Post-Authorisation Safety Study of Lesinurad (SATURATES)

AstraZeneca

Status: Withdrawn

Conditions: Hyperuricemia; Gout

Treatments: Drug: Control group: xanthine oxidase inhibitor monotherapy; Drug: Zurampic®

Study type: Observational

Funder types: Industry

Identifiers

NCT04072471

D5310R00016

EUPAS30385 (Registry Identifier)

Details and patient eligibility

About

Non-interventional population-based prospective cohort study in multiple databases comparing patients with gout who initiate lesinurad in combination with an existing xanthine oxidase inhibitor (XOI) (lesinurad+XOI cohort) to a propensity score-matched cohort of similar patients from the same data source who continue treatment with XOI monotherapy (XOI mono cohort). Study will characterize the cardiovascular safety of lesinurad in combination with XOI in patients with gout aged 18+ years compared with similar patients who continue XOI monotherapy. Primary objective: to assess the relative incidence of major adverse cardiac events plus hospitalization for unstable angina (MACE+ events) in patients with gout in both cohorts. Secondary objectives: to describe the characteristics of the cohorts prior to matching; to assess the relative incidence of hospitalisation for acute kidney injury between the matched cohorts; to assess the relative incidence of individual MACE+ components in the matched cohorts.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• More than one dispensing/prescription for an xanthine oxidase inhibotor (XOI) within the past 183 days prior to the index date and days' supply extending beyond the index date
• A coded diagnosis of gout at any time in the past or on the index date
• Age 18 years or older
• Continuous enrolment in the database for the past 183 days

Exclusion criteria

• Patients on urate-lowering therapy medications within 6 months prior to the index date to manage gout (probenecid, benzbromarone, or pegloticase) other than an XOI (allopurinol, febuxostat) or lesinurad (not including medications to treat gout flares).
• Patients with severe renal impairment defined using clinical diagnostic codes (i.e., a diagnosis code of CKD stage IV, end-stage renal disease, or an indicator that eCrCl is < 30 mL/min at any time prior to the index date).

Trial design

0 participants in 2 patient groups

Zurampic®

Description:

Patients exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) (lesinurad+XOI)

Treatment:

Drug: Zurampic®

Control group: xanthine oxidase inhibitor monotherapy

Description:

Patients exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat).

Treatment:

Drug: Control group: xanthine oxidase inhibitor monotherapy