Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
FOURIER
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
3 other identifiers
interventional
27,564
47 countries
1269
Brief Summary
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2013
Typical duration for phase_3
1269 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2013
CompletedStudy Start
First participant enrolled
February 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2016
CompletedResults Posted
Study results publicly available
February 15, 2018
CompletedMay 28, 2024
May 1, 2024
3.8 years
January 8, 2013
December 15, 2017
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary Outcomes (8)
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to All Cause Death
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Myocardial Infarction
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Stroke
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
- +3 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
Evolocumab
EXPERIMENTALParticipants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.
Interventions
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Eligibility Criteria
You may qualify if:
- Male or female ≥ 40 to ≤ 85 years of age
- History of clinically evident cardiovascular disease at high risk for a recurrent event
- Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (\> 2.6 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
You may not qualify if:
- New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction \< 30%
- Uncontrolled hypertension
- Uncontrolled or recurrent ventricular tachycardia
- Untreated hyperthyroidism or hypothyroidism
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (1284)
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Birmingham, Alabama, 35235, United States
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Birmingham, Alabama, 35294, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Anchorage, Alaska, 99508, United States
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Glendale, Arizona, 85306, United States
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Phoenix, Arizona, 85015, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85723, United States
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Alhambra, California, 91801, United States
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Banning, California, 92220, United States
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Beverly Hills, California, 90211, United States
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Encino, California, 91436, United States
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Escondido, California, 92029, United States
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Glendale, California, 91204, United States
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Harbor City, California, 90710, United States
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Huntington Beach, California, 92646, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90807, United States
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Long Beach, California, 90822, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92663, United States
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Oceanside, California, 92056, United States
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Oxnard, California, 93030, United States
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Palm Springs, California, 92262, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95816, United States
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San Diego, California, 92103, United States
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San Diego, California, 92161, United States
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San Pedro, California, 90732, United States
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Santa Ana, California, 92704, United States
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Tarzana, California, 91356, United States
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Thousand Oaks, California, 91360, United States
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Torrance, California, 90502, United States
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Torrance, California, 90503, United States
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Valley Village, California, 91607, United States
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Aurora, Colorado, 80012, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80218, United States
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Greeley, Colorado, 80631, United States
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Littleton, Colorado, 80120, United States
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Longmont, Colorado, 80501, United States
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Bridgeport, Connecticut, 06610, United States
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Newark, Delaware, 19718, United States
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Seaford, Delaware, 19973, United States
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Wilmington, Delaware, 19803, United States
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Washington D.C., District of Columbia, 20037, United States
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Atlantis, Florida, 33462, United States
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Aventura, Florida, 33180, United States
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Bay Pines, Florida, 33744, United States
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Boynton Beach, Florida, 33472, United States
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Bradenton, Florida, 34205, United States
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Clearwater, Florida, 33756, United States
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Crystal River, Florida, 34429, United States
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Daytona Beach, Florida, 32117, United States
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Deerfield Beach, Florida, 33442, United States
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Delray Beach, Florida, 33484, United States
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Edgewater, Florida, 32141, United States
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Fleming Island, Florida, 32003, United States
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Fort Lauderdale, Florida, 33308, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville Beach, Florida, 32250, United States
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Lakeland, Florida, 33805, United States
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Largo, Florida, 33777, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33173, United States
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New Port Richey, Florida, 34653, United States
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Orlando, Florida, 32806, United States
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Palm Harbor, Florida, 34684, United States
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Pembroke Pines, Florida, 33024, United States
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Pembroke Pines, Florida, 33028, United States
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Pensacola, Florida, 32501, United States
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Ponte Vedra, Florida, 32081, United States
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Port Charlotte, Florida, 33952, United States
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Safety Harbor, Florida, 34695, United States
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Sanford, Florida, 32771, United States
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Sarasota, Florida, 34232, United States
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Sarasota, Florida, 34239, United States
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St. Petersburg, Florida, 33709, United States
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St. Petersburg, Florida, 33713, United States
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Tampa, Florida, 33614, United States
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Wellington, Florida, 33449, United States
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West Palm Beach, Florida, 33401, United States
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Athens, Georgia, 30606, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30909, United States
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Dunwoody, Georgia, 30338, United States
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East Point, Georgia, 30344, United States
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Eatonton, Georgia, 31024, United States
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Gainesville, Georgia, 30501, United States
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Macon, Georgia, 31201, United States
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Savannah, Georgia, 31406, United States
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Suwanee, Georgia, 30024, United States
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Boise, Idaho, 83704, United States
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Boise, Idaho, 83706, United States
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Coeur d'Alene, Idaho, 83814, United States
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Meridian, Idaho, 83642, United States
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Nampa, Idaho, 83686, United States
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Addison, Illinois, 60101, United States
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Belleville, Illinois, 62220, United States
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Chicago, Illinois, 60616, United States
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Hazel Crest, Illinois, 60429, United States
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Jerseyville, Illinois, 62052, United States
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Quincy, Illinois, 62301, United States
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Evansville, Indiana, 47714, United States
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Indianapolis, Indiana, 46227, United States
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Indianapolis, Indiana, 46237, United States
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Indianapolis, Indiana, 46260, United States
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Munster, Indiana, 46321, United States
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Valparaiso, Indiana, 46383, United States
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Ames, Iowa, 50010, United States
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Des Moines, Iowa, 50266, United States
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Iowa City, Iowa, 52242, United States
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Waterloo, Iowa, 50702, United States
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Hutchinson, Kansas, 67502, United States
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Kansas City, Kansas, 66160, United States
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Overland Park, Kansas, 66210, United States
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Wichita, Kansas, 67203, United States
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Wichita, Kansas, 67214, United States
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Lexington, Kentucky, 40504, United States
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Owensboro, Kentucky, 42303, United States
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Baton Rouge, Louisiana, 70808, United States
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Covington, Louisiana, 70433, United States
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Hammond, Louisiana, 70403, United States
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Lafayette, Louisiana, 70508, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71203, United States
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Natchitoches, Louisiana, 71457, United States
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Slidell, Louisiana, 70458, United States
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Auburn, Maine, 04210, United States
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Bangor, Maine, 04401, United States
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Biddeford, Maine, 04005, United States
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Portland, Maine, 04101, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21204, United States
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Baltimore, Maryland, 21236, United States
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Baltimore, Maryland, 21237, United States
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Charlotte Hall, Maryland, 20622, United States
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Columbia, Maryland, 21044, United States
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Columbia, Maryland, 21045, United States
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Hollywood, Maryland, 20636, United States
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Salisbury, Maryland, 21804, United States
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Towson, Maryland, 21204, United States
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Ayer, Massachusetts, 01432, United States
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Billerica, Massachusetts, 01821, United States
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Fall River, Massachusetts, 02720, United States
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Haverhill, Massachusetts, 01830, United States
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Hyannis, Massachusetts, 02601, United States
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Newton, Massachusetts, 02459, United States
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Quincy, Massachusetts, 02169, United States
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Springfield, Massachusetts, 01199, United States
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Watertown, Massachusetts, 02472, United States
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Ann Arbor, Michigan, 48106, United States
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Dearborn, Michigan, 48124, United States
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Flint, Michigan, 48532, United States
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Grandville, Michigan, 49418, United States
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Lansing, Michigan, 48912, United States
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Muskegon, Michigan, 49444, United States
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Novi, Michigan, 48374, United States
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Saginaw, Michigan, 48601, United States
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Saginaw, Michigan, 48604, United States
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Traverse City, Michigan, 49684, United States
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Minneapolis, Minnesota, 55417, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Paul, Minnesota, 55102, United States
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Olive Branch, Mississippi, 38654, United States
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Tupelo, Mississippi, 38801, United States
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Columbia, Missouri, 65212, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64128, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63128, United States
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Billings, Montana, 59101, United States
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Billings, Montana, 59102, United States
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Great Falls, Montana, 59405, United States
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Kalispell, Montana, 59901, United States
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Missoula, Montana, 59802, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68131, United States
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Las Vegas, Nevada, 89128, United States
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Elizabeth, New Jersey, 07202, United States
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Voorhees Township, New Jersey, 08043, United States
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Westwood, New Jersey, 07675, United States
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Albany, New York, 12208, United States
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Buffalo, New York, 14203, United States
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Buffalo, New York, 14215, United States
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Cortlandt Manor, New York, 10567, United States
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Kingston, New York, 12401, United States
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New Hyde Park, New York, 11042, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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New York, New York, 10033, United States
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New York, New York, 10036, United States
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Rochester, New York, 14609, United States
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Stony Brook, New York, 11794, United States
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Syracuse, New York, 13202, United States
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Troy, New York, 12180, United States
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West Seneca, New York, 14224, United States
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Williamsville, New York, 14221, United States
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Asheville, North Carolina, 28801, United States
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Asheville, North Carolina, 28805, United States
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Calabash, North Carolina, 28467, United States
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Cary, North Carolina, 27518, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28277, United States
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Durham, North Carolina, 27710, United States
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Greensboro, North Carolina, 27408, United States
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Hickory, North Carolina, 28601, United States
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High Point, North Carolina, 27262, United States
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Lenoir, North Carolina, 28645, United States
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Mooresville, North Carolina, 28117, United States
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Raleigh, North Carolina, 27609, United States
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Statesville, North Carolina, 28625, United States
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Tabor City, North Carolina, 28463, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27127, United States
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Fargo, North Dakota, 58122, United States
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Grand Forks, North Dakota, 58201, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45224, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43201, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45414, United States
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Elyria, Ohio, 44035, United States
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Garfield Heights, Ohio, 44125, United States
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Marion, Ohio, 43302, United States
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Sandusky, Ohio, 44870, United States
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Springfield, Ohio, 45505, United States
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Toledo, Ohio, 43608, United States
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Toledo, Ohio, 43615, United States
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Toledo, Ohio, 43623, United States
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Westlake, Ohio, 44145, United States
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Willoughby, Ohio, 44094, United States
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Oklahoma City, Oklahoma, 73135, United States
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Pryor, Oklahoma, 74362, United States
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Tulsa, Oklahoma, 74133, United States
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Bend, Oregon, 97701, United States
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Portland, Oregon, 97225, United States
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Portland, Oregon, 97239, United States
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Abington, Pennsylvania, 19001, United States
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Altoona, Pennsylvania, 16602, United States
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Camp Hill, Pennsylvania, 17011, United States
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Chambersburg, Pennsylvania, 17201, United States
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Feasterville, Pennsylvania, 19053, United States
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Indiana, Pennsylvania, 15701, United States
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Jersey Shore, Pennsylvania, 17740, United States
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Norristown, Pennsylvania, 19401, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Sellersville, Pennsylvania, 18960, United States
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Uniontown, Pennsylvania, 15401, United States
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York, Pennsylvania, 17405, United States
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Cranston, Rhode Island, 02920, United States
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Cumberland, Rhode Island, 02864, United States
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Johnston, Rhode Island, 02919, United States
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Pawtucket, Rhode Island, 02860, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29407, United States
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Charleston, South Carolina, 29425, United States
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Columbia, South Carolina, 29204, United States
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Fountain Inn, South Carolina, 29644, United States
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Moncks Corner, South Carolina, 29461, United States
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Mt. Pleasant, South Carolina, 29464, United States
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North Myrtle Beach, South Carolina, 29582, United States
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Old Point Station, South Carolina, 29707, United States
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Orangeburg, South Carolina, 29118, United States
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Rapid City, South Dakota, 57701, United States
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Germantown, Tennessee, 38138, United States
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Jackson, Tennessee, 38305, United States
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Memphis, Tennessee, 38112, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37205, United States
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Nashville, Tennessee, 37208, United States
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Tullahoma, Tennessee, 37388, United States
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Arlington, Texas, 76012, United States
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Austin, Texas, 78758, United States
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Dallas, Texas, 75216, United States
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Grapevine, Texas, 76051, United States
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Houston, Texas, 77025, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77074, United States
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Kerrville, Texas, 78028, United States
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Longview, Texas, 75605, United States
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Odessa, Texas, 79761, United States
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Plano, Texas, 75023, United States
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Plano, Texas, 75024, United States
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San Antonio, Texas, 78229, United States
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Sugar Land, Texas, 77478, United States
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Tomball, Texas, 77375, United States
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Wichita Falls, Texas, 76301, United States
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Layton, Utah, 84041, United States
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Murray, Utah, 84107, United States
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West Jordan, Utah, 84088, United States
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White River Junction, Vermont, 05009, United States
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Burke, Virginia, 22015, United States
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Danville, Virginia, 24541, United States
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Falls Church, Virginia, 22042, United States
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Hopewell, Virginia, 23860, United States
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Richmond, Virginia, 23219, United States
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Richmond, Virginia, 23294, United States
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Roanoke, Virginia, 24014, United States
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Suffolk, Virginia, 23435, United States
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Virginia Beach, Virginia, 23455, United States
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Federal Way, Washington, 98003, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98195, United States
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Selah, Washington, 98942, United States
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Green Bay, Wisconsin, 54301, United States
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Madison, Wisconsin, 53713, United States
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Marshfield, Wisconsin, 54449, United States
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Bahía Blanca, Buenos Aires, B8000FTD, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1209, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426EGR, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1428AQK, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430CKE, Argentina
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La Plata, Buenos Aires, B1902AGY, Argentina
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La Plata, Buenos Aires, B1902COS, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Mar del Plata, Buenos Aires, B7602CBM, Argentina
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Quilmes, Buenos Aires, B1878GEG, Argentina
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Córdoba, Córdoba Province, X5000BNB, Argentina
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Córdoba, Córdoba Province, X5000EPU, Argentina
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Córdoba, Córdoba Province, X5002AOQ, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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Rosario, Santa Fe Province, S2000CVD, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IAF, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina
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Corrientes, W3400AMZ, Argentina
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Córdoba, X5003DCE, Argentina
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Salta, A4400ANG, Argentina
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Salta, A4400CRC, Argentina
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Woden, Australian Capital Territory, 2605, Australia
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Camperdown, New South Wales, 2050, Australia
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Concord, New South Wales, 2139, Australia
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Kogarah, New South Wales, 2217, Australia
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Liverpool, New South Wales, 2170, Australia
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Woolloongabba, New South Wales, 4102, Australia
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Auchenflower, Queensland, 4066, Australia
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Herston, Queensland, 4029, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Ashford, South Australia, 5035, Australia
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Ashford, South Australia, 5036, Australia
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Fullarton, South Australia, 5063, Australia
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Woodville South, South Australia, 5011, Australia
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Hobart, Tasmania, 7000, Australia
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Box Hill, Victoria, 3128, Australia
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Epping, Victoria, 3076, Australia
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Footscray, Victoria, 3011, Australia
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Geelong, Victoria, 3220, Australia
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Heidelberg, Victoria, 3084, Australia
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Nedlands, Western Australia, 6009, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Salzburg, 5020, Austria
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Vienna, 1060, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Vienna, 1160, Austria
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Vienna, 1190, Austria
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Wels, 4600, Austria
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Aalst, 9300, Belgium
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Antwerp, 2020, Belgium
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Antwerp, 2060, Belgium
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Blankenberge, 8370, Belgium
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Bonheiden, 2820, Belgium
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Brussels, 1020, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Gozée, 6534, Belgium
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Ieper, 8900, Belgium
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La Louvière, 7100, Belgium
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Liège, 4000, Belgium
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Lodelinsart, 6042, Belgium
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Natoye, 5360, Belgium
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Turnhout, 2300, Belgium
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Fortaleza, Ceará, 60430-350, Brazil
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Vitória, Espírito Santo, 29042-751, Brazil
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Brasília, Federal District, 71625-009, Brazil
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Goiânia, Goiás, 74223-130, Brazil
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Haskovo, 6300, Bulgaria
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Calgary, Alberta, T2N 4Z6, Canada
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Temuco, Cautín, 4781156, Chile
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Medellín, Antioquia, 050012, Colombia
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Benátky nad Jizerou, 294 71, Czechia
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Aalborg, 9000, Denmark
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Harjumaa, 74001, Estonia
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Besançon, 25030, France
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Kopavogur, 201, Iceland
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Vijayawada, Andhra Pradesh, 520 008, India
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Ichinomiya-shi, Aichi-ken, 491-8551, Japan
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Daugavpils, 5417, Latvia
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Related Publications (31)
Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
PMID: 28304224BACKGROUNDFonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762.
PMID: 28832867BACKGROUNDFonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.
PMID: 31166576BACKGROUNDSchludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.
PMID: 35760720BACKGROUNDBerg DD, Moura FA, Bellavia A, Scirica BM, Wiviott SD, Bhatt DL, Raz I, Bohula EA, Giugliano RP, Park JG, Feinberg MW, Braunwald E, Morrow DA, Sabatine MS. Assessment of Atherothrombotic Risk in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2023 Jun 27;81(25):2391-2402. doi: 10.1016/j.jacc.2023.04.031.
PMID: 37344040BACKGROUNDClinical Benefit of Evolocumab Treatment Among Patients With Atherosclerotic Cardiovascular Disease: Exploration Based on the Chinese Subgroup of FOURIER Study, ZHANG Lihua1 , LI Weimin2 , YAO Zhuhua3 , CHEN Jiyan4 , DONG Jun5 , LI Jing1 (Chinese Circulation Journal, 2023, 38: 704.)
BACKGROUNDMonguillon V, Kelly PJ, O'Donoghue ML, Park JG, Bohula EA, Saver JL, Atar D, Keech AC, Sever PS, Wang H, Paiva da Silva Lima G, Sabatine MS, Giugliano RP. Efficacy and Safety of Very Low Achieved LDL Cholesterol in Patients With Previous Ischemic Stroke. Circulation. 2026 Jan 13;153(2):86-93. doi: 10.1161/CIRCULATIONAHA.125.077549. Epub 2025 Nov 3.
PMID: 41178569DERIVEDZimerman A, Kunzler ALF, Weber BN, Ran X, Murphy SA, Wang H, Honarpour N, Keech AC, Sever PS, Sabatine MS, Giugliano RP. Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial. Circulation. 2025 May 20;151(20):1467-1476. doi: 10.1161/CIRCULATIONAHA.124.072756. Epub 2025 Apr 21.
PMID: 40255182DERIVEDGaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
PMID: 36779348DERIVEDErviti J, Wright J, Bassett K, Ben-Eltriki M, Jauca C, Saiz LC, Leache L, Gutierrez-Valencia M, Perry TL. Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data. BMJ Open. 2022 Dec 30;12(12):e060172. doi: 10.1136/bmjopen-2021-060172.
PMID: 36585131DERIVEDFagundes A Jr, Morrow DA, Oyama K, Furtado RHM, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Keech AC, Sever P, Giugliano RP, Sabatine MS, Bergmark BA. Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial. J Am Coll Cardiol. 2022 Aug 30;80(9):887-897. doi: 10.1016/j.jacc.2022.05.051.
PMID: 36007987DERIVEDFurtado RHM, Fagundes AA Jr, Oyama K, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Mar;15(3):e011382. doi: 10.1161/CIRCINTERVENTIONS.121.011382. Epub 2022 Feb 25.
PMID: 35209731DERIVEDOyama K, Giugliano RP, Tang M, Bonaca MP, Saver JL, Murphy SA, Ruzza A, Keech AC, Sever PS, Sabatine MS, Bergmark BA. Effect of evolocumab on acute arterial events across all vascular territories : results from the FOURIER trial. Eur Heart J. 2021 Dec 14;42(47):4821-4829. doi: 10.1093/eurheartj/ehab604.
PMID: 34537830DERIVEDKeech AC, Oyama K, Sever PS, Tang M, Murphy SA, Hirayama A, Lu C, Tay L, Deedwania PC, Siu CW, Lira Pineda A, Choi D, Charng MJ, Amerena J, Wan Ahmad WA, Chopra VK, Pedersen TR, Giugliano RP, Sabatine MS; FOURIER Study Group. Efficacy and Safety of Long-Term Evolocumab Use Among Asian Subjects - A Subgroup Analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) Trial. Circ J. 2021 Oct 25;85(11):2063-2070. doi: 10.1253/circj.CJ-20-1051. Epub 2021 May 15.
PMID: 33980763DERIVEDOyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.
PMID: 33197560DERIVEDSchmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
PMID: 33078867DERIVEDDeedwania P, Murphy SA, Scheen A, Badariene J, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):139-147. doi: 10.1001/jamacardio.2020.3151.
PMID: 32785614DERIVEDGencer B, Mach F, Murphy SA, De Ferrari GM, Huber K, Lewis BS, Ferreira J, Kurtz CE, Wang H, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial. JAMA Cardiol. 2020 Aug 1;5(8):952-957. doi: 10.1001/jamacardio.2020.0882.
PMID: 32432684DERIVEDBergmark BA, O'Donoghue ML, Murphy SA, Kuder JF, Ezhov MV, Ceska R, Gouni-Berthold I, Jensen HK, Tokgozoglu SL, Mach F, Huber K, Gaciong Z, Lewis BS, Schiele F, Jukema JW, Pedersen TR, Giugliano RP, Sabatine MS. An Exploratory Analysis of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition and Aortic Stenosis in the FOURIER Trial. JAMA Cardiol. 2020 Jun 1;5(6):709-713. doi: 10.1001/jamacardio.2020.0728.
PMID: 32347887DERIVEDWiviott SD, Giugliano RP, Morrow DA, De Ferrari GM, Lewis BS, Huber K, Kuder JF, Murphy SA, Forni DM, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS. Effect of Evolocumab on Type and Size of Subsequent Myocardial Infarction: A Prespecified Analysis of the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):787-793. doi: 10.1001/jamacardio.2020.0764.
PMID: 32347885DERIVEDGiugliano RP, Pedersen TR, Saver JL, Sever PS, Keech AC, Bohula EA, Murphy SA, Wasserman SM, Honarpour N, Wang H, Lira Pineda A, Sabatine MS; FOURIER Investigators. Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis. Stroke. 2020 May;51(5):1546-1554. doi: 10.1161/STROKEAHA.119.027759. Epub 2020 Apr 21.
PMID: 32312223DERIVEDCharytan DM, Sabatine MS, Pedersen TR, Im K, Park JG, Pineda AL, Wasserman SM, Deedwania P, Olsson AG, Sever PS, Keech AC, Giugliano RP; FOURIER Steering Committee and Investigators. Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial. J Am Coll Cardiol. 2019 Jun 18;73(23):2961-2970. doi: 10.1016/j.jacc.2019.03.513.
PMID: 31196453DERIVEDMurphy SA, Pedersen TR, Gaciong ZA, Ceska R, Ezhov MV, Connolly DL, Jukema JW, Toth K, Tikkanen MJ, Im K, Wiviott SD, Kurtz CE, Honarpour N, Giugliano RP, Keech AC, Sever PS, Sabatine MS. Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial. JAMA Cardiol. 2019 Jul 1;4(7):613-619. doi: 10.1001/jamacardio.2019.0886.
PMID: 31116355DERIVEDO'Donoghue ML, Fazio S, Giugliano RP, Stroes ESG, Kanevsky E, Gouni-Berthold I, Im K, Lira Pineda A, Wasserman SM, Ceska R, Ezhov MV, Jukema JW, Jensen HK, Tokgozoglu SL, Mach F, Huber K, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk. Circulation. 2019 Mar 19;139(12):1483-1492. doi: 10.1161/CIRCULATIONAHA.118.037184.
PMID: 30586750DERIVEDQamar A, Giugliano RP, Keech AC, Kuder JF, Murphy SA, Kurtz CE, Wasserman SM, Sever PS, Pedersen TR, Sabatine MS. Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data. JAMA Cardiol. 2019 Jan 1;4(1):59-63. doi: 10.1001/jamacardio.2018.4178.
PMID: 30540337DERIVEDMartin SS, Giugliano RP, Murphy SA, Wasserman SM, Stein EA, Ceska R, Lopez-Miranda J, Georgiev B, Lorenzatti AJ, Tikkanen MJ, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Comparison of Low-Density Lipoprotein Cholesterol Assessment by Martin/Hopkins Estimation, Friedewald Estimation, and Preparative Ultracentrifugation: Insights From the FOURIER Trial. JAMA Cardiol. 2018 Aug 1;3(8):749-753. doi: 10.1001/jamacardio.2018.1533.
PMID: 29898218DERIVEDSabatine MS, De Ferrari GM, Giugliano RP, Huber K, Lewis BS, Ferreira J, Kuder JF, Murphy SA, Wiviott SD, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR. Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Disease: Analysis From FOURIER. Circulation. 2018 Aug 21;138(8):756-766. doi: 10.1161/CIRCULATIONAHA.118.034309.
PMID: 29626068DERIVEDBohula EA, Giugliano RP, Leiter LA, Verma S, Park JG, Sever PS, Lira Pineda A, Honarpour N, Wang H, Murphy SA, Keech A, Pedersen TR, Sabatine MS. Inflammatory and Cholesterol Risk in the FOURIER Trial. Circulation. 2018 Jul 10;138(2):131-140. doi: 10.1161/CIRCULATIONAHA.118.034032. Epub 2018 Mar 12.
PMID: 29530884DERIVEDBonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018 Jan 23;137(4):338-350. doi: 10.1161/CIRCULATIONAHA.117.032235. Epub 2017 Nov 13.
PMID: 29133605DERIVEDSabatine MS, Leiter LA, Wiviott SD, Giugliano RP, Deedwania P, De Ferrari GM, Murphy SA, Kuder JF, Gouni-Berthold I, Lewis BS, Handelsman Y, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Dec;5(12):941-950. doi: 10.1016/S2213-8587(17)30313-3. Epub 2017 Sep 15.
PMID: 28927706DERIVEDGiugliano RP, Pedersen TR, Park JG, De Ferrari GM, Gaciong ZA, Ceska R, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Ott BR, Kanevsky E, Pineda AL, Somaratne R, Wasserman SM, Keech AC, Sever PS, Sabatine MS; FOURIER Investigators. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet. 2017 Oct 28;390(10106):1962-1971. doi: 10.1016/S0140-6736(17)32290-0. Epub 2017 Aug 28.
PMID: 28859947DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 9, 2013
Study Start
February 8, 2013
Primary Completion
November 11, 2016
Study Completion
November 11, 2016
Last Updated
May 28, 2024
Results First Posted
February 15, 2018
Record last verified: 2024-05