>>SOUTH SAN FRANCISCO, Calif., March 8 /PRNewswire-FirstCall/ -- CoTherix, Inc. announced today top-line safety and efficacy results from the STEP clinical study. The analysis of this study showed that the combination of Ventavis® (iloprost) Inhalation Solution added to Tracleer® (bosentan) therapy was well tolerated and provided clinical benefit in patients with pulmonary arterial hypertension (PAH).
The STEP (acronym for: iloprost inhalation solution Safety and pilot efficacy Trial in combination with bosentan for Evaluation in Pulmonaryarterial hypertension) trial was a double-blind, placebo-controlled trial, in which PAH patients treated with Tracleer, an oral endothelin receptor antagonist, were randomized to receive either Ventavis (inhaled iloprost) or inhaled placebo in combination with Tracleer for 12 weeks. Fifteen U.S. clinical sites enrolled 65 patients into the intent-to-treat analysis population (32 Ventavis and 33 placebo). Baseline characteristics were well balanced across the two arms. Compliance with scheduled doses was over 90% in each arm, with the majority of patients taking six inhalations per day.
Common adverse events that occurred more frequently in the Ventavis arm were those known to be associated with inhaled prostacyclin administration and included flushing, headache, cough and jaw pain. Syncope occurred less frequently when compared to placebo (one Ventavis and two placebo), and no serious syncope adverse events were reported in either treatment group. No clinically relevant increases in laboratory abnormalities, including liver function tests, were observed in the combination treatment arm. Serious adverse events were infrequent (five Ventavis patients and seven placebo patients). No deaths occurred in either treatment arm.
Clinical benefits of adding Ventavis to Tracleer were observed in a number of secondary endpoints. Combination treated patients (Ventavis plus Tracleer) in the 6-minute walk test walked a mean difference of 26 meters farther than patients treated only with Tracleer (p=0.051). Other important clinical endpoints, including change in NYHA functional class, reduction in mean pulmonary artery pressure and delay in clinical deterioration were statistically significant (p values range from 0.02 to <0.0001).
"Like many other areas of medicine, we believe that the field of PAH is moving toward combination therapy," said Lewis J. Rubin, M.D., Professor of Medicine and Director, Pulmonary Hypertension Program at the University of California, San Diego. "This trial brings us one step closer in understanding how combination therapies may be used to effectively treat PAH."<<
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Cheers, Tuck |
