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

(C03) DIURETICS
DIURETICS
(C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
(M01AE53) ketoprofen, combinations
ketoprofen, combinations
(N02BB02) metamizole sodium
metamizole sodium

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

1000
Study design details

Main study objective

To analyze the incidence of hospitalization due to acute kidney injury (AKI) associated to the exposure to the “triple whammy” combination versus non-exposure to that combination.

Outcomes

Incidence of hospitalization due to acute kidney injury (AKI) associated to the exposure to the “triple whammy” combination versus non-exposure to that combination. 1) Hospitalization due to AKI with the combination "triple whammy" that includes metamizole versus the combination that includes an NSAID different to metamizole 2) Hospitalization due to AKI based on the time window from the index date and according to its duration 3) Incidence of requiring renal replacement therapy and mortality associated to the "triple whammy" combination.

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. The risk of hospitalization due to AKI will be determined according to the time of exposure to the "triple whammy" combination ("current users" vs "recent users" vs "past users"), the "continuous duration" and the "cumulative duration" of this association (≤3 months, >3 and ≤6 months, >6 and ≤9 months and >9 months and ≤12 months), compared with no exposure to this association. Additionally, the main variable will be analyzed in the subgroup of patients over 75 years of age.