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Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals.
Am J Cardiol 2004; 93(12):1481-6AJ

Abstract

This study assessed whether the co-administration of ezetimibe and simvastatin would be more effective than simvastatin monotherapy in allowing high-risk patients to achieve a low-density lipoprotein (LDL) cholesterol goal of <100 mg/dl. Men and women with LDL cholesterol >/=130 mg/dl and meeting National Cholesterol Education Program Adult Treatment Panel III criteria for coronary heart disease (CHD) or CHD risk equivalent were randomized to 1 of 4 daily treatments for 23 weeks: simvastatin 20 mg (n = 253), ezetimibe 10 mg plus simvastatin 10 mg (n = 251), ezetimibe 10 mg plus simvastatin 20 mg (n = 109), and ezetimibe 10 mg plus simvastatin 40 mg (n = 97). In all groups, patients not at goal had their simvastatin doses doubled at weeks 6, 12, and/or 18, up to a maximum of 80 mg. The primary efficacy objective was LDL cholesterol goal attainment (<100 mg/dl) after 5 weeks of treatment. Ezetimibe plus any dose of simvastatin produced greater reductions in LDL cholesterol and allowed more patients to achieve goal after 5 weeks (p <0.001) and at the end of the study (p <0.001) than simvastatin 20 mg alone. At 5 weeks, 75%, 83%, and 87% of patients receiving ezetimibe plus simvastatin 10, 20, and 40 mg had LDL cholesterol <100 mg/dl compared with 46% of patients receiving simvastatin 20 mg. In patients who started on ezetimibe plus simvastatin 10, 20 and 40 mg, 33%, 22%, and 12%, respectively, required simvastatin titration during the study compared with 68% of patients who started on simvastatin 20 mg. The corresponding median simvastatin doses used were 10, 20, 40, and 40 mg, respectively. Ezetimibe plus simvastatin was well tolerated, with an overall safety profile similar to that of simvastatin monotherapy. Thus, through the dual inhibition of cholesterol absorption and synthesis, ezetimibe plus simvastatin allowed more patients to reach LDL cholesterol <100 mg/dl at a lower simvastatin dose and with fewer dose titrations than simvastatin monotherapy.

Authors+Show Affiliations

Miami Research Associates, Coral Gables, Florida 33146, USA. tfeldmanmd@aol.comNo 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 availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15194017

Citation

Feldman, Theodore, et al. "Treatment of High-risk Patients With Ezetimibe Plus Simvastatin Co-administration Versus Simvastatin Alone to Attain National Cholesterol Education Program Adult Treatment Panel III Low-density Lipoprotein Cholesterol Goals." The American Journal of Cardiology, vol. 93, no. 12, 2004, pp. 1481-6.
Feldman T, Koren M, Insull W, et al. Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. Am J Cardiol. 2004;93(12):1481-6.
Feldman, T., Koren, M., Insull, W., McKenney, J., Schrott, H., Lewin, A., ... Mitchel, Y. (2004). Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. The American Journal of Cardiology, 93(12), pp. 1481-6.
Feldman T, et al. Treatment of High-risk Patients With Ezetimibe Plus Simvastatin Co-administration Versus Simvastatin Alone to Attain National Cholesterol Education Program Adult Treatment Panel III Low-density Lipoprotein Cholesterol Goals. Am J Cardiol. 2004 Jun 15;93(12):1481-6. PubMed PMID: 15194017.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. AU - Feldman,Theodore, AU - Koren,Michael, AU - Insull,William,Jr AU - McKenney,James, AU - Schrott,Helmut, AU - Lewin,Andrew, AU - Shah,Sukrut, AU - Sidisin,Michelle, AU - Cho,Meehyung, AU - Kush,Debra, AU - Mitchel,Yale, PY - 2003/12/18/received PY - 2004/02/14/revised PY - 2004/02/14/accepted PY - 2004/6/15/pubmed PY - 2004/7/9/medline PY - 2004/6/15/entrez SP - 1481 EP - 6 JF - The American journal of cardiology JO - Am. J. Cardiol. VL - 93 IS - 12 N2 - This study assessed whether the co-administration of ezetimibe and simvastatin would be more effective than simvastatin monotherapy in allowing high-risk patients to achieve a low-density lipoprotein (LDL) cholesterol goal of <100 mg/dl. Men and women with LDL cholesterol >/=130 mg/dl and meeting National Cholesterol Education Program Adult Treatment Panel III criteria for coronary heart disease (CHD) or CHD risk equivalent were randomized to 1 of 4 daily treatments for 23 weeks: simvastatin 20 mg (n = 253), ezetimibe 10 mg plus simvastatin 10 mg (n = 251), ezetimibe 10 mg plus simvastatin 20 mg (n = 109), and ezetimibe 10 mg plus simvastatin 40 mg (n = 97). In all groups, patients not at goal had their simvastatin doses doubled at weeks 6, 12, and/or 18, up to a maximum of 80 mg. The primary efficacy objective was LDL cholesterol goal attainment (<100 mg/dl) after 5 weeks of treatment. Ezetimibe plus any dose of simvastatin produced greater reductions in LDL cholesterol and allowed more patients to achieve goal after 5 weeks (p <0.001) and at the end of the study (p <0.001) than simvastatin 20 mg alone. At 5 weeks, 75%, 83%, and 87% of patients receiving ezetimibe plus simvastatin 10, 20, and 40 mg had LDL cholesterol <100 mg/dl compared with 46% of patients receiving simvastatin 20 mg. In patients who started on ezetimibe plus simvastatin 10, 20 and 40 mg, 33%, 22%, and 12%, respectively, required simvastatin titration during the study compared with 68% of patients who started on simvastatin 20 mg. The corresponding median simvastatin doses used were 10, 20, 40, and 40 mg, respectively. Ezetimibe plus simvastatin was well tolerated, with an overall safety profile similar to that of simvastatin monotherapy. Thus, through the dual inhibition of cholesterol absorption and synthesis, ezetimibe plus simvastatin allowed more patients to reach LDL cholesterol <100 mg/dl at a lower simvastatin dose and with fewer dose titrations than simvastatin monotherapy. SN - 0002-9149 UR - https://www.unboundmedicine.com/medline/citation/15194017/Treatment_of_high_risk_patients_with_ezetimibe_plus_simvastatin_co_administration_versus_simvastatin_alone_to_attain_National_Cholesterol_Education_Program_Adult_Treatment_Panel_III_low_density_lipoprotein_cholesterol_goals_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002914904003534 DB - PRIME DP - Unbound Medicine ER -