Date: 2014-03-17
Type of information: Results
phase: 4
Announcement: results
Company: Actelion (Switzerland)
Product: bosentan
Action
mechanism: Bosentan is a dual endothelin receptor antagonist with affinity for both endothelin A and B (ETA and ETB) receptors. Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
Disease: pulmonary arterial hypertension (PAH)
Therapeutic area: Rare diseases
Country:
Trial
details: The primary objective of COMPASS-2 was to demonstrate that bosentan prolongs the time to first morbidity or mortality event in patients with symptomatic PAH already receiving sildenafil therapy. COMPASS-2 was a prospective, double-blind, placebo-controlled, event-driven study evaluating the progression of PAH in two groups of patients already treated with sildenafil, one group receiving placebo and the second group receiving bosentan. Sildenafil and bosentan are approved treatments for PAH but which exerts their effects through different pathological pathways of the disease. The study was designed to demonstrate a relative risk reduction of 43% in the primary endpoint.
Latest
news: * On March 17, 2014, Actelion has announced the results of COMPASS-2, a Phase IV, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension (PAH) already treated with sildenafil. COMPASS-2 did not meet the primary endpoint of time to first morbidity or mortality event; bosentan showed a risk reduction of 17% versus placebo (p=0.25). In an exploratory analysis, bosentan on top of sildenafil showed an improvement of 21.8 meters in 6MWD at week 16 (p=0.01). The well characterized safety profile of bosentan was confirmed and a placebo-corrected incidence of 15.4% in liver enzyme elevations (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) greater than three times the upper limit of normal was observed over a median exposure to double-blind treatment of 23 months.
Full data from this study will be made available through scientific disclosure at upcoming congresses and peer-reviewed publications.
