Influence of Metabolic Profiles on Drug Safety in Routine Care

• Conditions: D50.0; Y57.9; D62; D65.1; D68.33; D68.35; D69.80; D69.9; G45; G95.1

• Registration Number: DRKS00013909
• Lead Sponsor: Bundesinstitut für Arzneimittel und Medizinprodukte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Study Completion: 2020-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10782

Inclusion Criteria

Age of =18 years /

Initial prescription of at least one anticoagulant or cholesterol lowering agent in a time frame of 01.01.2014-31.12.2017 or intake of at least one drug with verified pharmacogenetic effect, especially due to CYP2C9-, CYP2C19- und CYP2D6-variants that caused at least one Y57.9! diagnosis (ICD-10 code) in 2014-2017 /

Written informed consent

Exclusion Criteria

Inapplicable metabolic profile results /

Oncologic phenotype (ICD 10: all C-diagnoses and D0x, D4x, D37, D38, D39) /

Severe F-diagnoses ( ICD 10: F0x.x, F2x.x, F7x.x, F8x.x, F31.x, F33.x, F38.x, F39.x, F42.x, F43.x, F44.x, F60.x, F61.x, F62.x, F63.x, F69.x, F91.x, F92.x, F93.x, F94.x, F95.x, F98.x, F1x.2, F1x.3, F1x.4, F1x.5, F1x.6, F1x.7, F1x.8, F1x.9, F30.1, F30.2, F30.8, F30.9, F32.2, F32.3, F32.8, F32.9, F34.8 ,F34.9, F45.2, F45.4, F45.8, F45.9, F48.1, F48.8, F48.9, F50.4, F50.5, F53.1, F53.8, F53.9, F65.2, F65.3, F65.4, F65.6, F65.8, F65.9, F68.1, F68.8, F90.1) /

Known genetic hematopoietic diseases upon initial prescription of anticoagulant (ICD 10 Code: D55, D56 D57, D58, D61.0, D64.0, D64.4, D66, D67, D68.0, D68.1, D68.2, D71, D72.0, D74.0, D80.0, D82) /

Y69! diagnosis (Unspecified misadventure during surgical and medical care) in parallel with Y57.9! diagnosis /

Myopathy, myositis or muscle pain before initial prescription of cholesterol lowering agents (ICD 10 Code: M60.1, M60.8, M60.9, G72.0, M62.8, M62.9, M79.1, M79.7) /

Criteria due to TK customer management

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
On the basis of the primary outcomes, the study will examine whether genetic differences have an impact on the incidence of adverse drug reactions and therefore, the utilization of statutory health insurance services. In 2013-2019 the subsequent primary outcomes provided via routine care data of the health insurance provider Techniker Krankenkasse will be assessed:<br><br>Utilisation of health care insurance services /<br><br>Hospitalization due to adverse drug reactions /<br><br>Referral to a specialist due to medication problems /<br><br>Change of medication during the observation period /<br><br>Incidence of incapacity for work<br>

Secondary Outcome Measures

Name	Time	Method
On the basis of the secondary outcomes, the study will examine whether there is a possible benefit of cost reductions for health insurance services by determining the metabolic profile to predict and prevent adverse drug reactions in routine care. Thus, the effect of pharmacogenetic profiles on the incidence of adverse drug reactions and therefore, on the costs due to health insurance services will be examined. In 2013-2019 the subsequent secondary outcomes provided via routine care data of the health insurance provider Techniker Krankenkasse will be assessed:<br><br>Costs for drugs and treatment /<br>Sickness benefit<br>