N/A
N=289
CYP2D6 Polymorphism in Patients of General Practice in Austria
Disorder Due Cytochrome P450 CYP2D6 Variant
Bottom Line
View on ClinicalTrials.gov: NCT03859622 ↗Enrolled (actual)
289
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients — 233; 22; 21; 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karl Landsteiner Institute for Systematics in General Medicine
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients |
233; 22; 21; 11 | — |
| PRIMARY Frequency of CYP2D6 Alleles in Patients |
55; 25; 7; 5; 3; 122 | — |
| PRIMARY Frequency of CYP2D6 Genotypes in Patients |
23; 19; 5; 3; 2; 2 | — |
| SECONDARY Number of Participants in Whom the Family Physician Considered Prior Knowledge of Their Metabolizer Status Important Before the CYP2D6-specific Drug Was Prescriped. |
29 | — |
| SECONDARY Specific Number of Patients of the Whole Practice Population Whose Electronic Health Records (EHRs) Were Assessed. |
668 | — |
Summary
The CYP 2D6 enzyme metabolizes a significant number of drugs frequently prescribed in general practice/ family medicine. Various genetically different variants define if the patient is an ultra-rapid (UM), an normal (NM) (the normal case), an intermediate (IM) or a poor metabolizer (PM). It is estimated that approximately 20- 25 % of frequently described drugs are activated to more active or metabolized to ineffective or less effective drugs by CYP 2D6. Substrates of CYP 2D6 are mainly antidepressants, neuroleptics, opioids (e.g. codeine), beta-blockers, anti-arrhythmic drugs and various other single drugs. In case of an UM a drug can be metabolized too rapidly losing its therapeutic effect, requiring a higher dosage, or it can have a toxic effect, if it is converted too rapidly in the effective form (e.g. codeine). If metabolized too slowly (PM) it can accumulate and reach toxic levels.
In this observational study (1) data relating to the number of patients of a single Austrian general practice receiving one or more drugs metabolized by CYP 2D6 are collected by extracting their electronic records of the last 3 years. In addition (2) consecutive patients with unknown genetic status of their CYP 2D6 enzyme visiting the surgery for a routine blood test due to various reasons, are additionally tested for their CYP 2D6 metabolizing status, if they actually take a drug metabolized by CYP 2D6.
The aim of the study is to generate CYP 2D6 polymorphism data from Caucasian patients of an average Austrian general practice for the first time, which allows to group patients according to their NM, UM, IM and PM status. This can be of considerable clinical relevance when prescribing specific drugs. This study tries to investigate in how many patients the knowledge of the CYP 2D6 metabolizing status could have an influence on choosing the actually prescribed drug. In addition we plan to describe the distribution of frequent and relevant CYP 2D6 alleles including their combinations in patients of an average Austrian general practice for comparison reasons with other Caucasian populations.
Eligibility Criteria
Inclusion Criteria
- Patients with clinical diagnosis of hypertension, diabetes, chronic heart failure, hyperlipidemias, depression, schizophrenia, cardial arrhythmias, thyroid diseases and dementia
Exclusion Criteria
- acute infectious diseases
Data sourced from ClinicalTrials.gov (NCT03859622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.