Effect of Recombinant Apo A-I
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Nissen SE et al. JAMA 2003;290:2292 – 2300. PowerPoint PPT Presentation


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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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Nissen se et al jama 2003 290 2292 2300

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.


Baseline lipids and atherosclerosis

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.


Effect of recombinant apo a i milano etc 216 on change in percent atheroma volume

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.


Effect of recombinant apo a i milano etc 216 on change in total atheroma volume

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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