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

From the Cardiovascular Unit, Regional Hospital "1° de Octubre," ISSSTE, Mexico, D. F. (Dr A. Meaney, Dr Solache, Ms Mendoza, Dr Vela, Dr E. Meaney) and the Section of Postgraduate Studies and Research, Escuela Superior de Medicina, Instituto Politécnico Nacional, México, D. F. (Dr Ceballos, Dr Asbun, Dr E. Meaney).

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.

Key Words: LDL-cholesterol • statins • ezetimibe • intimamedia thickness reduction • PCR • cardiovascular risk • atherosclerosis • inflammation

Address for reprints: Alejandra Meaney, MD, PhD, Avenida Instituto Politécnico Nacional 1669, Col. Magdalena de las Salinas, Delegación Gustavo A. Madero, México, D. F. 07300; e-mail: ameaney{at}cinvestav.mx.

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