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

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 gastropar...

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Published in:	Gastroenterology (New York, N.Y. 1943) Vol. 154; no. 1; pp. 65 - 76.e11
Main Authors:	Pasricha, Pankaj J., Yates, Katherine P., Sarosiek, Irene, McCallum, Richard W., Abell, Thomas L., Koch, Kenneth L., Nguyen, Linda Anh B., Snape, William J., Hasler, William L., Clarke, John O., Dhalla, Sameer, Stein, Ellen M., Lee, Linda A., Miriel, Laura A., Van Natta, Mark L., Grover, Madhusudan, Farrugia, Gianrico, Tonascia, James, Hamilton, Frank A., Parkman, Henry P., DeVole, Nata, Earle, Karen, Kirkeby, Kjersti, Lee, Candice, Lin, Mimi, Ponting, Katie, Yee, Gloria, Pasricha, Pankaj Jay, Stein, Ellen, Kim, Yale, Garay, Gotzone, Orlando, Chiara, Mauer, Alan, Orthey, Perry, Palit, Amiya, Connery, Sean, Gomez, Yvette, Romero, Roberta, Vega, Natalia, Alvarado, Ben, Hatter, Lisa, Howard, Ronna, Nowotny, Lindsay, Herman, William, Kraftson, Andrew, Rothberg, Amy E., Wootten, Sophanara, Baxter, Lynn, Brown, Anya, Stuart, Paula, Culler, Samantha, Bernard, Cheryl, Hamilton, Frank, Serrano, Jose, James, Stephen, Torrance, Rebecca, Hall, Sherry, Belt, Patricia, Dodge, John, Donithan, Michele, Hallinan, Erin, Isaacson, Milana, May, Patrick K., Miriel, Laura, Sternberg, Alice, Van Natta, Mark, Wagoner, Annette, Wilson, Laura
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-01-2018
Subjects:	Adult Antiemetics - therapeutic use Aprepitant Aprepitant Treatment Chronic Disease Chronic Nausea and Vomiting Double-Blind Method Female Gastroparesis Gastroparesis - complications Humans Male Middle Aged Morpholines - therapeutic use Nausea - etiology Nausea - prevention & control RCT Treatment Outcome Vomiting - etiology Vomiting - prevention & control RCT AE CUNV Aprepitant Treatment VAS GSRS ANCOVA GERD GCSI GES SAE GpCRC PAGI-SYM GCSI-DD NK1R APRON Chronic Nausea and Vomiting Gastroparesis NIDDK
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Summary:	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. 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. 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). 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. [Display omitted]
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Members of the NIDDK Gastroparesis Clinical Research Consortium are listed in Appendix 1.
ISSN:	0016-5085 1528-0012
DOI:	10.1053/j.gastro.2017.08.033