Please use this identifier to cite or link to this item: http://hdl.handle.net/10397/74462
Title: Amisulpride in the prevention of nausea and vomiting induced by cisplatin-based chemotherapy : a dose-escalation study
Authors: Herrstedt, J
Summers, Y
Daugaard, G
Christensen, TB
Holmskov, K
Taylor, PD
Fox, GM
Molassiotis, A 
Keywords: Amisulpride
Chemotherapy
Cisplatin
Dopamine antagonist
Nausea
Vomiting
Issue Date: 2017
Publisher: Springer
Source: Supportive care in cancer, 2017, p. 1-7 How to cite?
Journal: Supportive care in cancer 
Abstract: Purpose: The purpose of this study was to investigate the antiemetic effect of the dopamine D2- and dopamine D3-receptor antagonist, amisulpride, in patients receiving cisplatin-based chemotherapy. Methods: This dose-finding, non-comparative study investigated the antiemetic effect and safety of increasing doses (2.5, 7.5 and 20 mg) of amisulpride against acute nausea and vomiting in the period 0–24 h after initiation of cisplatin-based chemotherapy. The 20 mg dose was also investigated in combination with the 5-HT3-receptor antagonist, ondansetron. The primary parameter was complete response (0–24 h), defined as no emesis and no need for rescue antiemetics. Secondary parameters were number of emetic episodes, severity of nausea and time to first emetic episode and start of nausea. Results: A total of 51 patients were enrolled and evaluable. None of the 10 patients in the 2.5 and 7.5 mg groups obtained a CR. In the 20 mg monotherapy cohort, two of the 18 subjects (11%) had a CR, 3/18 (17%) had no emesis and 12/18 (67%) had no significant nausea. Seven subjects (39%) had no nausea at all (a VAS score &ltMergeCell 5 mm). In the combination (ondansetron plus amisulpride) cohort, 19/23 (83%MergeCell 90% confidence interval: 65–94%) had a CR and 14/23 (61%) had no nausea at all. Conclusions: Amisulpride has antiemetic effect against cisplatin-induced acute nausea and vomiting. The effect against nausea is of particular interest. Randomised studies are warranted to further explore the effect and safety of amisulpride.
URI: http://hdl.handle.net/10397/74462
ISSN: 0941-4355
EISSN: 1433-7339
DOI: 10.1007/s00520-017-3825-2
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