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• W4238310366 abstract "We agree with Dr. Koller that the advent of effective and safe aquaretic drugs may potentially reduce the incidence of dilutional hyponatremia and thus the usefulness of incorporating serum sodium into the Model for End-Stage Liver Disease (MELD) formula to increase its prognostic power. However, for a number of reasons we believe that at the present time this should be regarded more as an optimistic theory than as a fact. First, only a total of 125 patients with cirrhosis and hyponatremia were enrolled in the 4 reported phase II clinical trials using VPA-985, a selective vasopressin V2-receptor antagonist.1-4 Second, although the use of VPA-985 for a maximum of only 7 days was associated with increased free-water clearance, normalization of serum sodium in the European multicenter study occurred in 50% of patients treated with 200 mg/day and in only 27% of the 100 mg/day group.4 An increase of ≥5 mEq/L of serum sodium was observed in 67% and 45%, respectively. However, how clinically significant is a short-term increase in natremia from 120 to 125 mEq/L in a given patient? How efficacious are aquaretics in the long term? How many patients will escape from the aquaretic effects of VPA-985 during continuous administration? Third, safety of aquaretic drugs is still largely unknown, especially when considering long-term therapy. In the North American multicenter trial, 24% of patients with cirrhosis developed adverse effects such as worsening encephalopathy and dehydration with systemic postural hypotension.3 Of major concern is the synergic interaction between aquaretic and natriuretic agents in patients with end-stage cirrhosis and circulatory dysfunction. Finally, Dr. Koller believes that aquaretics will be approved by the FDA this year, a statement that appears to us as excessively optimistic, considering that no large phase III trial has been reported so far. For all these reasons, we believe that it is not premature to validate the prognostic efficacy of serum sodium in a large cohort of patients listed for liver transplantation, as proposed in our study.5 What appears premature is to conclude, based on the reported experience, that there is a clear role for aquaretic agents in the management of patients with cirrhosis, ascites, and hyponatremia. Several uncontrolled studies have shown that terlipressin and other systemic vasoconstrictors reverse type 1 hepatorenal syndrome in a significant proportion of patients.6-8 However, the prognostic value of serum creatinine, one of the 3 components of MELD, has not been similarly challenged despite the availability of effective therapy. We believe that cirrhotics with dilutional hyponatremia or hepatorenal syndrome listed for liver transplantation should be treated if safe and effective therapies become available, irrespective of the system used for organ allocation. Moreover, routine use of aquaretics and systemic vasoconstrictors may be of help to identify in the future a subset of nonresponders to these therapies that in turn may reflect more severe disease and urgent need for liver transplantation. Andrés E. Ruf MD*, Federico G. Villamil MD*, * Liver Unit, Fundación Favaloro, Buenos Aires, Argentina." @default.
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• W4238310366 date "2005-01-01" @default.
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• W4238310366 title "Letters to the editor" @default.
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• W4238310366 doi "https://doi.org/10.1002/lt.20467" @default.
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