Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting - randomised clinical study subset data

Wo, John M.; Ejskjær, Niels; Hellström, Per M.; Malik, Rayaz A.; Pezzullo, John C.; Shaughnessy, Laura; Charlton, Philippa A.; Kosutic, Gordana; McCallum, Richard W.

doi:10.1111/j.1365-2036.2010.04567.x

Cited by 69 publications

(40 citation statements)

References 34 publications

(45 reference statements)

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“…In dia betic patients with severe gastroparesis, the intravenous ghrelin agonist TZP101 (ulimorelin) has been shown to reduce nausea, vomiting and overall symptoms com pared with placebo ( Figure 3). 124 Oral ghrelin agonists are being evaluated.…”

Section: Prokinetic Medicationsmentioning

confidence: 99%

Gastroparesis: pathogenesis, diagnosis and management

Hasler

2011

Nat Rev Gastroenterol Hepatol

110

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Gastroparesis is a prevalent condition that produces symptoms of delayed gastric emptying in the absence of physical blockage. The most common etiologies of gastroparesis are idiopathic, diabetic, and postsurgical disease, although some cases stem from autoimmune, paraneoplastic, neurologic or other conditions. Histologic examination of gastric tissues from patients with severe gastroparesis reveals heterogeneous and inconsistent defects in the morphology of enteric neurons, smooth muscle and interstitial cells of Cajal, and increased levels of inflammatory cells. Diagnosis is most commonly made by gastric emptying scintigraphy; however, wireless motility capsules and nonradioactive isotope breath tests have also been validated. A range of treatments have been used for gastroparesis including dietary modifications and nutritional supplements, gastric motor stimulatory or antiemetic medications, endoscopic or surgical procedures, and psychological interventions. Most treatments have not been subjected to controlled testing in patients with gastroparesis. The natural history of this condition is poorly understood. Active ongoing research is providing important insights into the pathogenesis, diagnosis, treatment and outcomes of this disease.

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Section: Prokinetic Medicationsmentioning

confidence: 99%

Gastroparesis: pathogenesis, diagnosis and management

Hasler

2011

Nat Rev Gastroenterol Hepatol

110

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“…Small studies have shown reduced overall post-meal symptom intensity, postprandial fullness, and symptom improvement after treatment with TZP-101 (80 μg/kg) for four days in six patients with severe gastroparesis, compared with six who received placebo. This improvement was sustained in the 30-day follow-up period (18,19). Higher doses were not as effective for symptom relief as the 80-μg/kg dose, possibly because ghrelin receptor agonists reduce gastric accommodation, which may induce upper gastrointestinal symptoms (20).…”

Section: Figurementioning

confidence: 80%

Pharmacological agents currently in clinical trials for disorders in neurogastroenterology

Camilleri¹

2013

J. Clin. Invest.

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Esophageal, gastrointestinal, and colonic diseases resulting from disorders of the motor and sensory functions represent almost half the patients presenting to gastroenterologists. There have been significant advances in understanding the mechanisms of these disorders, through basic and translational research, and in targeting the receptors or mediators involved, through clinical trials involving biomarkers and patient responses. These advances have led to relief of patients' symptoms and improved quality of life, although there are still significant unmet needs. This article reviews the pipeline of medications in development for esophageal sensorimotor disorders, gastroparesis, chronic diarrhea, chronic constipation (including opioid-induced constipation), and visceral pain. IntroductionGastrointestinal motility and functional disorders result in either abnormal propulsion of content or excessive sensation of normal or abnormal functions in different regions of the gut. These conditions constitute about 40% of referrals to gastroenterologists, and they result in significant disease burden. Advances in clinical management of these disorders are based on understanding the basic mechanisms involved in sensorimotor and secretory functions, coupled with clinical investigation and trial methodology.The most frequent gastrointestinal motility and functional disorders are esophagitis, gastroparesis, chronic diarrhea, chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), and visceral pain. This review summarizes the pathophysiology, lists commonly used current medications, and focuses on pharmacological agents in development for each disorder. At present, several approved medications relieve constipation and diarrhea; the major unmet needs are in gastroparesis, OIC, and visceral pain.

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“…The ghrelin receptor agonist ulimorelin (TZP-101) was evaluated in patients with gastroparesis and was shown to enhance gastric emptying in these patients [76]. Similarly, TZP-102, another oral ghrelin receptor agonist, showed reduction in symptoms of gastroparesis and was well tolerated [77].…”

Section: Ghrelin Receptor Agonistsmentioning

confidence: 98%

Emerging drugs for functional dyspepsia

Zala

Walker

Talley

2015

Expert Opinion on Emerging Drugs

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The optimal treatment for FD is yet to be determined. A proton pump inhibitor or a prokinetic agent constitutes primary treatment. Helicobacter pylori testing and eradication is recommended. Based on currently available data, acotiamide appears promising, particularly in postprandial distress syndrome. Further large-scale multicentered trials are required to define the duration of treatment and the side-effect profile.

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Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting - randomised clinical study subset data

Cited by 69 publications

References 34 publications

Gastroparesis: pathogenesis, diagnosis and management

Gastroparesis: pathogenesis, diagnosis and management

Pharmacological agents currently in clinical trials for disorders in neurogastroenterology

Emerging drugs for functional dyspepsia

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