Efficacy of fluvastatin, a totally synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. FLUENT Study Group. Fluvastatin Long-Term Extension Trial.
The Fluvastatin Long-Term Extension Trial (FLUENT) was designed to assess the safety and efficacy of fluvastatin over a prolonged period of time. In this way, FLUENT represents a clinical scenario that is closer to office-based chronic treatment of hyperlipidemic patients. A total of 918 patients with severe primary hypercholesterolemia (mean baseline low density lipoprotein cholesterol [LDL-C], 227 mg/dL) were enrolled into the study and received open-label fluvastatin, 20 or 40 mg daily, depending on response. Results of the first year of treatment have been published previously and showed statistically significant changes in LDL-C (-30.7%), total cholesterol (-21.9%), and high density lipoprotein cholesterol (HDL-C; +3.5%). Of the original number of patients completing the 1-year study, 761 completed a second year of evaluation; the results are presented here. Any patient who did not achieve LDL-C levels of < or = 130 mg/dL could receive cholestyramine (usually 8 g/day) or fluvastatin up to 80 mg/day. At the end of the 2-year period there were significant changes in LDL-C with fluvastatin (20 mg/day, -25.4%; 40 mg/day, -30.6%; 80 mg/day, -33.7%; p < 0.001 vs baseline for all values). The combination of fluvastatin and cholestyramine changed LDL-C by -34.6%. Similar dose-response results were seen with reductions in total cholesterol and the LDL-C: HDL-C ratio. There were no unexpected or severe adverse events or laboratory abnormalities. In conclusion, fluvastatin offers a range of LDL-C reduction (25-34%) similar to other HMG-CoA reductase inhibitors, that conforms with guideline recommendations for over 90% of hypercholesterolemic patients.
Zavoral
J H
JH
Preventive Cardiology Institute, Fairview Southdale Hospital, Edina, Minnesota 55435, USA.
Haggerty
B J
BJ
Winick
A G
AG
Bergmann
S D
SD
D000328:Adult; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D002792:Cholestyramine Resin / Q000008:administration & dosage / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D006903:Hydroxymethylglutaryl CoA Reductases / Q000008:administration & dosage / Q000627:therapeutic use*; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D012449:Safety
D000924:Anticholesteremic Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004338:Drug Combinations; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D002792:Cholestyramine Resin; D000077340:Fluvastatin; D002784:Cholesterol; D006903:Hydroxymethylglutaryl CoA Reductases