Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial

Carlin, Jesse L.; Lieberman, Verna R.; Dahal, Arya; Keefe, Madison S.; Xiao, Changfu; Birznieks, Gunther; Abell, Thomas L.; Lembo, Anthony; Parkman, Henry P.; Polymeropoulos, Mihael H.

doi:10.1053/j.gastro.2020.07.029

Cited by 56 publications

(52 citation statements)

References 33 publications

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“…In a placebo‐controlled, randomized trial in patients with gastroparesis, several secondary endpoints [e.g., nausea, vomiting, and retching severity scores measured by the Patient Assessment of Upper Gastrointestinal Disorders ‐ Symptom Severity (PAGI‐SYM)] as well as overall symptom severity (using the GCSI) showed improvement with aprepitant compared to placebo 56 . More recently, tradipitant improved nausea/vomiting and overall GCSI score during 4 weeks of treatment in a placebo‐controlled study in patients with gastroparesis, with greater efficacy in patients with idiopathic compared to diabetic gastroparesis 57 …”

Section: Treatmentmentioning

confidence: 99%

“…56 More recently, tradipitant improved nausea/vomiting and overall GCSI score during 4 weeks of treatment in a placebo-controlled study in patients with gastroparesis, with greater efficacy in patients with idiopathic compared to diabetic gastroparesis. 57…”

Section: Pyloric Botulinum Toxin Injection or Myotomy Is Effective For Gastroparesis Statement Not Endorsedmentioning

confidence: 99%

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A North American perspective on the ESNM consensus statement on gastroparesis

Camilleri

Dilmaghani

Vosoughi

et al. 2021

Neurogastroenterology Motil

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We congratulate the members of the European Society of Neurogastroenterology and Motility (ESNM) with expertise in gastroparesis and the United European Gastroenterology (UEG) Federation Sister Societies for developing comprehensive recommendations on gastroparesis.We noted their due diligence, conduct of a Delphi consensus processes, systematic literature reviews, and grading of the strength using accepted criteria.

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Section: Treatmentmentioning

confidence: 99%

Section: Pyloric Botulinum Toxin Injection or Myotomy Is Effective For Gastroparesis Statement Not Endorsedmentioning

confidence: 99%

A North American perspective on the ESNM consensus statement on gastroparesis

Camilleri

Dilmaghani

Vosoughi

et al. 2021

Neurogastroenterology Motil

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“…Another potential mechanism for the symptomatic benefit may be related to increased fasting and accommodation volumes of the stomach without deleterious effect on gastric emptying, which has been demonstrated in healthy controls ( Jacob et al, 2017 ). The novel NK 1 receptor antagonist, tradipitant, improved several symptoms of gastroparesis in a 4-weeks, randomized, controlled trial ( Carlin et al, 2021 ). The symptomatic benefit was most marked in patients with vomiting among the baseline symptoms; it was interesting to note that improvement of nausea was associated with improvement of all the other symptoms evaluated.…”

Section: Introduction: Definitions and Currently Available Prokinetic Treatmentsmentioning

confidence: 99%

New Developments in Prokinetic Therapy for Gastric Motility Disorders

Camilleri

Atieh

2021

Front. Pharmacol.

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Prokinetic agents amplify and coordinate the gastrointestinal muscular contractions to facilitate the transit of intra-luminal content. Following the institution of dietary recommendations, prokinetics are the first medications whose goal is to improve gastric emptying and relieve symptoms of gastroparesis. The recommended use of metoclopramide, the only currently approved medication for gastroparesis in the United States, is for a duration of less than 3 months, due to the risk of reversible or irreversible extrapyramidal tremors. Domperidone, a dopamine D2 receptor antagonist, is available for prescription through the FDA’s program for Expanded Access to Investigational Drugs. Macrolides are used off label and are associated with tachyphylaxis and variable duration of efficacy. Aprepitant relieves some symptoms of gastroparesis. There are newer agents in the pipeline targeting diverse gastric (fundic, antral and pyloric) motor functions, including novel serotonergic 5-HT4 agonists, dopaminergic D2/3 antagonists, neurokinin NK1 antagonists, and ghrelin agonist. Novel targets with potential to improve gastric motor functions include the pylorus, macrophage/inflammatory function, oxidative stress, and neurogenesis. In the current review, we discuss the use of pharmacological approaches with potential to enhance motor functions in the management of gastroparesis.

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“…Tradipitant (VLY-686) is a novel NK1 receptor antagonist in development for the treatment of gastroparesis and atopic dermatitis. Tradipitant was shown to be effective in the treatment of nausea and vomiting in gastroparesis in a 4-week randomized study (19). Given this evidence to support the use of tradipitant as an NK1 receptor antagonist to treat nausea and vomiting and specifically in motion sickness, we designed and conducted the Motion Sifnos study.…”

Section: Introductionmentioning

confidence: 99%

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study

et al. 2020

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Introduction: Novel therapies are needed for the treatment of motion sickness given the inadequate relief and bothersome and dangerous adverse effects of currently approved therapies. Neurokinin-1 (NK1) receptor antagonists have the potential to be effective in improving the symptoms of motion sickness, given the involvement of Substance P in nauseogenic and emetic pathways and the expression of NK1 receptors in the gastrointestinal system. Here we evaluated the efficacy of tradipitant, a novel NK1 receptor antagonist, in preventing motion sickness in variable sea conditions. Methods: A total of 126 adults participated in the Motion Sifnos study. Groups of participants were assigned to one of seven boat trips lasting ∼4 h on the Pacific Ocean. Participants were randomized 1:1 to tradipitant 170 mg or placebo and completed the Motion Sickness Severity Scale (MSSS) every 30 min, in addition to other assessments. Severity of motion sickness was assessed with the incidence of vomiting and the MSSS. Results: Participants on tradipitant had a significantly lower incidence of vomiting as compared to those on placebo across all boat trips (tradipitant = 17.5%, placebo = 39.7%, p = 0.0039). For trips exposed to rough sea conditions, the difference in the incidence of vomiting between the groups was more dramatic (tradipitant = 15.79%, placebo = 72.22%, p= 0.0009). Across these trips, motion sickness symptoms were significantly lower in the tradipitant group compared to the placebo group (tradipitant = 3.19, placebo = 4.57, p = 0.0235). Discussion: Tradipitant has the potential to be an effective therapy for the prevention of vomiting and treatment of nausea in people with motion sickness.

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Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial

Cited by 56 publications

References 33 publications

A North American perspective on the ESNM consensus statement on gastroparesis

A North American perspective on the ESNM consensus statement on gastroparesis

New Developments in Prokinetic Therapy for Gastric Motility Disorders

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study

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