| Autor: |
J P D, Reckless, P, Henry, T, Pomykaj, S T, Lim, R, Massaad, K, Vandormael, A O, Johnson-Levonas, K, Lis, P, Brudi, C, Allen |
| Rok vydání: |
2008 |
| Předmět: |
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| Zdroj: |
International journal of clinical practice. 62(4) |
| ISSN: |
1742-1241 |
| Popis: |
The aim of this study was to investigate the efficacy and safety profile of switching to ezetimibe/simvastatin (Eze/Simva) 10/40 mg compared with doubling the statin dose upon discharge in patients taking a statin and admitted to the hospital for the investigation of a coronary event.This phase IV, multi-centre, randomised, open-label, active-controlled, parallel group study enrolled 424 patients (aged/= 18 years) hospitalised for an acute coronary event and taking a stable dose of a statin (/= 6 weeks) that could be doubled per the product label. Upon discharge from the hospital, patients were stratified by their statin dose/potency (high, medium and low) and randomised 1 : 1 to doubling of the statin dose (n = 211) or Eze/Simva 10/40 mg (n = 213) for 12 weeks. The primary efficacy variable was the absolute low-density lipoprotein cholesterol (LDL-C) value (mmol/l) at study end-point.Mean baseline LDL-C for the two treatment groups were 2.48 and 2.31 mmol/l for the Eze/Simva and statin groups respectively. At study end-point, least squares mean LDL-C values were 1.74 mmol/l in the Eze/Simva group and 2.22 mmol/l in the statin group resulting in a significant between-group difference of -0.49 mmol/l (p/= 0.001). Eze/Simva 10/40 mg also produced significantly lower total cholesterol (-0.49 mmol/l), non-high-density lipoprotein cholesterol [(non-HDL-C); -0.53 mmol/l] and apolipoprotein B (-0.14 mmol/l) values compared with doubling the statin dose (p/= 0.001 for all). Both treatments produced similar effects on triglycerides, C-reactive protein and HDL-C; the between treatment group differences were not significant (p/= 0.160). Significantly more patients achieved LDL-C levels2.5 (100 mg/dl; 86% vs. 72%),2.0 (77 mg/dl; 70% vs. 42%) and1.8 mmol/l (70 mg/dl; 60% vs. 31%) with Eze/Simva than statin (all p/= 0.001). Eze/Simva was generally well tolerated, with a safety profile similar to statin. There were no differences in the incidences of liver transaminases/= 3 x upper limit of normal (ULN) or creatine kinase/= 10 x ULN between the groups.In patients taking a statin and admitted to the hospital for investigation of a coronary event, treatment with Eze/Simva 10/40 mg for 12 weeks produced greater improvements in lipids with a similar safety profile compared with doubling of the statin dose. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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