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Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease.
Int J Clin Pract. 2005 Jun; 59(6):619-27.IJ

Abstract

This randomised, double-blind, placebo (PBO)-controlled study evaluated the efficacy and safety of ezetimibe (EZE) co-administered with ongoing atorvastatin (ATV) therapy in 450 hypercholesterolemic patients with coronary heart disease (CHD) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal < or =2.60 mmol/l while on a stable dose of ATV 10 or 20 mg/day for > or =6 weeks. After a 4-week diet/baseline active run-in period, patients with LDL-C >2.60 mmol/l and < or =4.20 mmol/l were stratified by ATV dose and randomised (1 : 1) to EZE 10 mg or PBO for 6 weeks while continuing open-label ATV. Significantly more patients achieved an LDL-C goal < or =2.6 mmol/l with EZE than PBO (81.3 vs. 21.8%; p < or = 0.001). Compared to PBO, co-administration of EZE with ongoing ATV led to significantly (p < or = 0.001) greater reductions in LDL-C, total cholesterol, triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B; HDL-C was significantly (p < or = 0.05) increased. Co-administration of EZE and ATV was well tolerated, with an overall safety profile similar to ATV alone.

Authors+Show Affiliations

Universidad de Sevilla, Sevilla, Spain. jmcruzfer@telefonica.netNo 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

15924587

Citation

Cruz-Fernández, J M., et al. "Efficacy and Safety of Ezetimibe Co-administered With Ongoing Atorvastatin Therapy in Achieving Low-density Lipoprotein Goal in Patients With Hypercholesterolemia and Coronary Heart Disease." International Journal of Clinical Practice, vol. 59, no. 6, 2005, pp. 619-27.
Cruz-Fernández JM, Bedarida GV, Adgey J, et al. Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. Int J Clin Pract. 2005;59(6):619-27.
Cruz-Fernández, J. M., Bedarida, G. V., Adgey, J., Allen, C., Johnson-Levonas, A. O., & Massaad, R. (2005). Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. International Journal of Clinical Practice, 59(6), 619-27.
Cruz-Fernández JM, et al. Efficacy and Safety of Ezetimibe Co-administered With Ongoing Atorvastatin Therapy in Achieving Low-density Lipoprotein Goal in Patients With Hypercholesterolemia and Coronary Heart Disease. Int J Clin Pract. 2005;59(6):619-27. PubMed PMID: 15924587.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. AU - Cruz-Fernández,J M, AU - Bedarida,G V, AU - Adgey,J, AU - Allen,C, AU - Johnson-Levonas,A O, AU - Massaad,R, PY - 2005/6/1/pubmed PY - 2005/8/19/medline PY - 2005/6/1/entrez SP - 619 EP - 27 JF - International journal of clinical practice JO - Int J Clin Pract VL - 59 IS - 6 N2 - This randomised, double-blind, placebo (PBO)-controlled study evaluated the efficacy and safety of ezetimibe (EZE) co-administered with ongoing atorvastatin (ATV) therapy in 450 hypercholesterolemic patients with coronary heart disease (CHD) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal < or =2.60 mmol/l while on a stable dose of ATV 10 or 20 mg/day for > or =6 weeks. After a 4-week diet/baseline active run-in period, patients with LDL-C >2.60 mmol/l and < or =4.20 mmol/l were stratified by ATV dose and randomised (1 : 1) to EZE 10 mg or PBO for 6 weeks while continuing open-label ATV. Significantly more patients achieved an LDL-C goal < or =2.6 mmol/l with EZE than PBO (81.3 vs. 21.8%; p < or = 0.001). Compared to PBO, co-administration of EZE with ongoing ATV led to significantly (p < or = 0.001) greater reductions in LDL-C, total cholesterol, triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B; HDL-C was significantly (p < or = 0.05) increased. Co-administration of EZE and ATV was well tolerated, with an overall safety profile similar to ATV alone. SN - 1368-5031 UR - https://www.unboundmedicine.com/medline/citation/15924587/Efficacy_and_safety_of_ezetimibe_co_administered_with_ongoing_atorvastatin_therapy_in_achieving_low_density_lipoprotein_goal_in_patients_with_hypercholesterolemia_and_coronary_heart_disease_ L2 - https://doi.org/10.1111/j.1368-5031.2005.00565.x DB - PRIME DP - Unbound Medicine ER -