Study identification

PURI

https://redirect.ema.europa.eu/resource/44348

EU PAS number

EUPAS30385

Study ID

44348

Official title and acronym

An Observational Post-Authorisation Safety Study of Lesinurad Patients (SATURATES)

DARWIN EU® study

No

Study countries

Italy
Spain
United States

Study description

*The study was withdrawn as Lesinurad was withdrawn from the market in Europe by the market authorization holder. Hence the commitment to do this PASS was removed by the European Medicines Agency.* - 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.

Study status

Planned
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner
HealthCore United States

Contact details

Elena Rivero

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)