Why the study?
Does fenofibrate/pravastatin combination therapy improve lipid profiles and maintain safety in high-risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy?
Population
248 high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy.
Comparison
Fenofibrate/pravastatin 160/40 mg fixed-dose… vs Pravastatin 40 mg monotherapy.
Design
RCT, randomized, double-blind phase followed by open-label phase
Follow-up
64 weeks
Key result
Fenofibrate/pravastatin 160/40 mg combination therapy significantly reduced non-HDL cholesterol by 16.3% at 64 weeks compared to baseline on pravastatin monotherapy (p<0.0001).
Authors
Loading...
Supports adding fenofibrate to pravastatin in uncontrolled mixed hyperlipidemia; extends RCT evidence for long-term lipid and safety benefits.
RCT (n=248)
Double-blind
randomized
Does fenofibrate/pravastatin combination therapy improve lipid profiles and maintain safety in high-risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy?
p-value: p=< 0.0001
Long-term co-administration of fenofibrate and pravastatin is well tolerated and improves the overall lipid profile in high-risk patients with mixed hyperlipidemia inadequately controlled by pravastatin monotherapy.
Farnier et al. (2011) conducted an RCT in mixed hyperlipidemia not controlled by pravastatin monotherapy (n=248). fenofibrate/pravastatin combination therapy vs. pravastatin 40 mg monotherapy was evaluated on non-HDL cholesterol reduction at week 64 compared to baseline (p=< 0.0001). Fenofibrate/pravastatin 160/40 mg combination therapy significantly reduced non-HDL cholesterol by 16.3% at 64 weeks compared to baseline on pravastatin monotherapy (p<0.0001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: