Integrated safety studies of the urate reabsorption inhibitor lesinurad in treatment of gout.

ABSTRACT:

Objective

Lesinurad (LESU) is a selective urate reabsorption inhibitor approved at 200 mg daily for use with a xanthine oxidase inhibitor (XOI) to treat hyperuricaemia in gout patients failing to achieve target serum urate on XOI. The aim of the study was to investigate the long-term safety of LESU + XOI therapy.

Methods

Safety data were pooled from three 12-month phase III (core) trials evaluating LESU 200 and 400 mg/day combined with an XOI (LESU200+XOI and LESU400+XOI), and two 12-month extension studies using descriptive statistics. To adjust for treatment duration, treatment-emergent adverse events (TEAEs) were expressed as exposure-adjusted incidence rates (patients with events per 100 person-years).

Results

In the core studies, exposure-adjusted incidence rates

SUBMITTER: Terkeltaub R 

PROVIDER: S-EPMC6293483 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature