Genetically Guided Statin Therapy

NCT01894230 | Completed Results

• 2 other identifiers: Pro00044989Pro00045542
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects. This study will assist physicians/providers in making a personalized health care plan for prevention of cardiovascular disease.

Conditions

Hypercholesterolemia; Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction

Keywords

high cholesterol; genetic testing; medication adherence; statins; Adverse Effects; pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Morisky Medication Adherence Scale (MMAS) Score

  The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.

  3 months and 8 months

Secondary Outcomes (9)

• Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8

  Baseline, Month 3, Month 8

• Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up

  Baseline to Last patient follow-up in study (3 months or 8 months)

• Number of Participants Reporting New Statin Prescriptions

  Baseline, Month 3, Month 8

• Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8

  Month 3 and Month 8

• Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8

  Month 3 and Month 8

Study Arms (2)

Genotype results plus usual care

EXPERIMENTAL

SLCO1B1\*5 allele testing, results reported at randomization: genetic testing for SLCO1B1\*5 allele and reporting of results to patient and provider at randomization.

Genetic: SLCO1B1*5 allele testing, results reported at randomization; Genetic: Genetic testing for SLCO1B1*5 allele

Usual care only

ACTIVE COMPARATOR

SLCO1B1\*5 allele testing, results reported at end of study: genetic testing for SLCO1B1\*5 allele and reporting of results to patient and provider at end of study

Genetic: SLCO1B1*5 allele testing, results reported at end of study; Genetic: Genetic testing for SLCO1B1*5 allele

Interventions

SLCO1B1*5 allele testing, results reported at randomization GENETIC

Genetic testing for SLCO1B1\*5 allele and reporting of results to patient and provider at randomization

Also known as: genotype informed statin therapy (GIST)

Genotype results plus usual care

SLCO1B1*5 allele testing, results reported at end of study GENETIC

Genetic testing for SLCO1B1\*5 allele and reporting of results to patient and provider at end of study

Usual care only

Genetic testing for SLCO1B1*5 allele GENETIC

Blood test for SLCO1B1\*5 allele

Genotype results plus usual care; Usual care only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current patient (defined as seen in the last year) of the Duke Primary Care at Pickett Road, Pickens Family Medicine Center or Travis Air Force Base
• Age greater than or equal to 18 years
• Current non-utilization of statin therapy for either of the following reasons: (a) Prior side effects thought to be attributed by the patient to statin use AND/OR (b) Physician removal of statin due to presumed associated side effects
• No statin use for the past 6 weeks
• Active email account
• Computer access available in order to complete on-line surveys
• Ability to provide informed consent

You may not qualify if:

• Prior rhabdomyolysis, or Creatine Kinase (CK) elevation \> 10 times the upper limit of normal with any statin therapy
• Prior unexplained elevation in hepatic enzymes \[Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3 times upper limit of normal\] with any statin therapy
• Current daily grapefruit juice usage (on average \>1quart/day)
• Expected long term use (longer than 3 months) of the following medications known to interfere with statin metabolism or disposition at time of enrollment until the randomization is complete. However, short-term (\<14 days) is allowed for the duration of the study
• Participation in a drug research study in the past 30 days
• Previous use of 4 or more statins

Sponsors & Collaborators

• Duke University: lead
• David Grant U.S. Air Force Medical Center: collaborator

Study Sites (2)

David Grant US Air Force Medical Center

Travis Air Force Base, California, 94535, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Peyser B, Perry EP, Singh K, Gill RD, Mehan MR, Haga SB, Musty MD, Milazzo NA, Savard D, Li YJ, Trujilio G, Voora D. Effects of Delivering SLCO1B1 Pharmacogenetic Information in Randomized Trial and Observational Settings. Circ Genom Precis Med. 2018 Sep;11(9):e002228. doi: 10.1161/CIRCGEN.118.002228.

  PMID: 30354330 DERIVED

• Ramsey LB, Johnson SG, Caudle KE, Haidar CE, Voora D, Wilke RA, Maxwell WD, McLeod HL, Krauss RM, Roden DM, Feng Q, Cooper-DeHoff RM, Gong L, Klein TE, Wadelius M, Niemi M. The clinical pharmacogenetics implementation consortium guideline for SLCO1B1 and simvastatin-induced myopathy: 2014 update. Clin Pharmacol Ther. 2014 Oct;96(4):423-8. doi: 10.1038/clpt.2014.125. Epub 2014 Jun 11.

  PMID: 24918167 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Medication Adherence

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Deepak Voora
• Organization: Duke University

Deepak.vorra@duke.edu

919-668-1755

Study Officials

• Deepak Voora, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Henry Lau, MD

  David Grant US Air Force Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: June 23, 2017
• Results First Posted: June 23, 2017

Record last verified: 2017-06

Locations

US (2)