TY - JOUR
T1 - Treatment of type-1 hepatorenal syndrome with pentoxifylline
T2 - A randomized placebo controlled clinical trial
AU - Stine, Jonathan G.
AU - Wang, Jennifer
AU - Cornella, Scott L.
AU - Behm, Brian W.
AU - Henry, Zachary
AU - Shah, Neeral L.
AU - Caldwell, Stephen H.
AU - Northup, Patrick G.
N1 - Funding Information:
This work was also supported by a Transplant Hepatology Fellowship Award from the American Association for the Study of Liver Diseases (AASLD).
Funding Information:
This work was supported in part by grant funding from the National Institutes of Health (Grant 5T32DK007769-15). This work was also supported by a Transplant Hepatology Fellowship Award from the American Association for the Study of Liver Diseases (AASLD).
Funding Information:
This work was supported in part by grant funding from the National Institutes of Health (Grant 5T32DK007769-15).
Publisher Copyright:
© 2018, Fundacion Clinica Medica Sur. All rights reserved.
PY - 2018/3/1
Y1 - 2018/3/1
N2 - Introduction. Type-1 hepatorenal syndrome (HRS-1) portends a poor prognosis in patients with cirrhosis. Currently available medical therapies are largely ineffective, save for liver transplantation. We aimed to determine if pentoxifylline (PTX) therapy in addition to the standard of care of volume expansion with albumin and vasoconstriction with midodrine and octreotide (AMO) is safe and efficacious compared to AMO in HRS-1 treatment. Material and methods. Hospitalized subjects with decompensated cirrhosis and HRS-1 were enrolled. PTX or placebo was administered with AMO therapy for up to 14 days. The primary endpoint was HRS-1 resolution (serum creatinine ≤ 1.5 g/dL for > 24 h). Secondary endpoints were change in creatinine and MELD score, partial treatment response, 30-and 180-day overall and transplant free survival. Results. Twelve subjects with mean age 58.9 ± 6.2 years were enrolled and randomized. Mean MELD score was 26.5 ± 7.4 and 58.3% were male. Overall cohort 30- and 180-day survival was 58.3% and 33.3% respectively. Two subjects underwent liver transplantation. HRS-1 resolution (16.7% vs. 16.7%, p = 1.000), partial treatment response (33.3% vs. 16.7%, p = 0.505), change in creatinine (+0.48 g/dL, 95% CI -0.49-1.46 vs. +0.03 g/dL, 95% CI -0.64-0.70, p = 0.427), 30-day survival (66.6% vs. 50.0%, p = 0.558) and 180-day survival (50.0% vs. 16.7%, p = 0.221) were similar between the two groups. Serious adverse events necessitating treatment discontinuation were rare (n = 1, PTX). Discussion. The addition of PTX to AMO in the treatment of HRS-1 is safe when compared to the current standard of care. Future large-scale prospective study to validate the efficacy of this treatment seems warranted.
AB - Introduction. Type-1 hepatorenal syndrome (HRS-1) portends a poor prognosis in patients with cirrhosis. Currently available medical therapies are largely ineffective, save for liver transplantation. We aimed to determine if pentoxifylline (PTX) therapy in addition to the standard of care of volume expansion with albumin and vasoconstriction with midodrine and octreotide (AMO) is safe and efficacious compared to AMO in HRS-1 treatment. Material and methods. Hospitalized subjects with decompensated cirrhosis and HRS-1 were enrolled. PTX or placebo was administered with AMO therapy for up to 14 days. The primary endpoint was HRS-1 resolution (serum creatinine ≤ 1.5 g/dL for > 24 h). Secondary endpoints were change in creatinine and MELD score, partial treatment response, 30-and 180-day overall and transplant free survival. Results. Twelve subjects with mean age 58.9 ± 6.2 years were enrolled and randomized. Mean MELD score was 26.5 ± 7.4 and 58.3% were male. Overall cohort 30- and 180-day survival was 58.3% and 33.3% respectively. Two subjects underwent liver transplantation. HRS-1 resolution (16.7% vs. 16.7%, p = 1.000), partial treatment response (33.3% vs. 16.7%, p = 0.505), change in creatinine (+0.48 g/dL, 95% CI -0.49-1.46 vs. +0.03 g/dL, 95% CI -0.64-0.70, p = 0.427), 30-day survival (66.6% vs. 50.0%, p = 0.558) and 180-day survival (50.0% vs. 16.7%, p = 0.221) were similar between the two groups. Serious adverse events necessitating treatment discontinuation were rare (n = 1, PTX). Discussion. The addition of PTX to AMO in the treatment of HRS-1 is safe when compared to the current standard of care. Future large-scale prospective study to validate the efficacy of this treatment seems warranted.
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U2 - 10.5604/01.3001.0010.8660
DO - 10.5604/01.3001.0010.8660
M3 - Article
C2 - 29469046
AN - SCOPUS:85042289104
SN - 1665-2681
VL - 17
SP - 300
EP - 306
JO - Annals of Hepatology
JF - Annals of Hepatology
IS - 2
ER -