TY - JOUR
T1 - Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes
AU - Cannon, Christopher P.
AU - Blazing, Michael A.
AU - Giugliano, Robert P.
AU - McCagg, Amy
AU - White, Jennifer A.
AU - Theroux, Pierre
AU - Darius, Harald
AU - Lewis, Basil S.
AU - Oude Ophuis, Ton
AU - Jukema, J. Wouter
AU - de Ferrari, Gaetano M.
AU - Ruzyllo, Witold
AU - de Lucca, Paul
AU - Im, KyungAh
AU - Bohula, Erin A.
AU - Reist, Craig
AU - Wiviott, Stephen D.
AU - Tershakovec, Andrew M.
AU - Musliner, Thomas A.
AU - Braunwald, Eugene
AU - Califf, Robert M.
AU - AUTHOR GROUP
AU - Musliner, Thomas
AU - Tershakovec, Andrew
AU - Gurfinkel, Enrique
AU - Aylward, Philip
AU - Tonkin, Andrew
AU - Maurer, Gerald
AU - van de Werf, Frans
AU - Nicolau, Jose C.
AU - Genest, Jacques
AU - Armstrong, Paul
AU - Corbalan, Ramon
AU - Isaza, Daniel
AU - Spinar, Jindrich
AU - Grande, Peer
AU - Voitk, Juri
AU - Kesaniemi, Antero
AU - Bassand, Jean-Pierre
AU - Farnier, Michel
AU - Keltai, Matyas
AU - Mathur, Atul
AU - Mittal, Sanjay
AU - Reddy, Krishna
AU - Lewis, Basil
AU - White, Harvey
AU - Pedersen, Terje
AU - Britto, Frank
AU - Carrageta, Manuel
AU - Duris, Tibor
AU - Nijmeijer, R.
PY - 2015
Y1 - 2015
N2 - 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 pre-specified 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
AB - 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 pre-specified 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
U2 - 10.1056/NEJMoa1410489
DO - 10.1056/NEJMoa1410489
M3 - Article
C2 - 26039521
SN - 0028-4793
VL - 372
SP - 2387
EP - 2397
JO - New England journal of medicine
JF - New England journal of medicine
IS - 25
ER -
SDG 3 Good Health and Well-being