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Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study).
Am J Cardiol. 2011 Aug 15; 108(4):523-30.AJ

Abstract

The present multicenter, 6-week, randomized, double-blind, parallel-group, clinical trial evaluated the safety and efficacy of ezetimibe (10 mg) added to stable rosuvastatin therapy versus up-titration of rosuvastatin from 5 to 10 mg or from 10 to 20 mg. The study population included 440 subjects at moderately high/high risk of coronary heart disease with low-density lipoprotein (LDL) cholesterol levels higher than the National Cholesterol Education Program Adult Treatment Panel III recommendations (<100 mg/dl for moderately high/high-risk subjects without atherosclerotic vascular disease or <70 mg/dl for high-risk subjects with atherosclerotic vascular disease). Pooled data demonstrated that ezetimibe added to stable rosuvastatin 5 mg or 10 mg reduced LDL cholesterol by 21%. In contrast, doubling rosuvastatin to 10 mg or 20 mg reduced LDL cholesterol by 5.7% (between-group difference of 15.2%, p <0.001). Individually, ezetimibe plus rosuvastatin 5 mg reduced LDL cholesterol more than did rosuvastatin 10 mg (12.3% difference, p <0.001), and ezetimibe plus rosuvastatin 10 mg reduced LDL cholesterol more than did rosuvastatin 20 mg (17.5% difference, p <0.001). Compared to rosuvastatin up-titration, ezetimibe add-on achieved significantly greater attainment of LDL cholesterol levels of <70 or <100 mg/dl (59.4% vs 30.9%, p <0.001), and <70 mg/dl in all subjects (43.8% vs 17.5%, p <0.001); produced significantly greater reductions in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B (p <0.001); and resulted in similar effects on other lipid parameters. Adverse experiences were generally comparable among the groups. In conclusion, compared to up-titration doubling of the rosuvastatin dose, ezetimibe 10 mg added to stable rosuvastatin 5 mg or 10 mg produced greater improvements in many lipid parameters and achieved greater attainment of the National Cholesterol Education Program Adult Treatment Panel III recommended LDL cholesterol targets in subjects with elevated LDL cholesterol and at moderately high/high coronary heart disease risk.

Authors+Show Affiliations

Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA. hbaysmd@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21596364

Citation

Bays, Harold E., et al. "Safety and Efficacy of Ezetimibe Added On to Rosuvastatin 5 or 10 Mg Versus Up-titration of Rosuvastatin in Patients With Hypercholesterolemia (the ACTE Study)." The American Journal of Cardiology, vol. 108, no. 4, 2011, pp. 523-30.
Bays HE, Davidson MH, Massaad R, et al. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011;108(4):523-30.
Bays, H. E., Davidson, M. H., Massaad, R., Flaim, D., Lowe, R. S., Tershakovec, A. M., & Jones-Burton, C. (2011). Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). The American Journal of Cardiology, 108(4), 523-30. https://doi.org/10.1016/j.amjcard.2011.03.079
Bays HE, et al. Safety and Efficacy of Ezetimibe Added On to Rosuvastatin 5 or 10 Mg Versus Up-titration of Rosuvastatin in Patients With Hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. PubMed PMID: 21596364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). AU - Bays,Harold E, AU - Davidson,Michael H, AU - Massaad,Rachid, AU - Flaim,Doreen, AU - Lowe,Robert S, AU - Tershakovec,Andrew M, AU - Jones-Burton,Charlotte, Y1 - 2011/05/17/ PY - 2011/01/26/received PY - 2011/03/23/revised PY - 2011/03/25/accepted PY - 2011/5/21/entrez PY - 2011/5/21/pubmed PY - 2011/10/1/medline SP - 523 EP - 30 JF - The American journal of cardiology JO - Am J Cardiol VL - 108 IS - 4 N2 - The present multicenter, 6-week, randomized, double-blind, parallel-group, clinical trial evaluated the safety and efficacy of ezetimibe (10 mg) added to stable rosuvastatin therapy versus up-titration of rosuvastatin from 5 to 10 mg or from 10 to 20 mg. The study population included 440 subjects at moderately high/high risk of coronary heart disease with low-density lipoprotein (LDL) cholesterol levels higher than the National Cholesterol Education Program Adult Treatment Panel III recommendations (<100 mg/dl for moderately high/high-risk subjects without atherosclerotic vascular disease or <70 mg/dl for high-risk subjects with atherosclerotic vascular disease). Pooled data demonstrated that ezetimibe added to stable rosuvastatin 5 mg or 10 mg reduced LDL cholesterol by 21%. In contrast, doubling rosuvastatin to 10 mg or 20 mg reduced LDL cholesterol by 5.7% (between-group difference of 15.2%, p <0.001). Individually, ezetimibe plus rosuvastatin 5 mg reduced LDL cholesterol more than did rosuvastatin 10 mg (12.3% difference, p <0.001), and ezetimibe plus rosuvastatin 10 mg reduced LDL cholesterol more than did rosuvastatin 20 mg (17.5% difference, p <0.001). Compared to rosuvastatin up-titration, ezetimibe add-on achieved significantly greater attainment of LDL cholesterol levels of <70 or <100 mg/dl (59.4% vs 30.9%, p <0.001), and <70 mg/dl in all subjects (43.8% vs 17.5%, p <0.001); produced significantly greater reductions in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B (p <0.001); and resulted in similar effects on other lipid parameters. Adverse experiences were generally comparable among the groups. In conclusion, compared to up-titration doubling of the rosuvastatin dose, ezetimibe 10 mg added to stable rosuvastatin 5 mg or 10 mg produced greater improvements in many lipid parameters and achieved greater attainment of the National Cholesterol Education Program Adult Treatment Panel III recommended LDL cholesterol targets in subjects with elevated LDL cholesterol and at moderately high/high coronary heart disease risk. SN - 1879-1913 UR - https://www.unboundmedicine.com/medline/citation/21596364/Safety_and_efficacy_of_ezetimibe_added_on_to_rosuvastatin_5_or_10_mg_versus_up_titration_of_rosuvastatin_in_patients_with_hypercholesterolemia__the_ACTE_Study__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9149(11)01412-3 DB - PRIME DP - Unbound Medicine ER -