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Drug Evaluation

Relamorelin for the treatment of gastrointestinal motility disorders

&
Pages 1189-1197 | Received 29 Jun 2017, Accepted 25 Aug 2017, Published online: 31 Aug 2017

References

  • Camilleri M, Parkman HP, Shafi MA, et al.; American College of G. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2012;108(1):18–37.
  • Food and Drug Administration. Metoclopramide Information. 2009 Available from: https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm220099.htm
  • 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;94(5):1230–1234.
  • European Medicine Agency. Domperidone containing medications. 2013 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Domperidone-containing_medicines/human_referral_prac_000021.jsp&mid=WC0b01ac05805c516f
  • Weber FH Jr., Richards RD, McCallum RW. Erythromycin: a motilin agonist and gastrointestinal prokinetic agent. Am J Gastroenterol. 1993;88(4):485–490.
  • Richards RD, Davenport K, McCallum RW. The treatment of idiopathic and diabetic gastroparesis with acute intravenous and chronic oral erythromycin. Am J Gastroenterol. 1993;88(2):203–207.
  • 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.
  • Camilleri M. Pharmacology of the new treatments for lower gastrointestinal motility disorders and irritable bowel syndrome. Clin Pharmacol Ther. 2011;91(1):44–59.
  • Manabe N, Cremonini F, Camilleri M, et al. Effects of bisacodyl on ascending colon emptying and overall colonic transit in healthy volunteers. Aliment Pharmacol Ther. 2009;30(9):930–936.
  • Rao AS, Camilleri M. Review article: metoclopramide and tardive dyskinesia. Aliment Pharmacol Ther. 2010;31(1):11–19.
  • Date Y, Kojima M, Hosoda H, et al. Ghrelin, a novel growth hormone-releasing acylated peptide, is synthesized in a distinct endocrine cell type in the gastrointestinal tracts of rats and humans. Endocrinology. 2000;141(11):4255–4261.
  • Dass NB, Munonyara M, Bassil AK, et al. Growth hormone secretagogue receptors in rat and human gastrointestinal tract and the effects of ghrelin. Neuroscience. 2003;120:443–453.
  • Page AJ, Slattery JA, Milte C, et al. Ghrelin selectively reduces mechanosensitivity of upper gastrointestinal vagal afferents. Am J Physiol Gastrointest Liver Physiol. 2007;292(5):G1376–G1384.
  • Trudel L, Tomasetto C, Rio MC, et al. Ghrelin/motilin-related peptide is a potent prokinetic to reverse gastric postoperative ileus in rat. Am J Physiol Gastrointest Liver Physiol. 2002;282(6):G948–G952.
  • van der Lely AJ, Tschop M, Heiman ML, et al. Biological, physiological, pathophysiological, and pharmacological aspects of ghrelin. Endocr Rev. 2004;25(3):426–457.
  • Tack J, Depoortere I, Bisschops R, et al. Influence of ghrelin on interdigestive gastrointestinal motility in humans. Gut. 2006;55(3):327–333.
  • Tack J, Depoortere I, Bisschops R, et al. Influence of ghrelin on gastric emptying and meal-related symptoms in idiopathic gastroparesis. Aliment Pharmacol Ther. 2005;22(9):847–853.
  • Sha L, Farrugia G, van der Ploeg LHT, et al. Effect of RM-131 on circular smooth muscle cells in human and mouse colon and on colonic intraluminal pressure in conscious mice. Gastroenterology. 2014;146((Suppl. 1)):S363.
  • Snider RM, Forray C, Pfenning M, et al. Neurotensin stimulates inositol phospholipid metabolism and calcium mobilization in murine neuroblastoma clone N1E-115. J Neurochem. 1986;47(4):1214–1218.
  • van der Ploeg L, Laken H, Sharma S, et al. Preclinical gastrointestinal prokinetic efficacy and endocrine effects of the ghrelin mimetic RM-131. Life Sciences. 2014;109(1):20–29.
  • Kaplan L, White J, Spence S, et al. RM-131, a novel ghrelin analog, demonstrates potent prokinetic activity in phase 1 single- and multiple-dose studies in healthy volunteers. Am J Gastro. 2012;107:S706–7.
  • Shin A, Camilleri M, Busciglio I, et al. The ghrelin agonist RM-131 accelerates gastric emptying of solids and reduces symptoms in patients with type 1 diabetes mellitus. Clin Gastroenterol Hepatol. 2013;11(11):1453–1459.e4.
  • Shin A, Camilleri M, Busciglio I, et al. Randomized controlled phase Ib study of ghrelin agonist, RM-131, in type 2 diabetic women with delayed gastric emptying: pharmacokinetics and pharmacodynamics. Diabetes Care. 2013;36(1):41–48.
  • Delatour F, Le Guludec D, Caron F, et al. Effect of a single oral dose of two erythromycin ethylsuccinate formulations on gastric emptying in healthy volunteers: a scintigraphic study. Fundam Clin Pharmacol. 1998;12(3):292–297.
  • Nelson AD, Camilleri M, Acosta A, et al. Effects of ghrelin receptor agonist, relamorelin, on gastric motor functions and satiation in healthy volunteers. Neurogastroenterol Motil. 2016;28(11):1705–1713.
  • Lembo A, Camilleri M, McCallum R, et al. Relamorelin reduces vomiting frequency and severity and accelerates gastric emptying in adults with diabetic gastroparesis. Gastroenterology. 2016;151(1):87–96e6.
  • Acosta A, Camilleri M, Kolar G, et al. Relamorelin relieves constipation and accelerates colonic transit in a phase 2, placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2015;13(13):2312–9e1.
  • Acosta A, Camilleri M, Busciglio I, et al. Short-term effects of relamorelin on descending colon motility in chronic constipation: a randomized, controlled trial. Dig Dis Sci. 2016;61(3):852–860.
  • Camilleri M, McCallum RW, Tack J, et al. Efficacy and safety of relamorelin in diabetics with symptoms of gastroparesis: a randomized, placebo-controlled study. Gastroenterology. 2017. [Epub ahead of print].
  • Food and Drug Administration. Gastroparesis: clinical evaluation of drugs for treatment guidance for industry. 2015. Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm455645.pdf
  • Fehnel S, Nelson L, DiBennedetti D, et al. Development and psychometric evaluation of the diabetic gastroparesis symptom severity diary. Gastroenterology. 2017;152(5): S517.
  • Revicki DA, Camilleri M, Kuo B, et al. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009;30(6):670–680.
  • Revicki DA, Camilleri M, Kuo B, et al. Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012;24(5):456–463.
  • Carbone F, Rotondo A, Andrews CN, et al. 1077 A controlled cross-over trial shows benefit of prucalopride for symptom control and gastric emptying enhancement in idiopathic gastroparesis. Gastroenterology. 2016;150(4):S213–S4.
  • Parkman HP, Yates KP, Hasler WL, et al. Dietary intake and nutritional deficiencies in patients with diabetic or idiopathic gastroparesis. Gastroenterology. 2011;141(2):486–498, 98.e1-7.
  • Parkman HP, Yates K, Hasler WL, et al. Similarities and differences between diabetic and idiopathic gastroparesis. Clin Gastroenterol Hepatol. 2011;9(12):1056–1064; quiz e133-4.
  • Sun Y, Asnicar M, Saha PK, et al. Ablation of ghrelin improves the diabetic but not obese phenotype of ob/ob mice. Cell Metabolism. 2006;3(5):379–386.
  • Camilleri M. Novel diet, drugs, and gastric interventions for gastroparesis. Clin Gastroenterol Hepatol. 2016;14(8):1072–1080.
  • Parthasarathy G, Kudva YC, Low PA, et al. Relationship between gastric emptying and diurnal glycemic control in type 1 diabetes mellitus: a randomized trial. J Clin Endocrinol Metab. 2017;102(2):398–406.
  • Tong J, Davis HW, Gastaldelli A, et al. Ghrelin impairs prandial glucose tolerance and insulin secretion in healthy humans despite increasing GLP-1. J Clin Endocrinol Metab. 2016;101(6):2405–2414.
  • Dezaki K, Hosoda H, Kakei M, et al. Endogenous ghrelin in pancreatic islets restricts insulin release by attenuating Ca2+ signaling in beta-cells: implication in the glycemic control in rodents. Diabetes. 2004;53(12):3142–3151.
  • Tong J, Prigeon RL, Davis HW, et al. Physiologic concentrations of exogenously infused ghrelin reduces insulin secretion without affecting insulin sensitivity in healthy humans. J Clin Endocrinol Metab. 2013;98(6):2536–2543.
  • McCowen KC, Maykel JA, Bistrian BR, et al. Circulating ghrelin concentrations are lowered by intravenous glucose or hyperinsulinemic euglycemic conditions in rodents. J Endocrinol. 2002;175(2):R7–R11.
  • Chopin L, Walpole C, Seim I, et al. Ghrelin and cancer. Mol Cell Endocrinol. 2011;340(1):65–69.
  • Currow DC, Fearon K, Yan Y, et al. Anamorelin in patients with advanced non-small cell lung cancer and cachexia: results from the phase III studies ROMANA 1 and 2. J Clin Oncol. 2015;33(29_suppl):175.
  • Pietra C, Takeda Y, Tazawa-Ogata N, et al. Anamorelin HCl (ONO-7643), a novel ghrelin receptor agonist, for the treatment of cancer anorexia-cachexia syndrome: preclinical profile. J Cachexia Sarcopenia Muscle. 2014;5(4):329–337.

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