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Novartis Study Shows QTI571 Significantly Improved Walking Distance in Patients with Life-Threatening Pulmonary Arterial Hypertension
Date:9/25/2011

EAST HANOVER, N.J., Sept. 25, 2011 /PRNewswire/ -- Novartis announced new data today from the pivotal Phase III IMPRES clinical trial showing that the investigational therapy QTI571 (imatinib) significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo(1). Evidence indicates that QTI571 targets an underlying cause of PAH by counteracting uncontrolled growth of arterial smooth muscle cells(2).

The IMPRES study met its primary endpoint by demonstrating a significant improvement in the six-minute walk distance (6MWD) test in patients with elevated pulmonary vascular resistance (PVR) despite treatment with two or more specific PAH vasodilator therapies(1). The 6MWD is a predictor of survival in PAH patients(5,6), and is commonly used to assess exercise capacity in PAH clinical trials(7,8,9). In the study, patients treated with QTI571 increased their mean 6MWD by 31.8 meters compared with placebo (p=0.002)(1).

The study's secondary endpoints showed that QTI571 produced statistically significant improvements compared to placebo in pulmonary arterial pressure, cardiac output and pulmonary vascular resistance (all p<0.001)(1), but not in time to clinical worsening (i.e. death, hospitalization due to PAH, worsening of functional class, or >15% drop in 6MWD) (p=0.563)(1).

"These results are impressive as they were achieved in patients who were already receiving two or more established PAH drugs," said Marius Hoeper MD, Associate Professor, Department of Respiratory Medicine at Hannover Medical School, Germany and principal investigator of the IMPRES study. The data were presented for the first time at the European Respiratory Society (ERS) Annual Congress in Amsterdam, The Netherlands.

PAH is a debilitating disease of the heart and lungs that is characterized by a marked and sustained elevation in pulmonary artery pressure. The disease is chroni
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SOURCE Novartis Pharmaceuticals Corporation
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