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

c and rapidly progressive and can result in right ventricular heart failure and death(4). An estimated 260,000 people are affected worldwide(3) and approximately half of the people diagnosed with PAH die within five years,(10).

"If approved, QTI571 has the potential to provide a further treatment option for patients where current therapies are not providing sufficient benefit in the treatment of this life-threatening disease," said David Epstein, Division Head of Novartis Pharmaceuticals. "Novartis has a strong and growing portfolio of respiratory medicines, and we are committed to expanding the support we offer to patients suffering from a number of respiratory and pulmonary disorders."

QTI571 is an oral therapy that works by inhibiting the activity of proliferative factors including platelet-derived growth factor (PDGF) which is thought to be involved, along with its receptor, in the progression of PAH(10,11). In patients with this disease, PDGF may cause smooth muscle cells in the pulmonary arteries to multiply, restricting blood flow and increasing resistance in these arteries(12).

Safety data showed that the overall incidence of adverse events was similar for QTI571 and for placebo(1). Serious adverse events and discontinuations due to serious adverse events were more frequent with QTI571(1). Adverse events were as expected for this patient population and class of drug, and were similar to those previously reported with QTI571(13).

IMPRES was a 24-week randomized placebo-controlled, double-blind, multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of patients with PAH(1). The study involved a total of 202 patients with elevated PVR of >800 dynes.sec.cm-5 despite treatment with at least two other specific PAH medications (i.e. endothelin receptor antagonists, phosphodiesterase-5 inhibitors and/or prostacyclins)(1).

Treatment was initiated at a dose of 2
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SOURCE Novartis Pharmaceuticals Corporation
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