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Abstract: TH-PO035

Impact of Terlipressin on Serum Sodium Levels in Patients With Hepatorenal Syndrome (HRS): The North American Experience

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical‚ Outcomes‚ and Trials

Authors

  • Merwat, Shehzad Nawaz, The University of Texas Medical Branch at Galveston Development Office, Galveston, Texas, United States
  • Karim, Aftab, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States
  • Khattak, Muhammad Waqar, University of Illinois Chicago College of Medicine, Peoria, Illinois, United States
  • Mujtaba, Muhammad Ahmad, The University of Texas Medical Branch at Galveston Development Office, Galveston, Texas, United States
  • Zafar, Zunaira, St. Mary Medical Center, Langhorne, Pennsylvania, United States
  • Jamil, Khurram, Mallinckrodt Pharmaceuticals, Clinton, New Jersey, United States
Background

Hyponatremia is an electrolyte abnormality commonly observed in patients (pts) with advanced cirrhosis and is associated with a poor prognosis. HRS—a rapid kidney failure—occurs in pts with decompensated cirrhosis and ascites. In some pts with HRS, terlipressin (Terli) treatment successfully reversed HRS and improved renal function. However, hyponatremia has been previously reported as a common adverse event associated with Terli administration.

Methods

Data from the 3 largest (N=608), prospective, randomized, placebo-controlled, clinical studies in HRS (OT-0401, REVERSE, and CONFIRM) were pooled in a database and assessed in a subgroup analysis. Pts with HRS were randomly assigned to receive Terli or placebo (Pbo), both plus albumin. Overall and treatment-response-dependent changes in serum sodium levels were evaluated from baseline to end of treatment (EOT). Response (ie, HRS reversal) was defined as at least 1 serum creatinine (SCr) value of ≤1.5 mg/dL while on treatment. EOT was defined as the last date/time of treatment + 24 hours.

Results

Baseline characteristics were similar across treatment groups and were characteristic of advanced liver disease: in the Terli and Pbo groups, mean MELD (SD) scores were 33.0 (6.4) and 33.1 (5.9) and mean (SD) serum sodium levels were almost identical: 132.5 (6.1) mmol/L and 132.7 (6.0) mmol/L, respectively. By EOT, serum sodium levels increased significantly more in the Terli group vs the Pbo group, in general, and in all clinical response categories defined by changes in SCr (P≤.001; Table).

Conclusion

This subgroup analysis utilized the largest prospective database to evaluate the effects of Terli vs Pbo on serum sodium concentrations. In contrast to previous observations, by EOT, hyponatremia in pts with HRS improved to a significantly greater degree when treated with Terli vs Pbo. The improvement in serum sodium was greater in subjects who had a complete response vs a partial response.

Table. Change in serum sodium concentrations from baseline to EOT, pooled intent-to-treat population.

Funding

  • Commercial Support