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

Study identification

• 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

Navarre Health Service

Study timelines

Date when funding contract was signed

Planned: 18/11/2019

Study start date

Planned: 01/05/2023

Data analysis start date

Planned: 25/09/2023

Date of final study report

Planned: 11/03/2024

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