J Clin Pharmacol
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First published on May 14, 2009, doi:10.1177/0091270009337011

The Journal of Clinical Pharmacology 2009;49:838.

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©© 2009 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology, 10.1177/0091270009337011


Article

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

Alejandra Meaney 1, Guillermo Ceballos 2*, Juan Asbun 2, Gustavo Solache 1, Emma Mendoza 1, Agustín Vela 1, and Eduardo Meaney 3

1 Hospital 1o de Octubre, ISSSTE, Mexico
2 Instituto Politécnico Nacional, Mexico
3 Hospital 1o de Octubre, ISSSTE, and Instituto Politécnico Nacional, Mexico

* To whom correspondence should be addressed. E-mail: gceballosr{at}ipn.mx.


   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.
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R. S. Blumenthal and E. D. Michos
The HALTS Trial -- Halting Atherosclerosis or Halted Too Early?
N. Engl. J. Med., November 26, 2009; 361(22): 2178 - 2180.
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