Hyperlipidemia
Conditions
Keywords
High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Brief summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.
Interventions
BIOLOGICALEvolocumab
Administered by subcutaneous injection
DRUGEzetimibe
Administered orally once a day
BIOLOGICALPlacebo to Evolocumab
Administered by subcutaneous injection
OTHERPlacebo to Ezetimibe
Administered orally once daily
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 to ≤ 80 years of age * National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less * Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \<190 mg/dL * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion criteria
* History of coronary heart disease * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes) * Uncontrolled hypothyroidism or hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in VLDL-C at Week 12 | Baseline and Week 12 |
| Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 |
| Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | Weeks 10 and 12 |
| Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | Week 12 |
| Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Lipoprotein (a) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Triglycerides at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in HDL-C at Week 12 | Baseline and Week 12 |
Countries
Australia, Belgium, Canada, Denmark, France, South Africa, South Korea, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
Men and women ≥ 18 to ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL and fasting triglycerides ≤ 400 mg/dL with a 10-year Framingham Risk Score of 10% or less were eligible for this study. The first participant was enrolled on 21 January 2013 and the last participant was enrolled 29 July 2013.
Pre-assignment details
Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6 week screening period. Participants who completed the screening period and met final eligibility criteria were randomized 1:1:1:1:2:2 into 6 treatment groups. Randomization was stratified by LDL-C concentration (\< 130 mg/dL or ≥ 30 mg/dL).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2W Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | 77 |
| Placebo QM Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | 78 |
| Ezetimibe (Q2W) Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | 77 |
| Ezetimibe (QM) Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | 77 |
| Evolocumab Q2W Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | 153 |
| Evolocumab QM Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. | 153 |
| Total | 615 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Decision by sponsor | 2 | 0 | 3 | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Ezetimibe (Q2W) | Ezetimibe (QM) | Evolocumab Q2W | Evolocumab QM | Total | Placebo Q2W | Placebo QM |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 11.3 | 53.0 years STANDARD_DEVIATION 12.7 | 52.5 years STANDARD_DEVIATION 13.7 | 52.9 years STANDARD_DEVIATION 12.1 | 53.1 years STANDARD_DEVIATION 12.1 | 54.4 years STANDARD_DEVIATION 10.3 | 52.6 years STANDARD_DEVIATION 10.7 |
| Apolipoprotein B/Apolipoprotein A-1 Ratio | 0.691 ratio STANDARD_DEVIATION 0.187 | 0.712 ratio STANDARD_DEVIATION 0.173 | 0.687 ratio STANDARD_DEVIATION 0.169 | 0.707 ratio STANDARD_DEVIATION 0.17 | 0.697 ratio STANDARD_DEVIATION 0.178 | 0.671 ratio STANDARD_DEVIATION 0.193 | 0.713 ratio STANDARD_DEVIATION 0.194 |
| Apolipoprotein B Concentration | 107.2 mg/dL STANDARD_DEVIATION 19.7 | 106.2 mg/dL STANDARD_DEVIATION 17.8 | 104.5 mg/dL STANDARD_DEVIATION 17.2 | 108.3 mg/dL STANDARD_DEVIATION 17.9 | 106.2 mg/dL STANDARD_DEVIATION 18.1 | 103.7 mg/dL STANDARD_DEVIATION 16.8 | 107.3 mg/dL STANDARD_DEVIATION 19.9 |
| High-density Lipoprotein Cholesterol (HDL-C) Concentration | 58.5 mg/dL INTER_QUARTILE_RANGE 16.8 | 53.5 mg/dL INTER_QUARTILE_RANGE 18.5 | 53.0 mg/dL INTER_QUARTILE_RANGE 18 | 56.5 mg/dL INTER_QUARTILE_RANGE 18 | 55.3 mg/dL INTER_QUARTILE_RANGE 18.7 | 57.0 mg/dL INTER_QUARTILE_RANGE 23.6 | 54.0 mg/dL INTER_QUARTILE_RANGE 17.8 |
| LDL-C Concentration | 143.3 mg/dL STANDARD_DEVIATION 23.8 | 143.5 mg/dL STANDARD_DEVIATION 23.1 | 141.7 mg/dL STANDARD_DEVIATION 22.3 | 144.4 mg/dL STANDARD_DEVIATION 23.3 | 142.9 mg/dL STANDARD_DEVIATION 22.9 | 139.5 mg/dL STANDARD_DEVIATION 21.3 | 144.3 mg/dL STANDARD_DEVIATION 23.9 |
| Lipoprotein(a) | 28.0 nmol/L INTER_QUARTILE_RANGE 79.1 | 28.0 nmol/L INTER_QUARTILE_RANGE 65.7 | 20.0 nmol/L INTER_QUARTILE_RANGE 61.5 | 28.0 nmol/L INTER_QUARTILE_RANGE 86.9 | 25.0 nmol/L INTER_QUARTILE_RANGE 74.5 | 21.0 nmol/L INTER_QUARTILE_RANGE 62.9 | 21.5 nmol/L INTER_QUARTILE_RANGE 84 |
| Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration | 168.8 mg/dL STANDARD_DEVIATION 28.9 | 169.4 mg/dL STANDARD_DEVIATION 27.3 | 166.5 mg/dL STANDARD_DEVIATION 25.6 | 170.4 mg/dL STANDARD_DEVIATION 26.6 | 169.0 mg/dL STANDARD_DEVIATION 27.2 | 167.4 mg/dL STANDARD_DEVIATION 25.8 | 172.8 mg/dL STANDARD_DEVIATION 31 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 1 participants | 0 participants | 2 participants | 3 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 7 participants | 10 participants | 12 participants | 12 participants | 58 participants | 9 participants | 8 participants |
| Race/Ethnicity, Customized Black or African American | 6 participants | 6 participants | 9 participants | 9 participants | 40 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 participants | 11 participants | 14 participants | 21 participants | 69 participants | 6 participants | 8 participants |
| Race/Ethnicity, Customized Mixed Race | 1 participants | 0 participants | 0 participants | 1 participants | 2 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 68 participants | 66 participants | 139 participants | 132 participants | 546 participants | 71 participants | 70 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 63 participants | 60 participants | 132 participants | 129 participants | 511 participants | 64 participants | 63 participants |
| Sex: Female, Male Female | 53 Participants | 52 Participants | 104 Participants | 101 Participants | 406 Participants | 49 Participants | 47 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 49 Participants | 52 Participants | 209 Participants | 28 Participants | 31 Participants |
| Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) < 130 mg/dL | 22 participants | 22 participants | 45 participants | 45 participants | 181 participants | 23 participants | 24 participants |
| Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) ≥ 130 mg/dL | 55 participants | 55 participants | 108 participants | 108 participants | 434 participants | 54 participants | 54 participants |
| Total Cholesterol/High-density Lipoprotein Cholesterol Ratio | 4.055 ratio STANDARD_DEVIATION 1.082 | 4.335 ratio STANDARD_DEVIATION 1.118 | 4.170 ratio STANDARD_DEVIATION 1.17 | 4.175 ratio STANDARD_DEVIATION 1.071 | 4.210 ratio STANDARD_DEVIATION 1.191 | 4.148 ratio STANDARD_DEVIATION 1.311 | 4.444 ratio STANDARD_DEVIATION 1.465 |
| Triglycerides | 112.5 mg/dL INTER_QUARTILE_RANGE 64.9 | 116.5 mg/dL INTER_QUARTILE_RANGE 52.4 | 112.0 mg/dL INTER_QUARTILE_RANGE 62.6 | 119.0 mg/dL INTER_QUARTILE_RANGE 59.1 | 115.3 mg/dL INTER_QUARTILE_RANGE 65.5 | 113.5 mg/dL INTER_QUARTILE_RANGE 74.7 | 118.0 mg/dL INTER_QUARTILE_RANGE 83.4 |
| Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration | 22.5 mg/dL INTER_QUARTILE_RANGE 12.4 | 23.5 mg/dL INTER_QUARTILE_RANGE 10.5 | 22.5 mg/dL INTER_QUARTILE_RANGE 11.5 | 23.5 mg/dL INTER_QUARTILE_RANGE 11.8 | 23.0 mg/dL INTER_QUARTILE_RANGE 12.4 | 22.5 mg/dL INTER_QUARTILE_RANGE 13.2 | 23.8 mg/dL INTER_QUARTILE_RANGE 15.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 76 | 4 / 78 | 10 / 77 | 4 / 77 | 12 / 153 | 12 / 153 |
| serious Total, serious adverse events | 0 / 76 | 1 / 78 | 0 / 77 | 1 / 77 | 3 / 153 | 1 / 153 |
Outcome results
Primary
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -0.43 percent change | Standard Error 1.45 |
| Placebo QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -1.41 percent change | Standard Error 1.37 |
| Ezetimibe (Q2W) | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -17.52 percent change | Standard Error 1.46 |
| Ezetimibe (QM) | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -19.12 percent change | Standard Error 1.39 |
| Evolocumab Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -56.93 percent change | Standard Error 1.07 |
| Evolocumab QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -58.81 percent change | Standard Error 1 |
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-59.95, -53.04]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-60.66, -54.14]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-42.87, -35.94]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-42.97, -36.42]Repeated measures linear effects model
Primary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | 0.10 percent change | Standard Error 1.67 |
| Placebo QM | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -1.34 percent change | Standard Error 1.54 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -17.75 percent change | Standard Error 1.67 |
| Ezetimibe (QM) | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -18.57 percent change | Standard Error 1.56 |
| Evolocumab Q2W | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -57.04 percent change | Standard Error 1.23 |
| Evolocumab QM | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | -56.12 percent change | Standard Error 1.12 |
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-61.14, -53.14]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-58.46, -51.1]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-43.28, -35.31]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-41.24, -33.86]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 1.2 mg/dL | Standard Error 2.3 |
| Placebo QM | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 0.0 mg/dL | Standard Error 2.1 |
| Ezetimibe (Q2W) | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -23.1 mg/dL | Standard Error 2.3 |
| Ezetimibe (QM) | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -25.9 mg/dL | Standard Error 2.1 |
| Evolocumab Q2W | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -78.4 mg/dL | Standard Error 1.7 |
| Evolocumab QM | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -81.9 mg/dL | Standard Error 1.5 |
p-value: <0.00195% CI: [-85, -74.2]Repeated measures linear effects model
p-value: <0.00195% CI: [-87, -76.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-60.7, -49.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.1, -51]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in LDL-C at Week 12 | 1.9 mg/dL | Standard Error 2.5 |
| Placebo QM | Change From Baseline in LDL-C at Week 12 | -0.1 mg/dL | Standard Error 2.4 |
| Ezetimibe (Q2W) | Change From Baseline in LDL-C at Week 12 | -23.4 mg/dL | Standard Error 2.5 |
| Ezetimibe (QM) | Change From Baseline in LDL-C at Week 12 | -25.0 mg/dL | Standard Error 2.4 |
| Evolocumab Q2W | Change From Baseline in LDL-C at Week 12 | -78.4 mg/dL | Standard Error 1.9 |
| Evolocumab QM | Change From Baseline in LDL-C at Week 12 | -77.9 mg/dL | Standard Error 1.7 |
p-value: <0.00195% CI: [-86.4, -74.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-83.4, -72.2]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.1, -49]Repeated measures linear effects model
p-value: <0.00195% CI: [-58.5, -47.3]Repeated measures linear effects model
Secondary
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time frame: Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 0.0 percentage of participants |
| Placebo QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 0.0 percentage of participants |
| Ezetimibe (Q2W) | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 1.3 percentage of participants |
| Ezetimibe (QM) | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 2.8 percentage of participants |
| Evolocumab Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 73.6 percentage of participants |
| Evolocumab QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 71.3 percentage of participants |
p-value: <0.00195% CI: [64.4, 80.2]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [62.2, 78]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [62.4, 78.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [58.3, 75.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Time frame: Week 12
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 1.4 percentage of participants |
| Placebo QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 0.0 percentage of participants |
| Ezetimibe (Q2W) | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 1.4 percentage of participants |
| Ezetimibe (QM) | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 1.4 percentage of participants |
| Evolocumab Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 72.9 percentage of participants |
| Evolocumab QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 65.4 percentage of participants |
p-value: <0.00195% CI: [61.2, 78.4]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [55.6, 72.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [61.3, 78.4]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [53.5, 71.6]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 1.01 percent change | Standard Error 1.69 |
| Placebo QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 3.85 percent change | Standard Error 1.77 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -13.39 percent change | Standard Error 1.69 |
| Ezetimibe (QM) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -14.49 percent change | Standard Error 1.79 |
| Evolocumab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -48.12 percent change | Standard Error 1.25 |
| Evolocumab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -51.10 percent change | Standard Error 1.29 |
p-value: <0.00195% CI: [-53.12, -45.12]Repeated measures linear effects model
p-value: <0.00195% CI: [-59.12, -50.78]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.73, -30.73]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.81, -32.42]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 1.12 percent change | Standard Error 1.77 |
| Placebo QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 4.51 percent change | Standard Error 1.9 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -12.69 percent change | Standard Error 1.77 |
| Ezetimibe (QM) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -14.29 percent change | Standard Error 1.92 |
| Evolocumab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -48.45 percent change | Standard Error 1.31 |
| Evolocumab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -48.26 percent change | Standard Error 1.39 |
p-value: <0.00195% CI: [-53.78, -45.36]Repeated measures linear effects model
p-value: <0.00195% CI: [-57.28, -48.26]Repeated measures linear effects model
p-value: <0.00195% CI: [-39.95, -31.57]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.48, -29.45]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 0.05 percent change | Standard Error 1.51 |
| Placebo QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 1.54 percent change | Standard Error 1.41 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -13.47 percent change | Standard Error 1.52 |
| Ezetimibe (QM) | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -14.75 percent change | Standard Error 1.43 |
| Evolocumab Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -47.04 percent change | Standard Error 1.12 |
| Evolocumab QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -49.39 percent change | Standard Error 1.03 |
p-value: <0.00195% CI: [-50.67, -43.51]Repeated measures linear effects model
p-value: <0.00195% CI: [-54.27, -47.59]Repeated measures linear effects model
p-value: <0.00195% CI: [-37.15, -29.99]Repeated measures linear effects model
p-value: <0.00195% CI: [-37.99, -31.28]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 0.59 percent change | Standard Error 1.58 |
| Placebo QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | 1.84 percent change | Standard Error 1.53 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Apolipoprotein B at Week 12 | -13.17 percent change | Standard Error 1.58 |
| Ezetimibe (QM) | Percent Change From Baseline in Apolipoprotein B at Week 12 | -14.02 percent change | Standard Error 1.54 |
| Evolocumab Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -47.21 percent change | Standard Error 1.17 |
| Evolocumab QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | -46.59 percent change | Standard Error 1.12 |
p-value: <0.00195% CI: [-51.56, -44.05]Repeated measures linear effects model
p-value: <0.00195% CI: [-52.07, -44.79]Repeated measures linear effects model
p-value: <0.00195% CI: [-37.78, -30.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.21, -28.92]Repeated measures linear effects model
Secondary
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in HDL-C at Week 12 | -1.15 percent change | Inter-Quartile Range 1.43 |
| Placebo QM | Percent Change From Baseline in HDL-C at Week 12 | -5.27 percent change | Inter-Quartile Range 1.4 |
| Ezetimibe (Q2W) | Percent Change From Baseline in HDL-C at Week 12 | -2.79 percent change | Inter-Quartile Range 1.42 |
| Ezetimibe (QM) | Percent Change From Baseline in HDL-C at Week 12 | -1.47 percent change | Inter-Quartile Range 1.41 |
| Evolocumab Q2W | Percent Change From Baseline in HDL-C at Week 12 | 4.76 percent change | Inter-Quartile Range 1.05 |
| Evolocumab QM | Percent Change From Baseline in HDL-C at Week 12 | 4.06 percent change | Inter-Quartile Range 1.01 |
p-value: 0.00795% CI: [1.67, 10.16]Quade test
p-value: <0.00195% CI: [5.32, 13.34]Quade test
p-value: 0.01395% CI: [3.11, 12]Quade test
p-value: 0.04495% CI: [2.22, 8.84]Quade test
Secondary
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | -1.64 percent change | Inter-Quartile Range 1.26 |
| Placebo QM | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | -4.67 percent change | Inter-Quartile Range 1.32 |
| Ezetimibe (Q2W) | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | -0.92 percent change | Inter-Quartile Range 1.27 |
| Ezetimibe (QM) | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | 0.00 percent change | Inter-Quartile Range 1.33 |
| Evolocumab Q2W | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | 3.89 percent change | Inter-Quartile Range 0.93 |
| Evolocumab QM | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | 3.81 percent change | Inter-Quartile Range 0.95 |
p-value: 0.00795% CI: [2.23, 8.84]Quade test
p-value: <0.00195% CI: [5.53, 11.43]Quade test
p-value: 0.01395% CI: [0.85, 8.78]Quade test
p-value: 0.04495% CI: [-0.77, 8.39]Quade test
Secondary
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | 0.12 percent change | Inter-Quartile Range 2.72 |
| Placebo QM | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | 0.00 percent change | Inter-Quartile Range 2.96 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | 0.00 percent change | Inter-Quartile Range 2.72 |
| Ezetimibe (QM) | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | -2.08 percent change | Inter-Quartile Range 3.01 |
| Evolocumab Q2W | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | -18.37 percent change | Inter-Quartile Range 2.02 |
| Evolocumab QM | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | -19.24 percent change | Inter-Quartile Range 2.17 |
p-value: <0.00195% CI: [-25.28, -11.68]Quade test
p-value: <0.00195% CI: [-23.2, -15.28]Quade test
p-value: <0.00195% CI: [-24.39, -12.35]Quade test
p-value: <0.00195% CI: [-23.23, -11.08]Quade test
Secondary
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Lipoprotein (a) at Week 12 | 0.00 percent change | Inter-Quartile Range 2.75 |
| Placebo QM | Percent Change From Baseline in Lipoprotein (a) at Week 12 | 0.00 percent change | Inter-Quartile Range 3.26 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Lipoprotein (a) at Week 12 | 0.00 percent change | Inter-Quartile Range 2.75 |
| Ezetimibe (QM) | Percent Change From Baseline in Lipoprotein (a) at Week 12 | -2.05 percent change | Inter-Quartile Range 3.28 |
| Evolocumab Q2W | Percent Change From Baseline in Lipoprotein (a) at Week 12 | -20.41 percent change | Inter-Quartile Range 2.04 |
| Evolocumab QM | Percent Change From Baseline in Lipoprotein (a) at Week 12 | -17.82 percent change | Inter-Quartile Range 2.39 |
p-value: <0.00195% CI: [-27.76, -13.06]Quade test
p-value: <0.00195% CI: [-24.51, -11.12]Quade test
p-value: <0.00195% CI: [-28.13, -12.69]Quade test
p-value: <0.00195% CI: [-24.39, -7.14]Quade test
Secondary
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -0.31 percent change | Standard Error 1.48 |
| Placebo QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 1.51 percent change | Standard Error 1.38 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Non-HDL-C at Week 12 | -14.89 percent change | Standard Error 1.47 |
| Ezetimibe (QM) | Percent Change From Baseline in Non-HDL-C at Week 12 | -16.48 percent change | Standard Error 1.39 |
| Evolocumab Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -50.12 percent change | Standard Error 1.08 |
| Evolocumab QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -49.68 percent change | Standard Error 1.01 |
p-value: <0.00195% CI: [-53.34, -46.27]Repeated measures linear effects model
p-value: <0.00195% CI: [-54.49, -47.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.74, -31.71]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.51, -29.9]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -1.41 percent change | Standard Error 1.34 |
| Placebo QM | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 1.32 percent change | Standard Error 1.24 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -14.64 percent change | Standard Error 1.35 |
| Ezetimibe (QM) | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -16.48 percent change | Standard Error 1.25 |
| Evolocumab Q2W | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -50.22 percent change | Standard Error 0.99 |
| Evolocumab QM | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -51.96 percent change | Standard Error 0.9 |
p-value: <0.00195% CI: [-52.01, -45.61]Repeated measures linear effects model
p-value: <0.00195% CI: [-56.23, -50.33]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.79, -32.38]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.44, -32.53]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | 0.44 percent change | Standard Error 1.29 |
| Placebo QM | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | 6.42 percent change | Standard Error 1.5 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | -9.14 percent change | Standard Error 1.29 |
| Ezetimibe (QM) | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | -11.90 percent change | Standard Error 1.51 |
| Evolocumab Q2W | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | -38.49 percent change | Standard Error 0.95 |
| Evolocumab QM | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 | -39.41 percent change | Standard Error 1.08 |
p-value: <0.00195% CI: [-42, -35.86]Repeated measures linear effects model
p-value: <0.00195% CI: [-49.39, -42.27]Repeated measures linear effects model
p-value: <0.00195% CI: [-32.43, -26.28]Repeated measures linear effects model
p-value: <0.00195% CI: [-31.08, -23.94]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | 1.18 percent change | Standard Error 1.39 |
| Placebo QM | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | 7.02 percent change | Standard Error 1.67 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | -10.03 percent change | Standard Error 1.39 |
| Ezetimibe (QM) | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | -12.34 percent change | Standard Error 1.68 |
| Evolocumab Q2W | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | -38.45 percent change | Standard Error 1.02 |
| Evolocumab QM | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 | -37.65 percent change | Standard Error 1.21 |
p-value: <0.00195% CI: [-42.97, -36.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-48.66, -40.68]Repeated measures linear effects model
p-value: <0.00195% CI: [-31.73, -25.1]Repeated measures linear effects model
p-value: <0.00195% CI: [-29.31, -21.31]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -3.89 percent change | Inter-Quartile Range 3.64 |
| Placebo QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 4.89 percent change | Inter-Quartile Range 4.02 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -1.46 percent change | Inter-Quartile Range 3.6 |
| Ezetimibe (QM) | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -3.97 percent change | Inter-Quartile Range 4.04 |
| Evolocumab Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -9.16 percent change | Inter-Quartile Range 2.65 |
| Evolocumab QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -15.71 percent change | Inter-Quartile Range 2.92 |
p-value: 0.7295% CI: [-13.27, 2.73]Quade test
p-value: <0.00195% CI: [-30.98, -10.2]Quade test
p-value: 0.02795% CI: [-16.86, 1.45]Quade test
p-value: 0.04495% CI: [-21.19, -2.27]Quade test
Secondary
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -1.91 percent change | Inter-Quartile Range 3.13 |
| Placebo QM | Percent Change From Baseline in Triglycerides at Week 12 | 2.01 percent change | Inter-Quartile Range 3.86 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Triglycerides at Week 12 | 0.00 percent change | Inter-Quartile Range 3.15 |
| Ezetimibe (QM) | Percent Change From Baseline in Triglycerides at Week 12 | -2.41 percent change | Inter-Quartile Range 3.89 |
| Evolocumab Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -8.14 percent change | Inter-Quartile Range 2.31 |
| Evolocumab QM | Percent Change From Baseline in Triglycerides at Week 12 | -15.64 percent change | Inter-Quartile Range 2.78 |
p-value: 0.7295% CI: [-16.41, 3.95]Quade test
p-value: <0.00195% CI: [-26.67, -8.63]Quade test
p-value: 0.02795% CI: [-17.54, 1.26]Quade test
p-value: 0.04495% CI: [-21.69, -4.77]Quade test
Secondary
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -3.81 percent change | Inter-Quartile Range 3.09 |
| Placebo QM | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 4.22 percent change | Inter-Quartile Range 3.7 |
| Ezetimibe (Q2W) | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -2.69 percent change | Inter-Quartile Range 3.12 |
| Ezetimibe (QM) | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -3.33 percent change | Inter-Quartile Range 3.69 |
| Evolocumab Q2W | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -8.40 percent change | Inter-Quartile Range 2.28 |
| Evolocumab QM | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -16.17 percent change | Inter-Quartile Range 2.65 |
p-value: 0.07295% CI: [-11.3, 2.12]Quade test
p-value: <0.00195% CI: [-30.11, -10.68]Quade test
p-value: 0.08295% CI: [-14.13, 2.71]Quade test
p-value: 0.04495% CI: [-22.14, -3.54]Quade test
Secondary
Percent Change From Baseline in VLDL-C at Week 12
Time frame: Baseline and Week 12
Population: Ful analysis set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in VLDL-C at Week 12 | -1.58 percent change | Inter-Quartile Range 3.67 |
| Placebo QM | Percent Change From Baseline in VLDL-C at Week 12 | 0.00 percent change | Inter-Quartile Range 3.93 |
| Ezetimibe (Q2W) | Percent Change From Baseline in VLDL-C at Week 12 | -0.94 percent change | Inter-Quartile Range 3.65 |
| Ezetimibe (QM) | Percent Change From Baseline in VLDL-C at Week 12 | -3.61 percent change | Inter-Quartile Range 3.87 |
| Evolocumab Q2W | Percent Change From Baseline in VLDL-C at Week 12 | -9.52 percent change | Inter-Quartile Range 2.64 |
| Evolocumab QM | Percent Change From Baseline in VLDL-C at Week 12 | -16.33 percent change | Inter-Quartile Range 2.8 |
p-value: 0.7295% CI: [-18.81, 2.92]Quade test
p-value: <0.00195% CI: [-25.64, -7.02]Quade test
p-value: 0.08295% CI: [-18.1, 0.94]Quade test
p-value: 0.04495% CI: [-20.89, -4.54]Quade test