Trial reportEuropean journal of clinical pharmacology2017
Low-dose tolvaptan PK/PD: comparison of patients with hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion to healthy adults.
Trial report in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Criteria for Hyponatremic Overcorrection: Systematic Review and Cohort Study of Emergently Ill Patients.Journal of general internal medicine · 2020Pooled it
- Interventions for chronic non-hypovolaemic hypotonic hyponatraemia.The Cochrane database of systematic reviews · 2018Pooled it
- 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
- Effect of tolvaptan on hyponatremia in a dog with syndrome of inappropriate secretion of antidiuretic hormone.The Journal of veterinary medical science · 2023Article
- Safety and Efficacy of Vaptans in the Treatment of Hyponatremia from Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2023Review
- Case report: Twice-daily tolvaptan dosing regimen in a challenging case of hyponatremia due to SIAD.Frontiers in endocrinology · 2023Article
- Tolvaptan for the treatment of the syndrome of inappropriate antidiuresis (SIAD).Therapeutic advances in endocrinology and metabolism · 2023Review
- Approach to the Patient: Hyponatremia and the Syndrome of Inappropriate Antidiuresis (SIAD).The Journal of clinical endocrinology and metabolism · 2022Review
- Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study.Advances in therapy · 2021Observational
- The role of tolvaptan in managing hyponatremia in small cell lung cancer patients with SIADH: a retrospective study of 23 cases.Translational cancer research · 2021Article
- Risk factors for sodium overcorrection in non-hypovolemic hyponatremia patients treated with tolvaptan.European journal of clinical pharmacology · 2020Article
- Article
- The effects of tolvaptan dose on cardiac mortality in patients with acute decompensated heart failure after hospital discharge.Heart and vessels · 2018Article
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 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTolvaptan (TLV) is indicated to treat hyponatremia due to syndrome of inappropriate diuretic hormone (SIADH) in Europe. Treatment is to be initiated at 15 mg QD but post-approval reporting indicates increasing use of 7.5 mg as the starting dose. Physicians believe 7.5 mg is effective and has a lower incidence of overly rapid correction of serum sodium.
methodsSingle TLV doses of 3.75, 7.5, and 15 mg were administered to 14 healthy adults in a crossover design and to 29 subjects ≥18 years with SIADH and serum sodium between 120 and 133 mmol/L in a parallel-group design. Pharmacodynamics and TLV plasma concentrations were assessed for 24 h post-dose.
resultsIn SIADH subjects, corrections of serum sodium (Δ of ≥8 mmol/L in the first 8 h or ≥12 mmol/L in the first 24 h) were observed in one, one, and two subjects in the 3.75-, 7.5-, and 15-mg dose groups. Fluid balance (FB) for 0-6 h post-dose was correlated (r
conclusionStarting titration with 7.5 mg TLV will not eliminate the risk of rapid corrections in serum sodium. Monitoring FB may indicate that a subject is at risk for over correction.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.