The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study: Protocol for a point-of-care randomized controlled trial of statin pharmacogenetics in primary care.

Autor: Vassy JL; VA Boston Healthcare System, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: jvassy@partners.org., Brunette CA; VA Boston Healthcare System, Boston, MA, USA., Majahalme N; VA Boston Healthcare System, Boston, MA, USA., Advani S; VA Boston Healthcare System, Boston, MA, USA., MacMullen L; VA Boston Healthcare System, Boston, MA, USA., Hau C; VA Boston Healthcare System, Boston, MA, USA., Zimolzak AJ; VA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USA., Miller SJ; VA Boston Healthcare System, Boston, MA, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2018 Dec; Vol. 75, pp. 40-50. Date of Electronic Publication: 2018 Oct 24.
DOI: 10.1016/j.cct.2018.10.010
Abstrakt: Background: The association between the SLCO1B1 rs4149056 variant and statin-associated muscle symptoms (SAMS) is well validated, but the clinical utility of its implementation in patient care is unknown.
Design: The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study is a pseudo-cluster randomized controlled trial of SLCO1B1 genotyping among statin-naïve primary care and women's health patients across the Veteran Affairs Boston Healthcare System. Eligible patients of enrolled primary care providers are aged 40-75 and have elevated risk of cardiovascular disease by American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Patients give consent by telephone in advance of an upcoming appointment, but they are enrolled only if and when their provider co-signs an order for SLCO1B1 testing, performed on a blood sample already collected in clinical care. Enrolled patients are randomly allocated to have their providers receive results through the electronic health record at baseline (PGx + arm) versus after 12 months (PGx- arm). The primary outcome is the change in low-density lipoprotein cholesterol (LDL-C) after one year. Secondary outcomes are concordance with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for simvastatin prescribing, concordance with ACC/AHA guidelines for statin use, and incidence of SAMS. With 408 patients, the study has >80% power to exclude a between-group LDL-C difference of 10 mg/dL (non-inferiority design) and to detect between-group differences of 15% in CPIC guideline concordance (superiority design).
Conclusion: The outcomes of the I-PICC Study will inform the clinical utility of preemptive SLCO1B1 testing in the routine practice of medicine, including its proposed benefits and unforeseen risks.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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