title: [Use of itopride in the symptoms of functional dyspepsia in Russia: results of a phase IV prospective open-label multicenter clinical trial].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of itopride used to treat the symptoms of functional dyspepsia (FD) of the upper gastrointestinal tract.
  
  
  METHODS
  A prospective, open-label, multicenter trial using as a control the placebo response obtained in the previous investigations enrolled 96 adult patients. The diagnosis of FD corresponded to its Rome II criteria. Patients received itopride (Ganaton) oral tablets (50 mg) 3 times daily for 8 weeks. When included into the trial, the patients were orally given itopride (ganaton) tablets (50 mg) thrice daily before meals for 8 weeks. The patients' status was evaluated during (at weeks 4 and 8) and after (at week 12) treatment. Treatment response was assessed using the Global Patient Assessment (GPA) and the Leeds Dyspepsia Questionnaire (LDQ). To evaluate the safety of itopride use, the investigators studied the frequency of adverse events and carried out laboratory tests (renal and liver function tests) and electrocardiography (ECG).
  
  
  RESULTS
  The GPA showed that 53.76, 85.71, and 82.22% of the patients achieved a therapeutic effect of itopride at weeks 4, 8, and 12, respectively. The proportion of the patients who achieved the therapeutic effect (86%) at week 8 was higher than the historical placebo controls in the previous studies--45% (86% vs 45%; X2 = 68.868, df = 3; p < 0.001). The mean LDQ score at week 8 was significantly lower than that at baseline (2.09 and 9.36 scores; p < 0.001); 6 nonserious adverse events occurred in 3 (3.12%) of the 96 patients. During the follow-up period, there was a mild adverse event that was related to the test drug (atrial extrasystole as evidenced by ECG) and resolved a few days later.
  
  
  CONCLUSIONS
  Itopride is an effective and well-tolerated drug in the treatment of functional dyspepsia in the Russian patients.
authors.forename: V I
authors.initials: VI
authors.lastname: Kas'ianenko
authors.forename: N L
authors.initials: NL
authors.lastname: Denisov
authors.forename: Iu V
authors.initials: IuV
authors.lastname: Vasil'ev
mesh_terms: D000109:Acetylcholine / Q000378:metabolism; D001549:Benzamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001593:Benzyl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018492:Dopamine Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D065127:Dopamine D2 Receptor Antagonists; D004415:Dyspepsia / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D004562:Electrocardiography; D005260:Female; D005769:Gastrointestinal Motility / Q000187:drug effects*; D006801:Humans; D007677:Kidney Function Tests; D008111:Liver Function Tests; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D017448:Receptors, Dopamine D2; D012426:Russia; D011795:Surveys and Questionnaires
chemical_list: D001549:Benzamides; D001593:Benzyl Compounds; D002800:Cholinesterase Inhibitors; C581293:DRD2 protein, human; D018492:Dopamine Antagonists; D065127:Dopamine D2 Receptor Antagonists; D017448:Receptors, Dopamine D2; C102254:itopride; D000109:Acetylcholine