ArticleJournal of gastroenterology2020
Real-world effectiveness and safety of tolvaptan in liver cirrhosis patients with hepatic edema: results from a post-marketing surveillance study (START study).
Article in Journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed, 32 citations in OpenAlex.
- Tolvaptan for hyponatremia in patients with cirrhosis: a post hoc subgroup analysis of a multicenter, randomized, double-blind, placebo-controlled trial.Hepatology international · 2026Trial
- Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial.BMC gastroenterology · 2020Trial
- [Research progress of tolvaptan in the treatment of refractory ascites in cirrhosis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025Review
- Evaluation of tolvaptan-associated hepatic disorder using different national pharmacovigilance databases.Scientific reports · 2024Article
- Chronic Edema Management of the Lower Extremities.Cureus · 2024Review
- The Renin-Angiotensin System in Liver Disease.International journal of molecular sciences · 2024Review
- [Consensus recommendations on the diagnosis and treatment of hyponatremia from the Austrian Society for Nephrology 2024].Wiener klinische Wochenschrift · 2024Article
- Pharmacokinetics, pharmacodynamics and safety of 15 mg-tolvaptan administered orally for 7 consecutive days to Chinese patients with child-Pugh B cirrhosis.Frontiers in pharmacology · 2024Article
- Effect of early administration of tolvaptan on pleural effusion post-hepatectomy.Langenbeck's archives of surgery · 2023Article
- Efficacy and safety of tolvaptan for refractory fluid collection and edema in the terminal cancer patients.Fujita medical journal · 2023Article
- Tolvaptan for the treatment of the syndrome of inappropriate antidiuresis (SIAD).Therapeutic advances in endocrinology and metabolism · 2023Review
- Management of Cirrhotic Ascites under the Add-on Administration of Tolvaptan.International journal of molecular sciences · 2021Review
- Early Administration of Tolvaptan Can Improve Survival in Patients with Cirrhotic Ascites.Journal of clinical medicine · 2021Article
- Serum Copeptin and Zinc-α2-glycoprotein Levels Are Novel Biomarkers of Tolvaptan Treatment in Decompensated Cirrhotic Patients with Ascites.Internal medicine (Tokyo, Japan) · 2021Article
- Impact of acute kidney injury on prognosis and the effect of tolvaptan in patients with hepatic ascites.Journal of gastroenterology · 2021Article
- Durable response without recurrence to Tolvaptan improves long-term survival.Journal of gastroenterology · 2020Article
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis 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.
methodsA 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).
resultsCase 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 ≥ 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.
conclusionsThe 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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