Survival Benefit of Tolvaptan for Refractory Ascites in Patients with Advanced Cirrhosis

Tajiri, Kazuto; Tokimitsu, Yoshiharu; Ito, Hiroyuki; Atarashi, Yoshinari; Kawai, Kengo; Minemura, Masami; Yasumura, Satoshi; Takahara, Taro; Shimizu, Yukihiro; Sugiyama, Toshiro

doi:10.1159/000489258

Cited by 10 publications

(8 citation statements)

References 34 publications

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“…39,40 Moreover, one study assessed the efficacy of tolvaptan in elevating serum sodium in cirrhotic patients with hyponatremia, 41 while another one included exclusively tolvaptan non-responders. Four studies were excluded after reading the full text.…”

Section: Resultsmentioning

confidence: 99%

“…Two of them evaluated predictive factors of tolvaptan response only with univariate logistic regression, and thus, they provided inadequate data to be included in the quantitative metaanalysis. 39,40 Moreover, one study assessed the efficacy of tolvaptan in elevating serum sodium in cirrhotic patients with hyponatremia, 41 while another one included exclusively tolvaptan non-responders. 42 Quality assessment.…”

Section: Resultsmentioning

confidence: 99%

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Predictors of tolvaptan short‐term response in patients with refractory ascites: A meta‐analysis

Bellos

Kontzoglou

Perrea

2019

J of Gastro and Hepatol

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Background and Aim Tolvaptan represents an oral V2‐receptor antagonist, which has been suggested as a promising add‐on diuretic treatment for refractory ascites. The present meta‐analysis aims to accumulate current evidence and identify which clinical and laboratory factors are linked to short‐term response to tolvaptan therapy. Methods Medline, Scopus, Cochrane Central Register of Controlled Trials, http://Clinicaltrials.gov, and Google Scholar databases were searched from inception. All observational studies reporting the correlation of patients' characteristics with tolvaptan response were selected. Results Tolvaptan response was associated with significantly higher baseline body weight (mean difference: 4.59 kg, 95% confidence interval [CI]: [3.58, 5.61]), presence of hepatitis C (odds ratio: 1.59 95% CI: [1.18, 2.14]), lower blood urea nitrogen (BUN) (mean difference: −6.88 mg/dL, 95% CI: [−8.13, −5.63]), lower serum creatinine (mean difference: −0.17 mg/dL, 95% CI: [−0.30, −0.05]), lower C‐reactive protein (mean difference: −1.43 mg/dL, 95% CI: [−2.52, −0.35]), and higher sodium levels (mean difference: 1.00 mEq/L, 95% CI: [0.45, 1.55]). The outcomes of bodyweight, hepatitis C, BUN, and C‐reactive protein remain significant independently of response definition and risk of bias. Conclusions The present findings suggest bodyweight, BUN, C‐reactive protein, and hepatitis C as potential predictive factors of tolvaptan short‐term response in patients with refractory ascites. Future studies are needed to introduce cut‐off values and construct an optimal combined screening model.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Predictors of tolvaptan short‐term response in patients with refractory ascites: A meta‐analysis

Bellos

Kontzoglou

Perrea

2019

J of Gastro and Hepatol

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“…Nine studies [19][20][21][22][23][24][25][26][27] were included in the analysis, with a total of 736 patients. Among them, 451 patients presented clinical response to tolvaptan therapy, while the rest 285 were judged as nonresponders.…”

Section: Included Studiesmentioning

confidence: 99%

Tolvaptan Response Improves Overall Survival in Patients with Refractory Ascites: A Meta-Analysis

Bellos¹,

Kontzoglou²,

Psyrri³

et al. 2019

Dig Dis

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Background and Aims: Refractory ascites represents a significant complication of decompensated cirrhosis, associated with increased mortality rates. The aim of this meta-analysis was to evaluate whether response to treatment with tolvaptan is associated with improved overall survival in cirrhotic patients with refractory ascites. Methods: Medline, Scopus, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov, and Google Scholar databases were systematically searched from inception to April 11, 2019. All studies that assessed the overall survival of patients with ascites depending on their response to tolvaptan were held eligible. Results: Nine studies were included, with a total of 736 patients with cirrhosis and ascites. Response to tolvaptan was estimated to be linked to significantly improved overall survival (hazard ratio [HR] 0.42, 95% CI [0.31-0.58]). Subgroup analysis indicated that the same outcome was present when tolvaptan responsiveness was defined either as effective body weight loss (HR 0.44, 95% CI [0.30-0.63] or as effective sodium restoration (HR 0.35,]. Sensitivity analysis suggested that the presence of hepatocellular carcinoma, the sample size, and the quality of the studies did not significantly affect the overall result of the meta-analysis. Conclusions:The outcomes of the meta-analysis support the prognostic role of tolvaptan response in patients with cirrhosis and refractory ascites, as it was shown to lead to significantly improved overall survival. These findings should be confirmed by future large-scale studies, while efficient biomarkers should be identified in order to accurately predict response to tolvaptan and discriminate patients that would benefit from its administration.

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“…Multivariate analyses demonstrated that not only HCC complication (p=0.02) but also early reexacerbation (p<0.01) was identified as independent predictors for OS in responders (Table 5). It has been reported that a decrease in conventional diuretic dosages was independent prognostic factor of survival in patients treated with tolvaptan for refractory ascites [13]. We then examined OS in patients with dose-reduction of conventional diuretics (n=16) or without (n=39).…”

Section: Prognosis In View Of Tolvaptan Responsementioning

confidence: 99%

Long-term administration of Tolvaptan to patients with decompensated cirrhosis

et al. 2020

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Aim: Tolvaptan, an oral vasopressin-2 antagonist, sometimes improves hepatic edema including ascites in patients with decompensated cirrhosis. In this study, we examined the effectiveness and survival advantage in patients with the long-term administration of tolvaptan. Methods: A total of 115 patients with refractory ascites who were treated with tolvaptan were retrospectively analyzed based on their clinical records. Patients with a decrease in body weight of ≥1.5 kg from the baseline on day 7 were determined as responders. Re-exacerbation was defined as a return to the baseline BW, dose escalation of conventional diuretics, or abdominal drainage. Results: Of the 115 patients, 84 were included in this analysis. Response to tolvaptan treatment was observed in 55 out of the 84 patients (65.5%), with a mean weight reduction of 2.52 kg. Multivariate analyses demonstrated that body mass index (≥24) and urinary specific gravity (≥1.018) were significant predictors of the response to tolvaptan. However, cumulative re-exacerbation rates in responders at 6 and 12 months were 42.4 and 60.1%, respectively. Child-Pugh (classification C), HCC complication, and serum sodium levels (≥133 mEq/L) were determined as independent prognostic factors impacting overall survival (OS). Although there were no significant differences in OS between tolvaptan responders and non-responders, the responders without re-exacerbation within 3 months showed significantly longer OS than those with re-exacerbation within 3 months. Conclusion: A persistent therapeutic response, but not early response to tolvaptan, was associated with favorable survival of decompensated cirrhotic patients.

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Survival Benefit of Tolvaptan for Refractory Ascites in Patients with Advanced Cirrhosis

Cited by 10 publications

References 34 publications

Predictors of tolvaptan short‐term response in patients with refractory ascites: A meta‐analysis

Predictors of tolvaptan short‐term response in patients with refractory ascites: A meta‐analysis

Tolvaptan Response Improves Overall Survival in Patients with Refractory Ascites: A Meta-Analysis

Long-term administration of Tolvaptan to patients with decompensated cirrhosis

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