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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 monotherapyDrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

lesinurad

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Stopped

Post-Authorisation Safety Study of Lesinurad

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Zurampic®

Control group: xanthine oxidase inhibitor monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Zurampic®

Control group: xanthine oxidase inhibitor monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record