| Studies in Atherosclerosis and Cardiac Outcomes
Below are summaries of two key studies for fluvastatin. Copies of the studies are available at the journal web sites or by calling 1-888-NOW-NOVA.
LCAS
Effects of fluvastatin on coronary atherosclerosis in patients with mild to moderate cholesterol elevations.1 (Lipoprotein and Coronary Atherosclerosis Study [LCAS])
The primary objective of the study was to determine if treatment with fluvastatin reduced both the formation of new lesions and the progression of existing coronary atherosclerotic lesions. This randomized, double-blind, placebo-controlled trial enrolled 429 CHD patients with mild to moderate hypercholesterolemia defined as LDL-C 115-190 mg/dL despite Step 1 AHA diet. Patients were treated with conventional measures and either fluvastatin 40 mg/dL or placebo for 2.5 years. Patients with baseline LDL-C ≥ 160 mg/dL that remained elevated after 12 weeks of treatment were also assigned open-label cholestyramine as adjunctive treatment. The primary endpoint in LCAS was within patient per-lesion change in minimum lumen diameter of qualifying lesions.
Over the 2.5-year study, LDL-C was reduced by 23.9% in all fluvastatin patients (146 to 111 mg/dL) and by 22.5% in the fluvastatin-only group (137 to 106 mg/dL).
Primary endpoint analysis (340 patients) showed significantly less lesion progression in all fluvastatin versus all placebo patients. Patients receiving fluvastatin had a 72% reduction in lesion progression.
LIPS
Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention. A randomized controlled trial.2
The objective of this study was to determine whether treatment with fluvastatin reduces major adverse cardiac events (MACE) in patients who have undergone percutaneous cardiac intervention (PCI). This randomized, double-blind, placebo-controlled trial enrolled a total of 1677 patients following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL. Patients were randomized to receive fluvastatin 80 mg/dL or placebo for 3 to 4 years. The primary endpoint was survival time free of MACE, defined as cardiac death, nonfatal myocardial infarction or reintervention procedure. Benefits of fluvastatin treatment were seen as early as 1.5 years post-PCI. Results showed a 22% risk reduction for patients treated with fluvastatin versus placebo. Revascularization procedures comprised the majority of the initial recurrent cardiac events.
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