Open AccessEfficacy and safety of ezetimibe co‐administered with ongoing atorvastatin therapy in achieving low‐density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease
Author(s) -
CRUZFernández J. M.,
Bedarida G. V.,
Adgey J.,
Allen C.,
JohnsonLevonas A. O.,
Massaad R.
Publication year - 2005
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/j.1368-5031.2005.00565.x
Subject(s) - medicine , ezetimibe , atorvastatin , apolipoprotein b , coronary heart disease , placebo , cholesterol , lipoprotein , pharmacology , safety profile , gastroenterology , adverse effect , alternative medicine , pathology
Summary 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 ≤2.60 mmol/l while on a stable dose of ATV 10 or 20 mg/day for ≥6 weeks. After a 4‐week diet/baseline active run‐in period, patients with LDL‐C >2.60 mmol/l and ≤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 ≤2.6 mmol/l with EZE than PBO (81.3 vs. 21.8%; p ≤ 0.001). Compared to PBO, co‐administration of EZE with ongoing ATV led to significantly (p ≤ 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 ≤ 0.05) increased. Co‐administration of EZE and ATV was well tolerated, with an overall safety profile similar to ATV alone.