Ranitidine bismuth citrate and aspirin-induced gastric mucosal injury.
The aim of this study was to investigate the protective action of a new compound, ranitidine bismuth citrate, in the prevention of aspirin-induced acute mucosal injury to the upper gastrointestinal tract of healthy human volunteers. In a double-blind randomized three-way cross-over study 24 male volunteers received placebo, 900 mg aspirin or 900 mg aspirin and 800 mg ranitidine bismuth citrate at 12-h intervals for nine doses with a 2-week wash-out period between each treatment. The median (interquartile range) number of erosions seen at endoscopy when ranitidine bismuth citrate was given with aspirin (1 [0-4]) was significantly lower than aspirin alone (24 [16-32]) (P < 0.001) and not significantly different from either baseline or placebo (0 [0-2]). These findings were similarly reflected in the effects on microbleeding following the ninth dose: 12.1 (7.1-21.0) microL/10 min following aspirin alone compared to levels with placebo of 1.2 (0.4-2.9), and with aspirin and ranitidine bismuth citrate of 1.6 (0.8-2.6) (P < 0.005). Ranitidine bismuth citrate conferred substantial protection from aspirin-induced injury to the gastric and duodenal mucosa as determined by both endoscopic assessment and microbleeding rates, reducing injury to placebo levels.
Hudson
N
N
Department of Therapeutics, University Hospital, Nottingham, UK.
Murray
F E
FE
Cole
A T
AT
Turnbull
G M
GM
Lettis
S
S
Hawkey
C J
CJ
D000328:Adult; D001241:Aspirin / Q000009:adverse effects*; D001729:Bismuth / Q000627:therapeutic use*; D002951:Citrates / Q000627:therapeutic use*; D004311:Double-Blind Method; D004386:Duodenum / Q000187:drug effects; D005753:Gastric Mucosa / Q000187:drug effects*; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
D002951:Citrates; D006635:Histamine H2 Antagonists; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D001241:Aspirin; D001729:Bismuth