Trial Outcomes & Findings for Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia (NCT NCT02739984)
NCT ID: NCT02739984
Last Updated: 2018-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
424 participants
Primary outcome timeframe
Baseline and Weeks 10 and 12
Results posted on
2018-08-31
Participant Flow
Of 853 patients screened, a total of 424 participants were randomized at 58 centers in Belgium, Canada, Italy, Mexico, Poland, Spain and the United States from 17 May 2016 to 05 May 2017.
Participants received subcutaneous placebo during a 6-week screening period. Participants who completed the screening period and met final eligibility criteria were randomized in a 1:2 ratio to placebo or evolocumab. Randomization was stratified by low-density lipoprotein cholesterol (LDL-C) level (\> or \< 130 mg/dL).
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
281
|
|
Overall Study
Received Study Drug
|
141
|
280
|
|
Overall Study
COMPLETED
|
138
|
279
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Overall Study
Sponsor Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Baseline characteristics by cohort
| Measure |
Placebo
n=143 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=281 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.5 • n=143 Participants
|
62.5 years
STANDARD_DEVIATION 8.5 • n=281 Participants
|
62.5 years
STANDARD_DEVIATION 8.5 • n=424 Participants
|
|
Age, Customized
< 65 years
|
86 Participants
n=143 Participants
|
159 Participants
n=281 Participants
|
245 Participants
n=424 Participants
|
|
Age, Customized
65 - < 85 years
|
57 Participants
n=143 Participants
|
122 Participants
n=281 Participants
|
179 Participants
n=424 Participants
|
|
Age, Customized
≥ 85 years
|
0 Participants
n=143 Participants
|
0 Participants
n=281 Participants
|
0 Participants
n=424 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=143 Participants
|
121 Participants
n=281 Participants
|
186 Participants
n=424 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=143 Participants
|
160 Participants
n=281 Participants
|
238 Participants
n=424 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=143 Participants
|
54 Participants
n=281 Participants
|
78 Participants
n=424 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=143 Participants
|
227 Participants
n=281 Participants
|
346 Participants
n=424 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=143 Participants
|
0 Participants
n=281 Participants
|
0 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
7 Participants
n=143 Participants
|
8 Participants
n=281 Participants
|
15 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=143 Participants
|
4 Participants
n=281 Participants
|
6 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
32 Participants
n=143 Participants
|
41 Participants
n=281 Participants
|
73 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=143 Participants
|
2 Participants
n=281 Participants
|
2 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
White
|
102 Participants
n=143 Participants
|
223 Participants
n=281 Participants
|
325 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=143 Participants
|
1 Participants
n=281 Participants
|
1 Participants
n=424 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=143 Participants
|
2 Participants
n=281 Participants
|
2 Participants
n=424 Participants
|
|
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level
< 130 mg/dL
|
108 Participants
n=143 Participants
|
213 Participants
n=281 Participants
|
321 Participants
n=424 Participants
|
|
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level
≥ 130 mg/dL
|
35 Participants
n=143 Participants
|
68 Participants
n=281 Participants
|
103 Participants
n=424 Participants
|
|
LDL-C Concentration
|
110.4 mg/dL
STANDARD_DEVIATION 33.0 • n=141 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
108.6 mg/dL
STANDARD_DEVIATION 31.0 • n=280 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
109.2 mg/dL
STANDARD_DEVIATION 31.6 • n=421 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
|
Non-High-density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
145.5 mg/dL
STANDARD_DEVIATION 33.9 • n=141 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
144.6 mg/dL
STANDARD_DEVIATION 34.9 • n=280 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
144.9 mg/dL
STANDARD_DEVIATION 34.5 • n=421 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
|
Apolipoprotein B Concentration
|
98.1 mg/dL
STANDARD_DEVIATION 22.1 • n=138 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
97.1 mg/dL
STANDARD_DEVIATION 23.3 • n=272 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
97.5 mg/dL
STANDARD_DEVIATION 22.9 • n=410 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
|
Total Cholesterol Concentration
|
190.7 mg/dL
STANDARD_DEVIATION 35.0 • n=141 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
188.2 mg/dL
STANDARD_DEVIATION 36.8 • n=280 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
189.1 mg/dL
STANDARD_DEVIATION 36.2 • n=421 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
|
Lipoprotein(a) Concentration
|
99.4 nmol/L
STANDARD_DEVIATION 122.8 • n=137 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
88.0 nmol/L
STANDARD_DEVIATION 111.5 • n=273 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
91.8 nmol/L
STANDARD_DEVIATION 115.4 • n=410 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
|
Triglycerides Concentration
|
177.3 mg/dL
STANDARD_DEVIATION 89.2 • n=141 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
184.2 mg/dL
STANDARD_DEVIATION 102.2 • n=280 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
181.9 mg/dL
STANDARD_DEVIATION 98.0 • n=421 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
|
High-density Lipoprotein Cholesterol (HDL-C) Concentraion
|
45.2 mg/dL
STANDARD_DEVIATION 12.2 • n=141 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
43.6 mg/dL
STANDARD_DEVIATION 12.9 • n=280 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
44.2 mg/dL
STANDARD_DEVIATION 12.7 • n=421 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
|
|
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration
|
33.6 mg/dL
STANDARD_DEVIATION 14.3 • n=138 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
34.8 mg/dL
STANDARD_DEVIATION 15.4 • n=276 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
34.4 mg/dL
STANDARD_DEVIATION 15.0 • n=414 Participants • Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab) and with available baseline data.
|
PRIMARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-0.84 percent change
Standard Error 1.76
|
-64.98 percent change
Standard Error 1.31
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 12
|
-1.14 percent change
Standard Error 1.92
|
-54.28 percent change
Standard Error 1.42
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-8.3 mg/dL
Standard Error 2.2
|
-75.5 mg/dL
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
-8.6 mg/dL
Standard Error 2.3
|
-64.4 mg/dL
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
|
-0.05 percent change
Standard Error 1.63
|
-56.62 percent change
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12
|
-0.60 percent change
Standard Error 1.79
|
-46.89 percent change
Standard Error 1.33
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
|
2.31 percent change
Standard Error 1.58
|
-50.17 percent change
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 12
|
1.78 percent change
Standard Error 1.73
|
-40.34 percent change
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
|
-1.13 percent change
Standard Error 1.24
|
-42.19 percent change
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 12
|
-1.23 percent change
Standard Error 1.36
|
-34.97 percent change
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)
|
14.8 percentage of participants
Interval 9.8 to 21.8
|
92.7 percentage of participants
Interval 89.0 to 95.2
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
|
15.4 percentage of participants
Interval 10.2 to 22.6
|
84.5 percentage of participants
Interval 79.5 to 88.5
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12
|
0.7 percentage of participants
Interval 0.1 to 4.1
|
84.2 percentage of participants
Interval 79.5 to 88.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
|
0.8 percentage of participants
Interval 0.1 to 4.2
|
65.5 percentage of participants
Interval 59.4 to 71.1
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
|
9.63 percent change
Standard Error 3.29
|
-30.87 percent change
Standard Error 2.43
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 12
|
7.38 percent change
Standard Error 3.06
|
-25.18 percent change
Standard Error 2.28
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
|
6.61 percent change
Standard Error 2.94
|
-12.64 percent change
Standard Error 2.19
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
4.81 percent change
Standard Error 3.41
|
-8.90 percent change
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
|
-2.57 percent change
Standard Error 1.25
|
7.23 percent change
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12
|
-1.41 percent change
Standard Error 1.38
|
5.96 percent change
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline and weeks 10 and 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
|
3.42 percent change
Standard Error 2.57
|
-13.64 percent change
Standard Error 1.89
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).
Outcome measures
| Measure |
Placebo
n=141 Participants
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 Participants
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in VLDL-C at Week 12
|
3.02 percent change
Standard Error 2.94
|
-10.31 percent change
Standard Error 2.15
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Evolocumab
Serious events: 14 serious events
Other events: 37 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=141 participants at risk
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 participants at risk
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.71%
2/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.71%
1/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.71%
1/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
4/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.36%
1/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=141 participants at risk
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
|
Evolocumab
n=280 participants at risk
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
4/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
6/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
2.1%
3/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
6/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.8%
4/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
5/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.5%
5/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
8/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
3/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.71%
2/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
2.1%
3/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
6/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/141 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
11/280 • From the first dose of study drug (placebo or evolocumab) to week 12.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER