Trial Outcomes & Findings for Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study (NCT NCT01516879)
NCT ID: NCT01516879
Last Updated: 2022-07-22
Results Overview
Cholesterol was measured by means of ultracentrifugation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
905 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2022-07-22
Participant Flow
Adults with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 75 mg/dL and triglycerides ≤ 400 mg/dL were eligible. The first patient enrolled on 5 January 2012 and the last patient enrolled on 12 October 2012. All patients were counseled on the National Cholesterol Education Program Adult Treatment Panel III Therapeutic Lifestyle Changes diet.
Patients were assigned to 1 of 4 background lipid-lowering regimens for a 4-12 week stabilization period: diet alone, diet and 10 mg atorvastatin daily, diet and 80 mg atorvastatin daily, or diet, 80 mg atorvastatin and 10 mg ezetimibe daily. Patients meeting criteria were randomized 2:1 to evolocumab or placebo, stratified by background therapy.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
602
|
|
Overall Study
Received Treatment
|
302
|
599
|
|
Overall Study
COMPLETED
|
287
|
568
|
|
Overall Study
NOT COMPLETED
|
16
|
34
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
11
|
|
Overall Study
Other
|
5
|
10
|
Baseline Characteristics
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Baseline characteristics by cohort
| Measure |
Placebo
n=303 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=602 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Total
n=905 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 participants
n=5 Participants
|
41 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 participants
n=5 Participants
|
53 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
249 participants
n=5 Participants
|
478 participants
n=7 Participants
|
727 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 participants
n=5 Participants
|
26 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
17 participants
n=5 Participants
|
33 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
286 participants
n=5 Participants
|
569 participants
n=7 Participants
|
855 participants
n=5 Participants
|
|
Background Therapy
Diet Only
|
38 participants
n=5 Participants
|
74 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Background Therapy
Diet + Atorvastatin 10 mg
|
129 participants
n=5 Participants
|
256 participants
n=7 Participants
|
385 participants
n=5 Participants
|
|
Background Therapy
Diet + Atorvastatin 80 mg
|
73 participants
n=5 Participants
|
146 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
Background Therapy
Diet + Atorvastatin 80 mg + Ezetimibe 10 mg
|
63 participants
n=5 Participants
|
126 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Low-density Lipoprotein Cholesterol (LDL-C) Concentration
|
104.0 mg/dL
STANDARD_DEVIATION 21.6 • n=5 Participants
|
104.2 mg/dL
STANDARD_DEVIATION 22.1 • n=7 Participants
|
104.1 mg/dL
STANDARD_DEVIATION 22.0 • n=5 Participants
|
|
Total Cholesterol
|
179.1 mg/dL
STANDARD_DEVIATION 27.2 • n=5 Participants
|
176.8 mg/dL
STANDARD_DEVIATION 27.5 • n=7 Participants
|
177.6 mg/dL
STANDARD_DEVIATION 27.4 • n=5 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration
|
125.6 mg/dL
STANDARD_DEVIATION 26.9 • n=5 Participants
|
124.2 mg/dL
STANDARD_DEVIATION 25.6 • n=7 Participants
|
124.6 mg/dL
STANDARD_DEVIATION 26.1 • n=5 Participants
|
|
Apolipoprotein B Concentration
|
87.5 mg/dL
STANDARD_DEVIATION 16.3 • n=5 Participants
|
87.0 mg/dL
STANDARD_DEVIATION 16.3 • n=7 Participants
|
87.2 mg/dL
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
|
3.603 ratio
STANDARD_DEVIATION 1.11 • n=5 Participants
|
3.597 ratio
STANDARD_DEVIATION 1.04 • n=7 Participants
|
3.599 ratio
STANDARD_DEVIATION 1.06 • n=5 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.586 ratio
STANDARD_DEVIATION 0.170 • n=5 Participants
|
0.593 ratio
STANDARD_DEVIATION 0.170 • n=7 Participants
|
0.590 ratio
STANDARD_DEVIATION 1.70 • n=5 Participants
|
|
Lipoprotein(a) Concentration
|
89.3 nmol/L
STANDARD_DEVIATION 108.6 • n=5 Participants
|
84.0 nmol/L
STANDARD_DEVIATION 98.5 • n=7 Participants
|
85.8 nmol/L
STANDARD_DEVIATION 102.0 • n=5 Participants
|
|
Triglycerides Concentration
|
127.8 mg/dL
STANDARD_DEVIATION 65.8 • n=5 Participants
|
119.8 mg/dL
STANDARD_DEVIATION 63.2 • n=7 Participants
|
122.5 mg/dL
STANDARD_DEVIATION 64.1 • n=5 Participants
|
|
High-density Lipoprotein Cholesterol (HDL-C) Concentration
|
53.5 mg/dL
STANDARD_DEVIATION 16.1 • n=5 Participants
|
52.6 mg/dL
STANDARD_DEVIATION 15.5 • n=7 Participants
|
52.9 mg/dL
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration
|
21.5 mg/dL
STANDARD_DEVIATION 13.4 • n=5 Participants
|
20.0 mg/dL
STANDARD_DEVIATION 11.4 • n=7 Participants
|
20.5 mg/dL
STANDARD_DEVIATION 12.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).
Cholesterol was measured by means of ultracentrifugation.
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 52
|
6.83 percent change
Standard Error 1.75
|
-50.14 percent change
Standard Error 1.24
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Cholesterol was measured by means of ultracentrifugation.
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Change From Baseline in LDL-C at Week 52
|
5.1 mg/dL
Standard Error 1.9
|
-52.7 mg/dL
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set
An LDL-C response is defined as LDL-C level \< 70 mg/dL (1.8 mmol/L) at Week 52.
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percentage of Participants With an LDL-C Response at Week 52
|
6.4 percentage of participants
Interval 4.1 to 10.1
|
82.3 percentage of participants
Interval 78.8 to 85.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis set
Cholesterol was measured by means of ultracentrifugation.
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 12
|
3.17 percent change
Standard Error 1.31
|
-54.35 percent change
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 12
|
2.85 percent change
Standard Error 0.87
|
-32.30 percent change
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Week 52
|
5.26 percent change
Standard Error 1.16
|
-28.18 percent change
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52
|
8.44 percent change
Standard Error 1.68
|
-41.82 percent change
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 52
|
2.94 percent change
Standard Error 1.41
|
-41.26 percent change
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52
|
6.47 percent change
Standard Error 1.37
|
-30.67 percent change
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52
|
4.46 percent change
Standard Error 1.50
|
-41.75 percent change
Standard Error 1.09
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 52
|
-5.37 percent change
Standard Error 1.62
|
-27.72 percent change
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 52
|
8.99 percent change
Standard Error 2.39
|
-2.55 percent change
Standard Error 1.72
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52
|
0.35 percent change
Standard Error 0.90
|
5.77 percent change
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set
Cholesterol was measured by means of ultracentrifugation.
Outcome measures
| Measure |
Placebo
n=302 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52
|
31.89 percent change
Standard Error 4.69
|
2.74 percent change
Standard Error 3.36
|
SECONDARY outcome
Timeframe: Week 12 and Week 52Population: The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.
Cholesterol was measured by means of ultracentrifugation.
Outcome measures
| Measure |
Placebo
n=253 Participants
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=514 Participants
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Percent Change From Week 12 to Week 52 in LDL-C
|
2.57 percent change
Standard Error 1.56
|
2.44 percent change
Standard Error 1.14
|
Adverse Events
Placebo
Serious events: 13 serious events
Other events: 76 other events
Deaths: 0 deaths
Evolocumab
Serious events: 33 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=302 participants at risk
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 participants at risk
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
0.66%
2/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
2/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
2/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
2/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Exostosis of external ear canal
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
2/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Device breakage
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Skin infection
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatic enzyme increased
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
2/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
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)
Breast cancer
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
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)
Ovarian cancer metastatic
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
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)
Renal neoplasm
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
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)
Uterine cancer
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Convulsion
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
1/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
2/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.00%
0/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.17%
1/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=302 participants at risk
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
Evolocumab
n=599 participants at risk
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
|
|---|---|---|
|
Infections and infestations
Influenza
|
6.3%
19/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.5%
45/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
29/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
63/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
19/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.3%
56/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
17/302 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
36/599 • 52 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
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