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| |  Fluvastatin Shown to Slow Progression of Heart Disease ANAHEIM, Calif., March 18, 1997 -- New data shows the cholesterol-lowering drug fluvastatin has a significant impact on slowing the progression of coronary heart disease (CHD) in women and in patients with low levels of good cholesterol (called high-density lipoprotein cholesterol or HDL-C). The results of recent clinical trials were presented at the 46th Annual Scientific Session of the American College of Cardiology (ACC). "Data from these analyses provide us with further evidence regarding the advantages of using lipid-lowering therapy to treat a variety of patient populations with coronary heart disease and moderate elevations of low-density lipoprotein cholesterol," said LCAS investigator Christie Ballantyne, MD, Associate Professor of Medicine and Clinical Director of the Section of Atherosclerosis at Baylor College of Medicine and Co-Director of the Lipid Metabolism and Atherosclerosis Clinic of The Methodist Hospital in Houston, Texas. The findings presented at ACC were the result of two separate subset analyses of data from the Lipoprotein and Coronary Atherosclerosis Study (LCAS). This study was the first major trial with angiographic endpoints to demonstrate that therapy with fluvastatin, an HMG-CoA reductase inhibitor, produced regression and slowed progression of atherosclerosis in patients with CHD and moderate elevations of low-density lipoprotein cholesterol (LDL-C) levels (as low as 115 mg/dl). Benefits for Women with CHD Limited data exist regarding the benefits of preventing CHD in the elderly and women through lipid-lowering intervention. In LCAS, gender and age data were analyzed to assess the impact of luvastatin on the progression of CHD. Of the 340 patients with evaluable coronary atherosclerotic lesions, 17% were women and 25% were aged 65 years or older. In LCAS, women who received fluvastatin responded as well or better compared with men who received identical therapy. Treatment with fluvastatin reduced the rate of atherosclerotic progression in men (as measured by quantitative coronary angiography) and induced regression in women. Although both older and younger patients experienced slowed progression of atherosclerosis with fluvastatin, there was no difference in the rate of progression between the two groups. "This information provides evidence that women can benefit from more aggressive treatment of CHD, as well as older patients," said J. Alan Herd, MD, LCAS investigator and Professor of Medicine at Baylor College of Medicine. "Further, treatment with fluvastatin was as beneficial and safe in older as in younger patients." CHD is the leading cause of mortality for women in America, yet the condition is often diagnosed later and treated less aggressively than in men. "Two factors commonly associated with the discrepancy in treatment are that women tend to present with symptoms of CHD ten to 15 years later than men at least in part because of the cardioprotective effects of estrogen and many women are less likely to associate the onset of symptoms with heart disease," said Dr. Herd. Patients With Low HDL-C Benefit LCAS investigators also evaluated the ability of fluvastatin to influence the progression of CHD in patients with depressed HDL-C levels and elevated LDL-C levels. HDL-C is considered to be the "good" cholesterol, because it is associated with decreased risk for CHD. It has been hypothesized that HDL-C picks up free cholesterol from peripheral cells and transports it back to the liver for reprocessing. In LCAS, patients treated with fluvastatin demonstrated a significantly reduced progression of CHD. Further, patients with low HDL-C benefited from treatment more than patients with higher HDL-C, compared with placebo. "These findings are important given the fact that the major effect of fluvastatin is to lower LDL-C, with favorable but more modest effects on HDL-C and triglycerides," said Dr. Ballantyne. "LCAS clearly demonstrates that patients with moderate elevations of LDL-C and depressed levels of HDL-C can benefit from treatment with fluvastatin." This substudy supports the NCEP recommendation that the primary goal of treatment in patients with CHD is to lower LDL-C.
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