Liver safety of tolvaptan in patients with autosomal dominant polycystic kidney disease: interim data from a post-authorization safety study.

Background: After the risk of drug-induced liver injury was detected during tolvaptan clinical development for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a post-marketing pharmacovigilance study was required for European Union regulatory approval.

Methods: This is an interim analysis from a prospective, observational study enrolling patients prescribed tolvaptan for ADPKD in routine clinical practice. Data were obtained through physician records collected during regular care.

Visceral Adiposity and Progression of ADPKD: A Cohort Study of Patients From the TEMPO 3:4 Trial.

Rationale & Objective: Body mass index (BMI) is an independent predictor of kidney disease progression in individuals with autosomal dominant polycystic kidney disease (ADPKD). Adipocytes do not simply act as a fat reservoir but are active endocrine organs. We hypothesized that greater visceral abdominal adiposity would associate with more rapid kidney growth in ADPKD and influence the efficacy of tolvaptan.

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

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).

Hyponatremia in hospitalized patients: the potential role of tolvaptan.

Hyponatremia (typically defined as serum sodium level < 135 mEq/L) is a common electrolyte abnormality among hospitalized patients. Whether present at admission or acquired during hospitalization, hyponatremia is associated with higher mortality and longer hospital stays. Failure to adequately investigate and treat hyponatremia may also be associated with adverse outcomes.