A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
- Conditions
- Simvastatin Adverse ReactionPharmacogenomicsAccurate Medication
- Interventions
- Genetic: detection of genotype
- Registration Number
- NCT03261908
- Lead Sponsor
- Cui Yimin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2200
Inclusion Criteria
- Patients taking simvastatin therapy
- Signed informed consent.
Exclusion Criteria
- Patients not taking simvastatin therapy
- Intolerance or unwillingness to blood sample collection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description mutant genotype detection of genotype Through next generation sequencing, distinguish mutant genotype of simvastatin wild genotype detection of genotype Through next generation sequencing, distinguish wild genotype of simvastatin
- Primary Outcome Measures
Name Time Method Incidence of hepatic impairment At 2 years Incidence of myopathy At 2 years
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China