Study identification

PURI

https://redirect.ema.europa.eu/resource/104941

EU PAS number

EUPAS104667

Study ID

104941

Official title and acronym

Does metamizole cause less kidney injury than non-steroidal anti-inflammatory drugs when administered in combination with diuretics and antihypertensives? (Triple whammy with metamizole)

DARWIN EU® study

No

Study countries

Spain

Study description

The term "triple whammy" (TW) corresponds to the concurrent use of diuretics, renin-angiotensin-aldosterone system inhibitors (RAASI) and non-steroidal anti-inflammatory drugs (NSAIDs). These therapeutic classes have an impact on kidney function in various ways, such as by causing hypovolemia and decreasing glomerular perfusion and thus filtration rate. The objective of this study is to compare the impact of the exposure to the TW combination that includes metamizole as compared to the TW that includes an NSAID in terms of risk of hospitalisation for AKI, need for renal replacement therapy (RRT) and all-cause mortality during hospitalisation. The difference between the TW that includes metamizole and that which includes an NSAID on the change in serum creatinine (sCr) and the estimated glomerular filtration rate (eGFR) during the first year after the beginning of the exposure to TW will also be analyzed.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Dulce Maria Calvo Barbado

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Government of Navarre
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable