Multicenter randomized controlled trial of terlipressin versus sclerotherapy in the treatment of acute variceal bleeding: The TEST study

Failure to control bleeding and early rebleeding account for the high morta lity associated with variceal hemorrhage in cirrhosis. We compared endoscop ic sclerotherapy to terlipressin, a drug that effectively controls acute bl eeding while reducing in-hospital mortality. This multicenter randomized co ntrolled trial included 219 cirrhotic patients admitted for endoscopy-prove n acute variceal bleeding and randomized to receive repeated injections of terlipressin during 6 days (n = 105) or emergency sclerotherapy (n = 114). Success was defined as obtaining control of bleeding (24-hour bleeding-free period during the first 48 hours) and lack of early rebleeding (any furthe r bleeding from initial control to 5 days later) and survival during the st udy. Both groups were similar at inclusion. Failure rate for terlipressin w as 33% and 32% for sclerotherapy (not significant [NS]). Early rebleeding w as responsible for 43% and 44% of failures, respectively. This high efficac y was observed in both Child-Pugh class A + B and Child-Pugh class C patien ts. Both treatments were similar regarding transfusion requirements, in-hos pital stay, and 6-week mortality (26 vs. 19 patients). Side effects appeare d in 20% of patients receiving terlipressin and in 30% of those on scleroth erapy (P = .06); being serious in 4% and 7%, respectively (NS). In conclusi on, terlipressin and sclerotherapy are equally highly effective therapies a chieving the initial control of variceal bleeding and preventing early rebl eeding. Both treatments are safe, but terlipressin is better tolerated. The refore, terlipressin may represent a first-line treatment in acute variceal bleeding until the administration of elective therapy, especially in hospi tals where a skilled endoscopist is not available 24 hours a day.