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Am J Med. 1994 Jun 6;96(6A):79S-83S.

Fluvastatin in primary hypercholesterolemia: efficacy and safety in patients at high risk. An analysis of a clinical trial database.

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Clinical Research and Development, Sandoz Pharma Ltd., Basel, Switzerland.


Patients with primary hypercholesterolemia and established coronary artery disease (CAD) with additional associated risk factors for atherosclerosis are considered for lipid-lowering drug therapy at lower levels of total and/or low-density lipoprotein cholesterol (LDL-C) than are patients with isolated hypercholesterolemia. As regards prevention of cardiovascular morbid events, high-risk patients are expected to receive the most benefit from lipid-lowering treatment. Thus, it is of interest to evaluate the efficacy, safety, and tolerability of the new lipid-lowering agent fluvastatin, a new, wholly synthetic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, in patients at high risk. A retrospective analysis was based on data from controlled clinical trials in which 1,815 patients were treated with fluvastatin at a daily dose of > or = 20 mg and 783 patients received placebo. Of the fluvastatin-treated patients, 328 (18.1%) had CAD compared with 136 (17.4%) patients taking placebo. Within these groups, 186 fluvastatin patients and 75 placebo patients had at least one of the following additional risk factors: hypertension, obesity, and/or fasting blood glucose levels above the upper limit of normal (ULN). Patients at high risk, as defined above, were compared with patients without CAD or any risk factors (fluvastatin, n = 837; placebo, n = 375). The effect of 40 mg of fluvastatin on LDL and high-density lipoprotein cholesterol (HDL-C), and triglycerides tended to be enhanced in patients at high risk (HR) compared with those at low risk (LR). Changes from baseline in HR patients were: LDL-C, -26.6%; HDL-C, 6.4%; triglycerides, -13%. Changes in LR patients were: LDL-C, -24.8%; HDL-C, 4.4%; triglycerides, -6%. All of these changes were highly significant (0.001 < p < 0.01). No patient in the HR group experienced a confirmed (measured on two consecutive occasions) increase > 3 x ULN in aspartate (ASAT) or alanine (ALAT) aminotransferases, nor any notable increases in creatine kinase > 10 x ULN. The tolerability of fluvastatin, as assessed by analysis of adverse events, was not consistently influenced by concomitant high risk. This exploratory analysis of the efficacy and safety profile of fluvastatin in patients at high risk for atherosclerosis suggests that such treatment is efficacious, safe, and well tolerated. The observed tendency toward an improved efficacy in the high-risk group will need further confirmation using data from prospective studies in such patients.

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