N/A
N=100
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
Hyponatremia · Syndrome of Inappropriate ADH (SIADH) Secretion
Bottom Line
View on ClinicalTrials.gov: NCT02545101 ↗Enrolled (actual)
100
Serious AEs
10.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge — 10.3 mmol/L
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge |
10.3 | — |
| SECONDARY Change in Sodium Levels 24 Hours After Treatment Initiation |
3.3 | — |
| SECONDARY Change in Sodium Levels 6 Weeks After Treatment Initiation |
11.8 | — |
| SECONDARY Time (Hours) to Sodium Normalisation |
115.5 | — |
| SECONDARY Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) |
27; 20; 11; 7; 3; 32 | — |
| SECONDARY Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population) |
83 | — |
| SECONDARY Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) |
40; 25; 19; 6; 5; 5 | — |
| SECONDARY Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study |
12.67 | — |
| SECONDARY Time (Days) to Sodium Normalisation |
7 | — |
| SECONDARY Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia |
41; 37; 33; 31; 30; 28 | — |
| SECONDARY Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study |
27.96 | — |
Summary
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.
Eligibility Criteria
Inclusion Criteria
- Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
- Female and/or male patients aged 18 years and over.
- Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.
Exclusion Criteria
- A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.
Data sourced from ClinicalTrials.gov (NCT02545101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.