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Retrospective chart review study of Variquel shows bleed control in esophageal variceal hemorrhage.

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Last updated:26th Oct 2021
Published:26th Oct 2021
Mallinckrodt announced results from a retrospective medical chart review study of Variquel (terlipressin) 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.

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 percent) 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 of at least 100 mL of fresh blood of at least 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.

The study found that, based on Baveno V criteria, 116 patients (59.5 percent) achieved an initial bleed control within 36 hours and 111 patients (56.9 percent) within five days. Of the patients who had an initial bleed control in 36 hours, rebleeding was observed in 47 patients (40.5 percent) within three days, 50 patients (43.1 percent) within five days and 53 patients (45.7 percent) within seven days. Of the patients who had an initial bleed control in five days, rebleeding was observed in 46 patients (41.4 percent) within three days, 48 patients (43.2 percent) within five days and 48 patients (43.2 percent) 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. Results were presented at the American College of Gastroenterology Annual Scientific Meeting.

Condition: Oesophageal Varices
Type: drug

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