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Amisulpride: Efficacy and Adverse Events in the Management of Postoperative Nausea and Vomiting — a Systematic Review and Quantitative Meta-analysis
Background: Despite the advances in anesthesiology, postoperative nausea and vomiting (PONV) with its complex aetiology still remains a common postoperative complication for many patients. Dopamine D2-antagonist droperidol was a frequently used cost-effective antiemetic up until 2001, when the FDA i...
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| Format: | Dissertation |
| Sprache: | Englisch |
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Philipps-Universität Marburg
2020
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| Zusammenfassung: | Background: Despite the advances in anesthesiology, postoperative nausea and vomiting (PONV) with its complex aetiology still remains a common postoperative complication for many patients. Dopamine D2-antagonist droperidol was a frequently used cost-effective antiemetic up until 2001, when the FDA issued a black-box warning in its label. Since then, more focus has been put on the research on alternative agents blocking the dopamine receptor.
In 2010, a repurposed formula of intravenous amisulpride, an atypical antipsychotic, which has been on the market for over thirty years, was patented and since then various clinical trials were started to study its antiemetic potential in the management of PONV.
Objectives: The purpose of this meta-analysis was to evaluate the efficacy and safety of intravenous amisulpride on both prevention and treatment of PONV from the clinical data available so far.
Methods: A systematic review (meta-analysis) was conducted according to the 2009 PRISMA guidelines. Two independent investigators searched MEDLINE (PubMed), ClinicalTrials.gov and Cochrane Controlled Register of Trials (CENTRAL) databases for randomized, controlled trials on intravenous amisulpride without language or publication year restrictions. Studies with intervention group receiving intravenous amisulpride for prophylaxis or treatment of PONV as compared to placebo or another antiemetic were included in the meta- analysis. The primary endpoint of the study was the incidence of PONV (any episode of retching/vomiting or use of rescue medication) 24-hours postoperatively or 24-hours after IV amisulpride administration. Rescue medication use 24 hours after operation or study drug administration and the incidence of the most frequent treatment-emergent adverse events (TEAEs) were secondary endpoints of the study. Results were calculated using the Mantel- Haenszel Method and presented as relative risk (RR) with 95% confidence interval (CI).
Results: Data of five eligible trials (n=3313) were included in the final meta-analysis. Three of those trials investigated amisulpride for the prophylaxis of postoperative nausea and vomiting; while two studies analysed amisulpride versus placebo as treatment of PONV. The pooled effect estimate of all trials revealed a significant decrease in the incidence of PONV (RR = 0.78; 95% CI, 0.72–0.85, p < 0.00001) in patients receiving amisulpride as compared to placebo. Subgroup analysis according to the administered dose showed that only 1 and 5 mg and not 20 mg amisulpride doses significantly reduced the risk of PONV. Both 5 mg (RR = 0.9; 95% CI, 0.83–0.98; p = 0.02) and 10 mg amisulpride doses (RR = 0.85; 95% CI, 0.77–0.93; p= 0.0004) significantly reduced the incidence of PONV up to 24 hours after treatment with overall RR of 0.87 (95% CI; 0.82–0.93, p < 0.0001). Safety results showed a significant decrease in adverse events (AEs) in the amisulpride group as compared to placebo (RR = 0.9; 95% CI, 0.84-0.96; P = 0.008). Out of all the reported AEs, only increased blood prolactin level (RR = 8.97; 95% CI, 2.75-29.30; P = 0.0003) and insomnia (RR = 2.13; 95% CI, 0.99-4.57; P = 0.05), both reported in 1 study, occurred significantly more frequently in the amisulpride than the placebo group.
Conclusions: This meta-analysis shows that prophylactic use of intravenous amisulpride effectively reduces the risk of PONV and rescue medication use in the 24-hour postoperative period as well as up to 24 hours after its therapeutic use with overall lower incidence of adverse events as compared to placebo. It can be used in mono- and combination therapy with other antiemetics as a part of multimodal management of PONV. It’s favourable safety profile, no relevant QTc interval prolongation, low risk of drug interactions make it the most interesting potential droperidol substitute. Further studies on intravenous amisulpride with active controls are needed to compare its efficacy to well-established antiemetics such as dexamethasone and ondansetron. |
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| Umfang: | 83 Seiten |
| DOI: | 10.17192/z2020.0446 |