D0474 - Impact of Terlipressin on Serum Sodium Levels in Patients with Hepatorenal Syndrome Type 1 (HRS-1): CONFIRM Study

Nikolaos Pyrsopoulos, MD, MBA, PhD, FACG¹, Mohammad Khan, MD², Zunaira Zafar, MD³, Khurram Jamil, MD^4
1Rutgers New Jersey Medical School, Newark, NJ; ²Jefferson Northeast, Newtown, PA; ³St. Mary Medical Center, Yardley, PA; ⁴Mallinckrodt, Hampton, NJ

Introduction: Hyponatremia is a complication of decompensated advance liver disease and is associated with a poor prognosis. HRS-1 is rapid kidney failure occurring in patients (pts) with decompensated cirrhosis and ascites. Terlipressin was reported to successfully reverse HRS and improve kidney function in eligible pts with HRS-1. However, it was previously reported that terlipressin might worsen hyponatremia.

Methods: Data from CONFIRM—the largest, prospective, randomized, placebo-controlled clinical study of terlipressin in pts with HRS-1 (N=300)—were retrospectively analyzed. Pts were randomly assigned to receive terlipressin plus albumin (Terli) or placebo plus albumin (Pbo). Overall and treatment response-dependent changes in serum sodium (Na) levels were evaluated from baseline to the end of treatment (EOT). Complete response (CR=HRS reversal) was defined as at least 1 serum creatinine (SCr) value of ≤1.5 mg/dL while on treatment. Partial response (PR) was defined as ≥30% improvement in SCr but not HRS reversal, and no response (NR) meant no change or worsening of SCr. EOT was defined as the last date/time of treatment plus 24 hours.

Results: Baseline characteristics were compatible with decompensated liver disease and similar across treatment groups: in the Terli and Pbo groups, mean Model for End-Stage Liver Disease (MELD) (standard deviation [SD]) scores were 32.7 (6.6) and 33.1 (6.2), respectively. On average, hyponatremia was moderate. Mean (SD) serum Na levels in the safety population were almost identical: 133.1 (5.6) mmol/L and 133.3 (5.5) mmol/L, respectively. By EOT, serum Na levels increased significantly more in the Terli group vs the Pbo group, and in all clinical response categories defined by changes in SCr (Table). The improvement in serum Na was numerically higher in pts who had a CR vs PR; however, they were similar in the CR and NR groups (Table).

Discussion: In contrast to previous observations, by EOT, hyponatremia in pts with HRS-1 improved to a significantly higher level when treated with Terli vs Pbo in all response categories. The results suggest that the use of Terli is safe with respect to hyponatremia.




Disclosures:


Nikolaos Pyrsopoulos, MD, MBA, PhD, FACG¹, Mohammad Khan, MD², Zunaira Zafar, MD³, Khurram Jamil, MD⁴. D0474 - Impact of Terlipressin on Serum Sodium Levels in Patients with Hepatorenal Syndrome Type 1 (HRS-1): CONFIRM Study, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.