Clinical trial NCT04072471: Post-Authorisation Safety Study of Lesinurad
Official title: Post-Authorisation Safety Study of Lesinurad
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gout
Hyperuricemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients in this study will be 18 years of age or older, will have had at least 6 months (183 days) of continuous baseline data available before entering one of the cohorts, and will be current users of XOI monotherapy (i.e., \> 1 dispensing/prescription of a study XOI in the 183-day baseline period prior to the index date and days' supply extending beyond the index date). The study population will include patients from one primary care database in Italy (Health Search) and another in Spain (Information System for Research in Primary Care \[SIDIAP\]), as well as two US health systems (the HealthCore Integrated Research DatabaseSM \[HIRD\] and Medicare).

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.


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).

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE+)
timeFrame: 2 year follow-up
Secondary outcomes:
measure: Hospitalisation for acute kidney injury (AKI) including renal failure (with AKI as the primary diagnosis)
timeFrame: 2 year follow-up
measure: Each individual component of MACE+
timeFrame: 2 year follow-up
Other outcomes:
Locations:
Study officials:
References: