Effect of tolvaptan on the prognosis of patients with hepatic ascites

Hiramine, Yasunari; Uto, Hirofumi; Mawatari, Seiichi; Kanmura, Shuji; Imamura, Yasushi; Hiwaki, Takuya; Saishoji, Akiko; Yada, Takazumi; Inada, Yuji; Sakamoto, H; Higashi, Hisato; Kubozono, Osamu; Maenohara, Shigeho; Ido, Akio

doi:10.1111/hepr.13337

Cited by 18 publications

(19 citation statements)

References 43 publications

(96 reference statements)

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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: 83%

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: 83%

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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“…11 On the other hand, treatment with tolvaptan has been associated with increased liver toxicity, 12 which may be caused by direct DNA damage and by delayed progression of the cell cycle and induction of apoptosis in hepatocytes. 14 However, up to 30% of patients fail to achieve satisfactory response to tolvaptan administration in terms of increased urination or bodyweight reduction. 14 However, up to 30% of patients fail to achieve satisfactory response to tolvaptan administration in terms of increased urination or bodyweight reduction.…”

Section: Introductionmentioning

confidence: 99%

“…13 It has been recently proposed that tolvaptan represents a promising add-on treatment in patients with refractory ascites due to liver cirrhosis, as it has been shown not only to correct hyponatremia but also to improve long-term prognosis. 14 However, up to 30% of patients fail to achieve satisfactory response to tolvaptan administration in terms of increased urination or bodyweight reduction. 15 Several observational studies have evaluated potential prognostic factors of tolvaptan response, although no consensus exists regarding the most efficient predictive model.…”

Section: Introductionmentioning

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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“…Vaptans are selective antagonists of the vasopressin 2 (V2) receptors in the principal cells of the collecting ducts that enhance solute‐free water excretion and thus raise serum sodium levels . For example, tolvaptan has been shown to have a survival‐benefit compared to control . Additionally, a phase 2 trial has shown that tolvaptan significantly reduced the body weight and abdominal circumference compared to placebo in patients with liver cirrhosis‐associated ascites .…”

Section: Management Of Portal Hypertension In Pldmentioning

confidence: 99%

“…53 For example, tolvaptan has been shown to have a survival-benefit compared to control. 57 Additionally, a phase 2 trial has shown that tolvaptan significantly reduced the body weight and abdominal circumference compared to placebo in patients with liver cirrhosis-associated ascites. 58 Another randomized trial showed that a combination of conventional natriuretic drugs and tolvaptan was superior to conventional therapy alone in cirrhosis-associated ascites.…”

Section: Management Of Ascitesmentioning

confidence: 99%

Management of portal hypertension and ascites in polycystic liver disease

Bernts

Drenth

Tjwa

2019

Liver International

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Patients suffering from polycystic liver disease may develop Hepatic Venous Outflow Obstruction, Portal Vein Obstruction and/or Inferior Caval Vein Syndrome because of cystic mass effect. This can cause portal hypertension, leading to ascites, variceal haemorrhage or splenomegaly. For this review, we evaluate the evidence to provide clinical guidance for physicians faced with this complication. Diagnosis is made with imaging such as ultrasound, computed tomography or magnetic resonance imaging. Therapy includes conventional therapy with diuretics and paracentesis, and medical therapy using somatostatin analogues. Based on disease phenotype various (non‐)surgical liver‐volume reducing therapies, hepatic or portal venous stenting, transjugular intrahepatic portosystemic shunts and liver transplantation may be considered. Because of complicated anatomy, use of high‐risk interventions and lack of empirical evidence, patients should be treated in expert centres.

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Effect of tolvaptan on the prognosis of patients with hepatic ascites

Cited by 18 publications

References 43 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

Management of portal hypertension and ascites in polycystic liver disease

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