Clinical Experience with Fluvastatin, the First Synthetic HMG-CoA Reductase Inhibitor

Autor: L. A. Jokubaitis, J. M. Fattu, A. J. Troendle, R. I. Levy
Rok vydání: 1993
Předmět:
Zdroj: Drugs Affecting Lipid Metabolism ISBN: 9789401047463
DOI: 10.1007/978-94-011-1703-6_33
Popis: 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 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.
Databáze: OpenAIRE