title: Implications for Ezetimibe Therapy Use Based on IMPROVE-IT Criteria.
abstract: OBJECTIVE
  In the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), simvastatin/ezetimibe combination was associated with a 6% relative risk reduction in the combined cardiovascular outcome compared with simvastatin alone in patients with acute coronary syndrome. Given strict inclusion criteria (low-density lipoprotein cholesterol 50-125 mg/dL and no use of statins more potent than simvastatin 40 mg), the implications of this important trial in routine acute coronary syndrome care are unknown.
  
  
  METHODS
  We identified patients with acute coronary syndrome from the Veterans Affairs health care system over a 5-year period and determined what proportion would be candidates for ezetimibe on the basis of IMPROVE-IT criteria. We then evaluated what proportion could potentially see an increase in ezetimibe use if IMPROVE-IT criteria are not strictly followed.
  
  
  RESULTS
  Of 219,625 patients with acute coronary syndrome, 69,508 (31.6%) would qualify for ezetimibe on the basis of strict criteria. Among those who did not meet IMPROVE-IT criteria (n = 150,117), ezetimibe could potentially be prescribed by clinicians in a further 28% of patients (n = 61,635) using statins more potent than simvastatin 40 mg, 7.1% of patients (15,527) with a documented statin intolerance, and 10.4% of patients (22,758) with low-density lipoprotein cholesterol >125 mg/dL.
  
  
  CONCLUSIONS
  Our results provide a first look at the implications of this trial in a large health care system. Although 31.6% of patients would qualify for ezetimibe, there is a large potential for an increase in ezetimibe use in acute coronary syndrome outside of the strict trial inclusions. These findings call for a discussion on ezetimibe's role in patients with acute coronary syndrome already taking high-intensity statins or those with statin intolerance.
authors.affiliation: Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, Tex; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, Tex; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Tex; Section of Cardiology, Department of Medicine, Baylor College of Medicine, Houston, Tex; Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, Tex. Electronic address: virani@bcm.edu.
authors.forename: Salim S
authors.initials: SS
authors.lastname: Virani
authors.affiliation: Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, Tex; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, Tex.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Akeroyd
authors.affiliation: Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Tex; Section of Cardiology, Department of Medicine, Baylor College of Medicine, Houston, Tex; Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, Tex.
authors.forename: Vijay
authors.initials: V
authors.lastname: Nambi
authors.affiliation: Veterans Affairs Eastern Colorado Health Care System, Denver.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Maddox
authors.affiliation: Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Tex.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Gillette
authors.affiliation: Veterans Affairs Eastern Colorado Health Care System, Denver.
authors.forename: P
authors.initials: P
authors.lastname: Michael Ho
authors.affiliation: Veterans Affairs Eastern Colorado Health Care System, Denver.
authors.forename: John
authors.initials: J
authors.lastname: Rumsfeld
authors.affiliation: Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, Tex; Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, Tex.
authors.forename: Laura A
authors.initials: LA
authors.lastname: Petersen
authors.affiliation: Section of Cardiology, Department of Medicine, Baylor College of Medicine, Houston, Tex; Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, Tex.
authors.forename: Christie M
authors.initials: CM
authors.lastname: Ballantyne
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D019821:Simvastatin / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States; D014493:United States Department of Veterans Affairs
chemical_list: D000924:Anticholesteremic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin; D000069438:Ezetimibe
keywords: Ezetimibe; IMPROVE-IT; Moderate- to high-intensity statin therapy; Treatment practice