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Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study.
Int J Clin Pract. 2008 Apr; 62(4):539-54.IJ

Abstract

BACKGROUND

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.

DESIGN

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.

RESULTS

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 levels < 2.5 (< 100 mg/dl; 86% vs. 72%), < 2.0 (< 77 mg/dl; 70% vs. 42%) and < 1.8 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.

CONCLUSIONS

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.

Authors+Show Affiliations

Royal United Hospital, Bath, UK. mpsjpdr@bath.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18266852

Citation

Reckless, J P D., et al. "Lipid-altering Efficacy of Ezetimibe/simvastatin 10/40 Mg Compared With Doubling the Statin Dose in Patients Admitted to the Hospital for a Recent Coronary Event: the INFORCE Study." International Journal of Clinical Practice, vol. 62, no. 4, 2008, pp. 539-54.
Reckless JP, Henry P, Pomykaj T, et al. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008;62(4):539-54.
Reckless, J. P., Henry, P., Pomykaj, T., Lim, S. T., Massaad, R., Vandormael, K., Johnson-Levonas, A. O., Lis, K., Brudi, P., & Allen, C. (2008). Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. International Journal of Clinical Practice, 62(4), 539-54. https://doi.org/10.1111/j.1742-1241.2008.01697.x
Reckless JP, et al. Lipid-altering Efficacy of Ezetimibe/simvastatin 10/40 Mg Compared With Doubling the Statin Dose in Patients Admitted to the Hospital for a Recent Coronary Event: the INFORCE Study. Int J Clin Pract. 2008;62(4):539-54. PubMed PMID: 18266852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. AU - Reckless,J P D, AU - Henry,P, AU - Pomykaj,T, AU - Lim,S T, AU - Massaad,R, AU - Vandormael,K, AU - Johnson-Levonas,A O, AU - Lis,K, AU - Brudi,P, AU - Allen,C, Y1 - 2008/02/11/ PY - 2008/2/13/pubmed PY - 2008/8/1/medline PY - 2008/2/13/entrez SP - 539 EP - 54 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 62 IS - 4 N2 - BACKGROUND: 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. DESIGN: 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. RESULTS: 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 levels < 2.5 (< 100 mg/dl; 86% vs. 72%), < 2.0 (< 77 mg/dl; 70% vs. 42%) and < 1.8 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. CONCLUSIONS: 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. SN - 1742-1241 UR - https://www.unboundmedicine.com/medline/citation/18266852/Lipid_altering_efficacy_of_ezetimibe/simvastatin_10/40_mg_compared_with_doubling_the_statin_dose_in_patients_admitted_to_the_hospital_for_a_recent_coronary_event:_the_INFORCE_study_ L2 - https://doi.org/10.1111/j.1742-1241.2008.01697.x DB - PRIME DP - Unbound Medicine ER -