Effect of gastric mucosal protection in nonrheumatoid patients with short-term nonsteroidal anti-inflammatory drug therapy: a prospective randomized multicenter study.

BACKGROUND/AIMS: Since nonsteroidal anti-inflammatory drugs (NSAIDs) are known to cause gastrointestinal mucosal injury, concurrent administration of gastric protective agents in patients with rheumatoid disorders is often recommended. The present study was designed to determine the possible benefit of sucralfate, a gastric protective agent in patients receiving short-term therapy with NSAIDs for conditions other than rheumatoid arthritis.

METHODOLOGY

In nineteen general practitioners offices a total of 208 patients were studied. Patients received either sucralfate suspension (2 x 2 g/day) or no additional medicine while being put on NSAIDs for a mean of 9 days.

RESULTS

Forty patients (39%) in the sucralfate group and 71 (68%) in the control group developed gastrointestinal symptoms (p < 0.05). In the control group six patients (6%) had gastrointestinal hemorrhage and 2 patients (2%) experienced perforation of a duodenal ulcer. Gastrointestinal hemorrhage and perforation were not observed in the sucralfate group. Short-term NSAID use in nonrheumatoid patients carries a higher risk for symptoms and complications in patients that are 40 years old and above. These risk are even more pronounced in patients of 60 years of age or above, in patients with a history of peptic ulcer disease, in smokers, in patients with concomitant disease and concomitant steroid use, and with the use of diclofenac. The mean age of patients with gastrointestinal hemorrhage was 65 years. Both patients that suffered perforation of a duodenal ulcer were young (35 and 42 years) and had a history of duodenal ulcer disease.

CONCLUSION

Gastric protection with sucralfate reduces the frequency of both symptoms and complications in nonrheumatoid patients receiving short-term therapy with NSAIDs.