Ezetimibe and Improving Cardiovascular Outcomes: Current Evidence and Perspectives

Table 1

Pivotal trials of ezetimibe.

Trial	Year	Number of patients	Study population	Study design	Results
SANDS	2008	499	American-Indian men and women aged 40 years or older with type 2 diabetes and no prior CVD events	Randomized to aggressive (LDL-C < 70, SBP < 115 mmHg) (n = 252) vs. standard (LDL-C < 100, SBP < 130 mmHg) (n = 247) treatment	CIMT regressed in the aggressive group and increased in the standard group (−0.012 mm vs. 0.038 mm; ); carotid arterial cross-sectional area was also reduced (−0.02 mm (2) vs. 1.05 mm (2); )
ENHANCE	2008	720	Patients of heterozygous FH were taken to see atherosclerosis regression with ezetimibe	Simvastatin 80 mg (n = 363) or simvastatin 80 mg plus ezetimibe 10 mg (n = 357)	Ezetimibe plus simvastatin did not produce a significant reduction in carotid IMT despite the further reduction in LDL-C and hs-CRP achieved with this drug
ARBITER 6	2010	315	Patients of CAD/CAD equivalent with LDL-C <100 mg/dl and HDL-C <50 mg/dl for men or 55 mg/dl for women (on statin treatment) for CIMT progression	Ezetimibe (10 mg/day) or extended-release niacin (target dose, 2,000 mg/day)	Patients on niacin (n = 154) had significant regression in both mean CIMT (−0.0102 ± 0.0026 mm; ) and maximal CIMT (−0.0124 ± 0.0036 mm; ).; Ezetimibe (n = 161) did not reduce mean CIMT (−0.0016 ± 0.0024 mm; ) or maximal CIMT (−0.0005 ± 0.0029 mm; ) compared with baseline
VYCTOR	2009	90	To see effect aggressive lipid lowering on CIMT, LDL-C and hs-CRP in high-risk patients	90 high‐risk CAD were allocated to 3 groups: pravastatin 40 mg, simvastatin 40 mg, and simvastatin 20 mg with ezetimibe 10 mg	After 1 year of therapy, a significant reduction in LDL-C to a mean level of 45–48 mg/dL was seen with a significant reduction in all three groups and CIMT values were 0.93 ± 0.13 mm, 0.90 ± 0.11 mm, and 0.92 ± 0.01 mm for groups 1, 2, and 3, respectively
SHARP		9270	9270 patients with CKD	Simvastatin/ezetimibe 20/10 vs. placebo	LDL-C lowering with combination therapy reduced major atherosclerotic events in a wide range of CKD patients
SEAS	2008	1873	Patients of asymptomatic AS	Double blind randomized control trial between simvastatin/ezetimibe 40/10 vs. simvastatin 40 mg on cardiovascular outcomes	No effect on AS progression with LDL-C lowering. There were fewer ischemic cardiovascular events in the combination therapy
IMPROVE-IT	2010	18144	High-risk post-ACS patients	Randomized to simvastatin/ezetimibe 40/10 vs. simvastatin 10 mg	Simvastatin/ezetimibe combination superior to simvastatin monotherapy in reducing events (32.7 vs. 34.7%, )