PRIMARY GASTRODUODENAL PROPHYLAXIS WITH OMEPRAZOLE FOR NONSTEROIDAL ANTIINFLAMMATORY DRUG-USERS

Aim: To investigate the efficacy of omeprazole 20 mg o.m. as primary p rophylaxis against non-steroidal anti-inflammatory drug (NSAID)-associ ated ulcer disease or dyspeptic symptoms. Methods: A parallel group st udy compared patients randomized to receive omeprazole 20 mg o.m. or p lacebo as co-therapy with on-going NSAID treatment, over 6 months, in 19 specialist centres in Ireland, Hungary, France, the UK and the USA. One hundred and sixty-nine patients taking NSAIDs regularly, chronica lly and above defined minimum doses entered, the trial. The main outco me measure was the development of gastric or duodenal ulcers detected endoscopically, the development of multiple erosions in the stomach or duodenum, or the onset of moderate or severe dyspeptic symptoms, Resu lts: The estimated probability of remaining free of these end-points f or 6 months for patients taking omeprazole was 0.78 compared to 0.53 f or placebo (P = 0.004). Fourteen patients receiving placebo (16.5%) de veloped 15 ulcers, comprising nine gastric and six duodenal ulcers, co mpared to three patients (3.6%) receiving omeprazole (all gastric ulce rs), Logistic regression analysis showed that older patients were less likely, whilst those with rheumatoid arthritis were more likely, to r emain free of NSAID-associated problems, Conclusions: Omeprazole is an effective agent for gastroduodenal prophylaxis in patients taking NSA IDs. Its main effect is to reduce the rate of development of gastric a nd duodenal ulcers.