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Effects of PG-116800, a Matrix Metalloproteinase Inhibitor to Prevent Left Ventricular Remodeling After Acute Myocardial

PREMIER Trial. Effects of PG-116800, a Matrix Metalloproteinase Inhibitor to Prevent Left Ventricular Remodeling After Acute Myocardial Infarction. Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. W Douglas Weaver. PREMIER Trial.

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Effects of PG-116800, a Matrix Metalloproteinase Inhibitor to Prevent Left Ventricular Remodeling After Acute Myocardial

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  1. PREMIER Trial Effects of PG-116800, a Matrix Metalloproteinase Inhibitor to Prevent Left Ventricular Remodeling After Acute Myocardial Infarction Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. W Douglas Weaver

  2. PREMIER Trial 253 patients with ST elevation myocardial infarction (MI) and signs of heart failure. Age 18-80 years; first ST segment elevation MI; cardiac troponin or CKMB ≥3 times upper limit of normal; echocardiogram with an ejection fraction of 15-40% within 48 hours of MI. Randomized, Blinded Placebo n=128 PG-116800 Matrix Metalloproteinase (MMP) Inhibitor 200 mg twice daily for 90 days n=125 • Endpoints (90 days): • Primary: Left ventricular end diastolic volume index (LVEDVI) change • Secondary: LVEDVI change at 30 days; LVESV, LV ejection fraction and LV sphericity changes; clinical events Presented at ACC Scientific Sessions 2005

  3. PREMIER Trial LVEDVI at 90 days p=0.42 • The change in LVEDVI did not differ by treatment group. • The majority of patients were enrolled in Poland (n=173), with 45 patients in Canada and 35 patients in the US. • Randomized treatment was complete through 90 days in 79% of patients in the PG-116800 group and 84% of patients in the placebo group. • Discontinuation due to adverse event occurred in 6% of the PG-116800 group and 9% of the placebo group. • Baseline characteristics were well-balanced by treatment group, with 80% of patients having an anterior MI and 90% treated with primary PCI. Presented at ACC Scientific Sessions 2005

  4. PREMIER Trial LV End Diastolic Volume p=0.44 LV Ejection Fraction p=0.08 LV End Systolic Volume p=0.19 Sphericity Index p=0.10 Placebo PG-116800 • The change in LVEDVI did not differ by treatment group. • There was also no difference in change in LV end diastolic volume, LV end systolic volume, LV ejection fraction, or sphericity index. • There was also no difference in clinical events at 90 days, including death (3% vs 1%, p=0.21), severe heart failure (8% vs 7%, p=0.82), reinfarction (6% vs 2%, p=0.21) or recurrent ischemia (1% each, p=1.0). The frequency of serious adverse events was similar in both groups. Presented at ACC Scientific Sessions 2005

  5. PREMIER Trial: Summary • Among patients with ST elevation myocardial infarction and signs of heart failure, treatment with the matrix metalloproteinase inhibitor PG-116800 was not associated with an improvement in left ventricular end diastolic volume index at 90 days or other measures of LV remodeling compared with placebo. • The present inhibitor was designed to have high affinity for MMP 13 and low affinity for MMP 1 and 7. It is possible that targeting of other MMPs may have different therapeutic effects, or that timing of the therapy may be more beneficial earlier post-MI. Presented at ACC Scientific Sessions 2005

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