Our Focus: Ascites
Development of ascites, the abnormal accumulation of fluid in the peritoneal cavity of the abdomen, is a hallmark of progression into the decompensated phase of cirrhosis. The increased portal hypertension associated with decompensated cirrhosis causes lymphatic fluid to leak out across hepatic vasculature and pool in large volumes in the peritoneal cavity. Initial treatments include dietary modifications, diuretics and albumin infusion; however, a significant number of patients progress in their disease and no longer respond to these interventions. With progression, both quality of life and prognosis severely diminish. Ascites that is refractory to standard-of-care treatment with diuretics can lead to renal complications, hernias, and difficulty in eating, drinking, breathing and moving due to the abdominal distention. Survival rates at this disease stage can be as low as 50% at 6-12 months post-diagnosis.
More than 500,000 patients in the United States at any given time suffer from decompensated cirrhosis and approximately 400,000 have ascites. Data suggest that greater than 10 percent of ascites patients will go on to develop ascites that is not well managed by dietary modifications, diuretics or albumin infusion. Those patients require much more aggressive treatment approaches, and many will experience a significant increase in hospital admissions.
As first-line treatment approaches to ascites are determined to not be sufficient in managing an individual’s condition, considerably more invasive measures are used to eliminate the fluid. These include direct aspiration of the ascites (paracentesis), placement of a low flow ascites pump or a shunt that diverts the blood away from the congested portal veins (transjugular intrahepatic portosystemic shunt [TIPS]). Each of these approaches comes with significant risks such as infection, circulatory dysfunction or hepatic encephalopathy. OCE-205, with its unique mechanism of action, offers the promise of a non-invasive, therapeutic solution.
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