MARS® therapy shows promise in largest clinical trial for patients with acute-on-chronic liver failure

The RELIEF trial – the largest trial to date involving the use of extracorporeal liver support – compared MARS therapy to standard medical therapy in patients with acute-on-chronic liver failure (AOCLF.) Treatment of AOCLF is one of the relatively new MARS applications and the purpose of the RELIEF trial was to assess its efficacy and safety for this indication.

The RELIEF trial demonstrated a significant decrease in serum bilirubin and creatinine levels and an improvement in hepatic encephalopathy for patients treated with MARS therapy in comparison to patients receiving standard medical therapy. Although the study did not demonstrate a statistically significant difference in survival between MARS therapy and standard medical therapy, as indicated in the trial abstract and in the press release issued by EASL, the RELIEF findings show that MARS therapy, at low dosage, is a safe procedure, which has significant dialysis effect and improves severe hepatic encephalopathy in patients with cirrhosis and rapid deterioration of their liver function.

The MARS therapy is today the most widely used extracorporeal liver support therapy. This therapy has been in clinical use since 1993 and commercially available since 1999. Its clinical indications are many, including AOCLF, acute liver failure, graft dysfunction after liver transplantation, liver failure after hepatic resection, intractable pruritus in cholestatic liver diseases, and drug overdose and poisoning. The MARS system is used in 45 countries around the world and its safety and efficacy have been demonstrated by clinical experience with more than 9,000 patients (about 36,000 treatments) who have benefited from its use.
  
“This latest clinical trial adds additional evidence to support that MARS is an important therapeutic tool in controlling the most serious complications of liver disease,” says Dr. Josep Torner, Medical Director of Gambro’s Liver Business. “An ongoing collaboration with the hepatology community is critical to better define the indications for MARS and improve our understanding of the mechanisms of liver failure.”

For further information please contact:
Maria Lundbäck, Director External Communications Gambro, tel. +46 705 13 6534

In the U.S., the MARS® system is cleared for use in the treatment of drug overdose and poisonings only.  It is not indicated in the U.S. for the treatment of chronic liver conditions or as a bridge to liver transplant.