Accurate Medication, Pharmacogenomics, Simvastatin Adverse Reaction
Conditions
Brief summary
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.
Interventions
GENETICdetection of genotype
detection of genotype by next generation sequencing
Sponsors
Cui Yimin
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients taking simvastatin therapy * Signed informed consent.
Exclusion criteria
* Patients not taking simvastatin therapy * Intolerance or unwillingness to blood sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hepatic impairment | At 2 years |
| Incidence of myopathy | At 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Genotype detected by next generation sequencing | pre-dose of simvastatin(Baseline) | Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing. |
Countries
China
Contacts
Primary ContactQian Xiang, Ph.D
Outcome results
None listed