Effectiveness and safety of levosulpiride in the treatment of dysmotility-like functional dyspepsia

Abstract

Abstract:The objective of this study was to assess the effectiveness and safety of levosulpiride in patients with dysmotility-like functional dyspepsia including nonerosive reflux esophagitis in conditions of daily practice. The study was conducted as a prospective, open-label, multicenter design in 342 patients with dysmotility-like functional dyspepsia (n=279) and nonerosive reflux disease (n=63), who received levosulpiride 25 mg 3 times daily orally for 4 weeks. Individual symptoms (pain/discomfort, fullness, bloating, early satiety, pyrosis, regurgitation, and nausea/vomiting) and a global symptom score were assessed at 15, 30, and 60 days after starting treatment. Adverse events also were recorded. There were 151 men and 191 women (mean age 38.8 years) who referred dyspeptic symptoms for a mean of 10.2 (10.7) months. A total of 66.4% patients were treated with 75 mg/day levosulpiride and 33.6% with 50 mg/day. At the 15-day visit, a decrease greater than 50% in the global symptom score was observed. The frequency and intensity of individual symptoms showed a statistically significant decrease (p<0.001) at all visits compared with baseline. At the 30-day visit, all symptoms had almost disappeared, a trend that was maintained until the last visit. Treatment with levosulpiride was well tolerated and only 40 adverse events were recorded (galactorrhea 26.7%, somnolence 17.8%, fatigue 11.1%, headache 11.5%) and no patient had to abandon the study due to side effects. In conclusion, levosulpiride is an effective and safe drug in the treatment of dysmotility-like functional dyspepsia and non-erosive reflux disease.

Randomized Double Blind Placebo Controlled Trial to Assess the Efficacy and Tolerability of Levosulpiride in Dysmotility Type of Functional Dyspepsia

“…13,14 In this study, we found another finding that statistically significant improvement in symptom score occurred in Placebo group also. This result was supported by Fermin Mearin et al study, which has found that symptomatic response to Placebo is substantial in functional dyspepsia and clinical improvement might occur independently of detectable changes in the gastroduodenal motor activity or gastric hypersensitivity.…”

Design, Formulation and In-Vitro Evaluation of Sustained Release Tablet Formulations of Levosulpiride

“…16 Levosulpiride, as a gastroprokinetic agent, has shown promising results in the treatment of various gastric disorders such as functional dyspepsia and non-erosive reflux disorder. 17 Chemically, it is a synthetic benzamide derivative with a strong inhibitory effect on dopaminergic D 2 receptors both in the central nervous system and in the GIT. 18 Studies have shown Levosulpiride to be effective in the treatment of various diseases such as dyspepsia (functional or organic), diabetic gastroparesis, reflux esophagitis, iatrogenic emesis induced by drugs such as chemotherapy, calcitonin, and anesthetics, as well as noniatrogenic nausea and vomiting.…”

“…22 This property, together with antagonism at D2 receptors, may contribute to its gastrointestinal prokinetic effect. 17 In a randomized, double-blind trial, it was found that Levosulpiride had a similar effect to cisapride in the treatment of dysmotilitylike functional dyspepsia. 23 The drug is given mostly at the dosage of 25-50 mg three times a day because of its short half-life, which leads to poor treatment adherence by patients and adverse drug effects.…”

Simultaneous Estimation of Pantoprazole Sodium and Levosulpiride in Capsule Dosage Form by Simultaneous Equation Spectrophotometric Method

“…Pantoprazole sodium (PNT) is a sodium 5-(difluoromethoxy)-2-[[ (3,4-dimethoxy]-2-pyridinyl) methyl]sulfinyl]-1H-benzimidazole [1] (Figure 1); it is a proton pump inhibitor drug used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux disease [2]. It has molecular formula C 16 H 14 F 2 N 3 NaO 4 S with molar mass 405.36 g/mol [1].…”

“…It is an atypical neuroleptic (S)-enantiomer of sulpiride having molecular formula C 15 H 23 N 3 O 4 S with molar mass 341.43 g/mol. Levosulpiride is also claimed to have mood elevating property and used in the treatment of psychoses [3], particularly negative symptoms of schizophrenia, anxiety disorders, dysthymia, vertigo, dyspepsia, irritable bowel syndrome, and premature ejaculation [4].…”