Drug exposition and resulting adverse events
Conditions
Interventions
Group 1: All German patients (national pharmacovigilance data (BfArM) and claims data of statuory health insurance companies (DAPI)) from 2005-1-1 to 2015-12-31 serve as study population
Sponsors
Institut für Experimentelle und Klinische Pharmakologie, UKSH, Campus Kiel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An adverse event of the patient has been reported to the federal drug regulating authority (BfArM) and/or the patient has received medication via the German statuory health insurance
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of temporary synchrony for statins and rhabdomyolysis, calculation of the incidence rates of rhabdomyolysis during statin-therapy (mono preparations), calculation of the incidence of agranulocytosis during therapy with either metamizole or clozapin. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Peaks and p for temporal synchrony of monthly aggregated, averaged amount of all statins and monthly-aggregated, averaged reports of all statins and AE rhabdomyolysis (SMQ) with a time offset of 1 month for combination preparations (combinations with ezetimibe), mono and combination preparations summarized and just the combination partner (ezetimibe) - Peaks and p for temporal synchrony of monthly-aggregated, averaged DDD (defined daily dosages) of clozapine and monthly-aggregated, averaged reports of clozapine and AE (adverse event) agranulocytosis (SMQ, standardized MedDRA Query) with a time offset of 1 month - Peaks and p for temporal synchrony of monthly-aggregated, averaged DDD of metamizole and monthly-aggregated, averaged reports of metamizole and AE agranulocytosis (SMQ) with a time offset of 1 month - Do the 95%-confidence intervals of the two analyses given above overlap? - Rho/Peaks and p for all other combinations drug-event based on DDD and number of patients - Normalization of all data to the underlying straight line and calculation of rho/peaks and p on all combinations - Confirmation of no synchronie (p in “ peaks+avg+month+1” is >0.05 and/or peaks < 0) for nonsense combinations, e.g., clozapine_DDD and Simvastatin_allAE - Calculation and presentation of dynamic PRRs (FDA) for drugs and events, based on pharmacovigilance data as denominator and on prescription data as denominator - If metamizole was not available, assuming equal increase in ibuprofen + diclofenac + tramadol, how large is this increase? How many adverse events might be expected? - Calculation of cummulative incidence | — |
Countries
Germany
Contacts
Public ContactRuwen Böhm
Institut für Experimentelle und Klinische Pharmakologie, UKSH, Campus Kiel
Outcome results
None listed