Levosulpiride for Dyspepsia and Emesis
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Clin Drug Invest 2000 Feb; 19 (2): 151-162 1173-2563/00/0002-0151/$20.00/0 © Adis International Limited. All rights reserved.
Levosulpiride for Dyspepsia and Emesis A Review of its Pharmacology, Efficacy and Tolerability G.R. Corazza1 and M. Tonini2 1 Department of Internal Medicine and Therapeutics, Division of Gastroenterology, University of Pavia, Pavia, Italy 2 Experimental and Clinical Pharmacology, University of Pavia, Pavia, Italy
Abstract
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 11 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.
The term dyspepsia refers to chronic or recurrent discomfort (e.g. early satiety, postprandial fullness, nausea, retching, vomiting, upper abdominal bloating) or pain centred in the upper abdomen. Dyspepsia is remarkably common, with an annual incidence of about 25% in Western countries. Although dyspepsia may be due to gastroduodenal ulcer, gastro-oesophageal reflux or gastric cancer, up to 60% of cases are defined as idiopathic; these are classified as functional dyspepsia.[1,2] The pathophysiology of functional dyspepsia
remains obscure. However, recent research has focused on the possible role of dysmotility and altered perception. The strongest argument in favour of the role of dysmotility is the fact that treatment designed to correct impaired motor function results in diminished symptoms;[3] furthermore, the use of prokinetic drugs is currently the most effective treatment in symptomatic patients with gastroparesis and diabetes.[4] Evidence that significant amounts of dopamine are present in the gastrointestinal tract, where it
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causes a marked inhibitory effect on motility, is the rationale for the use of antidopaminergic compounds as prokinetic agents. In fact, dopamine acting at inhibitory dopamine D2 receptors located on excitatory neuronal structures and smoot
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