Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of XXXX .

@entity1 @entity5230 @entity571 @entity3522 @entity66 @entity1819 @entity1066 @entity1623 @entity3352 @entity1443 @entity5616 @entity309 @entity2275
OBJECTIVE: To evaluate the prophylactic effect of @entity5616 150 mg twice daily in @entity1 requiring one of the following non-steroidal anti-inflammatory drugs: @entity1623 , @entity5230 , @entity3522 , and @entity3352 . In addition, risk factors were studied in order to help in targeting of such treatment to specific groups of @entity1 . DESIGN: Double blind, placebo controlled, randomised, parallel group with endoscopic assessments at 0, 4, and 8 weeks. SETTING: Multicentre outpatient study at secondary referral centres in five European countries. @entity1 --297 @entity1 with @entity309 or @entity571 over the age of 18 without lesions in the stomach and duodenum at baseline endoscopy (after one week without taking non-steroidal anti-inflammatory drugs). Those taking other antirheumatic agents, concomitant ulcerogenic drugs, or treatment for peptic ulcers within the previous 30 days were excluded. Age, sex, @entity66 , and type of non-steroidal anti-inflammatory drug used were comparable in the two treatment groups. In all, 263 @entity1 completed the trial. INTERVENTIONS: @entity5616 150 mg twice daily or placebo (plus the selected non-steroidal anti-inflammatory drug) was prescribed within five days after the baseline endoscopy for two consecutive periods of four weeks. @entity1443 was permitted during the study, but not antacids. @entity1 were withdrawn if the most severe grade of damage (including ulceration) was found at the four week endoscopy or when indicated, or with lesser damage at the investigator's discretion. END POINT: Frequency of @entity2275 , or both. MEASUREMENTS AND MAIN RESULTS: The cumulative incidence of peptic ulceration by eight weeks was 10.3% (27/263); 2 out of 135 (1.5%) developed duodenal ulceration in the @entity5616 group, compared with 10 out of 126 (8%) taking placebo. The frequency of gastric ulceration was the same (6%) for the two groups at eight weeks. Though significantly fewer @entity1819 developed in the @entity5616 group by eight weeks. The frequency of non-ulcerative lesions in the duodenum did not differ greatly for the two groups at either time point. Twelve out of 75 (16%) @entity1 taking piroxicam developed peptic ulceration, of whom two thirds had duodenal ulceration. @entity1 with a history of peptic @entity1066 were particularly susceptible to recurrent ulceration, against which @entity5616 offered some protection. CONCLUSIONS: @entity5616 150 mg twice daily significantly reduced the incidence of duodenal ulceration but not gastric ulceration when prescribed concomitantly with one of four commonly used non-steroidal anti-inflammatory drugs.
