Efficacy of XXXX / @entity3413 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in @entity1 with a recent coronary event.

@entity1 @entity3413 @entity1674 @entity755 @entity3709 @entity165
OBJECTIVE: The aim of the study was to compare the efficacy/safety of doubling the dose of low-, medium- and high-potency statins on lipids/lipoproteins versus @entity3709 / @entity3413 (EZE/SIMVA) 10/40 mg in @entity1 with a recent coronary event. METHODS: In this open-label study, @entity1 were stratified by baseline statin therapy (low, medium and high potency) and randomized equally to statin dose doubling or EZE/SIMVA 10/40 mg for 12 weeks. Primary analysis concerned change in low-density lipoprotein @entity165 for the whole population. Treatment-by-stratum interaction evaluated the consistency of treatment effect across statin potency strata. Post hoc analysis of between-group efficacy within strata was performed using ANCOVA. RESULTS: Within each stratum, EZE/SIMVA produced significantly greater reductions in low-density lipoprotein @entity165 , total @entity165 , @entity755 and non-high-density lipoprotein @entity165 (HDL-C) compared to statin doubling. Numerical trends toward smaller between-group reductions were observed with higher-potency statins and reached statistical significance for @entity755 and non-HDL-C. No significant between-group differences in HDL-C and C-reactive protein were observed within each stratum. EZE/SIMVA produced larger reductions in @entity1674 versus low-potency statin, whereas it was similarly effective compared with intermediate-/high-potency statins. The safety/tolerability profiles of the treatments were similar across the strata. CONCLUSIONS: EZE/SIMVA 10/40 mg produced greater improvements in lipids with a similar safety profile compared to doubling the dose of low-, medium- and high-potency statins.
