DNA Diagnostic System for Statin Safety and Efficacy
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2007 |
| End Date: | December 2009 |
| Contact: | Richard L. Seip, PhD |
| Email: | rseip@harthosp.org |
| Phone: | 860-545-5005 |
Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken to lower cholesterol and
prevent heart disease. Statins lower cholesterol by different amounts in different patients
and sometimes statins cause muscle pain, cramps, or weakness. This study will examine
genetic differences in the blood of patients taking statins to predict both how well the
statins lower cholesterol, and whether muscle discomfort occurs. Finding such genetic
connections is the key to developing genetic tests that might eventually help determine
which statin is best for a patient. About 1000 people will be in the study.
prevent heart disease. Statins lower cholesterol by different amounts in different patients
and sometimes statins cause muscle pain, cramps, or weakness. This study will examine
genetic differences in the blood of patients taking statins to predict both how well the
statins lower cholesterol, and whether muscle discomfort occurs. Finding such genetic
connections is the key to developing genetic tests that might eventually help determine
which statin is best for a patient. About 1000 people will be in the study.
Statin efficacy in primary and secondary prevention of cardiovascular disease has led to
increasingly aggressive usage and dosage of statins. Their main clinically relevant safety
risk is statin-induced myopathy (SIM) evidenced as a constellation of neuromuscular side
effects (NMSE) that include myalgias (muscle aches, cramps, weakness) and myositis
(monitored by elevation of serum creatine kinase [CK] activity). NMSEs are disabling to
3-20% of patients on statins, require alteration of therapy, and reduce compliance. NMSEs
vary in extent between drugs and from patient to patient. We will develop a novel product
termed SIM PhyzioType™ system to provide clinicians with individualized information for each
patient on the safest statin drug among atorvastatin, simvastatin, and rosuvastatin, the 3
most prescribed statins. The PhyzioType consists of a multi-SNP (single nucleotide
polymorphism) ensemble that, interpreted with a biomathematical algorithm, predicts drug
response. We have developed a prototype PhyzioType system incorporating predictive models
for myalgia, serum CK activity, and LDLc reduction for atorvastatin and simvastatin
patients. We will recruit to obtain 250 patients treated with each drug and use existing
clinical records to characterize their NMSE and LDLc responses. We will use physiogenomic
analysis to identify those SNPs that differentiate the risk of NMSEs among the 3 statins and
combine them into the SIM PhyzioType system. This work will also contribute to the
pharmacology of SIM and unravel new pharmaceutical targets. We will create and validate the
SIM PhyzioType system with clinically useful prediction of NMSEs and potency for each of the
3 statins. In Phase III a prospective trial is planned for FDA approval of the SIM
PhyzioType product.
increasingly aggressive usage and dosage of statins. Their main clinically relevant safety
risk is statin-induced myopathy (SIM) evidenced as a constellation of neuromuscular side
effects (NMSE) that include myalgias (muscle aches, cramps, weakness) and myositis
(monitored by elevation of serum creatine kinase [CK] activity). NMSEs are disabling to
3-20% of patients on statins, require alteration of therapy, and reduce compliance. NMSEs
vary in extent between drugs and from patient to patient. We will develop a novel product
termed SIM PhyzioType™ system to provide clinicians with individualized information for each
patient on the safest statin drug among atorvastatin, simvastatin, and rosuvastatin, the 3
most prescribed statins. The PhyzioType consists of a multi-SNP (single nucleotide
polymorphism) ensemble that, interpreted with a biomathematical algorithm, predicts drug
response. We have developed a prototype PhyzioType system incorporating predictive models
for myalgia, serum CK activity, and LDLc reduction for atorvastatin and simvastatin
patients. We will recruit to obtain 250 patients treated with each drug and use existing
clinical records to characterize their NMSE and LDLc responses. We will use physiogenomic
analysis to identify those SNPs that differentiate the risk of NMSEs among the 3 statins and
combine them into the SIM PhyzioType system. This work will also contribute to the
pharmacology of SIM and unravel new pharmaceutical targets. We will create and validate the
SIM PhyzioType system with clinically useful prediction of NMSEs and potency for each of the
3 statins. In Phase III a prospective trial is planned for FDA approval of the SIM
PhyzioType product.
Inclusion Criteria:
- receiving, or documented to have received in the past, any of the statins including
atorvastatin, simvastatin, rosuvastatin treatment for hypercholesterolemia
- chart-documented clinical record of having had, never having had, or possibly having
had, statin-associated myopathy
Exclusion Criteria:
- never having taken any statin medication
We found this trial at
3
sites
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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