Abstract.
Fluvastatin (FL), the first synthetic HMG-CoA reductase inhibitor, was administered to 946 hypercholesterolemic patients in four Phase III trials of 18 to 54 weeks duration. At 20 mg QPM, FL treatment resulted in a mean change in LDL-C of -20.5% (p < 0.001). At 40 mg daily, the mean LDL-C change was -24.0%. Apolipoprotein B reductions were similar to the LDL-C reductions. Small but meaningful increases in HDL-C and corresponding decreases in triglycerides were noted. No effect upon Lp(a) was found. None of the adverse complaints common to the statin class were produced in FL subjects at a rate significantly above those on placebo. Three (0.3%) FL-treated and three (0.5%) control patients had elevations of CPK to greater than ten times the upper limit of normal (>10xULN). No cases of myositis were reported. Persistent transaminase elevations to >3xULN occurred in 13 (1.4%) FL-treated patients and six (1.2%) placebo controls. The data suggest that fluvastatin is an effective agent for treating hypercholesterolemia, with tolerability comparable to placebo and a safety profile that is potentially distinct from other HMG-CoA reductase inhibitors with respect to specific parameters.
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Jokubaitis, L.A., Troendle, A.J., Fattu, J.M., Levy, R.I. (1993). Clinical Experience with Fluvastatin, the First Synthetic HMG-CoA Reductase Inhibitor. In: Catapano, A.L., Gotto, A.M., Smith, L.C., Paoletti, R. (eds) Drugs Affecting Lipid Metabolism. Medical Science Symposia Series, vol 2. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-1703-6_33
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DOI: https://doi.org/10.1007/978-94-011-1703-6_33
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