Different studies, most of them completed in Italy (Macarri et al 1991; Gatto et al 1992; Arienti et al 1994; Corazza et al 1996) where levosulpiride has been around the marketplace for a lot more than 15 years, possess confirmed the high efficiency of the medication in the control of dyspeptic symptoms and its own favorable protection profile. weighed against baseline. On the 30-time go to, all symptoms got almost vanished, a craze that was taken care of before last go to. Treatment with levosulpiride was well tolerated in support of 40 adverse occasions had been documented (galactorrhea 26.7%, somnolence 17.8%, fatigue 11.1%, headaches 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. in symptom production in the absence of mucosal lesions is controversial, although eradication is recommended in patients in whom no other causes of symptoms has been identified (Malfertheiner et al 2002). According to motor and/or sensory functional abnormalities causing dyspeptic symptoms, treatment options with prokinetics, serotoninergic agents, antacids, and pain modulating medications have been proposed, although proton-pump inhibitor drugs (PPIs), histamine-2 receptor antagonists, and prokinetic agents are the most commonly used (Malagelada 2001; Talley 2003a; Bytzer 2004; Delgado-Aros et al 2004). Antidopaminergic gastrointestinal prokinetics (bromopride, clebopride, domperidone, levosulpiride, and metoclopramide) have been exploited clinically for the management of motor disorders of the upper gastrointestinal tract (Andresen and Camilleri 2006). The prokinetic effect of these drugs is mediated through the blockade of enteric (neuronal and muscular) inhibitory D2 receptors. In this respect, levosulpiride, a selective dopamine D2-receptor antagonist with prokinetic activity, is a therapeutic option in the management of functional dyspepsia on the basis of dopaminergic pathways controlling gastrointestinal motility (Distrutti et al 2002). On the other hand the serotonergic (5-HT4) component of levosulpiride may enhance its therapeutic efficacy in functional dyspepsia (Tonini et al 2004). Different studies, many of them carried out in Italy (Macarri et al 1991; Gatto et al 1992; Arienti et al 1994; Corazza et al 1996) where levosulpiride has been in the market for more than 15 years, have demonstrated the high efficacy of the drug in the control of dyspeptic symptoms and its favorable safety profile. In a review conducted to assess the clinical pharmacology, therapeutic efficacy and tolerability of levosulpiride (Corazza and Tonini 2000), 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 cases (0.9%). The efficacy of levosulpiride and cisapride in reducing gastric emptying times with no relevant side-effects was found to be similar (Mansi et al 2000), and in a randomized, double-masked trial, levosulpiride was at least as effective as cisapride in the treatment of dysmotility-like functional dyspepsia (Mearin et al 2004). This study was conducted to assess the effectiveness and safety of levosulpiride in patients with dysmotility-like functional dyspepsia, including nonerosive reflux disease in conditions of daily practice. Patients and methods This was a prospective, open-label, Benidipine hydrochloride observational, multinational study conducted between June 1, 2004 and November 9, 2004, at 9 sites in Latin American (Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, TGFB Panama, Paraguay, Peru, and Dominican Republic) and was globally coordinated (1 site) in Spain. The study was carried out in the primary care setting. The objective of the study was to assess the effectiveness and tolerability of levosulpiride in the treatment of patients with functional dyspepsia. Levosulpiride was administered during 4 weeks according to the conditions of use established in the products technical form in any of the two available presentations (tablets or oral solution formulation). The duration of the study was 8 weeks (4-week treatment period and 4-week follow-up period). All patients were fully informed on the purposes and characteristics of the study and gave oral consent. Approval of the study protocol by the local ethics committees of the. Patients with history or suspicion of organic lesion were excluded from the study as were patients undergoing abdominal surgery, patients with lactose intolerance, pregnant women or nursing mothers, and patients treated with drugs or medications that were known to affect gastrointestinal motility. The study included 4 visits and its duration was of 60 days. 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. in symptom production in the absence of mucosal lesions is controversial, although eradication is recommended in patients in whom no other causes of symptoms has been identified (Malfertheiner et al 2002). According to motor and/or sensory functional abnormalities causing dyspeptic symptoms, treatment options with prokinetics, serotoninergic agents, antacids, and pain modulating medications have been proposed, although proton-pump inhibitor drugs (PPIs), histamine-2 receptor antagonists, and prokinetic agents are the most commonly used (Malagelada 2001; Talley 2003a; Bytzer 2004; Benidipine hydrochloride Delgado-Aros et al 2004). Antidopaminergic gastrointestinal prokinetics (bromopride, clebopride, domperidone, levosulpiride, and metoclopramide) have been exploited clinically for the management of motor disorders of the upper gastrointestinal tract (Andresen and Camilleri 2006). The prokinetic effect of these drugs is mediated through the blockade of enteric (neuronal and muscular) inhibitory D2 receptors. In this respect, levosulpiride, a selective dopamine D2-receptor antagonist with prokinetic activity, is a therapeutic option in the management of functional dyspepsia on the basis of dopaminergic pathways controlling gastrointestinal motility (Distrutti et al 2002). On the other hand the serotonergic (5-HT4) component of levosulpiride may enhance its therapeutic efficacy in functional dyspepsia (Tonini et al 2004). Different studies, many of them carried out in Italy (Macarri et al 1991; Gatto et al 1992; Arienti et al 1994; Corazza et al 1996) where levosulpiride has been in the market for more than 15 years, have demonstrated the high efficacy of the Benidipine hydrochloride drug in the control of dyspeptic symptoms and its favorable safety profile. In a review conducted to assess the clinical pharmacology, therapeutic efficacy and tolerability of levosulpiride (Corazza and Tonini 2000), 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 cases (0.9%). The efficacy of levosulpiride and cisapride in reducing gastric emptying times with no relevant side-effects was found to be similar (Mansi et al 2000), and in a randomized, double-masked trial, levosulpiride was at least as effective as cisapride in the treatment of dysmotility-like functional dyspepsia (Mearin et al 2004). This study was conducted to assess the effectiveness and safety of levosulpiride in patients with dysmotility-like functional dyspepsia, including nonerosive reflux disease in conditions of daily practice. Patients and methods This was a prospective, open-label, observational, multinational study conducted between June 1, 2004 and November 9, 2004, at 9 sites in Latin American (Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Paraguay, Peru, and Dominican Republic) and was globally coordinated (1 site) in Spain. The study was carried out in the primary care setting. The objective of the study was to assess the effectiveness and tolerability of levosulpiride in the treatment of patients with functional dyspepsia. Levosulpiride was administered during 4 weeks according to the conditions of use established in the products technical form in any of the two available presentations (tablets or oral solution formulation). The duration of the study was 8 weeks (4-week treatment period and 4-week follow-up period). All patients were Benidipine hydrochloride fully informed on the purposes and characteristics of the study and gave.