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Aprepitant has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders.
Gastroenterology. 2017 Oct 27;:
Authors: Pasricha PJ, Yates KP, Sarosiek I, McCallum RW, Abell TL, Koch KL, Nguyen LAB, Snape WJ, Hasler WL, Clarke JO, Dhalla S, Stein EM, Lee LA, Miriel LA, Van Natta ML, Grover M, Farrugia G, Tonascia J, Hamilton FA, Parkman HP, NIDDK Gastroparesis Clinical Research Consortium (GpCRC)
Abstract
BACKGROUND & AIMS: There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting due to gastroparesis or gastroparesis-like syndrome.
METHODS: We conducted a 4-week multicenter, double-masked trial of 126 patients with at leastmoderate symptoms of chronic nausea and vomiting of presumed gastric origin for at least 6 months. Patients were randomly assigned to groups given oral aprepitant (125 mg/day, n=63) or placebo (n=63). The primary outcome from the intention-to-treat analysis was reduction in nausea, defined as a decrease of 25 mm or more, or absolute level below 25 mm, on a daily patient-reported 0-100 visual analog scale (VAS) of nausea severity. We calculated relative risks of nausea improvement using stratified Cochran-Mental-Haenszel analysis.
RESULTS: Aprepitant did not reduce symptoms of nausea, based on the primary outcome measure (46% reduction in the VAS score in the aprepitant group vs 40% reduction in the placebo group; relative risk, 1.2; 95% CI, 0.8-1.7) (P=.43). However, patients in the aprepitant group had significant changes in secondary outcomes such as reduction in symptom severity (measured by the 0-5 Gastroparesis Clinical Symptom Index) for nausea (1.8 vs 1.0; P=.005), vomiting (1.6 vs 0.5; P=.001), and overall symptoms (1.3 vs 0.7; P=.001). Adverse events, predominantly mild or moderate in severity grade, were more common in aprepitant (22/63 patients, 35% vs 11/63, 17% in the placebo group) (P=.04).
CONCLUSIONS: In a randomized trial of patients with chronic nausea and vomiting due to gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea, when reduction in VAS score was used at the primary outcome. However, aprepitant had varying effects on secondary outcomes of symptom improvement. These findings support the need to identify appropriate patient outcomes for trials of therapies for gastroparesis, including potential additional trials for aprepitant. ClinicalTrials.gov no: NCT01149369.
PMID: 29111115 [PubMed - as supplied by publisher]