Amisulpride in the prevention of nausea and vomiting induced by cisplatin-based chemotherapy: a dose-escalation study

Herrstedt, Jørn; Summers, Yvonne; Daugaard, Gedske; Christensen, Thomas Broe; Holmskov, Karin; Taylor, Paul D.; Fox, Gabriel; Molassiotis, Alex

doi:10.1007/s00520-017-3825-2

Cited by 10 publications

(4 citation statements)

References 27 publications

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“…In the case of amisulpride, this limitation is mitigated somewhat by the low risk of drug–drug interactions and the wide safety margin evident from its existing higher dose oral use. Further reassurance is given by the comparability of the adverse event profile in these healthy subjects with that reported in both surgical and oncology patients 1–7…”

Section: Discussionmentioning

confidence: 95%

“…Amisulpride is a substituted benzamide that potently and selectively blocks dopamine D 2 and D 3 receptors and has been in clinical use since the 1980s as an oral antipsychotic agent. More recently, an intravenous (IV) formulation of amisulpride has been shown in multiple randomized, controlled trials to be an effective antiemetic for the prevention and treatment of nausea and vomiting in the postoperative and emetogenic chemotherapy settings 1–7…”

Section: Introductionmentioning

confidence: 99%

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<p>Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers</p>

Fox¹,

Roffel²,

Hartstra³

et al. 2019

CPAA

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PurposeIntravenous amisulpride, a dopamine D2/D3 antagonist, has recently been shown in trials to be an effective antiemetic at low doses. This study was conducted to investigate the metabolism and elimination of a single dose of intravenous 14C-labeled amisulpride in healthy, adult volunteers.Patients and methodsSix healthy male volunteers aged 18–65 years were given a single 10 mg dose of 14C-labeled amisulpride containing not more than 1.8 MBq of radioactivity, infused over 4 mins. Concentrations of amisulpride and total radioactivity were measured in plasma, whole blood, urine and feces at various time points up to 168 hrs after dosing. Metabolites detected in plasma, urine and feces were characterized using liquid chromatography tandem mass spectrometry (LC-MS/MS) with in-line radiometric detection.ResultsThe mean recovery of radioactivity in excreta was 96.4% (range 92.0–98.5%), of which 73.6% (range 70.6–79.2%) was recovered from urine and 22.8% (range 18.9–25.7%) from feces. Four metabolites of amisulpride were detected in urine, representing 15.0% of the excreted dose; three of these were also present in feces, representing 6.1% of the excreted dose. No metabolites were detected in plasma. Excretion was initially rapid, with about two-thirds of the drug-related material eliminated within 12 hrs, primarily in the urine. A second, slower phase of excretion was predominantly fecal and was essentially complete by 96 hrs after dosing. The terminal plasma elimination half-life of parent amisulpride was 3.7 hrs and that of total 14C-labeled drug material was 4.2 hrs.ConclusionIntravenous amisulpride undergoes limited metabolism and is excreted primarily via the renal route.Clinical trial registry numberClinicalTrials.gov NCT02881840.

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Section: Discussionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

<p>Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers</p>

Fox¹,

Roffel²,

Hartstra³

et al. 2019

CPAA

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show abstract

“…To manage medication-induced and post-operative nausea and vomiting, a modest dose of amisulpride has been used. [5] Amisulpride efficacy does not appear to come at the expense of any substantial side effects. It is neither a substrate for nor an inhibitor of cytochrome P450 isoenzymes, hence, it has a low risk of drug interactions.…”

Section: Discussionmentioning

confidence: 99%

Cyclic vomiting syndrome responding to amisulpride – A case report

Ram¹

2021

IJPP

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Cyclic vomiting syndrome (CVS) is an uncommon functional condition defined by recurring episodic stereotyped vomiting with a sudden start and an unknown origin. CVS can be triggered by a variety of conditions, and the course and management are often determined by the triggering factors. We present the case of a 13-year-old female youngster who complained of frequent bouts of vomiting that coincided with the onset of menses. We started her on oral amisulpride 50 mg a few days before each menstrual period. As a result of the treatment, in the following menstrual cycle, she had a dramatic improvement in her symptoms.

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“…Two studies have been published in patients with chemotherapy-induced nausea and vomiting; however, both were conducted in Europe and involved a higher intravenous dose of the drug than approved, and 1 study also involved an oral form of the drug that is not available in the United States. 32,33 In addition, repeated doses of intravenous amisulpride in the postoperative period have not been investigated. Finally, the drug has not been evaluated in children with PONV.…”

Section: Drug Interactionsmentioning

confidence: 99%

Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting

2021

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Objective: To review the pharmacology, efficacy, and safety of amisulpride and determine its role in the management of postoperative nausea and vomiting (PONV). Data Sources: A PubMed search (1946 to November 2020) using the terms amisulpride and APD421 was conducted. Study Selection and Data Extraction: Relevant reports on intravenous amisulpride were included. Data Synthesis: Six clinical trials were evaluated. In 4 trials on the prevention of PONV, a greater percentage of patients who received amisulpride 5 mg compared with placebo experienced a complete response (44%-60% vs 31%-33%, respectively, when used as monotherapy; 58% vs 47%, respectively, when used in combination with another antiemetic). In 2 trials on the treatment of PONV, a significantly greater percentage of patients who received amisulpride 10 mg compared with placebo experienced a complete response (31.4% vs 21.5%, respectively, in patients who had not received prophylaxis; 41.7% vs 28.5%, respectively, in patients who had received prophylaxis). Adverse effects included infusion site pain, chills, hypokalemia, procedural hypotension, and abdominal distension. Relevance to Patient Care and Clinical Practice: Amisulpride is effective for the management of PONV and may be less likely to cause QT prolongation and extrapyramidal symptoms than other dopamine antagonists. Additional information is needed on its use for chemotherapy-induced nausea and vomiting and in children. Conclusions: Amisulpride is an important new option for the multimodal management of PONV in adults, and it may be the preferred dopamine antagonist because of the more favorable safety profile that results from its unique pharmacological properties.

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Amisulpride in the prevention of nausea and vomiting induced by cisplatin-based chemotherapy: a dose-escalation study

Abstract: 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.

Cited by 10 publications

References 27 publications

<p>Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers</p>

<p>Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers</p>

Cyclic vomiting syndrome responding to amisulpride – A case report

Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting

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