Tradipitant safe and efficacious for treating Gastroparesis symptoms, finds trial
Tradipitant, an NK1R antagonist, has shown significant improvements in symptoms in patients with idiopathic or diabetic gastroparesis in a recent trial. The recent study was published in the journal, 'Gastroenterology' 2020.
Gastroparesis is associated with gastric emptying and other upper gastrointestinal symptoms like nausea, vomiting, abdominal discomfort, and pain. Antagonists of tachykinin receptor 1 (TACR1, also called NK1R) can reduce symptoms of nausea and vomiting in patients with idiopathic or diabetic gastroparesis. Tradipitant is an NK1R antagonist which can reduce these symptoms. Researchers from Washington D.C. conducted a trial to investigate the safety and efficacy of tradipitant, in patients with idiopathic or diabetic gastroparesis.
The trial was conducted in the United States from November 2016 through December 2018. There were 152 adults with gastroparesis who participated in the trial. Participants were randomly divided into two groups of 85mg oral tradipitant and placebo (n=75) twice daily for 4 weeks. Symptoms were assessed by a daily symptom dairy, gastroparesis cardinal symptom index scores, and other patient-reported questionnaires. The primary outcome from the intent to treat analysis was change from baseline to week 4 in average nausea severity, measured by the gastroparesis core symptom daily diary.
The key findings of the trial were:
• There were 77 participants in Tradipitant group and 75 in placebo group.
• Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P=.0099) and a significant increase in nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P=.0160).
• Patients with nausea and vomiting at baseline (n=101) had an even greater decrease in nausea when given tradipitant (reduction of 1.4) compared with those given placebo (reduction of 0.4) (P<.0001).
• There was also an increase in nausea-free days at week 4 (32.3% improvement on tradipitant vs 7.6% on placebo; P=.0003).
• Average nausea score was 1 or less at week 4 in 32.9% of patients given tradipitant compared with 11.8% of patients given placebo (P=.0013).
• A greater than 1-point improvement in gastroparesis cardinal symptom index score was observed in 46.6% of patients who were given tradipitant compared with 23.5% of patients given placebo (P=.0053).
Thus, the researchers concluded that in patients with idiopathic or diabetic gastroparesis receiving tradipitant there were statistically and clinically meaningful improvements in nausea and reduced vomiting, compared with placebo.
For further reading, click the following link: https://doi.org/10.1053/j.gastro.2020.07.029