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| |  Reductions in LDL by Fluvastatin XL/Ezetimibe Correlate With Decreased Inflammation in Hypercholesterolaemic Patients: Presented at DALM By Crina Frincu-Mallos, PhD NEW YORK, NY -- October 16, 2007 -- Adding ezetimibe to fluvastatin XL therapy results in significant reduction of plasma lipid levels and reduced blood concentrations of biomarkers of cardiovascular inflammation, researchers reported here at the XVI International Symposium on Drugs Affecting Lipid Metabolism (DALM). Luis A. Alvarez-Sala Walther, Chief, Lipidology Department, and Vice-Dean, Hospital Gregorio Maranon, Faculty of Medicine, Universidad Complutense, Madrid, Spain, together with a team of researchers presented the results in a poster session on October 6. This is the first clinical trial to analyse the effects of adding ezetimibe to fluvastatin on plasma levels lipid levels of and in levels of inflammatory biomarkers such as C reactive protein (CRP), explained the investigators. For their 12-week, randomised, multicentre, open-label trial, Dr. Alvarez-Sala Walther and colleagues randomised 82 patients with primary hypercholesterolemia into two treatment arms -- fluvastatin XL as a single agent or fluvastatin XL in combination with ezetimibe. The researchers evaluated plasma levels of low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B (apo B), as well as levels of high-sensitivity C reactive protein (hs-CRP), a biomarker of cardiovascular inflammation. The results show significant differences in the effects of the two therapies on lipid profiles. Fluvastatin XL single-agent therapy resulted in a 35.2% reduction in LDL-C levels compared with 49.9% in the combination arm (P =.0002). Triglyceride levels decreased by 3.8% in the group on fluvastatin XL monotherapy and by 21.0% in the group on the combination of ezetimibe plus fluvastatin XL (P =.02). ApoB levels were reduced by 22.5% with monotherapy and by 34.8% with combination therapy (P =.02). The reduction in hs-CRP levels was not significantly different between the two arms. However, combination therapy was more effective than monotherapy in reducing hs-CRP levels in patients with high blood pressure and one or more cardiovascular risk factors, explained researchers. Changes in hs-CRP levels were 2.8 ± 2.4 mg/L in patients with one or more cardiovascular risk factors compared with 1.2 ± 1.2 mg/L in patients without these risk factors (P =.0013). Hs-CRP levels were reduced by 3.0 ±2.5 mg/L in patients with hypertension compared with a reduction of 1.8 ±1.8 mg/L in patients without hypertension (P =.0136). Interestingly, the statistical analysis shows a direct correlation between the reduction in LDL-C levels and the hs-CRP decrease (r=0.399, P <.001). Adverse events (AEs) occurred in 58.5% (n=48) of evaluable patients on trial, with no difference in the number and distribution of AEs between the two study subgroups. Headache, constipation, and increased alanine aminotransferase levels were the most common AEs experienced. The investigators pointed out that the only serious adverse event, a deep thrombophlebitis resulting in the patient's hospitalisation, was determined to be unrelated to the study drugs. The results of this study suggest that ezetimibe in combination with fluvastatin XL is a well-tolerated, effective lipid-lowering regimen that allows the majority of patients to achieve treatment goals, the researchers concluded. Funding was provided by Novartis Farmacética.
[Presentation title: Relative Reductions in C-LDL and in Hs-CRP Correlate Directly in Hypercholesterolemic Patients Treated With Fluvastatin XL Alone or Combined With Ezetimibe. Abstract 347]
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