Real-World, Non-Interventional, Retrospective Study (SAMPLE) of Tolvaptan in Patients with Hyponatraemia Secondary to the Syndrome of Inappropriate Antidiuretic Hormone Secretion

Introduction The syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the most common cause of hyponatraemia in hospital inpatients. We present data on treatment setting, patient characteristics, and outcomes for patients treated with tolvaptan for SIADH across a range of real-world settings in Germany and Spain. Methods This was a non-interventional, observational, retrospective chart review study. Management was at the discretion of the treating physician, with tolvaptan prescribed according to local clinical practice. Hospital notes and/or medical charts were reviewed from treatment initiation for 6 weeks. Follow-up data were collected when patients were discharged early. Patients were eligible for inclusion if they were >= 18 years of age and had been treated with >= 2 doses of tolvaptan for one episode of hyponatraemia secondary to SIADH in 2014. Results The Full Analysis Set comprised 100 patients from 8 centres. The mean age of patients was 73.9 years. The primary endpoint of the mean increase in serum sodium level from baseline to hospital discharge, or to final available measurement, was 10.3 mmol/L (SD 6.4; 95% CI 9.0, 11.6), from 123.0 mmol/L (SD 6.0) to 133.3 mmol/L (SD 4.9). Seventy-seven patients (77.0%) achieved sodium normalisation within 6 weeks of tolvaptan initiation. Mean daily dose of tolvaptan was 12.7 mg (SD 9.2), and mean treatment duration 28.0 days (SD 16.5). Tolvaptan at off-label doses (< 15 mg/day) was prescribed to 72 patients at some point. A favourable safety and tolerability profile was reported. Conclusions Tolvaptan was well tolerated and effectively corrected sodium levels in hospitalised adults with hyponatraemia secondary to SIADH in real-world settings. ClinicalTrials.gov identifier NCT02545101.