Back to resultsMonoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 (MENDEL-2)
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Ezetimibe
Placebo to Evolocumab
Placebo to Ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 18 to ≤ 80 years of age
- National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
- Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
- History of coronary heart disease
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
- Uncontrolled hypothyroidism or hyperthyroidism
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Placebo Q2W
Placebo QM
Ezetimibe (Q2W)
Ezetimibe (QM)
Evolocumab Q2W
Evolocumab QM
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Secondary Outcome Measures
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01763827
Brief Title
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Acronym
MENDEL-2
Official Title
A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2013 (Actual)
Primary Completion Date
October 10, 2013 (Actual)
Study Completion Date
October 29, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
Arm Title
Placebo QM
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Arm Title
Ezetimibe (Q2W)
Arm Type
Active Comparator
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Arm Title
Ezetimibe (QM)
Arm Type
Active Comparator
Arm Description
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Arm Title
Evolocumab Q2W
Arm Type
Experimental
Arm Description
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Arm Title
Evolocumab QM
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia
Intervention Description
Administered orally once a day
Intervention Type
Biological
Intervention Name(s)
Placebo to Evolocumab
Intervention Description
Administered by subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo to Ezetimibe
Intervention Description
Administered orally once daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Change From Baseline in LDL-C at Week 12
Time Frame
Baseline and Week 12
Title
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time Frame
Weeks 10 and 12
Title
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Time Frame
Week 12
Title
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in Triglycerides at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in VLDL-C at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in HDL-C at Week 12
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 to ≤ 80 years of age
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
History of coronary heart disease
New York Heart Association (NYHA) III or IV heart failure
Uncontrolled cardiac arrhythmia
Uncontrolled hypertension
Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
Uncontrolled hypothyroidism or hyperthyroidism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Research Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Research Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Research Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Research Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Research Site
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Research Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Site
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Site
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Research Site
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Research Site
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
Research Site
City
Anthée
ZIP/Postal Code
5520
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1080
Country
Belgium
Facility Name
Research Site
City
Gozee
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Research Site
City
Gribomont
ZIP/Postal Code
6887
Country
Belgium
Facility Name
Research Site
City
Halen
ZIP/Postal Code
3545
Country
Belgium
Facility Name
Research Site
City
Ham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Research Site
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Facility Name
Research Site
City
Retie
ZIP/Postal Code
2470
Country
Belgium
Facility Name
Research Site
City
Tessenderlo
ZIP/Postal Code
3980
Country
Belgium
Facility Name
Research Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0A 1G0
Country
Canada
Facility Name
Research Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Research Site
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Gières
ZIP/Postal Code
38610
Country
France
Facility Name
Research Site
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Alberton
State/Province
Gauteng
ZIP/Postal Code
1449
Country
South Africa
Facility Name
Research Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Research Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Research Site
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
24691094
Citation
Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H; MENDEL-2 Investigators. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2531-2540. doi: 10.1016/j.jacc.2014.03.018. Epub 2014 Mar 29.
Results Reference
background
PubMed Identifier
33325247
Citation
Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.
Results Reference
background
PubMed Identifier
32564340
Citation
Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.
Results Reference
background
PubMed Identifier
29736889
Citation
Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.
Results Reference
background
PubMed Identifier
29353350
Citation
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Results Reference
background
PubMed Identifier
30755061
Citation
Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.
Results Reference
background
PubMed Identifier
30120772
Citation
Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.
Results Reference
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PubMed Identifier
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AmgenTrials clinical trials website
Learn more about this trial
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
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