Background: Remnant lipoproteinemia is a strong risk factor for cardiovascular (CV) diseases. This study examined which of 2 common lipid-lowering drugs (fibrates and statins) is more effective in patients with remnant lipoproteinemia and if lowering remnant lipoprotein levels can reduce CV risk.
Methods and Results:Remnant lipoprotein levels were measured by an immunoseparation method (remnantlike lipoprotein particles cholesterol: RLP-C) in 274 patients with coronary artery disease and high RLP-C levels (≥5.0 mg/dl). They were randomly assigned to receive bezafibrate (200-400 mg/day) or pravastatin (10-20 mg/day), and were prospectively followed-up for 1 year or until the occurrence of CV events. Complete follow-up data were obtained in 180 patients. RLP-C levels at 1 year of treatment were reduced more by bezafibrate than pravastatin (−37% and −25% from baseline, respectively). During follow-up, bezafibrate-treated patients had 3 CV events, compared with 12 events in pravastatin-treated patients (P<0.01). In multivariate logistic regression analysis, a decrease in RLP-C level was significantly associated with a reduction in CV events after adjustment for treatment group and changes in levels of other lipids.
Conclusions:Bezafibrate therapy decreased RLP-C levels to a greater extent than pravastatin and a decrease in RLP-C level may be associated with a reduction in CV events in patients with high RLP-C levels.
Effects of Fibrate and Statin on RLP-C
Methods
Study PatientsFrom 2003 December to 2005 March, 274 patients with CAD and high levels of RLP-C (≥5.0 mg/dl) at 17 hospitals (Appendix 1) were enrolled in this study. All patients met the following inclusion criteria: (1) total cholesterol (TC) level in fasting serum ≥180 mg/dl but <260 mg/dl; (2) TG level in fasting serum ≥150 mg/dl but <400 mg/dl; (3) presence of CAD based on angiographic evidence of organic diameter stenosis >50% of at least 1 major coronary artery, but patients were included if they had had a significant stenosis previously, which had been reduced to ≤50% after coronary revascularization; and (4) age 35-75 years. If lipid-lowering drugs were being administered at the time of enrollment, RLP-C, TC, high-density lipoprotein-cholesterol (HDL-C) and TG levels were measured after a wash-out period of more than 4 weeks. The exclusion criteria were: (1) acute coronary syndrome within 10 days prior to enrollment; (2) congestive heart failure (New York Heart Association class III or greater);