By Eric Ramos
A single dose of intravenous (IV) amisulpride was safe and prevented postoperative nausea and vomiting (PONV) in patients undergoing elective surgery under general anaesthesia, according to a study presented at the 2020 Virtual Meeting of the American Society of Anesthesiologists (ASA).
Andrew Wahlert, MD, Acacia Pharma, Inc., Indianapolis, Indiana, and colleagues conducted an analysis from 4 randomised, double-blind, placebo-controlled trials of (IV) amisulpride versus placebo for the prevention of PONV. Three trials were phase 3 studies and 1 was a phase 2 study.
“Antiemetics commonly used to treat postoperative nausea and vomiting are associated with side effects that may result in prolonged QT interval following surgery,” explained Dr. Wahlert. “The objective of this post-hoc analysis was to evaluate pooled safety data, including cardiac safety data, of amisulpride compared with placebo for the prevention of PONV.”
The 4 trials included 1,078 patients aged 18 years and older who were undergoing elective surgery under general anaesthesia and were at moderate or high risk of PONV. Patients were randomised to receive a single IV dose of amisulpride (1 mg, 5 mg or 20 mg) or placebo, alone or in combination with a non-dopaminergic antiemetic. The most common antiemetics co-administered with amisulpride were ondansetron, dexamethasone, or betamethasone.
“The incidence of QT prolongation above 470 ms for female patients and 450 ms for male patients was low and not materially different before or after the operation, or between any dose of ami and placebo,” said Dr. Wahlert. “Prolongation over 500 ms was very rare.”
ECG monitoring showed no significant differences in vital signs or ECG parameters between the amisulpride and placebo groups.
The incidence of treatment-emergent adverse events (TEAEs) was similar between patients who received any dose of amisulpride compared versus placebo (58.9% vs 61.5%, respectively). The most common TEAEs occurring in ≥2% of patients treated with amisulpride and at a higher rate than placebo were increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension.
A greater increase in mean serum prolactin values was reported for patients receiving amisulpride 5 mg than those receiving placebo.
“This increase was still within the normal range for nonpregnant females, and no clinical events related to hyperprolactinemia were reported,” said Dr. Wahlert.
Serious TEAEs were very infrequent in both the amisulpride and placebo groups (3.0% vs 3.0%, respectively).