Tradipitant significantly improved nausea and other symptoms in patients with idiopathic and diabetic gastroparesis compared with placebo, according to study results presented at the American College of Gastroenterology (ACG) 2022 Annual Meeting, held from October 21 to 26, 2022, in Charlotte, North Carolina, and virtually.
Tradipitant is a novel neurokinin-1 (NK-1) receptor antagonist that works to provide short-term relief of nausea in patients with gastroparesis.
Researchers pooled data from 2 separate, multicenter, randomized, double-blind, placebo-controlled trials (VP-VLY-686-3301 and VL-VLY-686-2301) to analyze the efficacy of tradipitant in relieving symptoms of idiopathic and diabetic gastroparesis.
A total of 342 patients diagnosed with idiopathic or diabetic gastroparesis were randomly assigned to receive 85mg tradipitant 2 times daily (treatment group; n=175) or placebo (control group; n=167).
Researchers assessed self-reported gastroparesis symptoms in all patients using the 5-point Gastroparesis Core Symptom Daily Diary (GCSDD) for nausea, the Gastroparesis Cardinal Symptom Index (GCSI) for typical gastroparesis symptoms, and the Patient Global Impression of Change (PGI-C), and Overall Patient Benefit (OPB) scales for overall symptom improvement.
After 4 weeks of treatment, patients taking tradipitant demonstrated significant improvements in nausea compared with placebo (average change, -1.15 vs -0.85; P =.0138). In particular, researchers observed a significantly increased number of nausea-free days in the tradipitant group compared with the placebo group (20.96% vs 12.52%; P =.0085).
Along with nausea, tradipitant compared with placebo improved other gastroparesis symptoms per GCSI scores (average change, -0.99 vs -0.76; P =.0265).
Overall symptoms of gastroparesis improved more in the treatment group than placebo group after 4 weeks, according to both PGI-C responder rates (79.3% vs 69%; P =.036) and OPB scores (85.3% vs 71.2%; P =.002).
“Pooling the data provided an opportunity to analyze a much larger data set, increase statistical power, and confirm results and subpopulations from the two separate studies,” the study authors wrote. “In the pooled analysis, we observed a clinically meaningful and significant effect on change of nausea severity at week 4. Improvements were also seen across core gastroparesis symptoms and overall measures of gastroparesis.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Carlin JL, Polymeropoulos C, Fisher M, et al. Pooled efficacy analysis of tradipitant in idiopathic and diabetic gastroparesis study VP-VLY-686-3301 and VP-VLY-686-2301. Abstract presented at: ACG 2022 Annual Meeting; October 21 to 26, 2022; Charlotte, NC. Abstract A0685.
This article first appeared on Gastroenterology Advisor.