Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction, Hypercholesterolemia
Conditions
Keywords
high cholesterol, genetic testing, medication adherence, statins, Adverse Effects, pharmacogenetics
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.
Detailed description
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) reductase inhibitors (statins) are commonly prescribed to lower low density lipoprotein cholesterol (LDLc) and to prevent cardiovascular disease (CVD), a leading cause of morbidity and mortality. Long-term adherence to statins in the primary care environment is challenging; consequences of statin non-adherence include higher LDLc levels, hospitalizations, costs, and death due to CVD. Medication non-adherence is complex and multifactorial and can be associated with a number of factors including medication cost, complexity of medication regimen, poor provider-patient relationship / communication, and adverse side effects. For statins, side effects such as muscle aches, cramping, and pain (referred to broadly as statin-related myopathy) are a frequent cause of non-adherence. These symptoms are non-specific and are frequent reasons for stopping statin therapy, due to patient or provider concern about the possibility of statin-related myopathy. Many patients may be needlessly deprived of the cardiovascular benefits of long-term statin use. A genetic risk factor for statin myopathy and subsequent non-adherence has recently been identified. In a genome-wide association study, a genetic variant (named SLCO1B1\*5) was a main contributor of statin myopathy. It was demonstrated that the SLCO1B1\*5 variant is not only a predictor of myopathy, but also of premature statin discontinuation. The risk with the \*5 allele is statin specific: greatest with simvastatin and atorvastatin use, the least with pravastatin or rosuvastatin. Therefore, the SLCO1B1\*5 variant is common, can predict myopathy, subsequent non-adherence, and due to its statin-specific effects creates a novel research paradigm for personalizing statins to an individual's genetic profile. Carriers of the SLCO1B1\*5 variant may do best on rosuvastatin, pravastatin, or fluvastatin whereas non-carriers may be treated with any statin. The objective of this study is to conduct a randomized trial comparing two strategies: 1. genetically guided statin therapy vs. 2. usual care (i.e., a strategy without genetics) on the effects of statin adherence and LDLc lowering. The overall hypothesis is that genetically guided statin therapy will lead to greater statin adherence and lower LDLc when compared to a non-guided strategy. The design of this trial will randomize primary care patients within Duke University Health System (DUHS) and travis Air Force Base (TAFB) clinics that are nonadherent to statins due to prior side-effects in an unblinded, 1:1 fashion, stratified by SLCO1B1\*5 genotype.
Interventions
GENETICSLCO1B1*5 allele testing, results reported at randomization
Genetic testing for SLCO1B1\*5 allele and reporting of results to patient and provider at randomization
GENETICSLCO1B1*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
GENETICGenetic testing for SLCO1B1*5 allele
Blood test for SLCO1B1\*5 allele
Sponsors
David Grant U.S. Air Force Medical Center
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morisky Medication Adherence Scale (MMAS) Score | 3 months and 8 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up | Baseline to Last patient follow-up in study (3 months or 8 months) | Medication possession ratio will be calculated based on number of statin medication refills over time from randomization to end of follow up. MPR is calculated as follows: 1.Sum of the days' supply of all statin medications is the sum of the number of pills dispensed for each statin prescription during follow up (taken from 3-month, 4-month and 8-month statin utilization review) 2.Sum of the days of follow up = date of 8-month follow up survey - date of randomization 3.MPR = #1/#2 MPR will be modeled as a linear regression with arm, genotype, and site as predictors. |
| Number of Participants Reporting New Statin Prescriptions | Baseline, Month 3, Month 8 | The number of new prescriptions is binary and will be modeled with logistic regression with arm, genotype, and site as predictors. Any variables imbalanced between arms will also be included as covariates. |
| Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8 | Month 3 and Month 8 | Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. Pain severity and pain interference will be compared between groups. Both of these measures will be modeled as a linear regression with arm, genotype, and site as predictors. Transformations of the response may be explored depending on the distribution of the regression residuals. Baseline pain scores will also be included as a covariate to account for baseline variability. Scores range from 0-10. Higher scores indicate higher pain severity. |
| Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8 | Month 3 and Month 8 | Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. -Pain severity and pain interference will be compared between groups -Both of these measures will be modeled as a linear regression with arm as predictor. Baseline pain scores will also be included as a covariate to account for baseline variability. Scores range from 0-10. Higher scores indicate higher pain interference with daily activities. |
| Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Baseline, Month 3, Month 8 | The continuous outcomes LDLc will be modeled as a linear regression with arm and baseline LDL as predictors. |
| Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Baseline, Month 3, Month 8 | Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability. Ranges from 0 to 100, where a zero score indicates the lowest level of mental health measured by the scales and 100 indicates the highest level of mental health. |
| Physical Activity Scale Score | Baseline and Month 8 | Activity levels will be compared at the end of 8-months. Activity levels are defined by a five-level ordinal variable (0-4; higher level corresponding to higher activity). which was calculated based on survey answers. An ordinal logistic regression model will be used with arm as predictor. The assumption of proportional odds will be checked, and if it is not met, a multinomial regression model will be used. -Baseline physical activity will also be included as a covariate to account for baseline variability. Scale score (0-4): 0 - Inactivity, 1 - Ligh-intensity activity, 2 - moderate-intensity activity, 3 - Hard-intensity activity, 5 - very hard-intensity activity |
| Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Baseline, Month 3, Month 8 | * Questionnaire administered at baseline, 3 months, and 8 months * This instrument assesses beliefs regarding necessity and concerns related to disease-specific medications * The score ranges from 5 to 25 representing the sum of 5 questions. This will be modeled with linear regression including treatment as predictor. Baseline BMQ scores will also be included as a covariate to account for baseline variability. Higher score corresponds to higher thought necessity and higher thought concerns about taking the medication. The higher the necessity score, the more the patient believed statins necessary for their health. The higher the concerns score, the more the patient was concerned about taking stains (side effects). |
| Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Baseline, Month 3, Month 8 | Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability. Ranges from 0 to 100, where a zero score indicates the lowest level of physical health measured by the scales and 100 indicates the highest level of physical health |
Countries
United States
Participant flow
Recruitment details
Eight participants that signed a consent either withdrew consent, were lost-to follow up, or were screen-failures and thus were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Genotype Results Plus Usual Care * Genetic testing for SLCO1B1\*5 allele
* Reporting for SLCO1B1\*5 allele at randomization
Reporting for SLCO1B1\*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization
Genetic testing for SLCO1B1\*5 allele: Blood test for SLCO1B1\*5 allele | 83 |
| Usual Care Only * Genetic testing for SLCO1B1\*5 allele
* Reporting for SLCO1B1\*5 allele at the end of study
Reporting for SLCO1B1\*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.
Genetic testing for SLCO1B1\*5 allele: Blood test for SLCO1B1\*5 allele | 76 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Non-adherent | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Genotype Results Plus Usual Care | Usual Care Only |
|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 10.8 | 62.7 years STANDARD_DEVIATION 10.2 | 62.5 years STANDARD_DEVIATION 11.5 |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 25 Participants | 14 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 127 Participants | 66 Participants | 61 Participants |
| Region of Enrollment United States | 159 participants | 83 participants | 76 participants |
| Sex: Female, Male Female | 91 Participants | 41 Participants | 50 Participants |
| Sex: Female, Male Male | 68 Participants | 42 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 83 | 0 / 76 |
| other Total, other adverse events | 1 / 83 | 0 / 76 |
| serious Total, serious adverse events | 4 / 83 | 6 / 76 |
Outcome results
Primary
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.
Time frame: 3 months and 8 months
Population: Only participants who re-initiated statin use were eligible to do statin specific MMAS and included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Morisky Medication Adherence Scale (MMAS) Score | MMAS Score 3 Months | 6.8 units on a scale | Standard Deviation 1.5 |
| Genotype Results Plus Usual Care | Morisky Medication Adherence Scale (MMAS) Score | MMAS Score 8 Months | 6.8 units on a scale | Standard Deviation 1.7 |
| Usual Care Only | Morisky Medication Adherence Scale (MMAS) Score | MMAS Score 3 Months | 6.9 units on a scale | Standard Deviation 1.6 |
| Usual Care Only | Morisky Medication Adherence Scale (MMAS) Score | MMAS Score 8 Months | 7.1 units on a scale | Standard Deviation 1.3 |
p-value: 0.96Regression, Linear
p-value: 0.57Regression, Linear
Secondary
Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8
* Questionnaire administered at baseline, 3 months, and 8 months * This instrument assesses beliefs regarding necessity and concerns related to disease-specific medications * The score ranges from 5 to 25 representing the sum of 5 questions. This will be modeled with linear regression including treatment as predictor. Baseline BMQ scores will also be included as a covariate to account for baseline variability. Higher score corresponds to higher thought necessity and higher thought concerns about taking the medication. The higher the necessity score, the more the patient believed statins necessary for their health. The higher the concerns score, the more the patient was concerned about taking stains (side effects).
Time frame: Baseline, Month 3, Month 8
Population: Only subjects that completed the Beliefs About Medications questionnaire were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Baseline, BMQ Necessity | 13.878 units on a scale | Standard Deviation 3.49 |
| Genotype Results Plus Usual Care | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 3, BMQ Necessity | 14.347 units on a scale | Standard Deviation 3.75 |
| Genotype Results Plus Usual Care | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 8, BMQ Necessity | 14.148 units on a scale | Standard Deviation 3.983 |
| Genotype Results Plus Usual Care | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Baseline, BMQ Concerns | 15.962 units on a scale | Standard Deviation 3.345 |
| Genotype Results Plus Usual Care | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 3, BMQ Concerns | 14.471 units on a scale | Standard Deviation 3.984 |
| Genotype Results Plus Usual Care | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 8, BMQ Concerns | 13.585 units on a scale | Standard Deviation 4.088 |
| Usual Care Only | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 3, BMQ Concerns | 15.333 units on a scale | Standard Deviation 3.914 |
| Usual Care Only | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Baseline, BMQ Necessity | 13.893 units on a scale | Standard Deviation 3.443 |
| Usual Care Only | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Baseline, BMQ Concerns | 16.067 units on a scale | Standard Deviation 2.974 |
| Usual Care Only | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 3, BMQ Necessity | 13.185 units on a scale | Standard Deviation 3 |
| Usual Care Only | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 8, BMQ Concerns | 14.593 units on a scale | Standard Deviation 3.71 |
| Usual Care Only | Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8 | Month 8, BMQ Necessity | 13.9 units on a scale | Standard Deviation 3.487 |
p-value: 0.0486Regression, Linear
p-value: 0.7235Regression, Linear
p-value: 0.2113Regression, Linear
p-value: 0.1739Regression, Linear
Secondary
Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8
Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. -Pain severity and pain interference will be compared between groups -Both of these measures will be modeled as a linear regression with arm as predictor. Baseline pain scores will also be included as a covariate to account for baseline variability. Scores range from 0-10. Higher scores indicate higher pain interference with daily activities.
Time frame: Month 3 and Month 8
Population: Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8 | Month 3 | 2.108 units on a scale | Standard Deviation 1.141 |
| Genotype Results Plus Usual Care | Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8 | Month 8 | 1.964 units on a scale | Standard Deviation 0.894 |
| Usual Care Only | Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8 | Month 3 | 1.971 units on a scale | Standard Deviation 1.049 |
| Usual Care Only | Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8 | Month 8 | 1.689 units on a scale | Standard Deviation 0.941 |
p-value: 0.5477Regression, Linear
p-value: 0.0429Regression, Linear
Secondary
Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8
Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. Pain severity and pain interference will be compared between groups. Both of these measures will be modeled as a linear regression with arm, genotype, and site as predictors. Transformations of the response may be explored depending on the distribution of the regression residuals. Baseline pain scores will also be included as a covariate to account for baseline variability. Scores range from 0-10. Higher scores indicate higher pain severity.
Time frame: Month 3 and Month 8
Population: Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8 | Month 3 | 1.608 units on a scale | Standard Deviation 1.978 |
| Genotype Results Plus Usual Care | Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8 | Month 8 | 1.939 units on a scale | Standard Deviation 1.93 |
| Usual Care Only | Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8 | Month 3 | 1.493 units on a scale | Standard Deviation 1.854 |
| Usual Care Only | Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8 | Month 8 | 1.689 units on a scale | Standard Deviation 2.248 |
p-value: 0.5965Regression, Linear
p-value: 0.4579Regression, Linear
Secondary
Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)
Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability. Ranges from 0 to 100, where a zero score indicates the lowest level of mental health measured by the scales and 100 indicates the highest level of mental health.
Time frame: Baseline, Month 3, Month 8
Population: Only subjects that completed the SF-12 Health Survey were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Baseline | 43.393 units on a scale 0 to 100 | Standard Deviation 11.801 |
| Genotype Results Plus Usual Care | Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Month 3 | 42.835 units on a scale 0 to 100 | Standard Deviation 11.438 |
| Genotype Results Plus Usual Care | Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Month 8 | 43.776 units on a scale 0 to 100 | Standard Deviation 11.344 |
| Usual Care Only | Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Baseline | 44.101 units on a scale 0 to 100 | Standard Deviation 12.114 |
| Usual Care Only | Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Month 3 | 44.595 units on a scale 0 to 100 | Standard Deviation 11.361 |
| Usual Care Only | Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC) | Month 8 | 44.327 units on a scale 0 to 100 | Standard Deviation 11.987 |
p-value: 0.6841Regression, Linear
p-value: 0.6658Regression, Linear
Secondary
Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)
Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability. Ranges from 0 to 100, where a zero score indicates the lowest level of physical health measured by the scales and 100 indicates the highest level of physical health
Time frame: Baseline, Month 3, Month 8
Population: Only subjects that completed the SF-12 Health Survey were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Baseline | 42.244 units on a scale | Standard Deviation 6.554 |
| Genotype Results Plus Usual Care | Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Month 3 | 41.389 units on a scale | Standard Deviation 6.891 |
| Genotype Results Plus Usual Care | Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Month 8 | 42.179 units on a scale | Standard Deviation 6.754 |
| Usual Care Only | Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Baseline | 41.692 units on a scale | Standard Deviation 7.281 |
| Usual Care Only | Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Month 3 | 41.566 units on a scale | Standard Deviation 5.708 |
| Usual Care Only | Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC) | Month 8 | 41.359 units on a scale | Standard Deviation 5.721 |
p-value: 0.8106Regression, Linear
p-value: 0.5233Regression, Linear
Secondary
Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8
The continuous outcomes LDLc will be modeled as a linear regression with arm and baseline LDL as predictors.
Time frame: Baseline, Month 3, Month 8
Population: All subjects with available data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Baseline LDLc | 152.7 mg/dL | Standard Deviation 41.1 |
| Genotype Results Plus Usual Care | Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Month 3 LDLc | 131.9 mg/dL | Standard Deviation 42 |
| Genotype Results Plus Usual Care | Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Month 8 LDLc | 128.6 mg/dL | Standard Deviation 37.9 |
| Usual Care Only | Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Month 8 LDLc | 141 mg/dL | Standard Deviation 44.4 |
| Usual Care Only | Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Baseline LDLc | 157.6 mg/dL | Standard Deviation 41.9 |
| Usual Care Only | Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8 | Month 3 LDLc | 144.4 mg/dL | Standard Deviation 43 |
p-value: 0.0482Regression, Linear
p-value: 0.12Regression, Linear
Secondary
Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up
Medication possession ratio will be calculated based on number of statin medication refills over time from randomization to end of follow up. MPR is calculated as follows: 1.Sum of the days' supply of all statin medications is the sum of the number of pills dispensed for each statin prescription during follow up (taken from 3-month, 4-month and 8-month statin utilization review) 2.Sum of the days of follow up = date of 8-month follow up survey - date of randomization 3.MPR = #1/#2 MPR will be modeled as a linear regression with arm, genotype, and site as predictors.
Time frame: Baseline to Last patient follow-up in study (3 months or 8 months)
Population: Only subjects who re-initiated statin medication and reported statin medication refills were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genotype Results Plus Usual Care | Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up | 0.632 ratio | Standard Deviation 0.333 |
| Usual Care Only | Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up | 0.685 ratio | Standard Deviation 0.483 |
p-value: 0.6692Regression, Linear
Secondary
Number of Participants Reporting New Statin Prescriptions
The number of new prescriptions is binary and will be modeled with logistic regression with arm, genotype, and site as predictors. Any variables imbalanced between arms will also be included as covariates.
Time frame: Baseline, Month 3, Month 8
Population: Only subjects reporting new prescriptions were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genotype Results Plus Usual Care | Number of Participants Reporting New Statin Prescriptions | Baseline to Month 3 | 41 Participants |
| Genotype Results Plus Usual Care | Number of Participants Reporting New Statin Prescriptions | Month 3 to Month 8 | 4 Participants |
| Usual Care Only | Number of Participants Reporting New Statin Prescriptions | Baseline to Month 3 | 27 Participants |
| Usual Care Only | Number of Participants Reporting New Statin Prescriptions | Month 3 to Month 8 | 4 Participants |
p-value: 0.037195% CI: [1.043, 3.929]Regression, Logistic
p-value: 0.881595% CI: [0.265, 4.687]Regression, Logistic
Secondary
Physical Activity Scale Score
Activity levels will be compared at the end of 8-months. Activity levels are defined by a five-level ordinal variable (0-4; higher level corresponding to higher activity). which was calculated based on survey answers. An ordinal logistic regression model will be used with arm as predictor. The assumption of proportional odds will be checked, and if it is not met, a multinomial regression model will be used. -Baseline physical activity will also be included as a covariate to account for baseline variability. Scale score (0-4): 0 - Inactivity, 1 - Ligh-intensity activity, 2 - moderate-intensity activity, 3 - Hard-intensity activity, 5 - very hard-intensity activity
Time frame: Baseline and Month 8
Population: Only subjects that completed the Physical Activity survey were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genotype Results Plus Usual Care | Physical Activity Scale Score | Baseline | 1.838 units on a scale | Standard Deviation 1.629 |
| Genotype Results Plus Usual Care | Physical Activity Scale Score | Month 8 | 1.923 units on a scale | Standard Deviation 1.152 |
| Usual Care Only | Physical Activity Scale Score | Baseline | 1.736 units on a scale | Standard Deviation 0.822 |
| Usual Care Only | Physical Activity Scale Score | Month 8 | 1.667 units on a scale | Standard Deviation 1.02 |
p-value: 0.838495% CI: [0.495, 2.38]Regression, Logistic