Observational studyAdvances in therapy2021
Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study.
Observational study in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01228682 (A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Outcomes with Sodium Overcorrection in Chronic Hyponatremia: A Systematic Review and Meta-analysis.Journal of general internal medicine · 2026Pooled it
- Tolvaptan vs Fluid Restriction in Moderate-Profound Hyponatremia: An Open-Label Randomized Clinical Trial.The Journal of clinical endocrinology and metabolism · 2026Trial
- Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study.Frontiers in pharmacology · 2025Trial
- Poor compliance of recurrent stone formers to increase their fluid intake in spite of repeated recommendation.Clinical kidney journal · 2026Article
- Effectiveness of Urea and Tolvaptan in the Treatment of Hypotonic Hyponatremia.Journal of clinical medicine · 2025Article
- Efficacy of Tolvaptan in Older Adults Undergoing Cardiac Surgery: A Single-Center Retrospective Analysis.Brazilian journal of cardiovascular surgery · 2024Article
- Safety assessment of tolvaptan: real-world adverse event analysis using the FAERS database.Frontiers in pharmacology · 2024Article
- Syndrome of Inappropriate Antidiuresis: From Pathophysiology to Management.Endocrine reviews · 2023Review
- Tolvaptan for the treatment of the syndrome of inappropriate antidiuresis (SIAD).Therapeutic advances in endocrinology and metabolism · 2023Review
- Renal water transport in health and disease.Pflugers Archiv : European journal of physiology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHyponatremia is a common condition of varying etiology among hospitalized patients and is associated with adverse outcomes. Treatment to normalize serum sodium is advisable. Tolvaptan received European Union marketing authorization for hyponatremia secondary to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Post-marketing pharmacovigilance activities were required to characterize the safety profile of tolvaptan more fully in this population, which is often elderly with a high burden of comorbid illness.
methodsThis was a prospective, observational, multinational, post-authorization pharmacovigilance study (NCT01228682) in seven European countries. Hospitalized patients were enrolled who received tolvaptan for hyponatremia associated with SIADH and consented to data collection. Tolvaptan was initiated and assessments performed at physician discretion per local standards of care. To reflect actual clinical practice, no assessments or procedures were required outside the standard of care. Patients who continued to receive long-term tolvaptan following hospital discharge and provided consent received follow-up from their community physicians.
resultsA total of 252 patients (mean age 70.6 years) enrolled. Mean tolvaptan treatment duration was 139.4 days, median 18.5 (range 1-1130) days; most frequent dose was 15 mg/day (used in 75% of patients). Serum sodium increased from baseline (mean 123.2 mmol/l) during treatment week 1 and remained stable during follow-up, with little difference across doses of 7.5, 15, and 30 mg/day. Hyponatremia symptoms (e.g., confusion, unsteady gait, lethargy) were present in 122/252 (48.4%) patients at pre-treatment baseline, decreasing to 46/252 (18.3%) during treatment. Sixty-two patients (24.6%; mean baseline serum sodium 120 mmol/l) experienced rapid correction of hyponatremia within 72 h. No osmotic demyelination syndrome occurred.
conclusionIn clinical practice, tolvaptan improved serum sodium and decreased hyponatremia symptoms in hyponatremia secondary to SIADH. Serum sodium should be monitored during treatment to minimize risk of rapid correction.
trial registrationClinicaltrials.gov identifier NCT01228682.
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