Myopathy Clinical Trial
Official title:
Study of Pharmacogenomic and Pharmacokinetic Risk Factors Associated With Statin Induced Muscle ADRs (Adverse Drug Reactions) in Singapore Population
To find out the pharmacokinetic and genetic risk factors involved in muscular side effects
(myalgia) associated with statin therapy. To learn better ways of identifying risk factors
associated with muscle side effects during statin therapy. To perform laboratory analysis to
identify factors predicting future outcomes. The genetic material, in combination with other
medical information and blood tests, will be available to researchers studying genetic and
other factors that contribute to myalgia caused in some patient population on statin
medication.
Patients on statin are selected for this study. This study will recruit 1500 subjects from
National heart Centre Singapore over a period of 2.5 years.
Participation in the full study includes the donation of genetic material. However, subjects
have the option of not having blood subjected to genetic analysis and still participate in
the study. In this case, blood samples will only be analyzed for the statin drug content.
Objective is to characterize the relationship between genetic polymorphisms and
inter-individual variability in plasma statin and metabolite concentration(s) and to quantify
its contribution towards clinically significant statin induced muscle ADR phenotypes myopathy
and/or myalgia in Singapore population. Methodology: This research involves the study of two
different kinds of muscle ADRs commonly associated with statin therapy, namely myalgia and
myopathy. The study of myalgia will include the recruitment and sample collection (blood)from
3000 subjects from the outpatient clinic at NUH and NHC, who are on either simvastatin or
atorvastatin. To identify genetic variants associated with altered stain exposure,
investigators will perform an analysis of the drug and metabolite levels in plasma, followed
by a genetic analysis of DNA from the blood samples of the recruited subjects. A subgroup of
30 subjects (15 from NUH and 15 from NHC) from this large cohort will be used to study
intra-subject variability in statin drug and metabolite exposure. The genetic association
analysis of genotype and statin blood measurements will be done using liner regression
analysis. To test the hypothesis that related pharmacokinetic variants are associated with
myalgia and myopathy, investigators will perform the case-control association analysis using
logistic regression to examine the frequency of genetic variant in patients with clinically
identified ADRs and compare it to control subjects without any ADRs. A separate cohort of 200
subjects will be recruited for the myopathy study through the NUH outpatient clinic following
subject identification through an IRB approved medical records review of patients who
were/are any statin drug/dose. Blood samples collected from these patients will be subjected
to genetic analysis to identify genetic variants associated with symptomatic phenotypes.
Potential Benefits and risks: The potential benefits of this study include, identifying
strong risk factors of statin induced muscle symptoms myalgia/myopathy that should inform
clinical practice in minimizing/ managing severity of statin associated muscle symptoms, by
identifying patient populations with an increased risk to statin induced myalgia and/or
myopathy. This information might ultimately inform treatment decisions including drug
selection and dosing and improved prediction of treatment response in a heterogeneous
population. The only possible risk in the study is that associated with blood-taking.
Obtaining blood can cause pain, bleeding, bruising, or swelling at the site of the needle
stick. Fainting sometimes occurs and infection rarely occurs.
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