An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
- Conditions
- HyponatremiaSyndrome of Inappropriate ADH (SIADH) Secretion
- Registration Number
- NCT02545101
- Lead Sponsor
- Otsuka Pharmaceutical Europe Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment) The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).
- Secondary Outcome Measures
Name Time Method Change in Sodium Levels 6 Weeks After Treatment Initiation From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6
Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) Baseline Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Change in Sodium Levels 24 Hours After Treatment Initiation From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan
Time (Hours) to Sodium Normalisation From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards Time (hours) to sodium normalisation, defined as a serum sodium level \> 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).
Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population) Baseline symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Time (Days) to Sodium Normalisation From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards Time (days) to sodium normalisation, defined as a serum sodium level \> 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).
Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).
For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) Baseline specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records
Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).
For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia Baseline symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records