'Preemptive' Statin-Myopathy Gene Test Offered to Patients

November 03, 2011

November 3, 2011 (Nashville, Tennessee) — Patients considered for simvastatin therapy here at Vanderbilt University Medical Center (VUMC) will be offered a genetic screening test that can identify variants known to increase the risk of myopathy associated with the drug, the institution has announced [1].

The test, actually a panel aimed at 184 different variants on 34 genes (VeraCode ADME Core Panel, Illumina, San Diego, CA) will be used to identify patients at increased simvastatin-related myopathy risk who might better avoid the drug.

Patients will be tested as part of the VUMC program Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment (PREDICT), which is exploring the feasibility of "preemptively" including pharmacogenomic data in the electronic medical records of selected patients for possible later use in guiding treatment decisions, Dr Dan Roden (VUMC) told heartwire .

VUMC is one of a handful of institutions and the first academic medical center to have such a program, according to Roden, who is its assistant vice chancellor for personalized medicine.

The commercially available panel screens for variants known to interact with a number of commonly used drugs, including simvastatin, clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), and warfarin. PREDICT has already enrolled 3486 patients screened before they went to left-heart catheterization and who therefore had a high probability of being prescribed clopidogrel, according to Roden. Enrollments will now focus on patients who could receive simvastatin and later on patients who could get warfarin; the current overall enrollment target is 10 000 patients.

The panel can identify patients with one or two copies of a variant of SLCO1B1, a gene involved in the regulation of statin uptake in the liver and associated with increased myopathy risk. Patients with two copies of the variant have an almost 20-fold increased risk of simvastatin-related myopathy, according to Roden.

The SLCO1B1 variant was identified in a genomewide association study as predictive of myopathy in patients taking simvastatin [2] but may have a similar effect in some other statins.

"One long-term goal of PREDICT is to show that doing medicine in this future-tense way results in better outcomes and therefore to make the test reimbursable," Roden said. Right now, he added, the panel's cost is covered by VUMC's research budget.

Neither VUMC nor clinicians involved in PREDICT have commercial ties related to the project, according to Roden.