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

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          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.

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          Most cited references 35

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          Current concepts in the management of Helicobacter pylori infection--the Maastricht 2-2000 Consensus Report.

          Significant progress and new insights have been gained in the 4 years since the first Maastricht Consensus Report, necessitating an update of the original guidelines. To achieve this, the European Helicobacter Pylori Study Group organized a meeting of specialists and experts from around the world, representatives from National Gastroenterology Societies and general practitioners from Europe to establish updated guidelines on the current management of Helicobacter pylori infection. The meeting took place on 21-22 September 2000. A "test and treat" approach is recommended in adult patients under the age of 45 years (the age cut-off may vary locally) presenting in primary care with persistent dyspepsia, having excluded those with predominantly gastro-oesophageal reflux disease symptoms, non-steroidal anti-inflammatory drug users and those with alarm symptoms. Diagnosis of infection should be by urea breath test or stool antigen test. As in the previous guidelines, the eradication of H. pylori is strongly recommended in all patients with peptic ulcer, including those with complications, in those with low-grade gastric mucosa-associated lymphoid tissue lymphoma, in those with atrophic gastritis and following gastric cancer resection. It is also strongly recommended in patients who are first-degree relatives of gastric cancer patients and according to patients' wishes after full consultation. It is advised that H. pylori eradication is considered to be an appropriate option in infected patients with functional dyspepsia, as it leads to long-term symptom improvement in a subset of patients. There was consensus that the eradication of H. pylori is not associated with the development of gastro-oesophageal reflux disease in most cases, and does not exacerbate existing gastro-oesophageal reflux disease. It was agreed that the eradication of H. pylori prior to the use of non-steroidal anti-inflammatory drugs reduces the incidence of peptic ulcer, but does not enhance the healing of gastric or duodenal ulcer in patients receiving antisecretory therapy who continue to take non-steroidal anti-inflammatory drugs. Treatment should be thought of as a package which considers first- and second-line eradication therapies together. First-line therapy should be with triple therapy using a proton pump inhibitor or ranitidine bismuth citrate, combined with clarithromycin and amoxicillin or metronidazole. Second-line therapy should use quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline. Where bismuth is not available, second-line therapy should be with proton pump inhibitor-based triple therapy. If second-line quadruple therapy fails in primary care, patients should be referred to a specialist. Subsequent failures should be handled on a case-by-case basis by the specialist. In patients with uncomplicated duodenal ulcer, eradication therapy does not need to be followed by further antisecretory treatment. Successful eradication should always be confirmed by urea breath test or an endoscopy-based test if endoscopy is clinically indicated. Stool antigen test is the alternative if urea breath test is not available.
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            Functional gastroduodenal disorders.

            While widely used in research, the 1991 Rome criteria for the gastroduodenal disorders, especially symptom subgroups in dyspepsia, remain contentious. After a comprehensive literature search, a consensus-based approach was applied, supplemented by input from international experts who reviewed the report. Three functional gastroduodenal disorders are defined. Functional dyspepsia is persistent or recurrent pain or discomfort centered in the upper abdomen; evidence of organic disease likely to explain the symptoms is absent, including at upper endoscopy. Discomfort refers to a subjective, negative feeling that may be characterized by or associated with a number of non-painful symptoms including upper abdominal fullness, early satiety, bloating, or nausea. A dyspepsia subgroup classification is proposed for research purposes, based on the predominant (most bothersome) symptom: (a) ulcer-like dyspepsia when pain (from mild to severe) is the predominant symptom, and (b) dysmotility-like dyspepsia when discomfort (not pain) is the predominant symptom. This classification is supported by recent evidence suggesting that predominant symptoms, but not symptom clusters, identify subgroups with distinct underlying pathophysiological disturbances and responses to treatment. Aerophagia is an unusual complaint characterized by air swallowing that is objectively observed and troublesome repetitive belching. Functional vomiting refers to frequent episodes of recurrent vomiting that is not self-induced nor medication induced, and occurs in the absence of eating disorders, major psychiatric diseases, abnormalities in the gut or central nervous system, or metabolic diseases that can explain the symptom. The current classification requires careful validation but the criteria should be of value in future research.
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              Prevalence of symptoms of dyspepsia in the community.

              To study the prevalence of dyspepsia in the community a postal questionnaire was sent to 2697 patients who were selected at random from the lists of patients registered in two health centres in Hampshire. A total of 2066 returned questionnaires were suitable for analysis (response rate 77%). It was found that the six month prevalence of dyspepsia was 38%. There was considerable overlap between symptoms of heartburn and upper abdominal pain, with over half of patients with dyspepsia experiencing both. One in four of these patients had consulted their general practitioner during that time. The proportion of patients with dyspepsia who consulted their general practitioner varied widely among the eight doctors who participated in the study, from 17% to 45%. Frequency of symptoms tended to fall with age, particularly in men, while the proportion of patients with dyspepsia who sought medical advice increased with age. Almost one in five of the 2066 patients had been investigated with radiology or endoscopy at some time, and 143 (7%) of them claimed to have had a diagnosis of peptic ulcer.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                March 2007
                March 2007
                : 3
                : 1
                : 149-155
                Affiliations
                [1 ]Grupo Ferrer Internacional Avda. Diagonal 549, E-08029, Barcelona, Spain
                [2 ]Department of Gastroenterology, Hospital de la Policía Nacional del Perú Lima, Perú
                [3 ]Gastroenterology and Internal Medicine, Hospital Chiriquí David, República de Panamá
                [4 ]Center of Medical Specialties Asunción del Paraguay, Paraguay
                [5 ]Gastroklinik Guatemala
                [6 ]Hospital de Diagnóstico San Salvador, El Salvador
                [7 ]Hospital Escuela Tegucigalpa, Honduras
                [8 ]Clínica Abreu, Santo Domingo República de Santo Domingo
                [9 ]Hospital Dr. Calderón Guardia San Pedro, San José, Costa Rica
                [10 ]Gastroenterology Clinic San Juan de Tibás, San José, Costa Rica
                Author notes
                Correspondence: R Lozano Grupo Ferrer Internacional, Avenida Diagonal 549, E-08029 Barcelona, Spain. Tel: +34 93 600 3794 Fax: +34 93 490 7078 Email: rlozano@ 123456ferrergrupo.com
                Article
                1936295
                18360622
                © 2007 Dove Medical Press Limited. All rights reserved
                Categories
                Original Research

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