title: A long-term study of acotiamide in patients with functional dyspepsia: results from an open-label phase III trial in Japan on efficacy, safety and pattern of administration.
abstract: BACKGROUND
  This long-term 48-week study of acotiamide was carried out to investigate the efficacy, safety and administration pattern in patients with functional dyspepsia (FD).
  
  
  METHODS
  This was a multicenter, open-label, single-arm, long-term phase III study in which patients with FD were given acotiamide, 100 mg t.i.d., for 48 weeks. The two major efficacy endpoints were global overall treatment efficacy (OTE) and the elimination rate of three cardinal symptoms (i.e. postprandial fullness, early satiation and upper abdominal bloating), which were evaluated weekly and daily by the patients, respectively. The long-term administration patterns were investigated by following the patients based on cessation and readministration criteria.
  
  
  RESULTS
  Efficacy was analyzed in 405 patients. The OTE improvement rate was 26.1% at week 1 and increased with time. It was 60.6% at week 8 and subsequently maintained. Similarly, the symptom elimination rate increased up to week 8. Many patients who met the cessation criterion achieved remission of FD symptoms after experiencing dose interruption and readministration. The incidence rate of adverse drug reactions was 11.5% and most of the adverse drug reactions were mild in severity except increased ALT in 1 patient.
  
  
  CONCLUSIONS
  FD symptoms were controlled by intermittent administration of acotiamide even in patients with relapsing FD.
authors.affiliation: Sakura Life Clinic, Sumida-ku, Tokyo, Japan. matsueda@slclinic.com
authors.forename: K
authors.initials: K
authors.lastname: Matsueda
authors.forename: M
authors.initials: M
authors.lastname: Hongo
authors.forename: S
authors.initials: S
authors.lastname: Ushijima
authors.forename: H
authors.initials: H
authors.lastname: Akiho
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000328:Adult; D001549:Benzamides / Q000494:pharmacology / Q000627:therapeutic use*; D004415:Dyspepsia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018721:Muscarinic Agonists / Q000494:pharmacology / Q000627:therapeutic use*; D019518:Postprandial Period; D012527:Satiation / Q000187:drug effects / Q000502:physiology; D012677:Sensation / Q000187:drug effects / Q000502:physiology*; D013844:Thiazoles / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001549:Benzamides; D018721:Muscarinic Agonists; D013844:Thiazoles; C410959:Z 338