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Trial record 2 of 2 for:    lts11717

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01507831
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)
Enrollment 2341
Recruitment Details The study was conducted at 320 centers in 27 countries. Overall, 5144 participants were screened between January 2012 and March 2013, 2801 of whom were screen failures. Screen failures were mainly due to exclusion criteria met. In addition 2 participants received study drug but did not undergo randomization. They were excluded from analysis.
Pre-assignment Details Randomization was stratified as per diagnosis of heterozygous familial hypercholesterolemia (heFH), prior history of myocardial infarction (MI) or ischemic stroke, intensity of statin treatment and geographic region. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo:alirocumab).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid modifying therapy (LMT) for 78 weeks. Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Period Title: Overall Study
Started 788 [1] 1553 [1]
Treated 788 1550
Completed 595 1113
Not Completed 193 440
Reason Not Completed
Randomized but not treated             0             3
Adverse Event             48             113
Death             6             2
Poor compliance to protocol             38             60
Physician Decision             0             4
Participant moved             5             19
Consent withdrawn by participant             34             72
Related to study drug administration             5             14
Last visit outside protocol visit window             51             143
Selection criteria finally not met             0             1
Site closure             0             3
Potential lost to follow-up             3             0
Other             3             6
[1]
Randomized
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W Total
Hide Arm/Group Description Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks. Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks. Total of all reporting groups
Overall Number of Baseline Participants 788 1553 2341
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 788 participants 1553 participants 2341 participants
60.6  (10.4) 60.4  (10.4) 60.5  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 788 participants 1553 participants 2341 participants
Female
314
  39.8%
570
  36.7%
884
  37.8%
Male
474
  60.2%
983
  63.3%
1457
  62.2%
Calculated LDL-C in mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 788 participants 1553 participants 2341 participants
121.9  (41.4) 122.7  (42.6) 122.4  (42.2)
[1]
Measure Description: Calculated LDL-C in mg/dL from Friedewald formula (LDL-C = Total cholesterol - High-density lipoprotein cholesterol - [Triglyceride/5]).
Calculated LDL-C in mmol/L  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 788 participants 1553 participants 2341 participants
3.157  (1.073) 3.178  (1.102) 3.171  (1.092)
1.Primary Outcome
Title Percentage of Participants Who Experienced Adverse Events (AEs)
Hide Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).
Time Frame Up to 10 weeks after last study drug administration (maximum of 86 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 788 1550
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 82.5 81.0
Any Serious AE 19.5 18.7
Any AE leading to death 1.3 0.5
Any AE leading to treatment discontinuation 5.8 7.2
2.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
Hide Description Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model (ITT analysis).
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.8  (1.0) -61.0  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Alirocumab group was compared to placebo group using an appropriate contrast statement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -61.9
Confidence Interval (2-Sided) 95%
-64.3 to -59.4
Estimation Comments Alirocumab vs. Placebo
3.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.7  (1.0) -62.8  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -63.5
Confidence Interval (2-Sided) 95%
-65.9 to -61.2
Estimation Comments Alirocumab vs. Placebo
4.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.5  (1.0) -63.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -64.8
Confidence Interval (2-Sided) 95%
-67.2 to -62.4
Estimation Comments Alirocumab vs. Placebo
5.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.4  (1.0) -64.2  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -65.5
Confidence Interval (2-Sided) 95%
-67.9 to -63.2
Estimation Comments Alirocumab vs. Placebo
6.Secondary Outcome
Title Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis
Hide Description Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 652 1278
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.5  (1.1) -57.8  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -61.3
Confidence Interval (2-Sided) 95%
-64.0 to -58.5
Estimation Comments Alirocumab vs. Placebo
7.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 753 1468
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.2  (1.0) -52.8  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -54.0
Confidence Interval (2-Sided) 95%
-56.3 to -51.7
Estimation Comments Alirocumab vs. Placebo
8.Secondary Outcome
Title Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 743 1444
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.2  (0.9) -54.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -55.5
Confidence Interval (2-Sided) 95%
-57.7 to -53.2
Estimation Comments Alirocumab vs. Placebo
9.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.7  (0.9) -51.6  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -52.3
Confidence Interval (2-Sided) 95%
-54.4 to -50.2
Estimation Comments Alirocumab vs. Placebo
10.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.6  (0.9) -53.1  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -53.7
Confidence Interval (2-Sided) 95%
-55.7 to -51.6
Estimation Comments Alirocumab vs. Placebo
11.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.3  (0.7) -37.8  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -37.5
Confidence Interval (2-Sided) 95%
-39.1 to -35.9
Estimation Comments Alirocumab vs. Placebo
12.Secondary Outcome
Title Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Apo B ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 753 1468
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.5  (0.9) -55.5  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -56.0
Confidence Interval (2-Sided) 95%
-58.3 to -53.7
Estimation Comments Alirocumab vs. Placebo
13.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Non-HDL-C ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.9  (0.8) -53.7  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -54.6
Confidence Interval (2-Sided) 95%
-56.6 to -52.6
Estimation Comments Alirocumab vs. Placebo
14.Secondary Outcome
Title Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Total-C ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.2  (0.6) -38.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -39.0
Confidence Interval (2-Sided) 95%
-40.4 to -37.5
Estimation Comments Alirocumab vs. Placebo
15.Secondary Outcome
Title Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
Hide Description Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Measure Type: Number
Unit of Measure: percentage of participants
8.5 80.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 71.5
Confidence Interval (2-Sided) 95%
51.6 to 99.1
Estimation Comments Alirocumab vs. Placebo
16.Secondary Outcome
Title Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
Hide Description Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Measure Type: Number
Unit of Measure: percentage of participants
8.5 82.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 93.4
Confidence Interval (2-Sided) 95%
66.1 to 132.0
Estimation Comments Alirocumab vs. Placebo
17.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Hide Description Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Measure Type: Number
Unit of Measure: percentage of participants
8.0 79.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 74.6
Confidence Interval (2-Sided) 95%
53.3 to 104.4
Estimation Comments Alirocumab vs. Placebo
18.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Hide Description Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Measure Type: Number
Unit of Measure: percentage of participants
8.0 81.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 97.3
Confidence Interval (2-Sided) 95%
68.2 to 138.9
Estimation Comments Alirocumab vs. Placebo
19.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Mean (Standard Error)
Unit of Measure: percent change
-3.7  (1.0) -29.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -25.6
Confidence Interval (2-Sided) 95%
-28.1 to -23.1
Estimation Comments Alirocumab vs. Placebo
20.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.6  (0.5) 4.0  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
3.3 to 5.9
Estimation Comments Alirocumab vs. Placebo
21.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Mean (Standard Error)
Unit of Measure: percent change
1.8  (1.2) -15.6  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -17.3
Confidence Interval (2-Sided) 95%
-20.1 to -14.6
Estimation Comments Alirocumab vs. Placebo
22.Secondary Outcome
Title Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 753 1468
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.2  (0.6) 4.0  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
1.6 to 4.2
Estimation Comments Alirocumab vs. Placebo
23.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Mean (Standard Error)
Unit of Measure: percent change
-3.1  (1.0) -28.2  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -25.1
Confidence Interval (2-Sided) 95%
-27.4 to -22.7
Estimation Comments Alirocumab vs. Placebo
24.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
HDL-C ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.2  (0.5) 5.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
4.3 to 6.8
Estimation Comments Alirocumab vs. Placebo
25.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Mean (Standard Error)
Unit of Measure: percent change
1.2  (1.1) -16.7  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -17.9
Confidence Interval (2-Sided) 95%
-20.5 to -15.3
Estimation Comments Alirocumab vs. Placebo
26.Secondary Outcome
Title Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Apo A1 ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 753 1468
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.6  (0.5) 4.6  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
2.8 to 5.2
Estimation Comments Alirocumab vs. Placebo
27.Other Pre-specified Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
4.4  (1.2) -56.8  (0.8)
28.Other Pre-specified Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Least Squares Mean (Standard Error)
Unit of Measure: percent change
4.6  (1.1) -59.9  (0.8)
29.Other Pre-specified Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 780 1530
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.6  (1.3) -52.4  (0.9)
30.Other Pre-specified Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 777 1523
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.9  (1.2) -58.0  (0.9)
31.Other Pre-specified Outcome
Title Percentage of Participants Who Experienced Cardiovascular (CV) Events
Hide Description CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).
Time Frame Up to 10 weeks after last study drug administration (maximum of 86 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 788 1550
Measure Type: Number
Unit of Measure: percentage of participants
5.1 4.6
32.Post-Hoc Outcome
Title Percentage of Participants Who Experienced Major Adverse CV Events
Hide Description Major adverse CV events were defined as all adverse CV events except Congestive heart failure (CHF) requiring hospitalization; and ischemia-driven coronary revascularization procedure.
Time Frame Up to 10 weeks after last study drug administration (maximum of 86 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
Overall Number of Participants Analyzed 788 1550
Measure Type: Number
Unit of Measure: percentage of participants
3.3 1.7
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 86 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).
 
Arm/Group Title Placebo Q2W Alirocumab 150 mg Q2W
Hide Arm/Group Description Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks. Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
All-Cause Mortality
Placebo Q2W Alirocumab 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Q2W Alirocumab 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   154/788 (19.54%)   290/1550 (18.71%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  0/788 (0.00%)  1/1550 (0.06%) 
Coagulopathy  1  0/788 (0.00%)  1/1550 (0.06%) 
Spontaneous haematoma  1  1/788 (0.13%)  0/1550 (0.00%) 
Cardiac disorders     
Angina unstable  1  9/788 (1.14%)  29/1550 (1.87%) 
Angina pectoris  1  6/788 (0.76%)  9/1550 (0.58%) 
Atrial fibrillation  1  7/788 (0.89%)  9/1550 (0.58%) 
Cardiac failure  1  3/788 (0.38%)  4/1550 (0.26%) 
Coronary artery disease  1  3/788 (0.38%)  10/1550 (0.65%) 
Acute myocardial infarction  1  11/788 (1.40%)  9/1550 (0.58%) 
Bradycardia  1  0/788 (0.00%)  2/1550 (0.13%) 
Myocardial ischaemia  1  2/788 (0.25%)  3/1550 (0.19%) 
Cardiac failure chronic  1  0/788 (0.00%)  2/1550 (0.13%) 
Atrial flutter  1  1/788 (0.13%)  2/1550 (0.13%) 
Cardiac failure congestive  1  3/788 (0.38%)  4/1550 (0.26%) 
Myocardial infarction  1  4/788 (0.51%)  4/1550 (0.26%) 
Ventricular tachycardia  1  1/788 (0.13%)  2/1550 (0.13%) 
Cardiac arrest  1  0/788 (0.00%)  3/1550 (0.19%) 
Ischaemic cardiomyopathy  1  1/788 (0.13%)  2/1550 (0.13%) 
Supraventricular tachycardia  1  0/788 (0.00%)  1/1550 (0.06%) 
Acute coronary syndrome  1  6/788 (0.76%)  2/1550 (0.13%) 
Aortic valve stenosis  1  1/788 (0.13%)  2/1550 (0.13%) 
Arteriosclerosis coronary artery  1  0/788 (0.00%)  1/1550 (0.06%) 
Atrioventricular block second degree  1  0/788 (0.00%)  1/1550 (0.06%) 
Coronary artery stenosis  1  2/788 (0.25%)  2/1550 (0.13%) 
Sinus bradycardia  1  0/788 (0.00%)  1/1550 (0.06%) 
Atrioventricular block  1  0/788 (0.00%)  1/1550 (0.06%) 
Extrasystoles  1  1/788 (0.13%)  0/1550 (0.00%) 
Hypertensive heart disease  1  0/788 (0.00%)  1/1550 (0.06%) 
Sick sinus syndrome  1  1/788 (0.13%)  1/1550 (0.06%) 
Silent myocardial infarction  1  0/788 (0.00%)  1/1550 (0.06%) 
Ventricular fibrillation  1  2/788 (0.25%)  1/1550 (0.06%) 
Cardiogenic shock  1  1/788 (0.13%)  0/1550 (0.00%) 
Coronary artery occlusion  1  1/788 (0.13%)  0/1550 (0.00%) 
Dressler's syndrome  1  1/788 (0.13%)  0/1550 (0.00%) 
Pleuropericarditis  1  1/788 (0.13%)  0/1550 (0.00%) 
Congenital, familial and genetic disorders     
Hypertrophic cardiomyopathy  1  1/788 (0.13%)  0/1550 (0.00%) 
Thyroglossal cyst  1  1/788 (0.13%)  0/1550 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/788 (0.00%)  1/1550 (0.06%) 
Vertigo positional  1  1/788 (0.13%)  0/1550 (0.00%) 
Endocrine disorders     
Thyrotoxic crisis  1  0/788 (0.00%)  1/1550 (0.06%) 
Eye disorders     
Cataract  1  1/788 (0.13%)  1/1550 (0.06%) 
Diabetic retinopathy  1  1/788 (0.13%)  0/1550 (0.00%) 
Vitreous detachment  1  0/788 (0.00%)  1/1550 (0.06%) 
Visual impairment  1  0/788 (0.00%)  1/1550 (0.06%) 
Age-related macular degeneration  1  0/788 (0.00%)  1/1550 (0.06%) 
Retinal haemorrhage  1  0/788 (0.00%)  1/1550 (0.06%) 
Endocrine ophthalmopathy  1  0/788 (0.00%)  1/1550 (0.06%) 
Macular hole  1  0/788 (0.00%)  1/1550 (0.06%) 
Open angle glaucoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Retinal vein thrombosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Blepharochalasis  1  1/788 (0.13%)  0/1550 (0.00%) 
Retinal artery occlusion  1  1/788 (0.13%)  0/1550 (0.00%) 
Retinal vein occlusion  1  2/788 (0.25%)  0/1550 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  0/788 (0.00%)  1/1550 (0.06%) 
Nausea  1  1/788 (0.13%)  0/1550 (0.00%) 
Vomiting  1  1/788 (0.13%)  0/1550 (0.00%) 
Abdominal pain  1  1/788 (0.13%)  3/1550 (0.19%) 
Dyspepsia  1  1/788 (0.13%)  0/1550 (0.00%) 
Gastritis  1  2/788 (0.25%)  1/1550 (0.06%) 
Haemorrhoids  1  0/788 (0.00%)  1/1550 (0.06%) 
Hiatus hernia  1  0/788 (0.00%)  1/1550 (0.06%) 
Large intestine polyp  1  0/788 (0.00%)  1/1550 (0.06%) 
Barrett's oesophagus  1  1/788 (0.13%)  1/1550 (0.06%) 
Abdominal hernia  1  1/788 (0.13%)  1/1550 (0.06%) 
Umbilical hernia  1  0/788 (0.00%)  1/1550 (0.06%) 
Abdominal adhesions  1  0/788 (0.00%)  1/1550 (0.06%) 
Colitis  1  3/788 (0.38%)  1/1550 (0.06%) 
Diverticulum intestinal  1  1/788 (0.13%)  0/1550 (0.00%) 
Duodenal ulcer haemorrhage  1  1/788 (0.13%)  1/1550 (0.06%) 
Gastroduodenal haemorrhage  1  0/788 (0.00%)  1/1550 (0.06%) 
Intestinal obstruction  1  0/788 (0.00%)  1/1550 (0.06%) 
Intestinal perforation  1  0/788 (0.00%)  1/1550 (0.06%) 
Pancreatitis  1  0/788 (0.00%)  1/1550 (0.06%) 
Pancreatitis acute  1  0/788 (0.00%)  1/1550 (0.06%) 
Pancreatitis relapsing  1  0/788 (0.00%)  1/1550 (0.06%) 
Peptic ulcer haemorrhage  1  0/788 (0.00%)  1/1550 (0.06%) 
Abdominal hernia obstructive  1  1/788 (0.13%)  0/1550 (0.00%) 
Alcoholic pancreatitis  1  1/788 (0.13%)  0/1550 (0.00%) 
Intussusception  1  1/788 (0.13%)  0/1550 (0.00%) 
Pancreatitis chronic  1  1/788 (0.13%)  0/1550 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/788 (0.13%)  0/1550 (0.00%) 
General disorders     
Non-cardiac chest pain  1  2/788 (0.25%)  13/1550 (0.84%) 
Chest pain  1  1/788 (0.13%)  0/1550 (0.00%) 
Coronary artery restenosis  1  1/788 (0.13%)  1/1550 (0.06%) 
Device failure  1  0/788 (0.00%)  1/1550 (0.06%) 
Multi-organ failure  1  4/788 (0.51%)  1/1550 (0.06%) 
Peripheral artery restenosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Death  1  1/788 (0.13%)  0/1550 (0.00%) 
Device malfunction  1  1/788 (0.13%)  0/1550 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/788 (0.00%)  3/1550 (0.19%) 
Hepatic steatosis  1  1/788 (0.13%)  0/1550 (0.00%) 
Cholecystitis  1  1/788 (0.13%)  1/1550 (0.06%) 
Cholecystitis acute  1  0/788 (0.00%)  2/1550 (0.13%) 
Bile duct stone  1  0/788 (0.00%)  1/1550 (0.06%) 
Drug-induced liver injury  1  1/788 (0.13%)  0/1550 (0.00%) 
Hepatocellular injury  1  0/788 (0.00%)  1/1550 (0.06%) 
Cholangitis  1  1/788 (0.13%)  0/1550 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypersensitivity  1  0/788 (0.00%)  1/1550 (0.06%) 
Cytokine release syndrome  1  1/788 (0.13%)  0/1550 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  1  0/788 (0.00%)  1/1550 (0.06%) 
Urinary tract infection  1  0/788 (0.00%)  3/1550 (0.19%) 
Influenza  1  2/788 (0.25%)  0/1550 (0.00%) 
Bronchitis  1  1/788 (0.13%)  0/1550 (0.00%) 
Lower respiratory tract infection  1  1/788 (0.13%)  2/1550 (0.13%) 
Gastroenteritis  1  2/788 (0.25%)  5/1550 (0.32%) 
Pneumonia  1  7/788 (0.89%)  6/1550 (0.39%) 
Cellulitis  1  1/788 (0.13%)  3/1550 (0.19%) 
Gastroenteritis viral  1  0/788 (0.00%)  2/1550 (0.13%) 
Pyelonephritis  1  0/788 (0.00%)  3/1550 (0.19%) 
Diverticulitis  1  0/788 (0.00%)  4/1550 (0.26%) 
Sepsis  1  1/788 (0.13%)  5/1550 (0.32%) 
Gastrointestinal viral infection  1  1/788 (0.13%)  0/1550 (0.00%) 
Labyrinthitis  1  0/788 (0.00%)  1/1550 (0.06%) 
Postoperative wound infection  1  1/788 (0.13%)  0/1550 (0.00%) 
Bronchopneumonia  1  0/788 (0.00%)  1/1550 (0.06%) 
Groin abscess  1  0/788 (0.00%)  1/1550 (0.06%) 
Infective exacerbation of chronic obstructive airways disease  1  0/788 (0.00%)  1/1550 (0.06%) 
Osteomyelitis  1  1/788 (0.13%)  1/1550 (0.06%) 
Pneumonia pneumococcal  1  0/788 (0.00%)  1/1550 (0.06%) 
Pyelonephritis acute  1  0/788 (0.00%)  1/1550 (0.06%) 
Device related infection  1  0/788 (0.00%)  1/1550 (0.06%) 
Incision site infection  1  0/788 (0.00%)  1/1550 (0.06%) 
Lobar pneumonia  1  0/788 (0.00%)  1/1550 (0.06%) 
Lyme disease  1  0/788 (0.00%)  1/1550 (0.06%) 
Pneumonia staphylococcal  1  0/788 (0.00%)  1/1550 (0.06%) 
Urinary tract infection pseudomonal  1  0/788 (0.00%)  1/1550 (0.06%) 
Wound abscess  1  0/788 (0.00%)  1/1550 (0.06%) 
Clostridium difficile colitis  1  1/788 (0.13%)  0/1550 (0.00%) 
Cystitis viral  1  1/788 (0.13%)  0/1550 (0.00%) 
Diabetic foot infection  1  1/788 (0.13%)  0/1550 (0.00%) 
Helicobacter gastritis  1  1/788 (0.13%)  0/1550 (0.00%) 
Neutropenic sepsis  1  1/788 (0.13%)  0/1550 (0.00%) 
Post procedural sepsis  1  1/788 (0.13%)  0/1550 (0.00%) 
Septic shock  1  1/788 (0.13%)  0/1550 (0.00%) 
Urosepsis  1  1/788 (0.13%)  0/1550 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  0/788 (0.00%)  1/1550 (0.06%) 
Laceration  1  0/788 (0.00%)  1/1550 (0.06%) 
Accidental overdose  1  1/788 (0.13%)  0/1550 (0.00%) 
Muscle strain  1  1/788 (0.13%)  0/1550 (0.00%) 
Tendon rupture  1  0/788 (0.00%)  2/1550 (0.13%) 
Joint injury  1  0/788 (0.00%)  1/1550 (0.06%) 
Rib fracture  1  0/788 (0.00%)  1/1550 (0.06%) 
Ankle fracture  1  0/788 (0.00%)  2/1550 (0.13%) 
Hand fracture  1  0/788 (0.00%)  1/1550 (0.06%) 
Traumatic haematoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Wrist fracture  1  1/788 (0.13%)  0/1550 (0.00%) 
Clavicle fracture  1  1/788 (0.13%)  1/1550 (0.06%) 
Intentional overdose  1  1/788 (0.13%)  2/1550 (0.13%) 
Post procedural haematoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Humerus fracture  1  0/788 (0.00%)  1/1550 (0.06%) 
Ligament rupture  1  2/788 (0.25%)  0/1550 (0.00%) 
Abdominal injury  1  0/788 (0.00%)  1/1550 (0.06%) 
Femoral neck fracture  1  1/788 (0.13%)  1/1550 (0.06%) 
Femur fracture  1  0/788 (0.00%)  1/1550 (0.06%) 
Fibula fracture  1  0/788 (0.00%)  1/1550 (0.06%) 
Hip fracture  1  1/788 (0.13%)  0/1550 (0.00%) 
Muscle rupture  1  1/788 (0.13%)  0/1550 (0.00%) 
Post procedural haematuria  1  0/788 (0.00%)  1/1550 (0.06%) 
Tibia fracture  1  0/788 (0.00%)  1/1550 (0.06%) 
Traumatic intracranial haemorrhage  1  0/788 (0.00%)  1/1550 (0.06%) 
Vascular pseudoaneurysm  1  0/788 (0.00%)  1/1550 (0.06%) 
Arterial injury  1  1/788 (0.13%)  0/1550 (0.00%) 
Postoperative respiratory failure  1  1/788 (0.13%)  0/1550 (0.00%) 
Spinal cord injury  1  1/788 (0.13%)  0/1550 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  1  0/788 (0.00%)  1/1550 (0.06%) 
Electrocardiogram QT prolonged  1  1/788 (0.13%)  0/1550 (0.00%) 
Troponin increased  1  1/788 (0.13%)  1/1550 (0.06%) 
Electrocardiogram ST segment depression  1  0/788 (0.00%)  1/1550 (0.06%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  2/788 (0.25%)  2/1550 (0.13%) 
Type 2 diabetes mellitus  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypokalaemia  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypoglycaemia  1  1/788 (0.13%)  3/1550 (0.19%) 
Hyperglycaemia  1  1/788 (0.13%)  2/1550 (0.13%) 
Dehydration  1  0/788 (0.00%)  1/1550 (0.06%) 
Hyperkalaemia  1  0/788 (0.00%)  1/1550 (0.06%) 
Lipomatosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Diabetic ketoacidosis  1  1/788 (0.13%)  0/1550 (0.00%) 
Lactic acidosis  1  1/788 (0.13%)  0/1550 (0.00%) 
Tumour lysis syndrome  1  1/788 (0.13%)  0/1550 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/788 (0.13%)  1/1550 (0.06%) 
Arthralgia  1  0/788 (0.00%)  2/1550 (0.13%) 
Osteoarthritis  1  3/788 (0.38%)  8/1550 (0.52%) 
Intervertebral disc protrusion  1  0/788 (0.00%)  4/1550 (0.26%) 
Arthritis  1  0/788 (0.00%)  2/1550 (0.13%) 
Musculoskeletal chest pain  1  3/788 (0.38%)  2/1550 (0.13%) 
Spinal osteoarthritis  1  1/788 (0.13%)  0/1550 (0.00%) 
Rotator cuff syndrome  1  1/788 (0.13%)  0/1550 (0.00%) 
Intervertebral disc degeneration  1  1/788 (0.13%)  1/1550 (0.06%) 
Lumbar spinal stenosis  1  2/788 (0.25%)  0/1550 (0.00%) 
Myositis  1  0/788 (0.00%)  2/1550 (0.13%) 
Osteonecrosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Polymyalgia rheumatica  1  1/788 (0.13%)  0/1550 (0.00%) 
Rhabdomyolysis  1  0/788 (0.00%)  1/1550 (0.06%) 
Spinal column stenosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Vertebral foraminal stenosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Ankylosing spondylitis  1  1/788 (0.13%)  0/1550 (0.00%) 
Osteochondrosis  1  1/788 (0.13%)  0/1550 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  2/788 (0.25%)  8/1550 (0.52%) 
Prostate cancer  1  3/788 (0.38%)  3/1550 (0.19%) 
Squamous cell carcinoma of skin  1  0/788 (0.00%)  3/1550 (0.19%) 
Colon cancer  1  0/788 (0.00%)  2/1550 (0.13%) 
Squamous cell carcinoma  1  0/788 (0.00%)  1/1550 (0.06%) 
B-cell lymphoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Benign ovarian tumour  1  0/788 (0.00%)  1/1550 (0.06%) 
Breast cancer  1  1/788 (0.13%)  1/1550 (0.06%) 
Laryngeal squamous cell carcinoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Neuroendocrine carcinoma metastatic  1  0/788 (0.00%)  1/1550 (0.06%) 
Non-Hodgkin's lymphoma metastatic  1  0/788 (0.00%)  1/1550 (0.06%) 
Pleomorphic liposarcoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Prostate cancer metastatic  1  0/788 (0.00%)  1/1550 (0.06%) 
Rectal adenocarcinoma  1  0/788 (0.00%)  1/1550 (0.06%) 
Renal cancer  1  0/788 (0.00%)  1/1550 (0.06%) 
Skin cancer  1  0/788 (0.00%)  1/1550 (0.06%) 
Squamous cell carcinoma of the oral cavity  1  0/788 (0.00%)  1/1550 (0.06%) 
Acute myeloid leukaemia  1  1/788 (0.13%)  0/1550 (0.00%) 
Adenocarcinoma of colon  1  1/788 (0.13%)  0/1550 (0.00%) 
Bladder cancer  1  1/788 (0.13%)  0/1550 (0.00%) 
Choroid melanoma  1  1/788 (0.13%)  0/1550 (0.00%) 
Chronic lymphocytic leukaemia  1  1/788 (0.13%)  0/1550 (0.00%) 
Ductal adenocarcinoma of pancreas  1  1/788 (0.13%)  0/1550 (0.00%) 
Endometrial cancer  1  1/788 (0.13%)  0/1550 (0.00%) 
Endometrial cancer stage I  1  1/788 (0.13%)  0/1550 (0.00%) 
Lentigo maligna  1  1/788 (0.13%)  0/1550 (0.00%) 
Lip squamous cell carcinoma  1  1/788 (0.13%)  0/1550 (0.00%) 
Malignant melanoma  1  1/788 (0.13%)  0/1550 (0.00%) 
Oesophageal carcinoma  1  1/788 (0.13%)  0/1550 (0.00%) 
Pancreatic carcinoma  1  1/788 (0.13%)  0/1550 (0.00%) 
Pancreatic carcinoma metastatic  1  1/788 (0.13%)  0/1550 (0.00%) 
Prostate cancer recurrent  1  1/788 (0.13%)  0/1550 (0.00%) 
Squamous cell carcinoma of lung  1  1/788 (0.13%)  0/1550 (0.00%) 
Tongue cancer metastatic  1  1/788 (0.13%)  0/1550 (0.00%) 
Nervous system disorders     
Headache  1  1/788 (0.13%)  2/1550 (0.13%) 
Syncope  1  6/788 (0.76%)  11/1550 (0.71%) 
Hypoaesthesia  1  2/788 (0.25%)  0/1550 (0.00%) 
Carpal tunnel syndrome  1  0/788 (0.00%)  2/1550 (0.13%) 
Transient ischaemic attack  1  0/788 (0.00%)  7/1550 (0.45%) 
Presyncope  1  1/788 (0.13%)  1/1550 (0.06%) 
Ischaemic stroke  1  1/788 (0.13%)  5/1550 (0.32%) 
Migraine  1  1/788 (0.13%)  0/1550 (0.00%) 
Carotid artery stenosis  1  1/788 (0.13%)  2/1550 (0.13%) 
Loss of consciousness  1  0/788 (0.00%)  3/1550 (0.19%) 
Carotid arteriosclerosis  1  1/788 (0.13%)  2/1550 (0.13%) 
Cerebrovascular accident  1  0/788 (0.00%)  2/1550 (0.13%) 
Dysarthria  1  0/788 (0.00%)  1/1550 (0.06%) 
Lacunar infarction  1  0/788 (0.00%)  3/1550 (0.19%) 
Haemorrhagic stroke  1  0/788 (0.00%)  2/1550 (0.13%) 
Nerve root compression  1  0/788 (0.00%)  1/1550 (0.06%) 
Ataxia  1  0/788 (0.00%)  1/1550 (0.06%) 
Brain stem infarction  1  0/788 (0.00%)  1/1550 (0.06%) 
Cerebellar infarction  1  0/788 (0.00%)  1/1550 (0.06%) 
Convulsion  1  0/788 (0.00%)  1/1550 (0.06%) 
Dementia  1  1/788 (0.13%)  1/1550 (0.06%) 
Demyelination  1  0/788 (0.00%)  1/1550 (0.06%) 
Frontotemporal dementia  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypoglycaemic coma  1  0/788 (0.00%)  1/1550 (0.06%) 
Miller Fisher syndrome  1  0/788 (0.00%)  1/1550 (0.06%) 
Optic neuritis  1  0/788 (0.00%)  1/1550 (0.06%) 
Parkinson's disease  1  1/788 (0.13%)  0/1550 (0.00%) 
Altered state of consciousness  1  1/788 (0.13%)  0/1550 (0.00%) 
Cerebral haemorrhage  1  1/788 (0.13%)  0/1550 (0.00%) 
Cerebral infarction  1  1/788 (0.13%)  0/1550 (0.00%) 
Generalised tonic-clonic seizure  1  1/788 (0.13%)  0/1550 (0.00%) 
Myoclonic epilepsy  1  1/788 (0.13%)  0/1550 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/788 (0.13%)  0/1550 (0.00%) 
Psychiatric disorders     
Depression  1  2/788 (0.25%)  2/1550 (0.13%) 
Confusional state  1  0/788 (0.00%)  1/1550 (0.06%) 
Alcohol abuse  1  1/788 (0.13%)  0/1550 (0.00%) 
Panic attack  1  0/788 (0.00%)  1/1550 (0.06%) 
Bipolar disorder  1  0/788 (0.00%)  2/1550 (0.13%) 
Suicidal ideation  1  0/788 (0.00%)  1/1550 (0.06%) 
Suicide attempt  1  1/788 (0.13%)  2/1550 (0.13%) 
Major depression  1  1/788 (0.13%)  1/1550 (0.06%) 
Depression suicidal  1  1/788 (0.13%)  0/1550 (0.00%) 
Mental disorder due to a general medical condition  1  1/788 (0.13%)  0/1550 (0.00%) 
Mental status changes  1  2/788 (0.25%)  0/1550 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/788 (0.13%)  2/1550 (0.13%) 
Nephrolithiasis  1  1/788 (0.13%)  3/1550 (0.19%) 
Renal failure acute  1  3/788 (0.38%)  2/1550 (0.13%) 
Renal failure chronic  1  0/788 (0.00%)  1/1550 (0.06%) 
Renal impairment  1  1/788 (0.13%)  0/1550 (0.00%) 
Urinary retention  1  1/788 (0.13%)  1/1550 (0.06%) 
Calculus ureteric  1  0/788 (0.00%)  1/1550 (0.06%) 
Diabetic nephropathy  1  0/788 (0.00%)  1/1550 (0.06%) 
Renal pain  1  0/788 (0.00%)  1/1550 (0.06%) 
Urethral stenosis  1  0/788 (0.00%)  2/1550 (0.13%) 
Calculus urinary  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypertonic bladder  1  1/788 (0.13%)  0/1550 (0.00%) 
Bladder spasm  1  0/788 (0.00%)  1/1550 (0.06%) 
Cystitis interstitial  1  0/788 (0.00%)  1/1550 (0.06%) 
Renal artery stenosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Ureteric stenosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Reproductive system and breast disorders     
Menorrhagia  1  0/788 (0.00%)  1/1550 (0.06%) 
Metrorrhagia  1  0/788 (0.00%)  1/1550 (0.06%) 
Galactorrhoea  1  0/788 (0.00%)  1/1550 (0.06%) 
Ovarian cyst  1  0/788 (0.00%)  1/1550 (0.06%) 
Prostatomegaly  1  1/788 (0.13%)  0/1550 (0.00%) 
Uterine haemorrhage  1  0/788 (0.00%)  1/1550 (0.06%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  6/788 (0.76%)  4/1550 (0.26%) 
Asthma  1  1/788 (0.13%)  3/1550 (0.19%) 
Dyspnoea  1  0/788 (0.00%)  1/1550 (0.06%) 
Epistaxis  1  0/788 (0.00%)  1/1550 (0.06%) 
Pulmonary embolism  1  1/788 (0.13%)  6/1550 (0.39%) 
Pleural effusion  1  2/788 (0.25%)  1/1550 (0.06%) 
Bronchitis chronic  1  0/788 (0.00%)  1/1550 (0.06%) 
Acute respiratory distress syndrome  1  0/788 (0.00%)  1/1550 (0.06%) 
Laryngeal oedema  1  0/788 (0.00%)  1/1550 (0.06%) 
Pneumonia aspiration  1  1/788 (0.13%)  1/1550 (0.06%) 
Pulmonary hypertension  1  0/788 (0.00%)  1/1550 (0.06%) 
Acute respiratory failure  1  1/788 (0.13%)  0/1550 (0.00%) 
Pulmonary oedema  1  1/788 (0.13%)  0/1550 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/788 (0.00%)  1/1550 (0.06%) 
Dermatitis allergic  1  0/788 (0.00%)  1/1550 (0.06%) 
Angioedema  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypersensitivity vasculitis  1  0/788 (0.00%)  1/1550 (0.06%) 
Vascular disorders     
Hypertension  1  2/788 (0.25%)  0/1550 (0.00%) 
Hypotension  1  1/788 (0.13%)  1/1550 (0.06%) 
Deep vein thrombosis  1  0/788 (0.00%)  2/1550 (0.13%) 
Peripheral arterial occlusive disease  1  1/788 (0.13%)  4/1550 (0.26%) 
Peripheral vascular disorder  1  1/788 (0.13%)  1/1550 (0.06%) 
Thrombophlebitis  1  1/788 (0.13%)  0/1550 (0.00%) 
Aortic aneurysm  1  1/788 (0.13%)  0/1550 (0.00%) 
Iliac artery occlusion  1  0/788 (0.00%)  2/1550 (0.13%) 
Peripheral artery stenosis  1  0/788 (0.00%)  1/1550 (0.06%) 
Subclavian artery stenosis  1  1/788 (0.13%)  1/1550 (0.06%) 
Aortic aneurysm rupture  1  0/788 (0.00%)  1/1550 (0.06%) 
Aortic dissection  1  0/788 (0.00%)  1/1550 (0.06%) 
Extremity necrosis  1  1/788 (0.13%)  1/1550 (0.06%) 
Femoral artery aneurysm  1  0/788 (0.00%)  1/1550 (0.06%) 
Hypertensive crisis  1  1/788 (0.13%)  0/1550 (0.00%) 
Peripheral ischaemia  1  2/788 (0.25%)  1/1550 (0.06%) 
Hypovolaemic shock  1  1/788 (0.13%)  0/1550 (0.00%) 
Lymphocele  1  1/788 (0.13%)  0/1550 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Q2W Alirocumab 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   366/788 (46.45%)   707/1550 (45.61%) 
Gastrointestinal disorders     
Diarrhoea  1  45/788 (5.71%)  89/1550 (5.74%) 
General disorders     
Injection site reaction  1  33/788 (4.19%)  91/1550 (5.87%) 
Infections and infestations     
Nasopharyngitis  1  103/788 (13.07%)  209/1550 (13.48%) 
Upper respiratory tract infection  1  68/788 (8.63%)  114/1550 (7.35%) 
Urinary tract infection  1  54/788 (6.85%)  87/1550 (5.61%) 
Influenza  1  43/788 (5.46%)  88/1550 (5.68%) 
Bronchitis  1  40/788 (5.08%)  83/1550 (5.35%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  52/788 (6.60%)  84/1550 (5.42%) 
Myalgia  1  23/788 (2.92%)  84/1550 (5.42%) 
Arthralgia  1  52/788 (6.60%)  80/1550 (5.16%) 
Nervous system disorders     
Headache  1  44/788 (5.58%)  76/1550 (4.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Manual reclassification was done by the Sponsor for the "other reasons" of non-completion of study as specified in the electronic case report (eCRF) form.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01507831     History of Changes
Other Study ID Numbers: LTS11717
2011-002806-59 ( EudraCT Number )
U1111-1121-3928 ( Other Identifier: UTN )
First Submitted: January 6, 2012
First Posted: January 11, 2012
Results First Submitted: November 18, 2015
Results First Posted: December 22, 2015
Last Update Posted: December 22, 2015