Tags

Type your tag names separated by a space and hit enter

Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event.
Cardiology. 2009; 113(2):89-97.C

Abstract

OBJECTIVE

The aim of the study was to compare the efficacy/safety of doubling the dose of low-, medium- and high-potency statins on lipids/lipoproteins versus ezetimibe/simvastatin (EZE/SIMVA) 10/40 mg in patients with a recent coronary event.

METHODS

In this open-label study, patients were stratified by baseline statin therapy (low, medium and high potency) and randomized equally to statin dose doubling or EZE/SIMVA 10/40 mg for 12 weeks. Primary analysis concerned change in low-density lipoprotein cholesterol for the whole population. Treatment-by-stratum interaction evaluated the consistency of treatment effect across statin potency strata. Post hoc analysis of between-group efficacy within strata was performed using ANCOVA.

RESULTS

Within each stratum, EZE/SIMVA produced significantly greater reductions in low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B and non-high-density lipoprotein cholesterol (HDL-C) compared to statin doubling. Numerical trends toward smaller between-group reductions were observed with higher-potency statins and reached statistical significance for apolipoprotein B and non-HDL-C. No significant between-group differences in HDL-C and C-reactive protein were observed within each stratum. EZE/SIMVA produced larger reductions in triglycerides versus low-potency statin, whereas it was similarly effective compared with intermediate-/high-potency statins. The safety/tolerability profiles of the treatments were similar across the strata.

CONCLUSIONS

EZE/SIMVA 10/40 mg produced greater improvements in lipids with a similar safety profile compared to doubling the dose of low-, medium- and high-potency statins.

Authors+Show Affiliations

Merck Schering-Plough, New Jersey, NJ, USA. philippe_brudi@merck.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19018143

Citation

Brudi, P, et al. "Efficacy of Ezetimibe/simvastatin 10/40 Mg Compared to Doubling the Dose of Low-, Medium- and High-potency Statin Monotherapy in Patients With a Recent Coronary Event." Cardiology, vol. 113, no. 2, 2009, pp. 89-97.
Brudi P, Reckless JP, Henry DP, et al. Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. Cardiology. 2009;113(2):89-97.
Brudi, P., Reckless, J. P., Henry, D. P., Pomykaj, T., Lim, S. T., Massaad, R., Vandormael, K., & Johnson-Levonas, A. O. (2009). Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. Cardiology, 113(2), 89-97. https://doi.org/10.1159/000172795
Brudi P, et al. Efficacy of Ezetimibe/simvastatin 10/40 Mg Compared to Doubling the Dose of Low-, Medium- and High-potency Statin Monotherapy in Patients With a Recent Coronary Event. Cardiology. 2009;113(2):89-97. PubMed PMID: 19018143.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. AU - Brudi,P, AU - Reckless,J P, AU - Henry,D P, AU - Pomykaj,T, AU - Lim,S T, AU - Massaad,R, AU - Vandormael,K, AU - Johnson-Levonas,A O, Y1 - 2008/11/15/ PY - 2008/06/27/received PY - 2008/08/13/accepted PY - 2008/11/20/pubmed PY - 2009/7/8/medline PY - 2008/11/20/entrez SP - 89 EP - 97 JF - Cardiology JO - Cardiology VL - 113 IS - 2 N2 - OBJECTIVE: The aim of the study was to compare the efficacy/safety of doubling the dose of low-, medium- and high-potency statins on lipids/lipoproteins versus ezetimibe/simvastatin (EZE/SIMVA) 10/40 mg in patients with a recent coronary event. METHODS: In this open-label study, patients were stratified by baseline statin therapy (low, medium and high potency) and randomized equally to statin dose doubling or EZE/SIMVA 10/40 mg for 12 weeks. Primary analysis concerned change in low-density lipoprotein cholesterol for the whole population. Treatment-by-stratum interaction evaluated the consistency of treatment effect across statin potency strata. Post hoc analysis of between-group efficacy within strata was performed using ANCOVA. RESULTS: Within each stratum, EZE/SIMVA produced significantly greater reductions in low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B and non-high-density lipoprotein cholesterol (HDL-C) compared to statin doubling. Numerical trends toward smaller between-group reductions were observed with higher-potency statins and reached statistical significance for apolipoprotein B and non-HDL-C. No significant between-group differences in HDL-C and C-reactive protein were observed within each stratum. EZE/SIMVA produced larger reductions in triglycerides versus low-potency statin, whereas it was similarly effective compared with intermediate-/high-potency statins. The safety/tolerability profiles of the treatments were similar across the strata. CONCLUSIONS: EZE/SIMVA 10/40 mg produced greater improvements in lipids with a similar safety profile compared to doubling the dose of low-, medium- and high-potency statins. SN - 1421-9751 UR - https://www.unboundmedicine.com/medline/citation/19018143/Efficacy_of_ezetimibe/simvastatin_10/40_mg_compared_to_doubling_the_dose_of_low__medium__and_high_potency_statin_monotherapy_in_patients_with_a_recent_coronary_event_ L2 - https://www.karger.com?DOI=10.1159/000172795 DB - PRIME DP - Unbound Medicine ER -