Evaluating the utilisation of Urospir® (spironolactone) in paediatric and adult patients in the United Kingdom: A drug utilisation study using the Clinical Practice Research Datalink (CPRD) database

23/04/2026
23/04/2026
EU PAS number:
EUPAS1000000988
Study
Planned
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Study identification

EU PAS number

EUPAS1000000988

Study ID

1000000988

Official title and acronym

Evaluating the utilisation of Urospir® (spironolactone) in paediatric and adult patients in the United Kingdom: A drug utilisation study using the Clinical Practice Research Datalink (CPRD) database

DARWIN EU® study

No

Study countries

United Kingdom

Study description

A drug utilisation study on Urospir®, a non-aqueous oral solution of the potassium-sparing diuretic spironolactone, which aims to evaluate its real-world use. Urospir® is available in two strengths: 25mg/5ml and 50mg/5ml. The potential risk of medication error between the two Urospir® strengths has been listed as an important potential risk in the risk management plan.The DUS will be a retrospective cohort study, collecting data from CPRD Gold and Aurum. Any patient prescribed Urospir® from the license date up to the last collection date of the most recent database release will be eligible for inclusion. The study will evaluate patient characteristics such as age, gender, ethnicity, medical conditions. In addition, the study will describe the use of Urospir®, including the initial treatment regimen, indications for prescribing, potential off-label use, potential medication errors, changes to treatment, discontinuation, switching to alternative therapy and add-on therapy. Descriptive analyses will be undertaken.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Debabrata Roy 0000-0003-2803-6323

Primary lead investigator
ORCID number:
0000-0003-2803-6323

Study timelines

Date when funding contract was signed

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

Rosemont Pharmaceuticals Ltd
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)