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Cited by 144Nausea and vomiting managementGastrointestinal motility and disordersViral gastroenteritis research and epidemiology

Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders

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Pasricha, Pankaj J., Yates, Katherine P., Sarosiek, Irene, McCallum, Richard W., Abell, Thomas L., Koch, Kenneth L., Nguyen, Linda Anh B., Snape, William J. +75 more·2018·Gastroenterology
DOI 10.1053/j.gastro.2017.08.033PMC PMC5742047
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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 caused by gastroparesis or gastroparesis-like syndrome. Methods We conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 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-to-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 of 63 patients, 35% vs 11 of 63, 17% in the placebo group) (P = .04). Conclusions In a randomized trial of patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea when reduction in VAS score was used as 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.

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  • In a 4-week, multicenter, randomized double-masked trial of 126 adults with gastroparesis (and related syndromes), oral aprepitant (125 mg) failed to significantly reduce nausea when measured by visual analog criteria, but achieved the secondary outcomes of significant reduction in nausea and vomiting severity index as measured by the Gastroparesis Clinical Symptom Index.

    “In a 4‐week, multicenter, randomized double‐masked trial of 126 adults with gastroparesis (and related syndromes), although oral aprepitant (125 mg) failed to significantly reduce nausea when measured by visual analog criteria, it achieved the secondary outcomes of significant reduction in nausea and vomiting severity index as measured by the Gastroparesis Clinical Symptom Index.”

    From Guidelines on management of cyclic vomiting syndrome in adults by the American Neurogastroenterology and Motility Society and the Cyclic Vomiting Syndrome Association (2019) · cites this paper as [44]

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  1. [19]Pasricha PJ Camilleri M Hasler WL Gastroparesis: Clinical and Regulatory Insights for Clinical Trials Clin Gastroenterol Hepatol 2017 PMC6642744 28410896

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Authors
Pasricha, P. J., Yates, K. P., Sarosiek, I., McCallum, R. W., Abell, T. L., Koch, K. L., Nguyen, L. A. B., Snape, W. J., Hasler, W. L., Clarke, J. O., Dhalla, S., Stein, E. M., Lee, L. A., Miriel, L. A., Van Natta, M. L., Grover, M., Farrugia, G., Tonascia, J., Hamilton, F. A., Parkman, H. P., Snape, W. J., DeVole, N., Earle, K., Kirkeby, K., Lee, C., Lin, M., Ponting, K., Yee, G., Pasricha, P. J., Clarke, J. O., Stein, E., Dhalla, S., Kim, Y., Nguyen, L. A. B., Garay, G., Orlando, C., Parkman, H. P., Mauer, A., Orthey, P., Palit, A., McCallum, R. W., Sarosiek, I., Connery, S., Gomez, Y., Romero, R., Vega, N., Alvarado, B., Abell, T. L., Hatter, L., Howard, R., Nowotny, L., Hasler, W. L., Herman, W., Kraftson, A., Rothberg, A. E., Wootten, S., Koch, K. L., Baxter, L., Brown, A., Stuart, P., Culler, S., Farrugia, G., Grover, M., Bernard, C., Hamilton, F., Serrano, J., James, S., Torrance, R., Hall, S., Tonascia, J., Belt, P., Dodge, J., Donithan, M., Hallinan, E., Isaacson, M., Lee, L. A., May, P. K., Miriel, L., Sternberg, A., Van Natta, M., Wagoner, A., Wilson, L., & Yates, K. P.
Affiliations
  • Johns Hopkins University (US)
  • Michigan Medicine (US)
ORCID
Venue
Gastroenterology
Publisher
Elsevier BV
Published
2018-01
Volume
154
Issue
1
Pages
65-76.e11
ISSN
0016-5085 (ISSN-L)
DOI
10.1053/j.gastro.2017.08.033
PMC
PMC5742047
OpenAlex
W2766218920
Cited by
143
References
35
Citations by year
2026: 5 · 2025: 8 · 2024: 14 · 2023: 16 · 2022: 18 · 2021: 22 · 2020: 19 · 2019: 25 · 2018: 16
FWCI
16.81
Type
journal article
Language
en
Open access
Licence
Locations
  • Gastroenterology (acceptedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (UL1TR000093, UL1TR001105, UL1TR000135, UL1TR000433, UL1TR000424)
  • National Institute of Diabetes and Digestive and Kidney Diseases (U01DK074008, U01DK073985, K23DK103911, U24DK074008, U01DK073974, U01DK074007, U01DK112193, U01DK073983, U01DK073975, U01DK074035)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Surgery › Nausea and vomiting management
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Infectious Diseases › Viral gastroenteritis research and epidemiology
Keywords
aprepitant, gastroparesis, chronic nausea, vomiting, NK1 receptor antagonists, symptom severity, adverse events, nausea severity
MeSH terms
Aprepitant, Adult, Antiemetics, Chronic Disease, Double-Blind Method, Female, Humans, Male, Middle Aged, Morpholines, Nausea, Vomiting, Treatment Outcome, Gastroparesis

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