A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting

ABSTRACT

Introduction

The issue of postoperative nausea and vomiting (PONV) remains important in surgical practice, contributing to patient distress, slower recovery, and increased use of healthcare resources. Many surgical patients report it to be a worse problem than the pain. New antiemetics of different classes are still needed to help manage PONV effectively, especially the treatment of established PONV after the failure of common prophylactic antiemetics such as 5-HT₃-antagonists and corticosteroids. Intravenous amisulpride, a drug with a long history of safe use in oral form as an antipsychotic, has recently been approved in the US (trade name: Barhemsys) as an intravenous antiemetic for the prevention and treatment of PONV.

Areas covered

This review article summarizes the published data on the clinical pharmacology, safety, and efficacy of intravenous amisulpride as an antiemetic, supplemented by published data on oral amisulpride, where relevant to the intravenous form. Literature was obtained via the PubMed search terms ‘intravenous amisulpride’ and ‘amisulpride AND safety.’ Both primary and secondary pharmacology are covered, along with clinical pharmacokinetics (distribution, metabolism, and excretion). The review of clinical safety and efficacy includes data from four studies in the prevention of PONV, two in the treatment of PONV and two investigating effects on the QT interval of the electrocardiogram in healthy volunteers.

Expert opinion

Given the importance of sufficient PONV prevention for patients and the healthcare system, the availability of intravenous amisulpride is helpful, restoring the dopamine-antagonist class as a potential mainstay in both combination prophylaxis and treatment.

KEYWORDS:

• Amisulpride
• antiemetic
• dopamine-antagonist
• emesis
• nausea
• post-operative nausea and vomiting
• patient satisfaction

Article highlights

• Intravenous amisulpride is an antiemetic recently approved in the United States for the management of postoperative nausea vomiting.

• Amisulpride is a selective dopamine D₂ and D₃ receptor antagonist that has been used in oral form for more than 30 years as an antipsychotic. It has been reported to have a favorable clinical safety profile.

• The effectiveness and safety of intravenous amisulpride in the management of PONV have been demonstrated in four randomized, placebo-controlled trials in prophylaxis and two in treatment.

• Unlike many other D₂ antagonists, amisulpride has a low propensity for prolongation of the electrocardiogram QT interval and for causing extrapyramidal toxicity.

Declaration of interest

G. Fox is an employee and stockholder of Acacia Pharma Ltd. P. Kranke has acted as a clinical advisor and clinical investigator in the referenced clinical studies investigating the antiemetic effect of amisulpride. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer declaration

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.