BREATHE-5
Bosentan Randomised Trial of Endothelin Antagonist Therapy-5
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 54 patients with WHO functional class III Eisenmenger syndrome, bosentan lowered pulmonary vascular resistance and improved 6-minute walk distance without worsening systemic oxygen saturation compared with placebo.
N
54
Disegno
Double-blind, placebo-controlled RCT over 16 weeks
Esito
Systemic pulse oximetry (safety) and pulmonary vascular resistance index (efficacy) at 16 weeks
Rilevanza
2
RisultatoPlacebo-corrected effect on pulse oximetry +1.0 % (95 % CI −0.7 to 2.8), i.e. no worsening. Pulmonary vascular resistance index −472 dyne·s·cm⁻⁵ (p=0.038); 6-minute walk distance +53.1 m (p=0.008).
Galiè N, Beghetti M, Gatzoulis MA, et al. Circulation. 2006;114(1):48-54. 10.1161/CIRCULATIONAHA.106.630715
Discussione e critica
Tiny and only 16 weeks long, with haemodynamic surrogates rather than mortality, and it excluded Down-syndrome patients who make up a large share of the real Eisenmenger population. It is the first and only placebo-controlled trial to show endothelin-receptor antagonism is safe in a right-to-left shunt.