title: Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules.
abstract: BACKGROUND
  Diclofenac-potassium (diclofenac--K) 25 mg liquid capsule is absorbed more quickly than the tablet formulation. It offers potential for rapid pain relief, but may alter gastro-duodenal tolerability.
  
  
  OBJECTIVE
  To evaluate the gastro-duodenal tolerance of diclofenac-K 25 mg liquid capsules vs. diclofenac-K 12.5 mg tablets, acetylsalicylic acid (ASA) 500 mg tablets and ibuprofen 200 mg liquid capsules.
  
  
  METHODS
  In an endoscopist-blinded, randomised, parallel-group study, volunteers received 15 doses of diclofenac-K 25 mg liquid capsules (n = 36), diclofenac-K 2 × 12.5 mg tablets (n = 36), ibuprofen 2 × 200 mg liquid capsules (n = 24) or ASA 2 × 500 mg tablets (n = 36) over 5 days. The primary outcome was the incidence of erosive gastro-duodenal lesions at Day 6. Secondary outcomes included modified Lanza score and change in gastric mucosal prostaglandin synthesis.
  
  
  RESULTS
  The lowest incidence of erosive gastro-duodenal lesions was with diclofenac-K liquid capsules (53%), compared to 61% with diclofenac-K tablets (P = 0.52), 75% with ibuprofen (P = 0.08) and 94% with ASA (P = 0.001). Results were similar for the Lanza scores, although diclofenac-K liquid capsules were significantly superior to ibuprofen liquid capsules (P = 0.04). Diclofenac-K liquid capsules inhibited prostaglandin synthesis by 52% compared to 64% for diclofenac-K tablets (P = 0.10), 50% for ibuprofen (P = 0.85) and 79% for ASA (P = 0.002). With respect to safety, adverse events were most frequent in the ASA group, predominantly gastrointestinal events.
  
  
  CONCLUSIONS
  Mucosal injury with diclofenac-K liquid 25 mg liquid capsules was similar to diclofenac-K 25 mg tablets, significantly lower than ASA 1 g tablets and showed some superiority over ibuprofen 400 mg liquid capsules (EudraCT Number 2009-011278-14).
authors.affiliation: Digestive Diseases Centre, Nottingham University Hospital, UK. cj.hawkey@nottingham.ac.uk
authors.forename: C
authors.initials: C
authors.lastname: Hawkey
authors.forename: I
authors.initials: I
authors.lastname: Burnett
authors.forename: M S
authors.initials: MS
authors.lastname: Gold
authors.forename: K
authors.initials: K
authors.lastname: Garsed
authors.forename: D
authors.initials: D
authors.lastname: Stevenson
authors.forename: J
authors.initials: J
authors.lastname: Mannath
authors.forename: A
authors.initials: A
authors.lastname: Norman
authors.forename: V
authors.initials: V
authors.lastname: Shepherd
authors.forename: V
authors.initials: V
authors.lastname: Subramanian
authors.forename: R D
authors.initials: RD
authors.lastname: Johnston
authors.forename: M
authors.initials: M
authors.lastname: Brown
mesh_terms: D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002214:Capsules; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004361:Drug Tolerance; D004386:Duodenum / Q000187:drug effects; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008297:Male; D010147:Pain Measurement; D013607:Tablets; D013997:Time Factors; D055815:Young Adult
chemical_list: D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D013607:Tablets; D004008:Diclofenac; D001241:Aspirin; D007052:Ibuprofen