Journal
JOURNAL OF CLINICAL PHARMACOLOGY
Volume 49, Issue 7, Pages 838-847Publisher
WILEY
DOI: 10.1177/0091270009337011
Keywords
LDL-cholesterol; statins; ezetimibe; intima-media thickness reduction; PCR; cardiovascular risk; atherosclerosis; inflammation
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Funding
- Merck Sharp Dohme, Mexico
- Mexican Association for the Prevention of Atherosclerosis and its Complications (AMPAC)
- National Association of Cardiologists serving the State Employees (ANCISSSTE)
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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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