Celera Corporation and Medco Health Solutions, Inc, have entered into a research collaboration to evaluate whether testing for a gene variant called KIF6 increases patient adherence with statin therapy. Current studies have suggested that only about 50 to 60 percent of the patients who receive a prescription for a lipid-lowering drug are taking the medication after six months. This level of adherence falls to 30 to 40 per cent after two years in patients with coronary artery disease.
"A study of this nature has the potential to show that understanding your genetic risk can improve statin adherence," said Medco vice president of Personalized Medicine Research and Development Dr Felix Frueh. "Medco's research partnership with Celera could help provide more evidence that personalized medicine can improve patient outcomes."
As part of this collaboration, the companies will conduct a prospective, randomized, open-label, multi-center study (AKROBATS - Additional KIF6 Risk Offers Better Adherence to Statins) to address the primary question of whether patient adherence with newly prescribed statin therapy is higher in those patients tested for KIF6 status than in those who are not offered the test. Medco expects to test approximately 650 members for their KIF6 status and compare adherence with statin therapy to an equally-sized control group whose KIF6 status is not known. Samples will be collected by using a simple cheek swab.
Testing will be performed by Berkeley HeartLab, Inc, a Celera subsidiary, using its laboratory developed test. Following review and approval by an Institutional Review Board, the study is expected to begin this fall, and patients' statin adherence is expected to be monitored by Medco's current pharmacy benefit methods over the course of 18 months.
"We believe this research collaboration presents an opportunity to demonstrate an important benefit of genetic testing as we hope to show that carriers of the KIF6 variant are more likely to adhere with their physician-prescribed statin treatment," said Celera chief executive officer Kathy Ordoñez.
All patients included in the study will be under the care of a physician who has already prescribed them a statin. The primary endpoint of this study is change in adherence to statin therapy in patients tested for KIF6 status compared to statin-treated patients who do not undergo KIF6 testing.
Medco has established a Personalized Medicine Program that offers solutions for payors to help enable them to leverage the potential advantages of personalized medicine by analyzing prescription claims histories to identify patients who could benefit from genetic testing, communicating with physicians about testing options and results and engaging patients to educate them about genetic tests. Outcomes from the current collaboration are expected to further strengthen this program.
The KIF6 gene encodes kinesin-like protein 6 ( KIF6 ). Published research studies have shown an association between KIF6 and cardiovascular risk and statin benefit3-7.
Statins are the most potent cholesterol-lowering agents available, which can help prevent heart attacks and strokes. Approximately 20 percent of Americans are prescribed a statin each year and are the most prescribed class of drugs in the United States , according to 2008 IMS data.
Celera is a healthcare business focusing on the integration of genetic testing into routine clinical care through a combination of products and services incorporating proprietary discoveries.