Integrating Pharmacogenetics In Clinical Care
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study will determine whether using a genetic test (for the SLCO1B1 gene) can help
      patients and providers choose the right type and dose of cholesterol-lowering statin
      medications to lower the risk of cardiovascular disease, while minimizing the muscle pain
      side effects that sometimes occur with statins.
    

Detailed description: 
      Variants at rs4149056 in the SLCO1B1 gene are associated with a greater risk of
      simvastatin-related myopathy. Despite the growing implementation of SLCO1B1 rs4149056
      genotyping in health systems across the United States, there is little randomized controlled
      trial data on the impact of SLCO1B1 testing on clinical outcomes. The IPICC Study will use a
      randomized design to determine the impact of the clinical integration of SLCO1B1 genotype
      testing on important patient outcomes, including statin prescribing, LDL cholesterol, and
      statin-related myopathy. In addition, by enrolling statin-naive patients with a recent
      cholesterol panel, this trial will capture a moment of clinical decision-making when SLCO1B1
      rs4149056 genotype might be most clinically relevant. This randomized-control trial has two
      primary aims:

      Aim 1 (Drug safety): To determine the impact of SLCO1B1 pharmacogenetic testing on
      concordance with Clinical Pharmacogenetics Implementation Consortium (CPIC) pharmacogenetic
      guidelines for safe simvastatin prescribing and on the incidence of statin-related myopathy
      in VA (drug safety).

      Aim 2 (Cardiovascular disease, CVD, prevention): To determine the impact of SLCO1B1
      pharmacogenetic testing on LDL cholesterol levels and concordance with CVD prevention
      guidelines.

      The I-PICC Study is enrolling 408 statin-naive primary care and women's health patients
      across the Veteran Affairs Boston Healthcare System. Eligible patients are aged 40-75 and
      have elevated risk of cardiovascular disease (CVD) according to American College of
      Cardiology/American Heart Association (ACC/AHA) guidelines. Primary care providers (PCPs) are
      also research subjects and consent via electronic health record (EHR) alerts. To model
      pharmacogenotyping at the point of care, the investigators are enrolling patients with recent
      cholesterol results when their PCPs order laboratory testing, indicating a moment of clinical
      decision-making about CVD risk. Enrolled patients are randomized to have their PCPs receive
      results through the EHR immediately (PGx+) vs. after 1 year (PGx-). The investigators will
      query clinical and pharmacy data for 1-year outcomes: myopathy and concordance with CPIC
      simvastatin guidelines (drug safety) and cholesterol levels and concordance with ACC/AHA
      guidelines (CVD risk reduction).
    

Intervention name(s): SLCO1B1 Genotype
Intervention type(s): Genetic
Intervention description(s): Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
Other intervention name(s): SLCO1B1 Pharmacogenetic Test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Pharmacogenetics; SLCO1B1 protein, human; OATP1B1 protein, human; Simvastatin; Cardiovascular disease; Cholesterol; Statin-related myotoxicity; Veterans; Point-of-care