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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C03X) OTHER DIURETICS

  OTHER DIURETICS

  (C09C) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  (M01A) ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

  ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

  (N02BA) Salicylic acid and derivatives

  Salicylic acid and derivatives
• Medical condition to be studied:
  Acute kidney injury

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  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
• Outcomes:
  hospitalization for AKI, Need for RRT during hospitalization due to AKI (analyzed in the participants who suffered hospitalization for AKI-cases) All-cause mortality during hospitalization (analyzed in the participants who suffered hospitalization for AKI-cases) Change in sCr and eGFR
• Data analysis plan:
  The comparison of categorical variables between cases and controls will be analyzed through the Chi-square test or Fisher's test, and in the case of quantitative variables through the t-Student or Mann-Whitney test. The association between the exposure and the risk of hospitalization due to AKI will be analyzed using conditional logistic regression models, adjusting for possible confounding factors. The adjusted Odds Ratio and 95% confidence interval will be estimated. Sensitivity analyses of the primary outcome restricting to cases and controls with eGFR or sCr data in the 12 months prior to the index date. A subgroup analysis of the risk of hospitalisation for AKI will be performed in: patients older than 75 year and patients with eGFR <60 mL/min