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Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study.
Int J Clin Pract. 2009 Apr; 63(4):547-59.IJ

Abstract

AIMS

To evaluate the efficacy of switching from a previous statin monotherapy to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg vs. rosuvastatin (ROSUVA) 10 mg.

METHODS

In this randomised, double-blind study, 618 patients with documented hypercholesterolaemia [low-density lipoprotein cholesterol (LDL-C) > or = 2.59 and < or = 4.92 mmol/l] and with high cardiovascular risk who were taking a stable daily dose of one of several statin medications for > or = 6 weeks prior to the study randomisation visit entered a 6-week open-label stabilisation/screening period during which they continued to receive their prestudy statin dose. Following stratification by study site and statin dose/potency, patients were randomised to EZE/SIMVA 10/20 mg (n = 314) or ROSUVA 10 mg (n = 304) for 6 weeks.

RESULTS

EZE/SIMVA produced greater reductions in LDL-C (-27.7% vs. -16.9%; p < or = 0.001), total cholesterol (-17.5% vs. -10.3%; p < or = 0.001), non-high-density lipoprotein cholesterol (HDL-C) (-23.4% vs. -14.0%; p < or = 0.001) and apolipoprotein B (-17.9% vs. -9.8%; p < or = 0.001) compared with ROSUVA, while both treatments were equally effective at increasing HDL-C (2.1% vs. 3.0%; p = 0.433). More patients achieved LDL-C levels < 2.59 mmol/l (73% vs. 56%), < 2.00 mmol/l (38% vs. 19%) and < 1.81 mmol/l (25% vs. 11%) with EZE/SIMVA than ROSUVA (p < or = 0.001). A borderline significantly greater reduction in triglycerides (p = 0.056) was observed for EZE/SIMVA (-11.0%) vs. ROSUVA (-5.3%). There were no between-group differences in the incidences of adverse events or liver transaminase and creatine kinase elevations.

CONCLUSION

EZE/SIMVA 10/20 mg produced greater improvements in LDL-C, total cholesterol, non-HDL-C and apoB with a similar safety profile as for ROSUVA 10 mg.

Authors+Show Affiliations

Point Medical, Rond Point de Nation, Dijon, France. michelfarnier@nerim.netNo 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

19222610

Citation

Farnier, M, et al. "Lipid-altering Efficacy of Ezetimibe/simvastatin 10/20 Mg Compared With Rosuvastatin 10 Mg in High-risk Hypercholesterolaemic Patients Inadequately Controlled With Prior Statin Monotherapy - the IN-CROSS Study." International Journal of Clinical Practice, vol. 63, no. 4, 2009, pp. 547-59.
Farnier M, Averna M, Missault L, et al. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009;63(4):547-59.
Farnier, M., Averna, M., Missault, L., Vaverkova, H., Viigimaa, M., Massaad, R., Vandormael, K., Johnson-Levonas, A. O., & Brudi, P. (2009). Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. International Journal of Clinical Practice, 63(4), 547-59. https://doi.org/10.1111/j.1742-1241.2009.02022.x
Farnier M, et al. Lipid-altering Efficacy of Ezetimibe/simvastatin 10/20 Mg Compared With Rosuvastatin 10 Mg in High-risk Hypercholesterolaemic Patients Inadequately Controlled With Prior Statin Monotherapy - the IN-CROSS Study. Int J Clin Pract. 2009;63(4):547-59. PubMed PMID: 19222610.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. AU - Farnier,M, AU - Averna,M, AU - Missault,L, AU - Vaverkova,H, AU - Viigimaa,M, AU - Massaad,R, AU - Vandormael,K, AU - Johnson-Levonas,A O, AU - Brudi,P, Y1 - 2009/02/16/ PY - 2009/2/19/entrez PY - 2009/2/19/pubmed PY - 2009/7/18/medline SP - 547 EP - 59 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 63 IS - 4 N2 - AIMS: To evaluate the efficacy of switching from a previous statin monotherapy to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg vs. rosuvastatin (ROSUVA) 10 mg. METHODS: In this randomised, double-blind study, 618 patients with documented hypercholesterolaemia [low-density lipoprotein cholesterol (LDL-C) > or = 2.59 and < or = 4.92 mmol/l] and with high cardiovascular risk who were taking a stable daily dose of one of several statin medications for > or = 6 weeks prior to the study randomisation visit entered a 6-week open-label stabilisation/screening period during which they continued to receive their prestudy statin dose. Following stratification by study site and statin dose/potency, patients were randomised to EZE/SIMVA 10/20 mg (n = 314) or ROSUVA 10 mg (n = 304) for 6 weeks. RESULTS: EZE/SIMVA produced greater reductions in LDL-C (-27.7% vs. -16.9%; p < or = 0.001), total cholesterol (-17.5% vs. -10.3%; p < or = 0.001), non-high-density lipoprotein cholesterol (HDL-C) (-23.4% vs. -14.0%; p < or = 0.001) and apolipoprotein B (-17.9% vs. -9.8%; p < or = 0.001) compared with ROSUVA, while both treatments were equally effective at increasing HDL-C (2.1% vs. 3.0%; p = 0.433). More patients achieved LDL-C levels < 2.59 mmol/l (73% vs. 56%), < 2.00 mmol/l (38% vs. 19%) and < 1.81 mmol/l (25% vs. 11%) with EZE/SIMVA than ROSUVA (p < or = 0.001). A borderline significantly greater reduction in triglycerides (p = 0.056) was observed for EZE/SIMVA (-11.0%) vs. ROSUVA (-5.3%). There were no between-group differences in the incidences of adverse events or liver transaminase and creatine kinase elevations. CONCLUSION: EZE/SIMVA 10/20 mg produced greater improvements in LDL-C, total cholesterol, non-HDL-C and apoB with a similar safety profile as for ROSUVA 10 mg. SN - 1742-1241 UR - https://www.unboundmedicine.com/medline/citation/19222610/Lipid_altering_efficacy_of_ezetimibe/simvastatin_10/20_mg_compared_with_rosuvastatin_10_mg_in_high_risk_hypercholesterolaemic_patients_inadequately_controlled_with_prior_statin_monotherapy___The_IN_CROSS_study_ L2 - https://doi.org/10.1111/j.1742-1241.2009.02022.x DB - PRIME DP - Unbound Medicine ER -