Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points

Introduction-Pharmacotherapy for upper gastrointestinal bleeding has been d ifficult to evaluate because clinical end points are infrequent and affecte d by other factors. Aims-To evaluate whether blood in the stomach at endoscopy reflected severi ty of bleeding, predicted clinical outcomes, and could be altered by therap eutic agents. Methods-We studied 414 consecutive admissions with suspected upper gastroin testinal bleeding. Patients were randomised to receive lansoprazole 60 mg f ollowed by 30 mg four times daily, tranexamic acid 2 g followed by I g four times daily, both drugs, or placebo for four days, until discharge or a cl inical end point occurred. Logistic regression analysis was used to determi ne predictors of endoscopic changes and clinical outcomes, and to investiga te the effects of drug treatments on blood in the stomach. Results-Of 414 patients with suspected upper gastrointestinal bleeding, 379 were endoscoped. Upper gastrointestinal bleeding was confirmed in 316. Six teen required surgery within 30 days and 16 died on the index admission. Tr ial treatments were evaluable on a per protocol basis in 228 patients. The amount of blood in the stomach was found to reflect initial risk, with sign ificant associations with high risk categorisation (odds ratio 3.7 (95% con fidence interval 1.5-9.4) for more than a trace v none/trace), age (1.5 (1. 1-1.9) per decade), and initial pulse (1.02 (1.00-1.04) per beat), and to p redict rebleeding (9.2 (4.6-18.7)) and surgery (8.2 (2.9-22.9)). Other stig mata were less significant in these respects. The amount of blood in the st omach at endoscopy was reduced significantly by both lansoprazole (0.22 (0. 07-0.63)) and tranexamic acid (0.27 (0.09-0.81)), although there was no evi dence of synergy. Conclusions-Blood in the stomach reflects clinical features in patients wit h acute upper gastrointestinal bleeding and is reduced by treatment with la nsoprazole and tranexamic acid.