Date: 2011-09-25
Type of information:
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: QTI571 (imatinib)
Action mechanism: 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 pulmonary arterial hypertension.
Disease: pulmonary arterial hypertension
Therapeutic area: Rare diseases - Cardiovascular diseases - Autoimmune diseases
Country:
Trial
details: 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 pulmonary arterial hypertension.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).
Treatment was initiated at a dose of 200 mg once-daily, which was increased to 400 mg once-daily after two weeks if well tolerated. The dose could be reduced to 200 mg once-daily if treatment was not well tolerated.
Latest
news: Novartis announced new data today from the pivotal Phase III IMPRES clinical trial showing that QTI571 (imatinib) significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo. Evidence indicates that QTI571 targets an underlying cause of PAH by counteracting uncontrolled growth of arterial smooth muscle cells.
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. The 6MWD is a predictor of survival in PAH patients and is commonly used to assess exercise capacity in PAH clinical trials. In the study, patients treated with QTI571 increased their mean 6MWD by 31.8 meters compared with placebo (p=0.002).
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), 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).The data were presented for the first time at the European Respiratory Society (ERS) Annual Congress in Amsterdam, The Netherlands.
