Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study.

ABSTRACT:

Introduction

Hyponatremia is a common condition of varying etiology among hospitalized patients and is associated with adverse outcomes. Treatment to normalize serum sodium is advisable. Tolvaptan received European Union marketing authorization for hyponatremia secondary to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Post-marketing pharmacovigilance activities were required to characterize the safety profile of tolvaptan more fully in this population, which is often elderly with a high burden of comorbid illness.

Methods

This was a prospective, observational, multinational, post-authorization pharmacovigilance study (NCT01228682) in seven European countries. Hospitalized patients were enrolled who received tolvaptan for hyponatremia associated wi

SUBMITTER: Estilo A 

PROVIDER: S-EPMC8572184 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature