Post-Authorisation Safety Study of Lesinurad

NCT04072471 | Withdrawn FDA Drug

• 2 other identifiers: D5310R00016EUPAS30385
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events (MACE+)

  MACE+ is a composite endpoint comprised of: hospitalisation for non-fatal AMI, stroke, or unstable angina and cardiovascular (CV) death. CV death includes the following causes, occurring in or out of the hospital: AMI, sudden cardiac, heart failure, CV procedures, CV haemorrhage, stroke, underlying cerebrovascular cause, other CV causes.

  2 year follow-up

Secondary Outcomes (2)

• Hospitalisation for acute kidney injury (AKI) including renal failure (with AKI as the primary diagnosis)

  2 year follow-up

• Each individual component of MACE+

  2 year follow-up

Study Arms (2)

Zurampic®

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

Drug: Zurampic®

Control group: xanthine oxidase inhibitor monotherapy

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

Drug: Control group: xanthine oxidase inhibitor monotherapy

Interventions

Zurampic® 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

Also known as: ATC code: M04A B05, Product name*: Zurampic®, Substance (INN)*: lesinurad

Zurampic®

Control group: xanthine oxidase inhibitor monotherapy DRUG

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

Control group: xanthine oxidase inhibitor monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

lesinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 28, 2019
• Study Start: January 29, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 19, 2021

Record last verified: 2021-03