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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 change in lipid and hs-CRP levels after 6 weeks of treatment in patients treated with high-potency statins* at baseline. *High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg †Presented as median values Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density lipoprotein cholesterol; hs-CRP = high sensitivity C-reactive protein; R = rosuvastatin; S = simvastatin; TG = triglycerides; Total C = total cholesterol
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Figure 2: Percent change in lipid and hs-CRP levels after 6 weeks of treatment in patients treated with high-potency statins* at baseline. *High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg †Presented as median values Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density lipoprotein cholesterol; hs-CRP = high sensitivity C-reactive protein; R = rosuvastatin; S = simvastatin; TG = triglycerides; Total C = total cholesterol

Mentions: Both treatment regimens resulted in improvements in LDL-C, non-HDL-C, total cholesterol, triglyceride, Apo B, LDL-C/HDL-C ratio and total cholesterol/HDL-C ratio levels after 6 weeks of treatment, although the percent change from baseline was greater in patients treated with EZ/Simva 10/20 mg for all endpoints compared with patients treated with rosuvastatin 10 mg in both potency strata groups (Figure 1 and Figure 2). Significant treatment-by-stratum interactions were observed for LDL-C (p = 0.013), total cholesterol (p = 0.025), non-HDL-C (p = 0.032), and Apo B (p = 0.016), with greater between treatment differences in favor of EZ/Simva observed in patients from the high-potency stratum compared with the low-potency stratum (Figure 1 and Figure 2). Treatment effects were consistent across the two subgroups (low-potency/high-potency) with the overall population in HDL-C, LDL-C/HDL-C, total cholesterol/HDL-C ratio, hs-CRP and triglyceride levels.


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 change in lipid and hs-CRP levels after 6 weeks of treatment in patients treated with high-potency statins* at baseline. *High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg †Presented as median values Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density lipoprotein cholesterol; hs-CRP = high sensitivity C-reactive protein; R = rosuvastatin; S = simvastatin; TG = triglycerides; Total C = total cholesterol
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Percent change in lipid and hs-CRP levels after 6 weeks of treatment in patients treated with high-potency statins* at baseline. *High potency stratum included: simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg †Presented as median values Apo B = apolipoprotein B; E = ezetimibe; LDL-C = low-density lipoprotein cholesterol; HDL-C = high-density lipoprotein cholesterol; hs-CRP = high sensitivity C-reactive protein; R = rosuvastatin; S = simvastatin; TG = triglycerides; Total C = total cholesterol
Mentions: Both treatment regimens resulted in improvements in LDL-C, non-HDL-C, total cholesterol, triglyceride, Apo B, LDL-C/HDL-C ratio and total cholesterol/HDL-C ratio levels after 6 weeks of treatment, although the percent change from baseline was greater in patients treated with EZ/Simva 10/20 mg for all endpoints compared with patients treated with rosuvastatin 10 mg in both potency strata groups (Figure 1 and Figure 2). Significant treatment-by-stratum interactions were observed for LDL-C (p = 0.013), total cholesterol (p = 0.025), non-HDL-C (p = 0.032), and Apo B (p = 0.016), with greater between treatment differences in favor of EZ/Simva observed in patients from the high-potency stratum compared with the low-potency stratum (Figure 1 and Figure 2). Treatment effects were consistent across the two subgroups (low-potency/high-potency) with the overall population in HDL-C, LDL-C/HDL-C, total cholesterol/HDL-C ratio, hs-CRP and triglyceride levels.

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