Trial Outcomes & Findings for CYP2D6 Polymorphism in Patients of General Practice in Austria (NCT NCT03859622)
NCT ID: NCT03859622
Last Updated: 2019-10-30
Results Overview
Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived. A patient can be considered a ultra-rapid (UM), a normal (NM), an intermediate (IM), or a poor metabolizer (PM) of a given drug
COMPLETED
289 participants
1 Year
2019-10-30
Participant Flow
Participant milestones
| Measure |
Observational Cohort Cross-sectional Study
The study takes place in an average Austrian general practice in 2017 and 2018 enrolling 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions. Only in case a patient is actually taking or has been prescribed a drug metabolized by CYP2D6 (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, the genetic polymorphism of CYP2D6 is determined. No further genetic investigations, additional blood collections or interventions are performed.
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|---|---|
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Overall Study
STARTED
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289
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Overall Study
COMPLETED
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289
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline: 289 participants
Baseline characteristics by cohort
| Measure |
Observational Cohort Cross-sectional Study
n=289 Participants
The study takes place in an average Austrian general practice in 2017 and 2018 enrolling 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions. Only in case a patient is actually taking or has been prescribed a drug metabolized by CYP2D6 (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, the genetic polymorphism of CYP2D6 is determined. No further genetic investigations, additional blood collections or interventions are performed. All participants gave written consent.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants • Baseline: 289 participants
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Age, Categorical
Between 18 and 65 years
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90 Participants
n=99 Participants • Baseline: 289 participants
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Age, Categorical
>=65 years
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199 Participants
n=99 Participants • Baseline: 289 participants
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Sex: Female, Male
Female
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166 Participants
n=99 Participants
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Sex: Female, Male
Male
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123 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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289 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
Austria
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289 Participants
n=99 Participants
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Number of patients with a prescription of a CYP2D6 specific drug and routine blood test
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289 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 1 YearPopulation: 289 unselected consecutive patients with a prescription of a CYP2D6 relevant drug during the last 3 years and who are visiting the practice office for a routine blood test. Due to technical problems the metabolizer status of two patients could not be determined!
Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived. A patient can be considered a ultra-rapid (UM), a normal (NM), an intermediate (IM), or a poor metabolizer (PM) of a given drug
Outcome measures
| Measure |
Frequencies of Metabolizer Status (PM, IM, NM, UM)
n=287 Participants
In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her metabolizer status (PM,IM,NM, UM) is analysed.
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|---|---|
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Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients
Normal Metabolizer (NM)
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233 Participants
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Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients
Poor Metabolizer (PM)
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22 Participants
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Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients
Intermediate Metabolizer (IM)
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21 Participants
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Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients
Ultra-rapid Metabolizer (UM)
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11 Participants
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PRIMARY outcome
Timeframe: 1 YearPopulation: In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her CYP2D6 alleles are analyzed.
The frequency of 19 different CYP2D6 alleles in 287 patients is determined. In 2 out of all 289 patients the determination was not possible due to technical problems. Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived.
Outcome measures
| Measure |
Frequencies of Metabolizer Status (PM, IM, NM, UM)
n=287 Participants
In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her metabolizer status (PM,IM,NM, UM) is analysed.
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|---|---|
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Frequency of CYP2D6 Alleles in Patients
*1s
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55 Participants
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Frequency of CYP2D6 Alleles in Patients
*4s
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25 Participants
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Frequency of CYP2D6 Alleles in Patients
*6s
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7 Participants
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Frequency of CYP2D6 Alleles in Patients
*5s
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5 Participants
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Frequency of CYP2D6 Alleles in Patients
*3s
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3 Participants
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Frequency of CYP2D6 Alleles in Patients
*1
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122 Participants
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Frequency of CYP2D6 Alleles in Patients
*4A-H,K,L or P
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80 Participants
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Frequency of CYP2D6 Alleles in Patients
*2A
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77 Participants
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Frequency of CYP2D6 Alleles in Patients
*41
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26 Participants
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Frequency of CYP2D6 Alleles in Patients
*35
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30 Participants
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Frequency of CYP2D6 Alleles in Patients
*5
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18 Participants
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Frequency of CYP2D6 Alleles in Patients
*9
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12 Participants
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Frequency of CYP2D6 Alleles in Patients
*10A or B
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9 Participants
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Frequency of CYP2D6 Alleles in Patients
*3
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8 Participants
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Frequency of CYP2D6 Alleles in Patients
*6A,B or D
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7 Participants
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Frequency of CYP2D6 Alleles in Patients
*39
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1 Participants
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Frequency of CYP2D6 Alleles in Patients
*2B-M
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1 Participants
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Frequency of CYP2D6 Alleles in Patients
*17
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1 Participants
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Frequency of CYP2D6 Alleles in Patients
*15
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1 Participants
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PRIMARY outcome
Timeframe: 1 YearPopulation: 289 unselected consecutive patients with a prescription of a CYP2D6 relevant drug during the last 3 years and who are visiting the practice office for a routine blood test. Due to technical problems the genotypes of two patients could not be determined!
The frequency of 61 different CYP2D6 genotypes in 287 patients is determined. In 2 out of all 289 patients the determination was not possible due to technical problems. Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived.
Outcome measures
| Measure |
Frequencies of Metabolizer Status (PM, IM, NM, UM)
n=287 Participants
In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her metabolizer status (PM,IM,NM, UM) is analysed.
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|---|---|
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Frequency of CYP2D6 Genotypes in Patients
*2A/*17
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*15/*35 xN
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*6A,B or D xN
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*4A-H,K,L or P xN
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*35 xN
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*1s
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23 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*4s
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19 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*6s
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5 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*5s
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3 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*1s xN
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4s/*5s
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*4s xN
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1s/*3s
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4s/*6s
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*3s/*6s
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*3s/*4s
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1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*2A
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29 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*4A-H,K,L or P
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25 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*1
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24 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*4A-H,K,L or P
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15 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*41
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11 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/*4A-H,K,L or P
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10 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/*41
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9 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*5
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9 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*2A
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7 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/*35
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6 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*35
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6 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*35
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5 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/*9
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4 Participants
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Frequency of CYP2D6 Genotypes in Patients
*35/*41
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4 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*41
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4 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*10A or B
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4 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/10A or B
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3 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/*6A,B or D
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3 Participants
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Frequency of CYP2D6 Genotypes in Patients
*41/*41
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3 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*5
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3 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*3
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3 Participants
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Frequency of CYP2D6 Genotypes in Patients
*9/*41
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*9/*35
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*5/*41
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*4A-H,K,L or P/*5
|
2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*9
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2 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*2A/*35 xN
|
2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*2A/*2A xN
|
2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*9
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2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*1/*6A,B or D
|
2 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*1/*2A xN
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2 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*1/*1 xN
|
2 Participants
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Frequency of CYP2D6 Genotypes in Patients
*6A, B or D/*41 xN
|
1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*5/*5
|
1 Participants
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Frequency of CYP2D6 Genotypes in Patients
*5/*35
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*35/*39
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*35/*35
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*3/*4A-H,K,L or P
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*3/*41
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*3/*10A or B
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*2A/*4A-H,K,L or P xN
|
1 Participants
|
|
Frequency of CYP2D6 Genotypes in Patients
*2A/*3 xN
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*2A/*3
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*2A/*2B-M
|
1 Participants
|
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Frequency of CYP2D6 Genotypes in Patients
*2A/*10A or B
|
1 Participants
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SECONDARY outcome
Timeframe: 1 YearPopulation: 289 unselected consecutive patients with a prescription of a CYP2D6 relevant drug during the last 3 years visiting the practice office for a routine blood test. Due to technical problems only 287 could be analyzed.
In how many patients would family physician's knowledge of the CYP 2D6 metabolizer status (ultrarapid (UM), normal (NM), intermediate (IM) and poor (PM)) have been of importance before prescribing a CYP2D6 specific drug. Remark: The relevant drug has already already been prescribed before analysis has been taken place.
Outcome measures
| Measure |
Frequencies of Metabolizer Status (PM, IM, NM, UM)
n=287 Participants
In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her metabolizer status (PM,IM,NM, UM) is analysed.
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|---|---|
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Number of Participants in Whom the Family Physician Considered Prior Knowledge of Their Metabolizer Status Important Before the CYP2D6-specific Drug Was Prescriped.
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29 Participants
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SECONDARY outcome
Timeframe: 1 YearPopulation: Specific number of participants of the whole practice population with a prescription of a CYP2D6 relevant drug. Participants belonging to this specific group did not need to sign an informed consent form. No other data (i.e. baseline assessments, other outcome measures and adverse events) were collected in this group.
The specific number of participants of the practice population with a prescription of drugs metabolized by CYP 2D6 within the last 3 years. These data were extracted from the electronic health records (EHRs) of the practice office. For this data extraction enrollement in the study and signing an informed consent was not necessary. No other data (i.e. baseline assessments, other outcome measures and adverse events) were collected in this group.
Outcome measures
| Measure |
Frequencies of Metabolizer Status (PM, IM, NM, UM)
n=3016 Participants
In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her metabolizer status (PM,IM,NM, UM) is analysed.
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|---|---|
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Specific Number of Patients of the Whole Practice Population Whose Electronic Health Records (EHRs) Were Assessed.
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668 Participants
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Adverse Events
Observational Cohort Cross-sectional Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.med.Gustav Kamenski
Karl Landsteiner Institute of General Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place