N/A N=159 Randomized Prevention

Genetically Guided Statin Therapy

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

Bottom Line

View on ClinicalTrials.gov: NCT01894230 ↗

Enrolled (actual)

159

Serious AEs

6.3%

Results posted

Jun 2017

Primary outcome: Primary: Morisky Medication Adherence Scale (MMAS) Score — 6.8; 6.9; 6.8; 7.1 units on a scale — p=0.96

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SLCO1B1*5 allele testing, results reported at randomization (Genetic); SLCO1B1*5 allele testing, results reported at end of study (Genetic); Genetic testing for SLCO1B1*5 allele (Genetic)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Morisky Medication Adherence Scale (MMAS) Score	6.8; 6.9; 6.8; 7.1	0.96
SECONDARY Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8	152.7; 157.6; 131.9; 144.4; 128.6; 141	0.0482 sig
SECONDARY Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up	0.632; 0.685	0.6692
SECONDARY Number of Participants Reporting New Statin Prescriptions	41; 27; 4; 4	0.0371 sig
SECONDARY Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8	1.608; 1.493; 1.939; 1.689	0.5965
SECONDARY Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8	2.108; 1.971; 1.964; 1.689	0.5477
SECONDARY Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)	42.244; 41.692; 41.389; 41.566; 42.179; 41.359	0.8106
SECONDARY Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)	43.393; 44.101; 42.835; 44.595; 43.776; 44.327	0.6841
SECONDARY Physical Activity Scale Score	1.838; 1.736; 1.923; 1.667	0.8384
SECONDARY Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8	13.878; 13.893; 14.347; 13.185; 14.148; 13.9	0.0486 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01894230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.