Additional KIF6 Risk Offers Better Adherence to Statins

Study Overview
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Brief Summary
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Many patients prescribed statins to lower their cholesterol stop taking their statin over time. The purpose of this study is to determine whether providing subjects their KIF6 carrier status (associated with increased cardiovascular event risk) will improve adherence to statin medications.

Detailed Description
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Coronary Heart Disease (CHD) remains a significant problem in the US, causing about 1 of every 5 deaths in 2005. In 2009, approximately 1.3 million Americans will have a new/recurrent myocardial infarction. Coronary heart disease (CHD) includes myocardial infarction, stable or unstable angina, demonstrated myocardial ischemia detected by noninvasive testing, and a history of coronary artery procedures (such a stent or bypass). Currently, statins are recommended by the AHA to manage elevated low-density lipoprotein-cholesterol (LDL-C). Unfortunately, the discontinuation of statins is quite substantial. For example, a large cohort study of older patients found that 2-year statin adherence rates were approximately 40% for acute coronary syndrome patients, 36% for chronic coronary artery disease, and 25% for primary prevention and is associated with increased mortality, hospitalizations, and costs. Recently, the kinesin 6 (KIF6) gene has been associated with a 30-55% increase in cardiovascular events in individuals carrying one or two risk variants ( 57% of the white population) in multiple prospective studies. Furthermore, KIF6 carriers receiving a statin have a substantial greater cardiovascular risk reduction (-34 to 50%) when using a statin compared to those that are non-carriers using a statin (6 to 20%). In this prospective, open label, trial, recruited subjects recently started on statin therapy will be provided information about their KIF6 carrier status and followed for 6 months to determine their statin adherence. Additionally, quality of life and factors adherence will be measured at baseline and after 6 months. Finally, pharmacy records will be evaluated for up to 1-year to determine statin discontinuation rates.

Official Title
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Additional KIF6 Risk Offers Better Adherence to Statins

Conditions
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Dyslipidemia, Cardiovascular Diseases

Intervention / Treatment
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* Genetic: KIF6 genetic test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women at least 18 years of age New statin prescription Medco RationalMed® Program Data contains patient contact information (e.g. phone number) Data contains provider contact information Willing to sign informed consent and send KIF6 test results to their provider Exclusion Criteria: Statin prescription in the previous 6 months Subject refusal to participate in this study (record reason from subject) Physician refusal to participate in this study (record reason from provider) Anticipated statin discontinuation within 6 months Any condition that would prevent the subject from completing the 6 month study follow-up period Subject with no contact red flag Subject residing in NY, NJ, MA, PA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| KIF6 tested<br>Recruited subjects, completing a valid KIF6 test with results | Genetic: KIF6 genetic test<br>* KIF6 carrier status with interpretation sheet provided to subject<br>|
| KIF6 test naïve<br>Database matched cohort not receiving a KIF6 test | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of days covered with statins in subjects tested for KIF6 status compared to statin-treated subjects who are not offered the test (KIF6 test naïve) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status |  | 6 months | 
| To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve |  | 6 months | 
| To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers |  | 6 months | 
| To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects |  | up to 12 months | 
| Shift in PDC between non-adherent, partially adherent, and adherent (< 0.2, >0.2 to <0.8, > 0.8, respectively) between KIF6 tested and KIF6 test naïve subjects |  | 6 month | 
| To compare SF-12 v2 summary measure scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS); and, a health utility index (SF-6D.), as well as, the Morisky Adherence Scale between KIF6 carriers and non-carriers |  | 6 months | 
| To determine cardiovascular costs associated with PDC |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Statins, Kinesin-like protein 6