Prevention of gastroduodenal damage with omeprazole in patients receiving continuous NSAIDs treatment. A double blind placebo controlled study.
OBJECTIVE
The aim of this study was to compare omeprazole (20 mg once daily) with placebo in the long-term prevention of gastroduodenal lesions induced by indomethacin, diclofenac and ketoprofen.


METHODS
114 patients with arthritic disorders and requiring indomethacin, diclofenac or ketoprofen were randomized in a double blind manner to receive omeprazole-20 mg once daily- or identical placebo for three weeks. The gastroduodenal mucosa damage was scored according to a 0-4 point endoscopic scale.


RESULTS
Of the 114 patients, 103 (50 in the omeprazole group, 53 in the placebo group) were submitted to endoscopy, while 11 patients dropped out for non-medical reasons. At the final endoscopy, 26/57 (46%) of omeprazole group, and 20/57 (35%) of the placebo group had normal gastroduodenal mucosa (score = 0) (p ns; 95% IC -0.073 + 0.284). A gastric ulcer was observed in 7/57 (12%) patients, all in the placebo group (p < 0.01 vs omeprazole); 2 patients (1 in the omeprazole group and 1 in the placebo group) developed a duodenal ulcer. Dyspeptic symptoms developed in 10% of the patients treated with omeprazole and 29% of those receiving placebo (p ns).


CONCLUSIONS
Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated gastric and duodenal ulcer.
Bianchi Porro
G
G
Gastro-intestinal Unit, L. Sacco University Hospital, Milano, Italy.
Lazzaroni
M
M
Petrillo
M
M
Manzionna
G
G
Montrone
F
F
Caruso
I
I
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004008:Diclofenac / Q000009:adverse effects; D004311:Double-Blind Method; D016145:Endoscopy, Digestive System; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000187:drug effects / Q000473:pathology; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology; D007660:Ketoprofen / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000139:chemically induced / Q000473:pathology / Q000517:prevention & control*; D012216:Rheumatic Diseases / Q000188:drug therapy; D012449:Safety; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D004008:Diclofenac; D007660:Ketoprofen; D009853:Omeprazole; D007213:Indomethacin