Trial Outcomes & Findings for Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan (NCT NCT02289963)
NCT ID: NCT02289963
Last Updated: 2017-06-26
Results Overview
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 up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
199 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2017-06-26
Participant Flow
The study was conducted at 27 centers in South Korea and Taiwan. Overall 316 participants were screened between January and September 2015, of whom 117 were screen failures. Screen failures were mainly due to exclusion criteria met.
Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, intensity of statin treatment and country. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio (Placebo:Alirocumab). A total of 199 participants were randomized.
Participant milestones
| Measure |
Placebo Q2W
Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
97
|
|
Overall Study
Treated
|
102
|
97
|
|
Overall Study
COMPLETED
|
97
|
87
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Poor compliance to protocol
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Last injection missed
|
2
|
2
|
|
Overall Study
End treatment visit outside visit window
|
0
|
4
|
|
Overall Study
Other than specified above
|
0
|
2
|
Baseline Characteristics
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Calculated LDL-C in mmol/L
|
2.572 mmol/L
STANDARD_DEVIATION 0.653 • n=5 Participants
|
2.513 mmol/L
STANDARD_DEVIATION 0.721 • n=7 Participants
|
2.543 mmol/L
STANDARD_DEVIATION 0.686 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C on- or off-treatment.
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 up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
|
6.3 percent change
Standard Error 2.9
|
-57.1 percent change
Standard Error 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
|
6.0 Percent Change
Standard Error 2.7
|
-60.2 Percent Change
Standard Error 2.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
|
4.7 percent change
Standard Error 2.2
|
-57.9 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
|
4.7 percent change
Standard Error 2.2
|
-58.4 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=96 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
|
4.1 percent change
Standard Error 2.3
|
-42.3 percent change
Standard Error 2.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Placebo Q2W
n=99 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=95 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
|
3.8 percent change
Standard Error 2.1
|
-45.4 percent change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
|
4.3 percent change
Standard Error 2.4
|
-47.2 percent change
Standard Error 2.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
|
4.1 percent change
Standard Deviation 2.2
|
-50.1 percent change
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
|
4.0 percent change
Standard Deviation 1.8
|
-31.2 percent change
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Apo B ITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=96 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
|
5.2 percent change
Standard Error 1.8
|
-40.9 percent change
Standard Error 1.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Non-HDL-C ITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
|
3.9 percent change
Standard Deviation 1.8
|
-47.3 percent change
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Total-C ITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
|
2.8 percent change
Standard Error 1.4
|
-32.9 percent change
Standard Error 1.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
|
14.2 percentage of participants
|
85.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis
|
14.1 percentage of participants
|
88.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
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 up to Week 24 regardless of status on- or off-treatment were included in the imputation model.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
|
-2.251 percent change
Standard Error 2.962
|
-35.862 percent change
Standard Error 3.011
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis
|
6.2 percent change
Standard Error 1.7
|
13.8 percent change
Standard Error 1.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
|
-3.627 percent change
Standard Error 3.111
|
-8.143 percent change
Standard Error 3.204
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=96 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis
|
3.2 percent change
Standard Error 1.2
|
4.5 percent change
Standard Error 1.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis
|
-1.676 percent change
Standard Error 2.732
|
-33.601 percent change
Standard Error 2.778
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: HDL-C ITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
|
2.0 percent change
Standard Error 1.5
|
7.1 percent change
Standard Error 1.6
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=102 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
|
2.113 percent change
Standard Error 3.192
|
-6.999 percent change
Standard Error 3.252
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Apo A-1 ITT population.
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Placebo Q2W
n=100 Participants
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=96 Participants
Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
|---|---|---|
|
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
|
1.5 percent change
Standard Error 1.1
|
4.5 percent change
Standard Error 1.1
|
Adverse Events
Placebo Q2W
Serious events: 10 serious events
Other events: 15 other events
Deaths: 0 deaths
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Serious events: 17 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=102 participants at risk
Participants exposed to Placebo (for Alirocumab) SC injection Q2W added to stable LMT (mean exposure of 23 weeks).
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 participants at risk
Participants exposed to Alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable LMT (mean exposure of 24 weeks).
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
2.1%
2/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Infections and infestations
Influenza
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Infections and infestations
Diarrhoea infectious
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Nervous system disorders
Ischaemic stroke
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Nervous system disorders
Neuromuscular pain
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Cardiac disorders
Coronary artery disease
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
2.1%
2/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Cardiac disorders
Angina unstable
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Vascular disorders
Brachiocephalic artery stenosis
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Loss of anatomical alignment after fracture reduction
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
0.00%
0/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Product Issues
Device failure
|
0.00%
0/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
1.0%
1/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
Other adverse events
| Measure |
Placebo Q2W
n=102 participants at risk
Participants exposed to Placebo (for Alirocumab) SC injection Q2W added to stable LMT (mean exposure of 23 weeks).
|
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
n=97 participants at risk
Participants exposed to Alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable LMT (mean exposure of 24 weeks).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.9%
4/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
6.2%
6/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
6/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
3.1%
3/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Nervous system disorders
Dizziness
|
2.9%
3/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
6.2%
6/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Nervous system disorders
Headache
|
2.9%
3/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
5.2%
5/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
1/102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
|
5.2%
5/97 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
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).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER