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Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency.

Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P - Lipids Health Dis (2010)

Bottom Line: Significant treatment-by-subgroup interaction occurred for LDL-C (p=0.013), total cholesterol (p=0.025), non-HDL-C (p=0.032), and apolipoprotein B (p=0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum.Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.

View Article: PubMed Central - HTML - PubMed

Affiliation: Tallinn University of Technology, Technomedicum, Ehitajate St, 5, 19086 Tallinn, Estonia. margus.viigimaa@regionaalhaigla.ee

ABSTRACT

Objective: This post-hoc analysis compared the lipid-altering efficacy of Ezetimibe/Simvastatin 10/20 mg (EZ/Simva) versus Rosuvastatin 10 mg (Rosuva) in patients stratified by statin potency/dose prior to randomization.

Methods: Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite prior statin treatment (n=618) were randomized 1:1 to EZ/Simva 10/20 mg or Rosuva 10 mg for 6 weeks. Percent change from baseline in lipids and attainment of lipid targets were assessed within each subgroup (low potency n=369, high potency n=249). Consistency of the treatment effect across subgroups was evaluated by testing for treatment-by-subgroup interaction. No multiplicity adjustments were made.

Results: Significant treatment-by-subgroup interaction occurred for LDL-C (p=0.013), total cholesterol (p=0.025), non-HDL-C (p=0.032), and apolipoprotein B (p=0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum. Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.

Conclusions: Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.

Trial registration: Registered at ClinicalTrials.gov: NCT00479713.

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Related in: MedlinePlus

Percent of patients achieving lipid targets at 6 weeks (treated with high-potency statins† at baseline). *Triple target = LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and Apo B <90 mg/dL †High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg ‡Ratio of the predictive odds of attaining target on EZ+Simva versus Rosuvastatin based on the logistic model (fitted within each subgroup) with terms for treatment and baseline values of the variable being modeled. Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; non-HDL-C = non-high-density lipoprotein cholesterol; R = rosuvastatin; S = simvastatin
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Figure 4: Percent of patients achieving lipid targets at 6 weeks (treated with high-potency statins† at baseline). *Triple target = LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and Apo B <90 mg/dL †High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg ‡Ratio of the predictive odds of attaining target on EZ+Simva versus Rosuvastatin based on the logistic model (fitted within each subgroup) with terms for treatment and baseline values of the variable being modeled. Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; non-HDL-C = non-high-density lipoprotein cholesterol; R = rosuvastatin; S = simvastatin

Mentions: Higher percentages of patients achieved the specified treatment targets in the EZ/Simva group compared with patients treated with rosuvastatin in both potency groups (Figures 3 and Figure 4). The magnitude of between-group differences was generally greater in the high-potency statin group compared with the low-potency statin group. In the low-potency group, the predictive odds of attaining all individual specified lipid levels and the triple combination were greater in patients treated with EZ/Simva compared with rosuvastatin (see table under Figure 3). In the high-potency group, the predictive odds of attaining all individual specified lipid levels and the triple combination were greater in patients treated with EZ/Simva compared with rosuvastatin (see table under Figure 4). In the high-potency group, the predictive odds of attaining the lipid levels were higher compared with those in the low-potency groups, although the treatment effects on attainment of specified levels for LDL-C, non-HDL-C, Apo B and the triple combination target were generally consistent across the two potency groups.


Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency.

Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P - Lipids Health Dis (2010)

Percent of patients achieving lipid targets at 6 weeks (treated with high-potency statins† at baseline). *Triple target = LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and Apo B <90 mg/dL †High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg ‡Ratio of the predictive odds of attaining target on EZ+Simva versus Rosuvastatin based on the logistic model (fitted within each subgroup) with terms for treatment and baseline values of the variable being modeled. Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; non-HDL-C = non-high-density lipoprotein cholesterol; R = rosuvastatin; S = simvastatin
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2992529&req=5

Figure 4: Percent of patients achieving lipid targets at 6 weeks (treated with high-potency statins† at baseline). *Triple target = LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and Apo B <90 mg/dL †High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg ‡Ratio of the predictive odds of attaining target on EZ+Simva versus Rosuvastatin based on the logistic model (fitted within each subgroup) with terms for treatment and baseline values of the variable being modeled. Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; non-HDL-C = non-high-density lipoprotein cholesterol; R = rosuvastatin; S = simvastatin
Mentions: Higher percentages of patients achieved the specified treatment targets in the EZ/Simva group compared with patients treated with rosuvastatin in both potency groups (Figures 3 and Figure 4). The magnitude of between-group differences was generally greater in the high-potency statin group compared with the low-potency statin group. In the low-potency group, the predictive odds of attaining all individual specified lipid levels and the triple combination were greater in patients treated with EZ/Simva compared with rosuvastatin (see table under Figure 3). In the high-potency group, the predictive odds of attaining all individual specified lipid levels and the triple combination were greater in patients treated with EZ/Simva compared with rosuvastatin (see table under Figure 4). In the high-potency group, the predictive odds of attaining the lipid levels were higher compared with those in the low-potency groups, although the treatment effects on attainment of specified levels for LDL-C, non-HDL-C, Apo B and the triple combination target were generally consistent across the two potency groups.

Bottom Line: Significant treatment-by-subgroup interaction occurred for LDL-C (p=0.013), total cholesterol (p=0.025), non-HDL-C (p=0.032), and apolipoprotein B (p=0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum.Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.

View Article: PubMed Central - HTML - PubMed

Affiliation: Tallinn University of Technology, Technomedicum, Ehitajate St, 5, 19086 Tallinn, Estonia. margus.viigimaa@regionaalhaigla.ee

ABSTRACT

Objective: This post-hoc analysis compared the lipid-altering efficacy of Ezetimibe/Simvastatin 10/20 mg (EZ/Simva) versus Rosuvastatin 10 mg (Rosuva) in patients stratified by statin potency/dose prior to randomization.

Methods: Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite prior statin treatment (n=618) were randomized 1:1 to EZ/Simva 10/20 mg or Rosuva 10 mg for 6 weeks. Percent change from baseline in lipids and attainment of lipid targets were assessed within each subgroup (low potency n=369, high potency n=249). Consistency of the treatment effect across subgroups was evaluated by testing for treatment-by-subgroup interaction. No multiplicity adjustments were made.

Results: Significant treatment-by-subgroup interaction occurred for LDL-C (p=0.013), total cholesterol (p=0.025), non-HDL-C (p=0.032), and apolipoprotein B (p=0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum. Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.

Conclusions: Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.

Trial registration: Registered at ClinicalTrials.gov: NCT00479713.

Show MeSH
Related in: MedlinePlus