Cardiovascular Diseases, Dyslipidemia
Conditions
Keywords
Adherence, Statins, Kinesin-like protein 6
Brief summary
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
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.
Interventions
GENETICKIF6 genetic test
KIF6 carrier status with interpretation sheet provided to subject
Sponsors
Celera Genomics
Medco Health Solutions, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status | 6 months |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed