By Thomas S. May
HELSINKI, FINLAND -- June 14, 2007 -- Combination therapy with fluvastatin and ezetimibe significantly reduces high-sensitivity C-reactive protein (hS CRP) levels in patients with primary hypercholesterolemia, researchers reported here at the 76th Congress of the European Atherosclerosis Society (EAS).
To evaluate the effect of fluvastatin extended-release (XL), either as monotherapy or in combination with ezetimibe, in patients with primary hypercholesterolemia, a team of researchers led by Victoria Cachofeiro, PhD, associate professor, Department Of Physiology, School Of Medicine, Universidad Complutense, Madrid, Spain, performed a randomised, multicentre, open-label, parallel-group study (n=82). Fluvastatin XL (80 mg/day) was administered alone or combined with ezetimibe (10 mg/day) for 12 weeks.
There was a significant decrease in hs-CRP (P <.02) in patients with baseline hs-CRP levels >2 mg/L in response to the fluvastatin XL/ezetimibe combination; whereas, no change was observed with the monotherapy. Similarly, only the combination treatment lowered hs-CRP in patients with either hypertension alone (P =.015) or several cardiovascular risk factors (CVRF) (P <.05). Moreover, there was a direct correlation between the relative reduction in hs-CRP and levels of both LDL-C (r =.476, P <.0001), and total cholesterol levels (r =.399, P <.0007), which were reduced to a greater extent with the fluvastatin-XL/ezetimibe combination than with fluvastatin monotherapy (LDL-C -49.9% vs. -35.2%, P =.0002; total cholesterol -38.2% vs. -27.5%, P =.0006).
According to Dr. Cachofeiro, these data provide the first evidence of efficacy and safety of fluvastatin XL 80 mg in combination with ezetimibe, and they also document the effects of the combination therapy on inflammatory markers. "We have shown that the combination of fluvastatin XL and ezetimibe significantly reduces CRP values in patients with high cardiovascular risk or with high baseline CRP, when compared with fluvastatin XL monotherapy," she said. "So in patients with hypercholesterolemia and other risk factors, the combination of fluvastatin XL with Ezetimibe is a good pharmacological option, not only because it helps to bring a relevant percentage of patients to lipid goals, but it also reduces CRP values significantly."
[Presentation title: The Synergistic Effect of Fluvastatin and Ezetimibe on Hs-CRP Levels in Patients with Primary Hypercholesterolemia at Higher Cardiovascular Risk. Abstract P729]
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