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    Clinical Trial Results:
    Long Term Safety Study of PRALUENT in Patients with Heterozygous Familial Hypercholesterolemia or with Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial

    Summary
    EudraCT number
    		 2018-002810-11
    Trial protocol
    		 EE   BG  
    Global end of trial date
    08 Apr 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jul 2021
    First version publication date
    23 Apr 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    R727-CL-1609
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03694197
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd., Tarrytown, NY, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the long term safety of PRALUENT in subjects with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) subjects at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (2016-003189-16). The secondary objectives of the study were: • To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) • To evaluate the effect of PRALUENT on other lipid parameters • To evaluate the effect of PRALUENT on gonadal steroid hormones
    Protection of trial subjects
    This clinical study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the International Council for Harmonisation (ICH) guidelines for GCP and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 96
    Country: Number of subjects enrolled
    Estonia: 39
    Country: Number of subjects enrolled
    Russian Federation: 260
    Country: Number of subjects enrolled
    South Africa: 304
    Country: Number of subjects enrolled
    Ukraine: 276
    Country: Number of subjects enrolled
    United States: 410
    Worldwide total number of subjects
    1385
    EEA total number of subjects
    135
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    680
    From 65 to 84 years
    702
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 The 1389 subjects who completed double-blind treatment and the end-of-study (EOS) visit in R727-CL-1532 (2016-003189-16) signed consent and were screened for this open-label study (EOS visit corresponded to day 1/visit 1 of this study).

    Pre-assignment
    Screening details
    		 First subcutaneous (SC) injection was administered in the clinic (day 1/visit 1). Four of the1389 subjects discontinued on day 1 before treatment: 2 discontinued due to failure to meet inclusion/exclusion criteria,1 withdrew consent, and 1 discontinued due to adverse event (AE). A total of 1385 subjects received any study drug on day 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Alirocumab 75 Q2W/Up150 Q2W
    Arm description
    		 All subjects initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alirocumab
    Investigational medicinal product code
    SUB74847
    Other name
    PRALUENT
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    75mg

    Number of subjects in period 1
    		Alirocumab 75 Q2W/Up150 Q2W
    Started
    1385
    Completed
    0
    Not completed
    1385
         Physician decision
    4
         Subject withdrew consent
    10
         Protocol became inconvenient to participate
    1
         Related to IMP administration
    1
         Adverse event, non-fatal
    9
         Study terminated by sponsor
    1350
         Subject moved
    5
         Not disclosed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alirocumab 75 Q2W/Up150 Q2W
    Reporting group description
    		 All subjects initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.

    Reporting group values
    		 Alirocumab 75 Q2W/Up150 Q2W Total
    Number of subjects
    		 1385 1385
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 680 680
        From 65-84 years
    		 702 702
        85 years and over
    		 3 3
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.6 ( 8.63 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 527 527
        Male
    		 858 858
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        White
    		 1178 1178
        Black or African American
    		 81 81
        Asian
    		 7 7
        American Indian or Alaska Native
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Other
    		 118 118
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 10 10
        Not Hispanic or Latino
    		 1372 1372
        Unknown or Not Reported
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Alirocumab 75 Q2W/Up150 Q2W
    Reporting group description
    		 All subjects initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.

    Primary: Number of subjects with adverse events (AE) after first administration of study drug through the last dose of study drug plus 2 weeks

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    End point title
    		 Number of subjects with adverse events (AE) after first administration of study drug through the last dose of study drug plus 2 weeks [1]
    End point description
    An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
    End point type
    Primary
    End point timeframe
    After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks; Safety analysis set (SAF): All subjects who received any study drug
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal inferential testing was performed.
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Subjects
        Any treatment emergent AE (TEAE)
    568
        Any treatment emergent serious AE (SAE)
    89
        Any TEAE leading to death
    5
        Any TEAE leading to perm. treatment discont.
    9
        Any neurocognitive disorders TEAE (by Sponsor CMQ)
    4
        Any neurocognitive disorders TEAE (by FDA CMQ)
    0
        Any NOD; n=687 (w/out diabetes at baseline)
    15
        Any hepatic disorders TEAE
    14
        Any neurological TEAE
    15
        Any general allergic TEAE
    25
        At least one TE injection site reaction
    22
        Any cataract TEAE
    5
        Any elevated ALT ≥3 ULN
    1
        Any DM/DC TEAE; n=698 (with diabetes at baseline)
    41
        Any DM/DC TEAE; n=687 (w/out diabetes at baseline)
    3
    No statistical analyses for this end point

    Secondary: Calculated low-density lipoprotein cholesterol (LDL-C) values from baseline over time

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    End point title
    		 Calculated low-density lipoprotein cholesterol (LDL-C) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); Safety analysis set (SAF): All subjects who received any study drug; Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Milligrams per decilitre (mg/dL)
    arithmetic mean (standard deviation)
        Baseline (n = 1367)
    117.8 ( 40.67 )
        Week 8 (n = 1345)
    58.9 ( 37.31 )
        Week 12 (n = 356)
    63.6 ( 40.79 )
        Week 24 (n = 769)
    56.2 ( 36.59 )
        Week 48 (n = 311)
    56.8 ( 36.13 )
        Week 72 (n = 54)
    52.2 ( 38.80 )
    No statistical analyses for this end point

    Secondary: Percent change in LDL-C from baseline over time

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    End point title
    		 Percent change in LDL-C from baseline over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 1328)
    -48.74 ( 31.121 )
        Week 12 (n = 353)
    -44.64 ( 35.338 )
        Week 24 (n = 754)
    -50.75 ( 30.249 )
        Week 48 (n = 301)
    -52.35 ( 27.929 )
        Week 72 (n = 54)
    -51.21 ( 32.742 )
    No statistical analyses for this end point

    Secondary: Total cholesterol (Total-C) values from baseline over time

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    End point title
    		 Total cholesterol (Total-C) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    199.5 ( 48.88 )
        Week 8 (n = 1346)
    139.5 ( 44.76 )
        Week 12 (n = 356)
    145.0 ( 48.68 )
        Week 24 (n = 769)
    137.3 ( 44.18 )
        Week 48 (n = 311)
    139.5 ( 44.53 )
        Week 72 (n = 54)
    131.7 ( 43.25 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in Total-C over time

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    End point title
    		 Percent change from baseline in Total-C over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 1346)
    -28.68 ( 20.158 )
        Week 12 (n = 356)
    -25.99 ( 23.058 )
        Week 24 (n = 769)
    -29.98 ( 20.930 )
        Week 48 (n = 311)
    -30.89 ( 21.004 )
        Week 72 (n = 54)
    -31.55 ( 22.238 )
    No statistical analyses for this end point

    Secondary: Lipoprotein-a (Lp(a)) values from baseline over time

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    End point title
    		 Lipoprotein-a (Lp(a)) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    39.7 ( 47.86 )
        Week 8 (n = 190)
    35.0 ( 41.99 )
        Week 12 (n = 353)
    32.7 ( 39.42 )
        Week 24 (n = 419)
    33.9 ( 42.54 )
        Week 48 (n = 311)
    38.6 ( 50.66 )
        Week 72 (n = 54)
    40.4 ( 56.47 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in Lp(a) over time

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    End point title
    		 Percent change from baseline in Lp(a) over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 190)
    -12.69 ( 35.452 )
        Week 12 (n = 353)
    10.63 ( 228.659 )
        Week 24 (n = 419)
    -6.80 ( 110.827 )
        Week 48 (n = 311)
    -7.89 ( 116.831 )
        Week 72 (n = 54)
    -22.23 ( 28.233 )
    No statistical analyses for this end point

    Secondary: Non-high-density lipoprotein cholesterol (non-HDL-C) values from baseline over time

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    End point title
    		 Non-high-density lipoprotein cholesterol (non-HDL-C) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    152.4 ( 48.81 )
        Week 8 (n = 1346)
    88.5 ( 43.54 )
        Week 12 (n = 356)
    94.3 ( 48.77 )
        Week 24 (n = 769)
    87.3 ( 43.56 )
        Week 48 (n = 311)
    88.9 ( 44.25 )
        Week 72 (n = 54)
    80.9 ( 42.67 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in non-HDL-C over time

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    End point title
    		 Percent change from baseline in non-HDL-C over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 1346)
    -40.35 ( 27.470 )
        Week 12 (n = 356)
    -36.89 ( 29.567 )
        Week 24 (n = 769)
    -41.47 ( 26.763 )
        Week 48 (n = 311)
    -42.33 ( 28.728 )
        Week 72 (n = 54)
    -43.28 ( 29.534 )
    No statistical analyses for this end point

    Secondary: High-density lipoprotein cholesterol (HDL-C) values from baseline over time

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    End point title
    		 High-density lipoprotein cholesterol (HDL-C) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    47.1 ( 13.92 )
        Week 8 (n = 1346)
    51.0 ( 14.82 )
        Week 12 (n = 356)
    50.6 ( 13.95 )
        Week 24 (n = 769)
    49.9 ( 14.80 )
        Week 48 (n = 311)
    50.5 ( 14.66 )
        Week 72 (n = 54)
    50.8 ( 14.61 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in HDL-C over time

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    End point title
    		 Percent change from baseline in HDL-C over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 1346)
    10.54 ( 22.735 )
        Week 12 (n = 356)
    10.33 ( 21.933 )
        Week 24 (n = 769)
    8.53 ( 21.824 )
        Week 48 (n = 311)
    9.81 ( 23.690 )
        Week 72 (n = 54)
    9.24 ( 21.505 )
    No statistical analyses for this end point

    Secondary: Fasting triglycerides (TGs) values from baseline over time

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    End point title
    		 Fasting triglycerides (TGs) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    179.2 ( 146.51 )
        Week 8 (n = 1346)
    154.8 ( 113.05 )
        Week 12 (n = 356)
    162.2 ( 182.00 )
        Week 24 (n = 769)
    169.3 ( 161.45 )
        Week 48 (n = 311)
    171.1 ( 131.35 )
        Week 72 (n = 54)
    156.9 ( 65.21 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in fasting TGs over time

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    End point title
    		 Percent change from baseline in fasting TGs over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 1346)
    -4.68 ( 49.230 )
        Week 12 (n = 356)
    -4.29 ( 40.748 )
        Week 24 (n = 769)
    0.42 ( 54.118 )
        Week 48 (n = 311)
    1.54 ( 69.156 )
        Week 72 (n = 54)
    -5.97 ( 41.440 )
    No statistical analyses for this end point

    Secondary: Apolipoprotein B (Apo B) values from baseline over time

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    End point title
    		 Apolipoprotein B (Apo B) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16). SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    103.8 ( 27.25 )
        Week 8 (n = 190)
    62.5 ( 27.63 )
        Week 12 (n = 353)
    68.0 ( 31.32 )
        Week 24 (n = 420)
    61.5 ( 26.20 )
        Week 48 (n = 311)
    63.7 ( 26.40 )
        Week 72 (n = 54)
    58.5 ( 25.82 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in Apo B over time

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    End point title
    		 Percent change from baseline in Apo B over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 190)
    -36.51 ( 34.460 )
        Week 12 (n = 353)
    -34.48 ( 27.905 )
        Week 24 (n = 420)
    -38.16 ( 24.867 )
        Week 48 (n = 311)
    -37.93 ( 23.767 )
        Week 72 (n = 54)
    -39.04 ( 26.383 )
    No statistical analyses for this end point

    Secondary: Apolipoprotein-A1 (Apo A1) values from baseline over time

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    End point title
    		 Apolipoprotein-A1 (Apo A1) values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16). SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    145.3 ( 24.95 )
        Week 8 (n = 190)
    148.5 ( 24.73 )
        Week 12 (n = 353)
    149.4 ( 25.38 )
        Week 24 (n = 420)
    150.7 ( 26.36 )
        Week 48 (n = 311)
    152.6 ( 25.96 )
        Week 72 (n = 54)
    151.4 ( 26.03 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in Apo A1 over time

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    End point title
    		 Percent change from baseline in Apo A1 over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 8 (n = 190)
    5.07 ( 13.385 )
        Week 12 (n = 353)
    2.99 ( 13.638 )
        Week 24 (n = 420)
    5.35 ( 14.108 )
        Week 48 (n = 311)
    4.77 ( 13.836 )
        Week 72 (n = 54)
    1.21 ( 13.170 )
    No statistical analyses for this end point

    Secondary: Gonadal hormone (follicle stimulating hormone [FSH] and luteinizing hormone [LH]) values for female subjects from baseline over time

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    End point title
    		 Gonadal hormone (follicle stimulating hormone [FSH] and luteinizing hormone [LH]) values for female subjects from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (Female subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    527
    Units: International units per litre (IU/L)
    arithmetic mean (standard deviation)
        FSH Baseline (n = 527)
    57.948 ( 26.7383 )
        FSH Week 8 (n = 84)
    59.264 ( 24.7912 )
        FSH Week 12 (n = 135)
    54.279 ( 23.9923 )
        FSH Week 24 (n = 280)
    57.664 ( 25.9830 )
        FSH Week 48 (n = 106)
    56.529 ( 25.1408 )
        FSH Week 72 (n = 23)
    58.600 ( 24.5205 )
        LH Baseline (n = 527)
    30.155 ( 13.1090 )
        LH Week 8 (n = 84)
    33.794 ( 14.4459 )
        LH Week 12 (n = 135)
    30.779 ( 13.0946 )
        LH Week 24 (n = 280)
    31.260 ( 13.7344 )
        LH Week 48 (n = 106)
    29.585 ( 13.9792 )
        LH Week 72 (n = 23)
    29.248 ( 11.0829 )
    No statistical analyses for this end point

    Secondary: Change from baseline in gonadal hormones (FSH and LH) for female subjects over time

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    End point title
    		 Change from baseline in gonadal hormones (FSH and LH) for female subjects over time
    End point description
    SAF (Female subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    527
    Units: IU/L
    arithmetic mean (standard deviation)
        FSH Week 8 (n = 84)
    -0.765 ( 12.0083 )
        FSH Week 12 (n = 135)
    -0.984 ( 12.1584 )
        FSH Week 24 (n = 280)
    -0.575 ( 8.7780 )
        FSH Week 48 (n = 106)
    -0.877 ( 15.9972 )
        FSH Week 72 (n = 23)
    -1.861 ( 8.6119 )
        LH Week 8 (n = 84)
    2.730 ( 8.2258 )
        LH Week 12 (n = 135)
    1.882 ( 8.2884 )
        LH Week 24 (n = 280)
    0.939 ( 6.3694 )
        LH Week 48 (n = 106)
    0.367 ( 8.5631 )
        LH Week 72 (n = 23)
    0.222 ( 6.8910 )
    No statistical analyses for this end point

    Secondary: Gonadal (FSH and LH) hormone values for male subjects from baseline over time

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    End point title
    		 Gonadal (FSH and LH) hormone values for male subjects from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (Male subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    858
    Units: International units per litre (IU/L)
    arithmetic mean (standard deviation)
        FSH Baseline (n = 858)
    8.006 ( 7.4451 )
        FSH Week 8 (n = 117)
    7.959 ( 7.5500 )
        FSH Week 12 (n = 215)
    7.766 ( 6.8204 )
        FSH Week 24 (n = 489)
    8.268 ( 8.1355 )
        FSH Week 48 (n = 203)
    9.597 ( 11.2138 )
        FSH Week 72 (n = 32)
    10.005 ( 13.2973 )
        LH Baseline (n = 858)
    6.500 ( 4.2832 )
        LH Week 8 (n = 117)
    7.094 ( 4.7226 )
        LH Week 12 (n = 215)
    6.688 ( 4.4079 )
        LH Week 24 (n = 489)
    6.931 ( 4.8597 )
        LH Week 48 (n = 203)
    7.677 ( 6.5478 )
        LH Week 72 (n = 32)
    8.173 ( 8.9083 )
    No statistical analyses for this end point

    Secondary: Change from baseline in gonadal hormones (FSH and LH) for male subjects over time

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    End point title
    		 Change from baseline in gonadal hormones (FSH and LH) for male subjects over time
    End point description
    SAF (Male subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    858
    Units: IU/L
    arithmetic mean (standard deviation)
        FSH Week 8 (n = 117)
    0.285 ( 3.7264 )
        FSH Week 12 (n = 215)
    -0.598 ( 4.1076 )
        FSH Week 24 (n = 489)
    0.331 ( 6.0522 )
        FSH Week 48 (n = 203)
    0.960 ( 10.3803 )
        FSH Week 72 (n = 32)
    2.458 ( 13.4730 )
        LH Week 8 (n = 117)
    0.535 ( 2.4847 )
        LH Week 12 (n = 215)
    -0.136 ( 3.2638 )
        LH Week 24 (n = 489)
    0.582 ( 4.4964 )
        LH Week 48 (n = 203)
    1.015 ( 6.6344 )
        LH Week 72 (n = 32)
    1.964 ( 9.3028 )
    No statistical analyses for this end point

    Secondary: Gonadotropin (estradiol) values for female subjects from baseline over time

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    End point title
    		 Gonadotropin (estradiol) values for female subjects from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (Female subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    527
    Units: picomoles per litre (pmol/L)
    arithmetic mean (standard deviation)
        Baseline (n = 527)
    55.589 ( 80.8238 )
        Week 8 (n = 84)
    58.676 ( 69.0119 )
        Week 12 (n = 135)
    59.673 ( 74.7587 )
        Week 24 (n = 280)
    64.304 ( 103.8955 )
        Week 48 (n = 106)
    64.503 ( 102.1595 )
        Week 72 (n = 23)
    57.926 ( 67.1795 )
    No statistical analyses for this end point

    Secondary: Change from baseline in gonadotropins (estradiol) for female subjects over time

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    End point title
    		 Change from baseline in gonadotropins (estradiol) for female subjects over time
    End point description
    SAF (Female subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    527
    Units: pmol/L
    arithmetic mean (standard deviation)
        Week 8 (n = 84)
    4.272 ( 77.1561 )
        Week 12 (n = 135)
    9.262 ( 73.1050 )
        Week 24 (n = 280)
    7.869 ( 78.4151 )
        Week 48 (n = 106)
    11.763 ( 97.5350 )
        Week 72 (n = 23)
    9.569 ( 38.0952 )
    No statistical analyses for this end point

    Secondary: Gonadotropin (testosterone) values for male subjects from baseline over time

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    End point title
    		 Gonadotropin (testosterone) values for male subjects from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (Male subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    858
    Units: nanomoles per litre (nmol/L)
    arithmetic mean (standard deviation)
        Baseline (n = 858)
    13.4370 ( 6.36321 )
        Week 8 (n = 117)
    14.5802 ( 5.99821 )
        Week 12 (n = 215)
    14.2443 ( 6.77070 )
        Week 24 (n = 489)
    13.5818 ( 6.11269 )
        Week 48 (n = 203)
    13.4798 ( 7.04977 )
        Week 72 (n = 32)
    12.7538 ( 6.37408 )
    No statistical analyses for this end point

    Secondary: Change from baseline in gonadotropins (testosterone) for male subjects over time

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    End point title
    		 Change from baseline in gonadotropins (testosterone) for male subjects over time
    End point description
    SAF (Male subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    858
    Units: nmol/L
    arithmetic mean (standard deviation)
        Week 8 (n = 117)
    0.6030 ( 4.46401 )
        Week 12 (n = 215)
    0.7965 ( 4.74765 )
        Week 24 (n = 489)
    0.1946 ( 5.89220 )
        Week 48 (n = 203)
    0.0498 ( 6.34201 )
        Week 72 (n = 32)
    1.2569 ( 5.29335 )
    No statistical analyses for this end point

    Secondary: Alanine aminotransferase values from baseline over time

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    End point title
    		 Alanine aminotransferase values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: Units per Liter (U/L)
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    0.516 ( 0.3218 )
        Week 8 (n = 201)
    0.468 ( 0.2745 )
        Week 12 (n = 350)
    0.505 ( 0.4940 )
        Week 24 (n = 769)
    0.493 ( 0.2851 )
        Week 48 (n = 310)
    0.533 ( 0.3267 )
        Week 72 (n = 54)
    0.468 ( 0.2340 )
    No statistical analyses for this end point

    Secondary: Change from baseline in alanine aminotransferase over time

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    End point title
    		 Change from baseline in alanine aminotransferase over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: U/L
    arithmetic mean (standard deviation)
        Week 8 (n = 201)
    -0.025 ( 0.3006 )
        Week 12 (n = 350)
    0.009 ( 0.5189 )
        Week 24 (n = 769)
    -0.036 ( 0.3294 )
        Week 48 (n = 310)
    -0.027 ( 0.3052 )
        Week 72 (n = 54)
    -0.062 ( 0.1872 )
    No statistical analyses for this end point

    Secondary: Aspartate aminotransferase values from baseline over time

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    End point title
    		 Aspartate aminotransferase values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    0.553 ( 0.2516 )
        Week 8 (n = 201)
    0.520 ( 0.2536 )
        Week 12 (n = 350)
    0.527 ( 0.2698 )
        Week 24 (n = 769)
    0.544 ( 0.3071 )
        Week 48 (n = 310)
    0.565 ( 0.2773 )
        Week 72 (n = 54)
    0.556 ( 0.2256 )
    No statistical analyses for this end point

    Secondary: Change from baseline in aspartate aminotransferase over time

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    End point title
    		 Change from baseline in aspartate aminotransferase over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: U/L
    arithmetic mean (standard deviation)
        Week 8 (n = 201)
    -0.022 ( 0.2856 )
        Week 12 (n = 350)
    -0.017 ( 0.3004 )
        Week 24 (n = 769)
    -0.013 ( 0.2901 )
        Week 48 (n = 310)
    -0.019 ( 0.2390 )
        Week 72 (n = 54)
    -0.037 ( 0.1730 )
    No statistical analyses for this end point

    Secondary: Alkaline phosphatase values from baseline over time

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    End point title
    		 Alkaline phosphatase values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    0.601 ( 0.1865 )
        Week 8 (n = 201)
    0.635 ( 0.2151 )
        Week 12 (n = 350)
    0.605 ( 0.1865 )
        Week 24 (n = 769)
    0.602 ( 0.2012 )
        Week 48 (n = 310)
    0.602 ( 0.2657 )
        Week 72 (n = 54)
    0.553 ( 0.1678 )
    No statistical analyses for this end point

    Secondary: Change from baseline in alkaline phosphatase over time

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    End point title
    		 Change from baseline in alkaline phosphatase over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: U/L
    arithmetic mean (standard deviation)
        Week 8 (n = 201)
    0.009 ( 0.1371 )
        Week 12 (n = 350)
    0.013 ( 0.1203 )
        Week 24 (n = 769)
    0.006 ( 0.1152 )
        Week 48 (n = 310)
    0.024 ( 0.2333 )
        Week 72 (n = 54)
    -0.011 ( 0.1029 )
    No statistical analyses for this end point

    Secondary: Total bilirubin values from baseline over time

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    End point title
    		 Total bilirubin values from baseline over time
    End point description
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (2016-003189-16); SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: micromoles per litre (umol/L)
    arithmetic mean (standard deviation)
        Baseline (n = 1385)
    10.76 ( 4.736 )
        Week 8 (n = 201)
    10.01 ( 4.123 )
        Week 12 (n = 350)
    10.26 ( 4.758 )
        Week 24 (n = 769)
    10.41 ( 4.922 )
        Week 48 (n = 310)
    10.06 ( 4.503 )
        Week 72 (n = 54)
    8.82 ( 3.770 )
    No statistical analyses for this end point

    Secondary: Change from baseline in total bilirubin over time

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    End point title
    		 Change from baseline in total bilirubin over time
    End point description
    SAF (All subjects who received any study drug); Here, "n" = number of subjects evaluable at that timepoint
    End point type
    Secondary
    End point timeframe
    Up to week 72
    End point values
    		 Alirocumab 75 Q2W/Up150 Q2W
    Number of subjects analysed
    1385
    Units: umol/L
    arithmetic mean (standard deviation)
        Week 8 (n = 201)
    -0.37 ( 3.120 )
        Week 12 (n = 350)
    -0.44 ( 3.854 )
        Week 24 (n = 769)
    -0.48 ( 3.962 )
        Week 48 (n = 310)
    -0.05 ( 3.991 )
        Week 72 (n = 54)
    0.71 ( 2.152 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events (AEs) were recorded from the time of signed informed consent until the end of study, up to 80 weeks.
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs) are reported. TEAEs are AEs that developed or worsened or became serious during the TEAE period (time from first dose of study drug to the last study visit).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Alirocumab 75 Q2W/Up150 Q2W
    Reporting group description
    		 All subjects initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No occurrence of non-serious adverse events met the 5% threshold for reporting.
    Serious adverse events
    		 Alirocumab 75 Q2W/Up150 Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    89 / 1385 (6.43%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Synovial sarcoma
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 1385 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Arterial injury
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cartilage injury
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Electric shock
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic haemorrhage
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    10 / 1385 (0.72%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    8 / 1385 (0.58%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    6 / 1385 (0.43%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    5 / 1385 (0.36%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Intestinal ischaemia
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    2 / 1385 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 1385 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 1385 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Alirocumab 75 Q2W/Up150 Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1385 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2018
    The protocol was amended to align with feedback received from the European Medicines Agency (EMA), and updated for clarity and consistency with R727-CL-1532 (2016-003189-16) neurocognitive function protocol Amendment 5.
    17 Sep 2018
    The protocol was amended to add back text that was inadvertently removed in protocol amendment 1, and to clarify language for blinding, study discontinuation, treatment compliance, adverse event (AE) reporting period, and procedures for reporting serious adverse events (SAEs).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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