Trial Outcomes & Findings for Integrating Pharmacogenetics In Clinical Care (NCT NCT02871934)
NCT ID: NCT02871934
Last Updated: 2022-02-21
Results Overview
The primary CVD prevention outcome is 12-month change in low-density lipoprotein (LDL) cholesterol, defined as LDL value at 12 months minus LDL value at baseline.
COMPLETED
NA
408 participants
12 months
2022-02-21
Participant Flow
Participant milestones
| Measure |
PGx+
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Overall Study
STARTED
|
193
|
215
|
|
Overall Study
COMPLETED
|
193
|
215
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrating Pharmacogenetics In Clinical Care
Baseline characteristics by cohort
| Measure |
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=215 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
63.9 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
64.1 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
383 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
187 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
395 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=99 Participants
|
185 Participants
n=107 Participants
|
341 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
193 Participants
n=99 Participants
|
215 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
|
Smokers
|
59 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Meeting ACC/AHA Criteria for Statin Therapy
ASCVD
|
52 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Meeting ACC/AHA Criteria for Statin Therapy
LDL-C > 190 mg/dL
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Meeting ACC/AHA Criteria for Statin Therapy
Diabetes
|
47 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Meeting ACC/AHA Criteria for Statin Therapy
10-year ASCVD risk >= 7.5%
|
171 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
367 Participants
n=206 Participants
|
|
SLCO1B1 Genotype
Normal function (T/T)
|
148 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
288 Participants
n=206 Participants
|
|
SLCO1B1 Genotype
Decrease function (T/C)
|
40 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
SLCO1B1 Genotype
Poor function (C/C)
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary CVD prevention outcome is 12-month change in low-density lipoprotein (LDL) cholesterol, defined as LDL value at 12 months minus LDL value at baseline.
Outcome measures
| Measure |
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=215 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
12-Month Change in LDL Cholesterol
|
-1.1 mg/dL
Standard Error 1.2
|
-2.2 mg/dL
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 12 monthsIn 2013, the ACC/AHA endorsed guidelines that recommended prescribing statins of specific intensities (moderate or high) for distinct populations. Using patient characteristics and prescription data, the investigators will generate a 2-level CVD prevention outcome (concordant vs. non-concordant) for each participant, a measure of whether a patient's statin prescription is adequate for his/her level of CVD risk.
Outcome measures
| Measure |
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=215 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Number of Participants With an American College of Cardiology/American Heart Association (ACC/AHA) Guideline Concordant Statin Prescription at 12 Months
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 monthsChart review of all patient notes during the 12 months after enrollment will be used to determine the proportion of patients in each arm who experienced statin-related muscle side effects during the observation period.
Outcome measures
| Measure |
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=215 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Number of Participants With Chart Review Documented Statin-related Myotoxicity at 12 Months
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsClinical Pharmacogenetics Implementation Consortium (CPIC) guidelines recommend specific simvastatin doses when a patient's SLCO1B1 genotype is known. The investigators will compare each patient's medication prescriptions one year after enrollment to this guideline to generate a 2-level safety outcome (potentially safe vs. potentially unsafe simvastatin prescription) for each participant.
Outcome measures
| Measure |
PGx+
n=193 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=215 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Number of Participants Meeting Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Safe Simvastatin Prescription at 12 Months
|
193 Participants
|
215 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data analyzed only for patients who completed the 12-month end-of-study survey.
Assessed by phone survey 12 months after enrollment. Consists of 2 items: "Do you agree or disagree with these statements?: "My health in the future will depend on my medicines" and "Medicines do more harm than good."
Outcome measures
| Measure |
PGx+
n=169 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=203 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Strongly agree
|
28 Participants
|
30 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Agree
|
65 Participants
|
84 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Uncertain
|
29 Participants
|
37 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Disagree
|
29 Participants
|
40 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"My health in the future will depend on my medicines." · Strongly disagree
|
17 Participants
|
12 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Strongly agree
|
9 Participants
|
10 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Agree
|
26 Participants
|
20 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Uncertain
|
46 Participants
|
56 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Disagree
|
63 Participants
|
89 Participants
|
|
Participant Response Distributions to Belief in Medications Questionnaire at 12 Months
"Medicines do more harm than good." · Strongly disagree
|
24 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Result recall only assessed in intervention arm participants. Control participants received results 12 months after enrollment.
Assessed by phone survey 12 months after enrollment. Whether patient remembers receiving PGx results from provider and, if so, remembers the results and interpretation.
Outcome measures
| Measure |
PGx+
n=169 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Number of Participants Recalling Pharmacogenetic Testing at 12 Months
|
11 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data analyzed only for patients who completed the 12-month end-of-study survey.
Assessed by phone survey 12 months after enrollment. Whether patient attributes muscle pains, weakness, or cramps to a statin taken in the prior 12 months.
Outcome measures
| Measure |
PGx+
n=169 Participants
Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately.
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
PGx-
n=203 Participants
Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months).
SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
|
|---|---|---|
|
Number of Participants Reporting Statin-related Muscle Side Effects at 12 Months
|
3 Participants
|
3 Participants
|
Adverse Events
PGx+
PGx-
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jason Vassy
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place