OCTREOTIDE COMPARED WITH PLACEBO IN A TREATMENT STRATEGY FOR EARLY REBLEEDING IN CIRRHOSIS, A DOUBLE-BLIND, RANDOMIZED PRAGMATIC TRIAL

beta-Blockers and sclerotherapy prevent long-term upper digestive rebl eeding in cirrhosis but they seem ineffective for early rebleeding, We compared octreotide with a placebo for the prevention of early reblee ding in cirrhotic patients. lifter control of acute upper digestive bl eeding, 262 consecutive cirrhotic patients were randomized to octreoti de 100 mu g subcutaneously three times a day for 15 days (n = 131) or to the placebo (n = 131), in a double blind pragmatic trial in which b eta-blockers and/or sclerotherapy were allowed together with the exper imental treatment. Separate randomization and analysis were performed according to whether patients were eligible for beta-blockers and/or s clerotherapy (101 placebo, 97 octreotide) or not (30 placebo, 34 octre otide). Rebleeding within 15 days was the primary measure of treatment efficacy; 6-week rebleeding rate was also assessed as a secondary mea sure. Fifteen-day cumulative proportions of patients rebleeding were 2 8% in the placebo group and 24% in the octreotide soup (P =.40); corre sponding figures among the 198 patients eligible to beta-blockers and/ or sclerotherapy were 26% and 16% (P =.05) and among the 64 not eligib le for these treatments 33% and 49% (P =.29), Among patients eligible to beta-blockers and/or sclerotherapy, a significant reduction of rebl eeding episodes (35 vs. 18, P =.03), blood transfusions (75 vs, 50, P =.04), and days of stay in hospital (1,544 vs. 1,190, P =.0001) was al so found in the octreotide group: this beneficial effect was confirmed 6 weeks after randomization, Mortality was not affected by octreotide in either group of patients. It is suggested that octreotide may redu ce the risk of early rebleeding in cirrhotic patients treated with bet a-blockers and/or sclerotherapy after control of acute upper digestive bleeding. Further studies are needed to confirm this result.