The Vytorin on Carotid Intima‐Media Thickness and Overall Arterial Rigidity (VYCTOR) Study

Abstract

This study assessed the effect of 3 lipid-lowering therapies on the reduction of the carotid intima-media thickness (IMT) in high-risk coronary Mexican patients. The study was a randomized, comparative, and open clinical trial. Ninety high-risk coronary patients were allocated to 3 groups: pravastatin 40 mg, simvastatin 40 mg, and simvastatin 20 mg and ezetimibe 10 mg initially. If the therapeutic goals were not attained (<100 mg/dL of low-density lipoprotein cholesterol [LDL-C] for type C and <70 mg for type D), patients in group 1 received pravastatin 40 mg and ezetimibe 10 mg, group 2 received simvastatin 80 mg, and group 3 received simvastatin 40 mg and ezetimibe 10 mg. The primary endpoint was the change of IMT over the course of 1 year. The secondary endpoints were changes in LDL-C and in high sensitive C-reactive protein (CRPhs). The overall baseline IMTs generated by combining measurements in the internal carotid artery were 1.33+/-0.32 mm, 1.30+/-0.11 mm, and 1.23+/-0.28 mm for groups 1, 2, and 3, respectively. After 1 year, IMT 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. At the end of the study, LDL-C levels were 48+/-41, 45+/-37, and 48+/-31 in groups 1, 2, and 3, respectively. No significant differences were observed in CRP, high-density lipoprotein cholesterol, triglycerides, blood pressure, and body mass index, among the groups. This study is one of the first providing evidence that dual therapy has a beneficial effect on a surrogate marker of atherosclerosis.

Effect of Combination Therapy of Ezetimibe and Rosuvastatin on Regression of Coronary Atherosclerosis in Patients With Coronary Artery Disease

“…In contrast to the ENHANCE study, some previous studies reported the beneficial effect of combination therapy with ezetimibe and a statin on carotid atherosclerosis, consistent with our results. 23,24) More recently, there have been several studies that supported the antiatherosclerotic effect of ezetimibe. Habara, et al reported that combination therapy with ezetimibe and fluvastatin increased the fibrous cap thickness of lipid-rich coronary plaque compared with fluvastatin alone in patients with stable CAD.…”

Changes in prescription patterns before and after reporting of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial (ENHANCE) results and expected effects on low-density lipoprotein-cholesterol reduction

“…4,[11][12][13][14][15][16][17] Similarly, significant reductions in cIMT and LDL-C lowering were observed in the Vytorin on Carotid-media Thickness and Overall Arterial Rigidity study (VYCTOR) with simvastatin 20 mg and ezetimibe 10 mg therapy. 23 However, in the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies trial (ARBITER 6) in CHD/CHD risk patients on long-term statin therapy, extended-release niacin significantly reduced cIMT thickness, and no significant change was observed with ezetimibe. The minimal cIMT change with ezetimibe in ARBITER 6 was consistent with the aforementioned studies in patients with extensive prior statin therapy and/or relatively low baseline cIMT, including ENHANCE.…”

Wpływ krótkotrwałego leczenia skojarzonego simwastatyną i ezetimibem na stężenie adipokin w osoczu pacjentów na izolowaną hipercholesterolemię

“…Unfortunately, the results of large clinical trials assessing the effects of the combined treatment with these agents are not so clear-cut. The effect of ezetimibe-simvastatin combination treatment on the carotid intima-media thickness was found in patients at high cardiovascular risk [4], as well as in patients with type 2 diabetes and no prior cardiovascular events [5], but not in patients with ischaemic heart disease or its equivalent [6] nor in patients with familial hypercholesterolemia [7]. Moreover, although in patients with mild-to-moderate, asymptomatic aortic-valve stenosis, simvastatin-ezetimibe combination treatment reduced the incidence of ischaemic cardiovascular events, the treatment had no overall effect on the course of aorticvalve stenosis [8].…”