title: Gastrointestinal safety of triflusal solution in healthy volunteers: a proof of concept endoscopic study.
abstract: OBJECTIVE
  Triflusal is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. It was initially marketed as capsules containing 300 mg of active substance. In 2006 a new 600 mg (10 ml) oral solution form of triflusal was authorized in Spain. The primary aim of this study was to compare the gastrointestinal safety of the new triflusal oral solution with triflusal capsules in healthy volunteers.
  
  
  METHODS
  Sixty healthy subjects were randomly assigned, in a 2.5:2.5: 1 ratio, into one of three groups, with 25 subjects receiving one bottle of triflusal oral solution (600 mg) daily, 25 subjects receiving two triflusal capsules (600 mg) once daily, and ten subjects receiving two placebo capsules once daily, respectively, during 7 consecutive days. Gastroscopy was performed at baseline before the administration of study drugs and after 4-8 h of the last dose of study drugs. Effects on the esophagus, stomach, and duodenum were measured in accordance with a modified Lanza scale.
  
  
  RESULTS
  No differences between groups were detected at baseline. After treatment, median global scores in the placebo, triflusal solution, and triflusal capsules groups were, respectively, 0, 1, and 3 (p = 0.003 for comparison between placebo and triflusal capsules and p = 0.042 for comparison between triflusal solution and triflusal capsules). There were no significant differences between the scores on the triflusal solution and placebo groups. All treatments were well tolerated.
  
  
  CONCLUSIONS
  In healthy subjects, triflusal solution induced less endoscopically apparent gastrointestinal mucosal damage than triflusal capsules and did not induce more damage than the placebo in healthy volunteers.
authors.affiliation: Clinical Pharmacology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Rosa M
authors.initials: RM
authors.lastname: Antonijoan
authors.forename: Ignasi
authors.initials: I
authors.lastname: Gich
authors.forename: Analia
authors.initials: A
authors.lastname: Azaro
authors.forename: Sergio
authors.initials: S
authors.lastname: Sainz
authors.forename: Joaquim
authors.initials: J
authors.lastname: Balanzó
authors.forename: Iñaki
authors.initials: I
authors.lastname: Izquierdo
authors.forename: Javier
authors.initials: J
authors.lastname: Borja
authors.forename: Esther
authors.initials: E
authors.lastname: Donado
authors.forename: Iris
authors.initials: I
authors.lastname: Blanch
authors.forename: Manel J
authors.initials: MJ
authors.lastname: Barbanoj
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002214:Capsules; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D041981:Gastrointestinal Tract / Q000187:drug effects*; D006801:Humans; D008297:Male; D010974:Platelet Aggregation / Q000187:drug effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects* / Q000493:pharmacokinetics; D012459:Salicylates / Q000009:adverse effects* / Q000493:pharmacokinetics; D013030:Spain; D013223:Statistics as Topic; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D002214:Capsules; D010975:Platelet Aggregation Inhibitors; D012459:Salicylates; C016167:triflusal