Implications for Ezetimibe Therapy Use Based on IMPROVE-IT Criteria.

Abstract

PURPOSE:

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: Salim S Virani, Julia M Akeroyd, Vijay Nambi, Thomas M Maddox, Michael A Gillette, P Michael Ho, John Rumsfeld, Laura A Petersen, Christie M Ballantyne
• Journal: The American journal of medicine (Am J Med) Vol. 128 Issue 11 Pg. 1253-6 (Nov 2015) ISSN: 1555-7162 [Electronic] United States
• PMID: 26071828 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Published by Elsevier Inc.

Chemical References

• Anticholesteremic Agents
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Simvastatin
• Ezetimibe

Topics

• Acute Coronary Syndrome (drug therapy)
• Adult
• Aged
• Anticholesteremic Agents (therapeutic use)
• Drug Therapy, Combination
• Ezetimibe (therapeutic use)
• Female
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Male
• Middle Aged
• Patient Selection
• Randomized Controlled Trials as Topic
• Simvastatin (therapeutic use)
• Treatment Outcome
• United States
• United States Department of Veterans Affairs