Genetics of Drug Metabolism
Conditions
Keywords
Pharmacogenomics, Adverse Drug Reactions
Brief summary
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits. The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as Pharmacogenomics.
Interventions
None listed
Sponsors
Syntactx
General Genetics Corporation
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test') * Males and females aged ≥65 years or male and females aged ≥18 years who have a disability * Subject is able and willing to provide written informed consent * Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications * Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug
Exclusion criteria
* Subject is currently hospitalized * Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results * Subject is unable to provide an accurate history due to mental incapacity * Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Meaningful Change in Drug Regimen | 90 days | The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: 1. A genotype known to affect a drug the subject is taking is identified, and 2. The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results | 90 days | — |
| Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test | 90 days | Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion |
| Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs | 90 days | — |
| Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results | 90 days | — |
| Number of target drug-related adverse events over the 90-day period prior to and following PGx testing | 90 days | — |
| Emergency department visits over the 90-day periods prior to and following PGx testing | 90 days | — |
| Hospitalizations over the 90-day period prior to and following receipt of PGx test results | 90 days | — |
| Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results | 90 days | — |
Countries
Puerto Rico, United States
Outcome results
None listed