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.
Study Type
OBSERVATIONAL
Enrollment
100
Unnamed facility
Bochum, Germany
Unnamed facility
Chemnitz, Germany
Unnamed facility
Dresden, Germany
Unnamed facility
Lübeck, Germany
Unnamed facility
Córdoba, Spain
Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
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).
Time frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)
Change in Sodium Levels 24 Hours After Treatment Initiation
Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan
Time frame: From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards
Change in Sodium Levels 6 Weeks After Treatment Initiation
Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Time (Hours) to Sodium Normalisation
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).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)
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
Time frame: Baseline
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Unnamed facility
Madrid, Spain
Unnamed facility
Santiago de Compostela, Spain
Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)
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 frame: Baseline
Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)
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
Time frame: Baseline
Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study
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).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Time (Days) to Sodium Normalisation
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).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia
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 frame: Baseline
Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study
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).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards