Fluvastatin Long-Term Extension Trial (FLUENT): summary of efficacy and safety.

The Fluvastatin Long-Term Extension Trial (FLUENT) evaluated the safety and efficacy of fluvastatin over a period of 48 weeks. All 918 enrolled patients had severe primary hypercholesterolemia (mean baseline low-density lipoprotein [LDL] cholesterol, 227 mg/dL) and had completed one of three previous short-term studies of fluvastatin. This open-label extension study used a starting dose of 20 mg of fluvastatin at bedtime. The dose was titrated to 40 mg to achieve LDL levels of < 3.36 mmol/L (130 mg/dL). If necessary, cholestyramine was added to the fluvastatin treatment to achieve this level. After 48 weeks of treatment, the mean percent change from baseline was statistically significant for LDL (-30.7%; p < 0.001), total (-21.9%; p < 0.001), and HDL (+3.5%; p < 0.001) cholesterol. Of the 836 patients who completed the study, only four (0.5%) withdrew because of drug-related adverse events, which were mainly gastrointestinal. There was one purported case of myopathy in a patient who had a recent history of strenuous physical activity. Newly occurring or worsening lens abnormalities were generally mild and did not require discontinuation of treatment. In conclusion, these results indicate that fluvastatin is safe, effective, and well tolerated in the long-term treatment of primary hypercholesterolemia.