Levosulpiride for dyspepsia and emesis - A review of its pharmacology, efficacy and tolerability

Objective: To review the clinical pharmacology of levosulpiride and establish its efficacy and tolerability profile in the treatment of patients with dyspepsia and emesis. Methods: A critical review was conducted to assess the clinical pharmacology, therapeutic efficacy and tolerability of levosulpiride and to establish whether it offers any advantage over currently available therapies. Results: Levosulpiride has been evaluated in 15 double-blind, randomised clinical trials in patients with dyspepsia (n = 1818, of whom 676 were treated with levosulpiride) and Il clinical trials in patients with emesis (n = 718, of whom 383 were treated with levosulpiride). It was shown to be effective in the treatment of dyspepsia (functional or organic dyspepsia, diabetic gastroparesis and reflux oesophagitis), the prevention and treatment of iatrogenic emesis resulting from pharmacological agents (anaesthetics, anticancer chemotherapy, calcitonin), and the treatment of severe non-iatrogenic nausea and vomiting. The incidence of adverse events was 11% in 840 patients with dyspepsia; most of them were mild and they resulted in treatment discontinuation in only eight (0.9%) cases. Conclusions: Levosulpiride should be considered among the drugs of choice for the treatment of various forms of dyspepsia and emesis.