Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01516879 DESCARTES | Hypercholesterolemia | Percent Change From Baseline in LDL-C at Week 52 Baseline and Week 52 | Evolocumab | -50.14 percent change (±1.24 Standard Error) |
| Placebo | 6.83 percent change (±1.75 Standard Error) | |||
| NCT01588496 TESLA | Hypercholesterolemia | Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 | Part A: Evolocumab | -16.5 percent change (±6.7 Standard Error) |
| NCT01588496 TESLA | Hypercholesterolemia | Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 | Part B: Evolocumab | -23.05 percent change (±3.78 Standard Error) |
| Part B: Placebo | 7.88 percent change (±5.26 Standard Error) | |||
| NCT01624142 TAUSSIG | Hypercholesterolemia | Number of Participants With Adverse Events From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. | HoFH | 94 Participants |
| HoFH | 76 Participants | |||
| HoFH | 38 Participants | |||
| HoFH | 6 Participants | |||
| HoFH | 2 Participants | |||
| HoFH | 29 Participants | |||
| HoFH | 3 Participants | |||
| HoFH | 4 Participants | |||
| Severe FH | 57 Participants | |||
| Severe FH | 5 Participants | |||
| Severe FH | 174 Participants | |||
| Severe FH | 143 Participants | |||
| Severe FH | 68 Participants | |||
| Severe FH | 14 Participants | |||
| Severe FH | 8 Participants | |||
| Severe FH | 18 Participants | |||
| NCT01763827 MENDEL-2 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | Evolocumab Q2W | -56.93 percent change (±1.07 Standard Error) |
| Evolocumab QM | -58.81 percent change (±1.00 Standard Error) | |||
| Ezetimibe (Q2W) | -17.52 percent change (±1.46 Standard Error) | |||
| Ezetimibe (QM) | -19.12 percent change (±1.39 Standard Error) | |||
| Placebo Q2W | -0.43 percent change (±1.45 Standard Error) | |||
| Placebo QM | -1.41 percent change (±1.37 Standard Error) | |||
| NCT01763827 MENDEL-2 | Hypercholesterolemia | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 | Evolocumab Q2W | -57.04 percent change (±1.23 Standard Error) |
| Evolocumab QM | -56.12 percent change (±1.12 Standard Error) | |||
| Ezetimibe (Q2W) | -17.75 percent change (±1.67 Standard Error) | |||
| Ezetimibe (QM) | -18.57 percent change (±1.56 Standard Error) | |||
| Placebo Q2W | 0.10 percent change (±1.67 Standard Error) | |||
| Placebo QM | -1.34 percent change (±1.54 Standard Error) | |||
| NCT01763866 LAPLACE-2 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | A10 EvoMab Q2W | -61.41 percent change (±1.61 Standard Error) |
| A10 EvoMab QM | -62.47 percent change (±1.83 Standard Error) | |||
| A10 EZE (Q2W) | -23.88 percent change (±2.34 Standard Error) | |||
| A10 EZE (QM) | -18.98 percent change (±2.57 Standard Error) | |||
| A10 PBO Q2W | 8.54 percent change (±2.24 Standard Error) | |||
| A10 PBO QM | 0.35 percent change (±2.60 Standard Error) | |||
| A80 EvoMab Q2W | -61.80 percent change (±2.77 Standard Error) | |||
| A80 EvoMab QM | -65.05 percent change (±2.42 Standard Error) | |||
| A80 EZE (Q2W) | -16.85 percent change (±3.88 Standard Error) | |||
| A80 EZE (QM) | -21.25 percent change (±3.42 Standard Error) | |||
| A80 PBO Q2W | 13.12 percent change (±3.99 Standard Error) | |||
| A80 PBO QM | 9.76 percent change (±3.39 Standard Error) | |||
| R40 EvoMab Q2W | -59.08 percent change (±2.23 Standard Error) | |||
| R40 EvoMab QM | -62.94 percent change (±2.44 Standard Error) | |||
| R40 PBO Q2W | 6.57 percent change (±3.11 Standard Error) | |||
| R40 PBO QM | -0.02 percent change (±3.51 Standard Error) | |||
| R5 EvoMab Q2W | -59.33 percent change (±1.74 Standard Error) | |||
| R5 EvoMab QM | -63.79 percent change (±1.76 Standard Error) | |||
| R5 PBO Q2W | 7.55 percent change (±2.39 Standard Error) | |||
| R5 PBO QM | 2.79 percent change (±2.50 Standard Error) | |||
| S40 EvoMab Q2W | -66.17 percent change (±2.93 Standard Error) | |||
| S40 EvoMab QM | -62.45 percent change (±3.85 Standard Error) | |||
| S40 PBO Q2W | 3.26 percent change (±3.40 Standard Error) | |||
| S40 PBO QM | 6.00 percent change (±4.80 Standard Error) | |||
| NCT01763866 LAPLACE-2 | Hypercholesterolemia | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 | A10 EvoMab Q2W | -61.56 percent change (±1.81 Standard Error) |
| A10 EvoMab QM | -58.19 percent change (±1.99 Standard Error) | |||
| A10 EZE (Q2W) | -21.96 percent change (±2.63 Standard Error) | |||
| A10 EZE (QM) | -17.08 percent change (±2.78 Standard Error) | |||
| A10 PBO Q2W | 9.86 percent change (±2.53 Standard Error) | |||
| A10 PBO QM | 0.97 percent change (±2.82 Standard Error) | |||
| A80 EvoMab Q2W | -61.80 percent change (±3.04 Standard Error) | |||
| A80 EvoMab QM | -58.68 percent change (±2.74 Standard Error) | |||
| A80 EZE (Q2W) | -14.60 percent change (±4.29 Standard Error) | |||
| A80 EZE (QM) | -19.80 percent change (±3.85 Standard Error) | |||
| A80 PBO Q2W | 14.49 percent change (±4.42 Standard Error) | |||
| A80 PBO QM | 11.83 percent change (±3.85 Standard Error) | |||
| R40 EvoMab Q2W | -58.89 percent change (±2.58 Standard Error) | |||
| R40 EvoMab QM | -52.40 percent change (±2.98 Standard Error) | |||
| R40 PBO Q2W | 9.42 percent change (±3.60 Standard Error) | |||
| R40 PBO QM | 2.59 percent change (±4.30 Standard Error) | |||
| R5 EvoMab Q2W | -60.09 percent change (±1.94 Standard Error) | |||
| R5 EvoMab QM | -59.40 percent change (±1.87 Standard Error) | |||
| R5 PBO Q2W | 8.12 percent change (±2.68 Standard Error) | |||
| R5 PBO QM | 5.10 percent change (±2.62 Standard Error) | |||
| S40 EvoMab Q2W | -65.86 percent change (±3.05 Standard Error) | |||
| S40 EvoMab QM | -57.02 percent change (±3.93 Standard Error) | |||
| S40 PBO Q2W | 4.70 percent change (±3.61 Standard Error) | |||
| S40 PBO QM | 3.40 percent change (±4.94 Standard Error) | |||
| NCT01763905 GAUSS-2 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | Evolocumab Q2W | -56.11 percent change (±1.83 Standard Error) |
| Evolocumab QM | -55.31 percent change (±1.53 Standard Error) | |||
| Ezetimibe (Q2W) | -19.21 percent change (±2.40 Standard Error) | |||
| Ezetimibe (QM) | -16.62 percent change (±2.03 Standard Error) | |||
| NCT01763905 GAUSS-2 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at Week 12 Baseline and Week 12 | Evolocumab Q2W | -56.14 percent change (±1.91 Standard Error) |
| Evolocumab QM | -52.60 percent change (±1.58 Standard Error) | |||
| Ezetimibe (Q2W) | -18.08 percent change (±2.52 Standard Error) | |||
| Ezetimibe (QM) | -15.05 percent change (±2.13 Standard Error) | |||
| NCT01763918 RUTHERFORD-2 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | Evolocumab Q2W | -61.23 percent change (±1.71 Standard Error) |
| Evolocumab QM | -63.25 percent change (±1.70 Standard Error) | |||
| Placebo Q2W | -1.08 percent change (±2.41 Standard Error) | |||
| Placebo QM | 2.30 percent change (±2.41 Standard Error) | |||
| NCT01763918 RUTHERFORD-2 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at Week 12 Baseline and Week 12 | Evolocumab Q2W | -61.25 percent change (±1.77 Standard Error) |
| Evolocumab QM | -55.74 percent change (±2.25 Standard Error) | |||
| Placebo Q2W | -2.02 percent change (±2.49 Standard Error) | |||
| Placebo QM | 5.53 percent change (±3.25 Standard Error) | |||
| NCT01764633 FOURIER | Hypercholesterolemia | Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | Evolocumab | 2.74 percentage of participants |
| Evolocumab | 10.91 percentage of participants | |||
| Evolocumab | 5.31 percentage of participants | |||
| Evolocumab | 9.13 percentage of participants | |||
| Evolocumab | 7.25 percentage of participants | |||
| Evolocumab | 12.57 percentage of participants | |||
| Placebo | 3.11 percentage of participants | |||
| Placebo | 6.01 percentage of participants | |||
| Placebo | 8.32 percentage of participants | |||
| Placebo | 10.66 percentage of participants | |||
| Placebo | 12.72 percentage of participants | |||
| Placebo | 14.64 percentage of participants | |||
| NCT01813422 GLAGOV | Hypercholesterolemia | Change From Baseline in Percent Atheroma Volume at Week 78 Baseline and week 78 | Evolocumab | -0.955 percent atheroma volume (±0.190 Standard Error) |
| Placebo | 0.053 percent atheroma volume (±0.189 Standard Error) | |||
| NCT01849497 | Hypercholesterolemia | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 Week 2 and Week 4 | Evolocumab AI/Pen | 89.2 percentage of participants |
| Evolocumab PFS | 96.0 percentage of participants | |||
| NCT01854918 OSLER-2 | Hypercholesterolemia | Number of Participants With Adverse Events 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period | Year 1: Evolocumab + Standard of Care | 57 Participants |
| Year 1: Evolocumab + Standard of Care | 225 Participants | |||
| Year 1: Evolocumab + Standard of Care | 17 Participants | |||
| Year 1: Evolocumab + Standard of Care | 5 Participants | |||
| Year 1: Evolocumab + Standard of Care | 1655 Participants | |||
| Year 1: Evolocumab + Standard of Care | 1070 Participants | |||
| Year 1: Evolocumab + Standard of Care | 55 Participants | |||
| Year 1: Evolocumab + Standard of Care | 195 Participants | |||
| Year 1: Standard of Care | 796 Participants | |||
| Year 1: Standard of Care | 519 Participants | |||
| Year 1: Standard of Care | 124 Participants | |||
| Year 1: Standard of Care | 7 Participants | |||
| Year 1: Standard of Care | 104 Participants | |||
| Year 1: Standard of Care | 0 Participants | |||
| Year 1: Standard of Care | 5 Participants | |||
| Year 1: Standard of Care | 0 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 45 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 1339 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 332 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 42 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 1789 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 379 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 16 Participants | |||
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 35 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 25 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 11 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 178 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 3 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 929 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 700 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 26 Participants | |||
| Years 2-3: SOC / Evolocumab + SOC | 214 Participants | |||
| NCT01879319 | Hypercholesterolemia | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 Weeks 4 and 8 | Evolocumab AI/Pen | 91.5 Percentage of participants |
| Evolocumab AMD | 93.9 Percentage of participants | |||
| NCT01953328 AMG145 | Hypercholesterolemia | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | A20 Evolocumab Q2W | -74.82 percent change (±3.26 Standard Error) |
| A20 Evolocumab QM | -76.93 percent change (±2.24 Standard Error) | |||
| A20 Placebo Q2W | -0.42 percent change (±3.26 Standard Error) | |||
| A20 Placebo QM | -2.67 percent change (±2.31 Standard Error) | |||
| A5 Evolocumab Q2W | -73.70 percent change (±2.26 Standard Error) | |||
| A5 Evolocumab QM | -69.98 percent change (±2.02 Standard Error) | |||
| A5 Placebo Q2W | 0.27 percent change (±2.21 Standard Error) | |||
| A5 Placebo QM | 3.91 percent change (±2.09 Standard Error) | |||
| NCT01953328 AMG145 | Hypercholesterolemia | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 | A20 Evolocumab Q2W | -74.46 percent change (±3.50 Standard Error) |
| A20 Evolocumab QM | -70.36 percent change (±2.61 Standard Error) | |||
| A20 Placebo Q2W | 1.39 percent change (±3.51 Standard Error) | |||
| A20 Placebo QM | -3.49 percent change (±2.67 Standard Error) | |||
| A5 Evolocumab Q2W | -73.57 percent change (±2.48 Standard Error) | |||
| A5 Evolocumab QM | -64.62 percent change (±2.12 Standard Error) | |||
| A5 Placebo Q2W | 1.28 percent change (±2.43 Standard Error) | |||
| A5 Placebo QM | 5.29 percent change (±2.19 Standard Error) | |||
| NCT01984424 GAUSS-3 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 Baseline and weeks 22 and 24 | Evolocumab | -54.50 percent change (±1.39 Standard Error) |
| Ezetimibe | -16.70 percent change (±1.91 Standard Error) | |||
| NCT01984424 GAUSS-3 | Hypercholesterolemia | Percent Change From Baseline in LDL-C at Week 24 Baseline and week 24 | Evolocumab | -52.76 percent change (±1.52 Standard Error) |
| Ezetimibe | -16.69 percent change (±2.11 Standard Error) | |||
| NCT02189837 FLOREY | Hypercholesterolemia | Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR) Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration. | Atorvastatin | 74.13 percent change (±24.84 Standard Error) |
| Evolocumab | 83.70 percent change (±26.06 Standard Error) | |||
| Evolocumab and Atorvastatin | 310.48 percent change (±26.68 Standard Error) | |||
| Placebo | -5.07 percent change (±26.06 Standard Error) | |||
| NCT02207634 EBBINGHAUS | Hypercholesterolemia | Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | Evolocumab | 0.1134 Z score |
| Placebo | 0.1206 Z score | |||
| NCT02304484 | Hypercholesterolemia | Number of Participants With Adverse Events From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. | Evolocumab | 153 Participants |
| Evolocumab | 14 Participants | |||
| Evolocumab | 6 Participants | |||
| Evolocumab | 12 Participants | |||
| Evolocumab | 2 Participants | |||
| Evolocumab | 1 Participants | |||
| Evolocumab | 0 Participants | |||
| Evolocumab | 0 Participants | |||
| Evolocumab | 526 Participants | |||
| Evolocumab | 415 Participants | |||
| Evolocumab | 206 Participants | |||
| Evolocumab | 38 Participants | |||
| NCT02392559 HAUSER-RCT | Hypercholesterolemia | Percent Change From Baseline to Week 24 in LDL-C Baseline, Week 24 | EvoMab 420 mg QM | -44.53 percent change (±2.17 Standard Error) |
| Placebo | -6.23 percent change (±3.08 Standard Error) | |||
| NCT02585895 | Hypercholesterolemia | Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy Week 5 and week 6 | Apheresis | 10.0 percentage of participants |
| Evolocumab | 84.2 percentage of participants | |||
| NCT02624869 HAUSER-OLE | Hypercholesterolemia | Number of Participants With Treatment-emergent Adverse Events (TEAEs) From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 0 Participants |
| HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 0 Participants | |||
| HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 69 Participants | |||
| HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 56 Participants | |||
| HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 2 Participants | |||
| HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 1 Participants | |||
| HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 2 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 36 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 0 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 0 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 25 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 2 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 0 Participants | |||
| HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 4 Participants | |||
| HoFH: Evolocumab 420 mg QM | 2 Participants | |||
| HoFH: Evolocumab 420 mg QM | 7 Participants | |||
| HoFH: Evolocumab 420 mg QM | 5 Participants | |||
| HoFH: Evolocumab 420 mg QM | 2 Participants | |||
| HoFH: Evolocumab 420 mg QM | 0 Participants | |||
| HoFH: Evolocumab 420 mg QM | 0 Participants | |||
| HoFH: Evolocumab 420 mg QM | 0 Participants | |||
| NCT02634580 GAUSS-4 | Hypercholesterolemia | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | Evolocumab | -59.75 percent change (±2.30 Standard Error) |
| Ezetimibe | -20.39 percent change (±3.19 Standard Error) | |||
| NCT02634580 GAUSS-4 | Hypercholesterolemia | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and week 12 | Evolocumab | -59.27 percent change (±2.50 Standard Error) |
| Ezetimibe | -19.13 percent change (±3.45 Standard Error) | |||
| NCT02662569 BERSON | Hyperlipidemias | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and weeks 10 and 12 | Evolocumab Q2W | -65.35 percent change (±3.09 Standard Error) |
| Evolocumab QM | -69.05 percent change (±2.96 Standard Error) | |||
| Placebo Q2W | 4.94 percent change (±3.48 Standard Error) | |||
| Placebo QM | 0.99 percent change (±3.31 Standard Error) | |||
| NCT02662569 BERSON | Hyperlipidemias | Percent Change From Baseline in LDL-C at Week 12 Baseline and week 12 | Evolocumab Q2W | -64.66 percent change (±3.20 Standard Error) |
| Evolocumab QM | -62.30 percent change (±3.02 Standard Error) | |||
| Placebo Q2W | 7.10 percent change (±3.66 Standard Error) | |||
| Placebo QM | 2.63 percent change (±3.41 Standard Error) | |||
| NCT02729025 ANITSCHKOW | Hyperlipidemias | Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 Baseline and week 16 | Evolocumab 420 mg QM | -8.31 percent change (±1.67 Standard Error) |
| Placebo | -5.31 percent change (±1.67 Standard Error) | |||
| NCT02739984 BANTING | Hypercholesterolemia | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 | Evolocumab | -64.98 percent change (±1.31 Standard Error) |
| Placebo | -0.84 percent change (±1.76 Standard Error) | |||
| NCT02739984 BANTING | Hypercholesterolemia | Percent Change From Baseline in LDL-C at Week 12 Baseline and week 12 | Evolocumab | -54.28 percent change (±1.42 Standard Error) |
| Placebo | -1.14 percent change (±1.92 Standard Error) | |||
| NCT02833844 | Hyperlipidemias | Percent Change From Baseline in LDL-C at Week 24 Baseline, Week 24 | Double-Blind Evolocumab | -55.23 percent change (±1.52 Standard Error) |
| Double-Blind Placebo | 1.68 percent change (±2.03 Standard Error) | |||
| NCT02867813 FOURIER OLE | Hypercholesterolemia | Number of Participants Who Experienced an Adverse Event Up to 5 years | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2084 Participants |
| Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2144 Participants | |||
| NCT03080935 | Dyslipidemias | Number of Participants Who Experienced an Adverse Event Up to 5 years | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 810 Participants |
| Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 686 Participants | |||
| NCT03433755 | Hypercholesterolemia | Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12 Baseline, Week 12 | Evolocumab 140 mg Q2W | -68.39 percent change (±3.55 Standard Error) |
| Evolocumab 420 mg QM | -63.09 percent change (±3.42 Standard Error) | |||
| Placebo Q2W | 2.48 percent change (±4.18 Standard Error) | |||
| Placebo QM | 2.72 percent change (±4.25 Standard Error) | |||
| NCT03433755 | Hypercholesterolemia | Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 Baseline, Weeks 10 and 12 | Evolocumab 140 mg Q2W | -68.86 percent change (±3.27 Standard Error) |
| Evolocumab 420 mg QM | -70.10 percent change (±3.21 Standard Error) | |||
| Placebo Q2W | 1.88 percent change (±3.72 Standard Error) | |||
| Placebo QM | -0.36 percent change (±3.78 Standard Error) | |||
| NCT03570697 | Coronary Artery Disease | Absolute Change From Baseline in Minimum FCT Baseline, week 50 | Evolocumab | 42.7 µm (±5.1 Standard Error) |
| Placebo | 21.5 µm (±5.2 Standard Error) | |||
| NCT03689946 | Hyperlipidemias | Change in Noncalcified Coronary Artery Plaque Volume (NCPV) baseline (pre-treatment) and 18 months after of treatment | Evolocumab, F18-NaF PET, CCTA | -45 mm^3 (±64 Standard Deviation) |