
   PubMed Web of Science ®Google Scholar
• Al-Saffar A, Lennernäs H, Hellström PM. Gastroparesis, metoclopramide, and tardive dyskinesia: risk revisited. Neurogastroenterol Motil. 2019;31(11):e13617. doi: 10.1111/nmo.13617.
   PubMedGoogle Scholar
• Qayed E, Muftah M. Frequency of hospital readmission and care fragmentation in gastroparesis: a nationwide analysis. World J Gastrointest Endosc. 2018;10(9):200–209. doi: 10.4253/wjge.v10.i9.200
   PubMedGoogle Scholar
• Camilleri M, Kuo B, Nguyen L, et al. ACG Clinical Guideline: GP. Am J Gastroenterol. 2022;117(8):1197–1220.
   PubMed Web of Science ®Google Scholar
• Thielemans L, Depoortere I, Perret J, et al. Desensitization of the human motilin receptor by motilides. J Pharmacol Exp Ther. 2005;313(3):1397–1405. doi: 10.1124/jpet.104.081497
   PubMed Web of Science ®Google Scholar
• Lee A, Kuo B. Metoclopramide in the treatment of diabetic GP. Expert Rev Endocrinol Metab. 2010;5(5):653–662. doi: 10.1586/eem.10.41
   PubMedGoogle Scholar
• Tonini M, Cipollina L, Poluzzi E, et al. Review article: clinical implications of enteric and central D2 receptor blockade by antidopaminergic gastrointestinal prokinetics. Aliment Pharmacol Ther. 2004;19(4):379–390.
   PubMed Web of Science ®Google Scholar
• Sanger GJ. Metoclopramide: A template for drug discovery. J Drug Des Res. 2017;4:1031.
   Google Scholar
• van der Padt A, van Schaik RH, Sonneveld P. Acute dystonic reaction to metoclopramide in patients carrying homozygous cytochrome P450 2D6 genetic polymorphisms. Neth J Med. 2006;64(5):160–162.
   PubMed Web of Science ®Google Scholar
• Gaedigk A, Sangkuhl K, Whirl-Carrillo M, et al. Prediction of CYP2D6 phenotype from genotype across world populations [published correction appears in genet med. 2016 Nov;18(11): 1167]. Genet Med. 2017;19(1):69–76. doi: 10.1038/gim.2016.80
   PubMed Web of Science ®Google Scholar
• Bateman DN. Clinical pharmacokinetics of metoclopramide. Clin Pharmacokinet. 1983;8(6):523–529. doi: 10.2165/00003088-198308060-00003
   PubMed Web of Science ®Google Scholar
• Gopisankar MG. CYP2D6 pharmacogenomics. Egypt J Med Hum Genet. 2017;18(4):309–313. doi: 10.1016/j.ejmhg.2017.03.001
   Google Scholar
• https://www.drugs.com/newdrugs/fda-approves-gimoti-metoclopramide-nasal-diabetic-gastroparesis-5269.html
   Google Scholar
• Nasal Metoclopramide Prescribing Information. cited 2024 Jan 3. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209388s000lbl.pdf
   Google Scholar
• Perkel MS, Moore C, Hersh T, et al. Metoclopramide therapy in patients with delayed gastric emptying: a randomized, double-blind study. Dig Dis Sci. 1979;24(9):662–666. doi: 10.1007/BF01314461
   PubMed Web of Science ®Google Scholar
• Ormrod D, Goa KL. Intranasal metoclopramide. Drugs. 1999;58(2):315–324. doi: 10.2165/00003495-199958020-00012
   PubMed Web of Science ®Google Scholar
• Parkman HP, Carlson MR, Gonyer D. Metoclopramide nasal spray reduces symptoms of gp in women, but not men, with diabetes: results of a phase 2b randomized study. Clin Gastroenterol Hepatol. 2015;13(7):1256–63.e1. doi: 10.1016/j.cgh.2014.12.030
   PubMed Web of Science ®Google Scholar
• McCallum RW, Fass R, Bhandari BR, et al. Symptom severity influences drug efficacy in women with diabetic GP: results of a phase 3 study with metoclopramide nasal spray. Gastroenterology. 2017;152(5):S1313.
   Web of Science ®Google Scholar
• Gimoti (metoclopramide) nasal spray package insert. Solana Beach (CA): Evoke Pharma; p. 1/21. https://evokepharma.com/wp-content/uploads/Prescribing-Information-Gimoti™-metoclopramide-nasal-spray.pdf
   Google Scholar
• Metoclopramide nasal spray (gimoti) for diabetic GP. JAMA. 2021;326(3):270–271. doi: 10.1001/jama.2020.26625
   PubMed Web of Science ®Google Scholar
• Gajendran M, Sarosiek I, McCallum R. Metoclopramide nasal spray for management of symptoms of acute and recurrent diabetic Gastroparesis in adults. Expert Rev Endocrinol Metab. 2021;16(2):25–35. doi: 10.1080/17446651.2021.1886922.
   PubMed Web of Science ®Google Scholar
• Kalas MA, Trivedi B, Kalas M, et al. Metoclopramide in gastroparesis: Its mechanism of action and safety profile. Gastrointestinal Disorders. 2023;5(3):317–328. doi: 10.3390/gidisord5030026
   Google Scholar
• Liu N, Abell T. Gastroparesis Updates on pathogenesis and management. Gut Liver. 2017;11(5):579–589. doi: 10.5009/gnl16336
   PubMed Web of Science ®Google Scholar
• Abell TL, Camilleri M, DiMagno EP, et al. Long-term efficacy of oral cisapride in symptomatic upper gut dysmotility. Dig Dis Sci. 1991;36(5):616–620. doi: 10.1007/BF01297028
   PubMed Web of Science ®Google Scholar
• Camilleri M, Atieh J. New developments in prokinetic therapy for gastric motility disorders. Front Pharmacol. 2021;12:711500. doi: 10.3389/fphar.2021.711500
   PubMed Web of Science ®Google Scholar
• Carbone F, Van den Houte K, Clevers E, et al. Prucalopride in Gastroparesis: a randomized placebo-controlled crossover study. Am J Gastroenterol. 2019;114(8):1265–1274. doi: 10.14309/ajg.0000000000000304.
   PubMed Web of Science ®Google Scholar
• Andrews CN, Woo M, Buresi M, et al. Prucalopride in diabetic and connective tissue disease-related Gastroparesis: randomized placebo-controlled crossover pilot trial. Neurogastroenterol Motil. 2021;33(1):e13958. doi: 10.1111/nmo.13958.
   PubMed Web of Science ®Google Scholar
• Camilleri M, Piessevaux H, Yiannakou Y, et al. Efficacy and safety of prucalopride in chronic constipation: an integrated analysis of six randomized, controlled clinical trials. Dig Dis Sci. 2016;61(8):2357–2372. doi: 10.1007/s10620-016-4147-9
   PubMed Web of Science ®Google Scholar
• Ali H, Pamarthy R, Sarfraz S. Role of prucalopride in treating functional constipation and gastroparesis: a systemic review. Cureus. 2021;13(4):e14306. doi: 10.7759/cureus.14306
   PubMed Web of Science ®Google Scholar
• Parkman HP, Pagano AP, Vozzelli MA, et al. Gastrokinetic effects of erythromycin: myogenic and neurogenic mechanisms of action in rabbit stomach. Am J Physiol. 1995;269(3 Pt 1):G418–26.
   PubMed Web of Science ®Google Scholar
• Janssens J, Peeters TL, Vantrappen G, et al. Improvement of gastric emptying in diabetic gastroparesis by erythromycin. Preliminary studies. N Engl J Med. 1990;322(15):1028–1031. doi: 10.1056/NEJM199004123221502
   PubMed Web of Science ®Google Scholar
• Sanger GJ, Wang Y, Hobson A, et al. Motilin: towards a new understanding of the gastrointestinal neuropharmacology and therapeutic use of motilin receptor agonists. Br J Pharmacol. 2013;170(7):1323–1332. doi: 10.1111/bph.12075
   PubMed Web of Science ®Google Scholar
• Bruley des Varannes S, Parys V, Ropert A, et al. Erythromycin enhances fasting and postprandial proximal gastric tone in humans. Gastroenterology. 1995;109(1):32–39.
   PubMed Web of Science ®Google Scholar
• Adão D, Gois AF, Pacheco RL, et al. Erythromycin prior to endoscopy for acute upper gastrointestinal haemorrhage. Cochrane Database Syst Rev. 2023;2(2). CD013176. doi: 10.1002/14651858.CD013176.pub2
   PubMedGoogle Scholar
• Ray WA, Murray KT, Meredith S, et al. Oral erythromycin and the risk of sudden death from cardiac causes. N Engl J Med. 2004;351(11):1089–1096. doi: 10.1056/NEJMoa040582
   PubMed Web of Science ®Google Scholar
• Camilleri M, Kuo B. Editorial: Finding the ideal prokinetic for gastroparesis - we are not there yet. Authors’ reply. Aliment Pharmacol Ther. 2021;54(2):212–213. doi: 10.1111/apt.16475
   PubMed Web of Science ®Google Scholar
• Belkacemi L, Darmani NA. Dopamine receptors in emesis: molecular mechanisms and potential therapeutic function. Pharmacol Res. 2020;161:105124. doi: 10.1016/j.phrs.2020.105124
   PubMed Web of Science ®Google Scholar
• Yoshikawa T, Yoshida N, Hosoki K. Involvement of dopamine D3 receptors in the area postrema in R(+)-7-OH-DPAT-induced emesis in the ferret. Eur J Pharmacol. 1996;301(1–3):143–149. doi: 10.1016/0014-2999(96)00061-1
   PubMed Web of Science ®Google Scholar
• Claassen S, Zünkler BJ. Comparison of the effects of metoclopramide and domperidone on HERG channels. Pharmacology. 2005;74(1):31–36. doi: 10.1159/000083234
   PubMed Web of Science ®Google Scholar
• Sanger GJ, Andrews PLR. Review article: an analysis of the pharmacological rationale for selecting drugs to inhibit vomiting or increase gastric emptying during treatment of gastroparesis. Aliment Pharmacol Ther. 2023;57(9):962–978. doi: 10.1111/apt.17466
   PubMed Web of Science ®Google Scholar
• Patterson D, Abell T, Rothstein R, et al. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol. 1999 May;94(5):1230–1234.
   PubMed Web of Science ®Google Scholar
• Silvers D, Kipnes M, Broadstone V, et al. Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial. DOM-USA-5 study group. Clin Ther. 1998;20(3):438–453. doi: 10.1016/S0149-2918(98)80054-4
   PubMed Web of Science ®Google Scholar
• Ortiz A, Cooper CJ, Alvarez A, et al. Cardiovascular safety profile and clinical experience with high-dose domperidone therapy for nausea and vomiting. Am J Med Sci. 2015;349(5):421–424.
   PubMed Web of Science ®Google Scholar
• Field J, Wasilewski M, Bhuta R, et al. Effect of chronic domperidone use on QT interval: a large single center study. J Clin Gastroenterol. 2019;53(9):648–652. doi: 10.1097/MCG.0000000000001183
   PubMed Web of Science ®Google Scholar
• Sarosiek I, Van Natta M, Parkman HP, et al. Effect of domperidone therapy on gastroparesis symptoms: results of a dynamic cohort study by NIDDK gastroparesis consortium. Clin Gastroenterol Hepatol. 2022;20(3):e452–64. doi: 10.1016/j.cgh.2021.05.063.
   PubMed Web of Science ®Google Scholar
• Domperidone: an indication of how many sudden deaths in France could be prevented by avoiding this low-efficacy drug. Prescrire Analysis. 19. 2014 Feb. https://english.prescrire.org/Docu/DownloadDocu/PDFs/domperidone_an_indication_of_how_many_sudden_deaths.pdf
   Google Scholar
• Bashashati M, Sarosiek I, Siddiqui T, et al. Adverse effects of domperidone: prolonged quest for knowledge? Dig Dis Sci. 2016;61(12):3384–3386. doi: 10.1007/s10620-016-4333-9
   PubMed Web of Science ®Google Scholar
• Heckert J, Parkman HP. Therapeutic response to domperidone in gastroparesis: a prospective study using the GCSI-daily diary. Neurogastroenterol Motil. 2018;30(1):1. doi: 10.1111/nmo.13246
   Web of Science ®Google Scholar
• Whiting RL, Choppin A, Luehr G, et al. Preclinical evaluation of the effects of trazpiroben (TAK-906), a novel, potent dopamine D2/D3 receptor antagonist for the management of gastroparesis. J Pharmacol Exp Ther. 2021 Oct;379(1):85–95.
   PubMed Web of Science ®Google Scholar
• De Colle C, van der Hart M, Chen J, et al. A potent and selective dopamine d2 receptor antagonist as a potential alternative to metoclopramide and domperidone for the treatment of gastroparesis [Abstract]. Gastroenterology. 2016;150(4):1079NG1101.
   Web of Science ®Google Scholar
• McCallum RW, Parkman HP, Fass R, et al. Metoclopramide nasal spray in women with symptomatic diabetic gastroparesis: a randomized, double-blind, placebo-controlled phase 3 study. Clin Gastroenterol Hepatol. Published online Nov 2, 2023. doi: 10.1016/j.cgh.2023.10.022
   Google Scholar
• Tack J, McCallum R, Kuo B, et al. Randomized clinical trial: a phase 2b controlled study of the efficacy and safety of trazpiroben (TAK-906) for idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2023;35(10):e14652. doi: 10.1111/nmo.14652
   PubMed Web of Science ®Google Scholar