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Nissen SE et al. JAMA 2003;290:2292 – 2300.

Effect of Recombinant Apo A-I Milano on Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.

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Nissen SE et al. JAMA 2003;290:2292 – 2300.

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  1. Effect of Recombinant Apo A-IMilano on Coronary Atherosclerosis in Patients with Acute Coronary Syndrome • Study Design: Double-blind, randomized, placebo-controlled multicenter pilot trial comparing the effect of intravenous recombinant apo A-IMilano/phospholipid complexes (ETC-216) or placebo on coronary atheroma burden as measured by intravascular ultrasound (IVUS) • Intervention:123 patients screened, 59 randomized, and 47 completed protocol; in ratio of 1:2:2, patients received 5 weekly infusions of placebo or ETC-216 at 15 mg/kg or 45 mg/kg; atheroma burden was measured by IVUS at baseline and end of 5 weeks • Results: Mean percent atheroma volume decreased by 1.06% in combined ETC-216 group (p=.02); absolute reduction in atheroma volume in combined ETC-216 groups was –14.1 mm3, or 4.2% decrease from baseline (p<.001). Nissen SE et al. JAMA 2003;290:2292–2300.

  2. Baseline Lipids and Atherosclerosis *Data from 4, 11, and 4 patients of the respective groups †Data from 10, 19, and 15 patients of the respective groups Nissen SE et al. JAMA 2003;290:2292–2300.

  3. Effect of Recombinant Apo A-IMilano (ETC-216) on Change in Percent Atheroma Volume Mean Median Change from Baseline, % 0.14 0.03 –0.34 –0.73 –0.81† –1.06 –1.14* –1.29 Placebo 15 mg/kg 45 mg/kg Combined *p=.03 †p=.02 (1° endpoint) Nissen SE et al. JAMA 2003;290:2292–2300.

  4. Effect of Recombinant Apo A-IMilano (ETC-216) on Change in Total Atheroma Volume Mean Median Change from Baseline, mm3 –0.2 –2.9 –12.0† –12.6 –15.0* –13.3‡ –15.1 –14.1 Placebo 15 mg/kg 45 mg/kg Combined *p=.02 †p=.007 ‡p<.001 (2° endpoint) Nissen SE et al. JAMA 2003;290:2292–2300.

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