Abstract | BACKGROUND: STUDY DESIGN: The study will recruit up to 18,000 moderate- to high-risk patients stabilized after ACS. Patients are randomized in a 1:1 ratio to once-daily doses of either ezetimibe/ simvastatin 10/40 mg or simvastatin monotherapy 40 mg. Follow-up visits are at 1 and 4 months, and every 4 months thereafter. If consecutive measures of LDL-C are >79 mg/dL at follow-up visits, the simvastatin dose will be increased to 80 mg in a double-blind manner. The primary end point is the first occurrence of cardiovascular death, nonfatal myocardial infarction, rehospitalization for unstable angina, coronary revascularization (occurring at least 30 days after randomization), or stroke. Patients will be followed for a minimum of 2.5 years and until at least 5,250 patients experience a primary end point. SUMMARY: IMPROVE-IT will determine whether the addition of ezetimibe to statin therapy, using ezetimibe/ simvastatin, improves cardiovascular outcomes compared with simvastatin monotherapy in patients after ACS. In addition, the difference in achieved LDL-C levels between the groups will provide data on whether the target for LDL-C lowering should be reduced further.
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Authors | Christopher P Cannon, Robert P Giugliano, Michael A Blazing, Robert A Harrington, John L Peterson, Christine McCrary Sisk, John Strony, Thomas A Musliner, Carolyn H McCabe, Enrico Veltri, Eugene Braunwald, Robert M Califf, IMPROVE-IT Investigators |
Journal | American heart journal
(Am Heart J)
Vol. 156
Issue 5
Pg. 826-32
(Nov 2008)
ISSN: 1097-6744 [Electronic] United States |
PMID | 19061694
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anticholesteremic Agents
- Azetidines
- Drug Combinations
- Ezetimibe, Simvastatin Drug Combination
- Simvastatin
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Topics |
- Acute Coronary Syndrome
(drug therapy)
- Anticholesteremic Agents
(administration & dosage)
- Azetidines
(therapeutic use)
- Double-Blind Method
- Drug Combinations
- Ezetimibe, Simvastatin Drug Combination
- Humans
- Multicenter Studies as Topic
- Simvastatin
(administration & dosage, therapeutic use)
- Treatment Outcome
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