PMID- 22291820 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20121002 LR - 20211021 IS - 1896-9151 (Electronic) IS - 1734-1922 (Print) IS - 1734-1922 (Linking) VI - 7 IP - 5 DP - 2011 Oct TI - Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial. PG - 767-75 LID - 10.5114/aoms.2011.25550 [doi] AB - INTRODUCTION: When a standard dose of statins fails to achieve lipid control in patients at high risk for coronary artery disease (CAD), increasing the statin dosage or co-administration of additional agents is recommended. The aim of this study was to compare the safety and lipid-lowering efficacy of doubling the standard statin dose (STAT2) to that of co-administering ezetimibe 10 mg/day (EZE+statin) in Canadian patients at high CAD risk with persistent hyperlipidemia upon statin treatment. MATERIAL AND METHODS: Six-week, open-label, randomized, multicentre study. The primary outcome was the change in plasma LDL-C and secondary measures included the change in additional lipid parameters. Safety was assessed with the incidence of emergent adverse events (AEs). RESULTS: Eight hundred eighty-five patients (EZE+statin, n=586; STAT2, n=299) completed the study. The mean (SD) percent change in low-density lipoprotein cholesterol (LDL-C) was - 30.9% (18.2) for the EZE+statin group and -18.4% (19.0) for the STAT2 group (p=0.001). Percent and absolute decreases in total cholesterol (TC), triglycerides and the TC to high-density lipoprotein cholesterol ratio (TC/HDL-C) were significantly greater for the EZE+statin group (p = 0.001). After 6 weeks of treatment, 70% of the patients in the EZE+statin group and 48% of patients in the STAT2 group (OR=2.45, p<0.001) achieved target LDL-C levels of<2.5 mmol/l. Incidence of AEs was similar between groups, with the exception of a higher incidence of muscle disorders in the STAT2 group. CONCLUSIONS: In patients at high CAD risk who are above the LDL-C target while on statin monotherapy, co-administration of ezetimibe is well tolerated and more effective in improving the lipid profile compared to doubling the existing statin dose. FAU - Shekhar Pandey, A AU - Shekhar Pandey A AD - Cambridge Cardiac Care Centre, Cambridge, Ontario, Canada. FAU - Bissonnette, Stephane AU - Bissonnette S FAU - Boukas, Stella AU - Boukas S FAU - Rampakakis, Emmanouil AU - Rampakakis E FAU - Sampalis, John S AU - Sampalis JS LA - eng PT - Journal Article DEP - 20111108 PL - Poland TA - Arch Med Sci JT - Archives of medical science : AMS JID - 101258257 PMC - PMC3258811 OTO - NOTNLM OT - ezetimibe OT - hypercholesterolemia OT - low-density lipoprotein cholesterol OT - statin EDAT- 2012/02/01 06:00 MHDA- 2012/02/01 06:01 PMCR- 2011/12/01 CRDT- 2012/02/01 06:00 PHST- 2010/07/20 00:00 [received] PHST- 2010/11/20 00:00 [revised] PHST- 2010/12/28 00:00 [accepted] PHST- 2012/02/01 06:00 [entrez] PHST- 2012/02/01 06:00 [pubmed] PHST- 2012/02/01 06:01 [medline] PHST- 2011/12/01 00:00 [pmc-release] AID - 17609 [pii] AID - 10.5114/aoms.2011.25550 [doi] PST - ppublish SO - Arch Med Sci. 2011 Oct;7(5):767-75. doi: 10.5114/aoms.2011.25550. Epub 2011 Nov 8.