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Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

Publication ,  Journal Article
Cannon, CP; Blazing, MA; Giugliano, RP; McCagg, A; White, JA; Theroux, P; Darius, H; Lewis, BS; Ophuis, TO; Jukema, JW; De Ferrari, GM; Im, K ...
Published in: N Engl J Med
June 18, 2015

BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known. METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years. RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P=0.016). Rates of prespecified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups. CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

June 18, 2015

Volume

372

Issue

25

Start / End Page

2387 / 2397

Location

United States

Related Subject Headings

  • Triglycerides
  • Simvastatin
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • General & Internal Medicine
  • Female
  • Ezetimibe
 

Citation

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Cannon, C. P., Blazing, M. A., Giugliano, R. P., McCagg, A., White, J. A., Theroux, P., … IMPROVE-IT Investigators, . (2015). Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med, 372(25), 2387–2397. https://doi.org/10.1056/NEJMoa1410489
Cannon, Christopher P., Michael A. Blazing, Robert P. Giugliano, Amy McCagg, Jennifer A. White, Pierre Theroux, Harald Darius, et al. “Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.N Engl J Med 372, no. 25 (June 18, 2015): 2387–97. https://doi.org/10.1056/NEJMoa1410489.
Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387–97.
Cannon, Christopher P., et al. “Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.N Engl J Med, vol. 372, no. 25, June 2015, pp. 2387–97. Pubmed, doi:10.1056/NEJMoa1410489.
Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM, IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387–2397.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

June 18, 2015

Volume

372

Issue

25

Start / End Page

2387 / 2397

Location

United States

Related Subject Headings

  • Triglycerides
  • Simvastatin
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • General & Internal Medicine
  • Female
  • Ezetimibe