[Efficacy and safety of fluvastatin extended-release tablets in Chinese patients with hyperlipidemia: a multi-center, randomized, double-blind, double dummy, active-controlled, parallel-group study]

Abstract

Objective: To assess the efficacy and safety of fluvastatin sodium extended-release tablets (fluvastatin XL) 80 mg once daily compared to fluvastatin sodium immediate-release capsules (fluvastatin IR) 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk.

Methods: In this multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study, after 6-week open-label treatment with fluvastatin IR 40 mg once daily, patients who did not reach their lipid goals were randomized to 12-week double-blind treatment with fluvastatin XL 80 mg once daily or fluvastatin IR 40 mg twice daily.

Results: (1) There were 218 patients enrolled in each group. At the study endpoint, no statistical difference was found in the mean percent change from baseline for LDL-C with -8.69% [from (3.504 ± 0.060) mmol/L to (3.153 ± 0.065) mmol/L] in the fluvastatin XL group and -7.89% [from (3.491 ± 0.050) mmol/L to (3.181 ± 0.060) mmol/L] in the fluvastatin IR group (P > 0.05). The 95%CI for difference between the two groups in adjusted mean percent change from baseline was (-4.70%-3.09%), which was within the pre-specified non-inferiority margin. In the fluvastatin XL group, the proportion of patients with moderate cardiovascular (CV) risk and high CV risk achieving their LDL-C treatment goals at endpoint was 50.0% and 31.5% respectively, while the proportion was 42.5% and 24.5% respectively in the fluvastatin IR group. No significant difference was found between the two groups in the proportion of patients who reached their lipid goals and the changes from baseline with other lipid parameters. (2) Similar safety profiles were observed in the two treatment groups, with 21.1% adverse event (AE) (8.3% study-drug related AE) in the fluvastatin XL group and 17.0% AE (6.3% study-drug related AE) in the fluvastatin IR group.

Conclusion: The efficacy of fluvastatin XL 80 mg once daily is comparable to fluvastatin IR 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk and both treatments are safe and well-tolerated.