A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

• Conditions: Simvastatin Adverse Reaction; Pharmacogenomics; Accurate Medication

• 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

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22
• Study Start: 2018-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

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

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