TY - JOUR
T1 - Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders
AU - For the
AU - NIDDK Gastroparesis Clinical Research Consortium (GpCRC)
AU - NIDDK Gastroparesis Clinical Research Consortium (GpCRC)
AU - Pasricha, Pankaj J.
AU - Yates, Katherine P.
AU - Sarosiek, Irene
AU - McCallum, Richard W.
AU - Abell, Thomas L.
AU - Koch, Kenneth L.
AU - Nguyen, Linda Anh B.
AU - Snape, William J.
AU - Hasler, William L.
AU - Clarke, John O.
AU - Dhalla, Sameer
AU - Stein, Ellen M.
AU - Lee, Linda A.
AU - Miriel, Laura A.
AU - Van Natta, Mark L.
AU - Grover, Madhusudan
AU - Farrugia, Gianrico
AU - Tonascia, James
AU - Hamilton, Frank A.
AU - Parkman, Henry P.
AU - DeVole, Nata
AU - Earle, Karen
AU - Kirkeby, Kjersti
AU - Lin, Mimi
AU - Ponting, Katie
AU - Yee, Gloria
AU - Kim, Yale
AU - Garay, Gotzone
AU - Orlando, Chiara
AU - Mauer, Alan
AU - Orthey, Perry
AU - Palit, Amiya
AU - Connery, Sean
AU - Gomez, Yvette
AU - Vega, Natalia
AU - Alvarado, Ben
AU - Hatter, Lisa
AU - Howard, Ronna
AU - Nowotny, Lindsay
AU - Herman, William
AU - Kraftson, Andrew
AU - Rothberg, Amy E.
AU - Wootten, Sophanara
AU - Baxter, Lynn
AU - Romero, Roberta
AU - Stuart, Paula
AU - Culler, Samantha
AU - Bernard, Cheryl
AU - Serrano, Jose
AU - James, Stephen
N1 - Publisher Copyright:
© 2018 AGA Institute
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
KW - Aprepitant Treatment
KW - Chronic Nausea and Vomiting
KW - Gastroparesis
KW - RCT
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U2 - 10.1053/j.gastro.2017.08.033
DO - 10.1053/j.gastro.2017.08.033
M3 - Article
C2 - 29111115
AN - SCOPUS:85038259806
SN - 0016-5085
VL - 154
SP - 65-76.e11
JO - Gastroenterology
JF - Gastroenterology
IS - 1
ER -