A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

N/AUnknownNCT03261908

Cui Yimin2,200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,200

Conditions

Simvastatin Adverse Reaction Pharmacogenomics Accurate Medication

Interventions

detection of genotypeGENETIC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients taking simvastatin therapy * Signed informed consent. Exclusion Criteria: * Patients not taking simvastatin therapy * Intolerance or unwillingness to blood sample collection.

Outcomes

Primary Outcomes

Incidence of hepatic impairment

Time frame: At 2 years

Incidence of myopathy

Time frame: At 2 years

Secondary Outcomes

Genotype detected by next generation sequencing

Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.

Time frame: pre-dose of simvastatin(Baseline)

Data from ClinicalTrials.gov

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