title: GR122311X (ranitidine bismuth citrate), a new drug for the treatment of duodenal ulcer.
abstract: BACKGROUND
  Ranitidine bismuth citrate (GR122311X) is a new drug which offers potential benefits in healing duodenal ulcers and prevention of relapse.
  
  
  METHODS
  This randomized, multi-centre double-blind study of 1620 patients compared the effect of 4 weeks of treatment with GR122311X 200 mg b.d. (n = 401), 400 mg b.d. (n = 404) or 800 mg b.d. (n = 404) or ranitidine hydrochloride 150 mg b.d. (n = 411) on the rates of duodenal ulcer healing and of overall success (ulcers healed and remaining ulcer free in the 24-week follow-up phase).
  
  
  RESULTS
  All four treatments were equally effective at ulcer healing (79%, 85%, 84% and 81% of patients, respectively). GR122311X 400 mg b.d. (38%) and 800 mg b.d. (37%) were significantly more effective than ranitidine hydrochloride 150 mg b.d. (32%) with respect to overall success (P = 0.050 and P = 0.030, respectively) but there was no difference with GR122311X 200 mg b.d. (31%). GR122311X caused effective, dose-related suppression of H. pylori (47%, 61% and 74%); H. pylori eradication rates were 18%, 21% and 22%. GR122311X was safe and well tolerated, with an adverse event profile similar to that of ranitidine hydrochloride 150 mg b.d. Median week 4 trough plasma bismuth levels were 1.3 ng/mL, 2.3 ng/mL and 3.3 ng/mL with GR122311X 200 mg b.d., 400 mg b.d. and 800 mg b.d. respectively. No individual plasma bismuth concentrations were of clinical concern.
  
  
  CONCLUSIONS
  GR122311X is a safe and effective ulcer healing drug, and provides a platform on which anti-H. pylori therapy can be based.
authors.affiliation: Rotherham General Hospitals NHS Trust, UK.
authors.forename: K D
authors.initials: KD
authors.lastname: Bardhan
authors.forename: C P
authors.initials: CP
authors.lastname: Dekkers
authors.forename: S K
authors.initials: SK
authors.lastname: Lam
authors.forename: A
authors.initials: A
authors.lastname: Nowak
authors.forename: O B
authors.initials: OB
authors.lastname: Schaffalitzky de Muckadell
authors.forename: K
authors.initials: K
authors.lastname: Schutze
authors.forename: G
authors.initials: G
authors.lastname: Tildesley
authors.forename: L
authors.initials: L
authors.lastname: Kler
authors.forename: J K
authors.initials: JK
authors.lastname: Forster
authors.forename: L F
authors.initials: LF
authors.lastname: Lacey
mesh_terms: D000328:Adult; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000097:blood / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D006635:Histamine H2 Antagonists; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D001729:Bismuth