A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Cui Yimin

Status: Unknown

Conditions: Pharmacogenomics; Accurate Medication; Simvastatin Adverse Reaction

Treatments: Genetic: detection of genotype

Study type: Observational

Funder types: Other

Identifiers

NCT03261908

2016[1237]

Details and patient eligibility

About

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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients taking simvastatin therapy
• Signed informed consent.

Exclusion criteria

• Patients not taking simvastatin therapy
• Intolerance or unwillingness to blood sample collection.

Trial design

2,200 participants in 2 patient groups

wild genotype

Description:

Through next generation sequencing, distinguish wild genotype of simvastatin

Treatment:

Genetic: detection of genotype

mutant genotype

Description:

Through next generation sequencing, distinguish mutant genotype of simvastatin

Treatment:

Genetic: detection of genotype