Post-Authorisation Safety Study of Lesinurad

NCT ID: NCT04072471

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2023-06-30

Brief Summary

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.

Conditions

Gout; Hyperuricemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Zurampic®

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

Zurampic®

Intervention Type: DRUG

non-interventional study where patients are exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) during the normal course of clinical practice

Control group: xanthine oxidase inhibitor monotherapy

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

Control group: xanthine oxidase inhibitor monotherapy

Intervention Type: DRUG

non-interventional study where patients are exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat) during the normal course of clinical practice

Interventions

Zurampic®

non-interventional study where patients are exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) during the normal course of clinical practice

Intervention Type: DRUG

Control group: xanthine oxidase inhibitor monotherapy

non-interventional study where patients are exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat) during the normal course of clinical practice

Intervention Type: DRUG

Other Intervention Names

ATC code: M04A B05; Product name*: Zurampic®; Substance (INN)*: lesinurad

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EUPAS30385

Identifier Type: REGISTRY

Identifier Source: secondary_id

D5310R00016

Identifier Type: -

Identifier Source: org_study_id