Positive Response to Tolvaptan Treatment Would Be a Good Prognostic Factor for Cirrhotic Patients with Ascites

Kida, Yoshihisa

doi:10.1159/000494438

Cited by 8 publications

(11 citation statements)

References 27 publications

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“…Tolvaptan also reduced the clinical symptoms that otherwise impact a patient's survival, functional capacity, and QOL [22]. The findings of the current study are further supported by the results from recent studies, where treatment with tolvaptan improved Table 3 Incidence rate of adverse drug reactions by the timing of occurrence reported by physicians (C 0.5%) Spironolactone: androgen deprivation therapy equivalent J Gastroenterol the prognosis in liver cirrhosis patients with ascites [23][24][25].…”

Section: Discussionsupporting

confidence: 82%

Real-world effectiveness and safety of tolvaptan in liver cirrhosis patients with hepatic edema: results from a post-marketing surveillance study (START study)

et al. 2020

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Background This large-scale post-marketing surveillance study (START study) evaluated the effectiveness and safety of tolvaptan in Japanese liver cirrhosis patients with hepatic edema in real-world clinical settings. Here, we present the final analysis outcomes. Methods A prospective, multicenter, non-interventional study involving patients who received tolvaptan for the treatment of liver cirrhosis with hepatic edema with an insufficient response to conventional diuretics. The observation period was up to 6 months. Effectiveness evaluation included changes in body weight and clinical symptoms. Safety analysis included evaluation of adverse drug reactions (ADRs). Results Case reports of 1111 patients were collected. Of these, 1109 were included in the safety analysis and 1098 in the effectiveness analysis. The mean age was 69.4 ± 11.5 years and 695 (62.7%) patients were male. After tolvaptan treatment, a decrease in body weight from baseline was -2.6 ± 2.7 kg on day 7 and -3.8 ± 4.1 kg on day 14. Moreover, clinical symptoms significantly improved over the 14-day treatment. Frequently reported ADRs were thirst (6.6%), hepatic encephalopathy (2.3%), dehydration (1.5%), and hypernatremia (1.2%). A serum sodium level of C 150 mEq/L was reported in five patients (0.5%). Multivariate analyses showed that the baseline blood urea nitrogen (BUN) level (cut-off value: 22.4 mg/ dL) was the predictive factor for tolvaptan treatment response.Conclusions The results suggest that tolvaptan was effective and well-tolerated in liver cirrhosis patients with hepatic edema. In the real-world clinical setting, tolvaptan provides a useful option for the treatment of hepatic edema.

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Section: Discussionsupporting

confidence: 82%

Real-world effectiveness and safety of tolvaptan in liver cirrhosis patients with hepatic edema: results from a post-marketing surveillance study (START study)

et al. 2020

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“…The present meta-analysis was based on 17 studies, [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] involving 1362 cirrhotic patients. The present meta-analysis was based on 17 studies, [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] involving 1362 cirrhotic patients.…”

Section: Resultsmentioning

confidence: 99%

“…Included studies. The present meta-analysis was based on 17 studies, [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] involving 1362 cirrhotic patients. The methodological characteristics (study design, inclusion and exclusion criteria, tolvaptan dose, concomitant medications, and response definition) of the included studies are summarized in Table 1.…”

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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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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“…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%

“…In addition, similarly to prediction of hepatorenal treatment response [41], urinary sodium has been proposed as a promising marker of tolvaptan response [35], although limited evidence is currently available to draw safe conclusions about its exact role. As a result, future large-scale studies are needed in Kida, 2019 Subtotal (95% CI) Heterogeneity: Tau 2 = 0.11; Chi 2 = 11.50, df = 6 (p = 0.07); I 2 = 48% Test for overall effect: Z = 4.38 (p < 0.0001) 1.1.2 Effective sodium elevation Wang, 2018 Subtotal (95% CI) Heterogeneity: Tau 2 = 0.00; Chi 2 = 0.27, df = 1 (p = 0.60); I 2 = 0% Test for overall effect: Z = 3.76 (p = 0.0002) Total (95% CI) Heterogeneity: Tau 2 = 0.08; Chi 2 = 13.06, df = 8 (p = 0.11); I 2 = 39% Test for overall effect: Z = 5.48 (p < 0.00001) Test for subgroup differences: Chi 2 = 0.41, df = 1 (p = 0.52); I 2 = 0% -0.77 -1. order to construct a combined model effectively discriminating the population in which the benefits of tolvaptan therapy would outweigh the risks of liver toxicity.…”

Section: Implications For Current Clinical Practice and Future Researchmentioning

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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Positive Response to Tolvaptan Treatment Would Be a Good Prognostic Factor for Cirrhotic Patients with Ascites

Cited by 8 publications

References 27 publications

Real-world effectiveness and safety of tolvaptan in liver cirrhosis patients with hepatic edema: results from a post-marketing surveillance study (START study)

Real-world effectiveness and safety of tolvaptan in liver cirrhosis patients with hepatic edema: results from a post-marketing surveillance study (START study)

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

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