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Authors
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Physician at Brigham and Women's Hospital and Harvard Medical SchoolChristopher Cannon, MD
Physician at Brigham and Women's Hospital and Harvard Medical SchoolPhysician at Brigham and Women's Hospital and Harvard Medical School
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Director of Outpatient Services at Duke Heart CenterMichael Blazing, MD
Director of Outpatient Services at Duke Heart CenterDirector of Outpatient Services at Duke Heart Center
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Senior Investigator with the TIMI Study GroupRobert Giugliano, MD, SM
Senior Investigator with the TIMI Study GroupSenior Investigator with the TIMI Study Group
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Director of the Department of Cardiology, Vascular Medicine, Nephrology and Conservative Intensive Care Medicine at the Vivantes Neukoelln Medical CenterHarald Darius, MD
Director of the Department of Cardiology, Vascular Medicine, Nephrology and Conservative Intensive Care Medicine at the Vivantes Neukoelln Medical CenterDirector of the Department of Cardiology, Vascular Medicine, Nephrology and Conservative Intensive Care Medicine at the Vivantes Neukoelln Medical Center
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Director, Cardiovascular Clinical Research Institute at Lady Davis Carmel Medical CenterBasil Lewis, MD, FRCP, FESC, FACC
Director, Cardiovascular Clinical Research Institute at Lady Davis Carmel Medical CenterDirector, Cardiovascular Clinical Research Institute at Lady Davis Carmel Medical Center
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Chairman of Leiden Vascular Medicine at Leiden University Medical CenterJ. Wouter Jukema, MD, PhD, FESC, FACC
Chairman of Leiden Vascular Medicine at Leiden University Medical CenterChairman of Leiden Vascular Medicine at Leiden University Medical Center
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Senior Investigator, Chairman of CEC, TIMI Study Group, Cardiovascular Division at Brigham HealthStephen Wiviott, MD
Senior Investigator, Chairman of CEC, TIMI Study Group, Cardiovascular Division at Brigham HealthSenior Investigator, Chairman of CEC, TIMI Study Group, Cardiovascular Division at Brigham Health
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Experts
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Medical Director of Trial Design for the Harvard Clinical Research InstituteRobert Yeh, MD, MSc
Medical Director of Trial Design for the Harvard Clinical Research InstituteMedical Director of Trial Design for the Harvard Clinical Research Institute
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Assistant Professor, Division of Cardiology, UTHSCSAAnjlee Mehta, MD
Assistant Professor, Division of Cardiology, UTHSCSAAssistant Professor, Division of Cardiology, UTHSCSA
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Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of MedicineAmit Kakkar, MD
Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of MedicineInterventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of Medicine
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Women’s Heart Specialist in DallasMonika Sanghavi, MD
Women’s Heart Specialist in DallasWomen’s Heart Specialist in Dallas
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Chief Medical Officer at The FH FoundationJosh Knowles, MD, PhD
Chief Medical Officer at The FH FoundationChief Medical Officer at The FH Foundation
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Lead Moderators
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Medical Student at Oakland University William Beaumont School of MedicineRenae Shibata
Medical Student at Oakland University William Beaumont School of MedicineMedical Student at Oakland University William Beaumont School of Medicine
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Moderators
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Medical Student at Tufts University School of MedicineHannah Buettner
Medical Student at Tufts University School of MedicineMedical Student at Tufts University School of Medicine
About the Discussion
@NEJM Ask the Authors & Experts: Ezetimibe Added to Statin Therapy Following Acute Coronary Syndromes
Original Article
Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes
Background
Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known.
Methods
We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin–ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years.
Results
The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin–ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan–Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin–ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P=0.016). Rates of prespecified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups.
Conclusions
When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.)
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Authors
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Physician at Brigham and Women's Hospital and Harvard Medical SchoolChristopher Cannon, MD
Physician at Brigham and Women's Hospital and Harvard Medical School
Physician at Brigham and Women's Hospital and Harvard Medical School
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Director of Outpatient Services at Duke Heart CenterMichael Blazing, MD
Director of Outpatient Services at Duke Heart Center
Director of Outpatient Services at Duke Heart Center
-
Senior Investigator with the TIMI Study GroupRobert Giugliano, MD, SM
Senior Investigator with the TIMI Study Group
Senior Investigator with the TIMI Study Group
-
Director of the Department of Cardiology, Vascular Medicine, Nephrology and Conservative Intensive Care Medicine at the Vivantes Neukoelln Medical CenterHarald Darius, MD
Director of the Department of Cardiology, Vascular Medicine, Nephrology and Conservative Intensive Care Medicine at the Vivantes Neukoelln Medical Center
Director of the Department of Cardiology, Vascular Medicine, Nephrology and Conservative Intensive Care Medicine at the Vivantes Neukoelln Medical Center
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Director, Cardiovascular Clinical Research Institute at Lady Davis Carmel Medical CenterBasil Lewis, MD, FRCP, FESC, FACC
Director, Cardiovascular Clinical Research Institute at Lady Davis Carmel Medical Center
Director, Cardiovascular Clinical Research Institute at Lady Davis Carmel Medical Center
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Chairman of Leiden Vascular Medicine at Leiden University Medical CenterJ. Wouter Jukema, MD, PhD, FESC, FACC
Chairman of Leiden Vascular Medicine at Leiden University Medical Center
Chairman of Leiden Vascular Medicine at Leiden University Medical Center
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Senior Investigator, Chairman of CEC, TIMI Study Group, Cardiovascular Division at Brigham HealthStephen Wiviott, MD
Senior Investigator, Chairman of CEC, TIMI Study Group, Cardiovascular Division at Brigham Health
Senior Investigator, Chairman of CEC, TIMI Study Group, Cardiovascular Division at Brigham Health
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Experts
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Medical Director of Trial Design for the Harvard Clinical Research InstituteRobert Yeh, MD, MSc
Medical Director of Trial Design for the Harvard Clinical Research Institute
Medical Director of Trial Design for the Harvard Clinical Research Institute
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Assistant Professor, Division of Cardiology, UTHSCSAAnjlee Mehta, MD
Assistant Professor, Division of Cardiology, UTHSCSA
Assistant Professor, Division of Cardiology, UTHSCSA
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Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of MedicineAmit Kakkar, MD
Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of Medicine
Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of Medicine
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Women’s Heart Specialist in DallasMonika Sanghavi, MD
Women’s Heart Specialist in Dallas
Women’s Heart Specialist in Dallas
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Chief Medical Officer at The FH FoundationJosh Knowles, MD, PhD
Chief Medical Officer at The FH Foundation
Chief Medical Officer at The FH Foundation
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Lead Moderators
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Medical Student at Oakland University William Beaumont School of MedicineRenae Shibata
Medical Student at Oakland University William Beaumont School of Medicine
Medical Student at Oakland University William Beaumont School of Medicine
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Moderators
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Medical Student at Tufts University School of MedicineHannah Buettner
Medical Student at Tufts University School of Medicine
Medical Student at Tufts University School of Medicine
