Mallinckrodt plc, announced results from a retrospective medical chart review study examining treatment patterns and outcomes in hospitalized patients with esophageal variceal hemorrhage (EVH) and liver cirrhosis treated with terlipressin. EVH is a major complication of cirrhosis and a leading cause of death in people with cirrhosis.1 Results were presented at the American College of Gastroenterology Annual Scientific Meeting being held virtually and live in Las Vegas from October 22-27. Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration. The retrospective medical chart review study assessed real world outcomes in 195 hospitalized adult patients across 18 hospitals in the U.K. (where terlipressin is approved and available) from January 1, 2016, through September 30, 2019. To be eligible for the analysis, patients had to be at least 18 years of age at hospital admission, be admitted within 24-36 hours after occurrence of EVH, had a history of liver cirrhosis, complete hospital information from admission to discharge and no prior history of EVH in three months. Data were collected from hospital admission up to 90 days post-discharge or until death using an electronic case report form. Nearly all patients (n=192; 98.5%) in the analysis were treated with terlipressin within a day of hospital admission and the mean treatment duration was 4.3 days. The primary clinical outcome was control of bleeding within 36 hours and five days defined per Baveno V criteria, which define treatment failure as death or fresh hematemesis or nasogastric aspiration of =100 mL of fresh blood =two hours after the start of a specific drug treatment or therapeutic endoscopy, 3-g drop in hemoglobin within any 24-hour period if no transfusion is administered, and hypovolemic shock.2,3 The study found that, based on Baveno V criteria, 116 patients (59.5%) achieved an initial bleed control within 36 hours and 111 patients (56.9%) within five days. Of the patients who had an initial bleed control in 36 hours, rebleeding was observed in 47 patients (40.5%) within three days, 50 patients (43.1%) within five days and 53 patients (45.7%) within seven days. Of the patients who had an initial bleed control in five days, rebleeding was observed in 46 patients (41.4%) within three days, 48 patients (43.2%) within five days and 48 patients (43.2%) within seven days of the initial bleed control. The study had limitations inherent to the retrospective nature of the study design, and data collected was limited to the information available and extracted from patient medical charts. Terlipressin has previously been studied and approved by the National Health Service in the U.K. in this patient population, and scientific evidence of the published study was summarized in a Cochrane review.4 Terlipressin is one of the accepted vasoactive therapies recommended by the European Association for the Study of the Liver guidelines, which recommends that vasoconstrictive therapy should be initiated as soon as acute variceal bleeding is suspected and before endoscopy. This study was sponsored by Mallinckrodt.