Table 1. Number of deaths in randomised, placebo-controlled trials of pulmonary arterial hypertension-specific therapies
First author [ref.]Study acronymPatients nStudy period weeksPrimary end-pointDeaths n
Study drugComparator
Rubin [7]238Haemodynamics#Epoprostenol, n=1Conventional therapy, n=3
Barst [8]8112Survival and change in 6MWD#Epoprostenol, n=0Conventional therapy, n=8
Badesch [9]11112Change in 6MWDEpoprostenol, n=4Conventional therapy, n=5
Simonneau [10]47012Change in 6MWDTreprostinil, n=9Placebo, n=10
Hiremath [11]TRUST4412Change in 6MWDTreprostinil, n=3Placebo, n=5
Galiè [12]ALPHABET13012Change in 6MWDBeraprost, n=1Placebo, n=1
Barst [13]11636Disease progression: death, transplantation, epoprostenol rescue or 25% decrease in peak oxygen consumptionBeraprost, n=1Placebo, n=2
Olschewski [14]AIR20312Improved by one NYHA FC and 10% increase in 6MWDIloprost, n=1Placebo, n=4
McLaughlin [15]STEP6712Change in 6MWD, NHYA FC, Borg dyspnoea index#Iloprost/bosentan, n=0Placebo/bosentan, n=0
Hoeper [16]COMBI4012Change in 6MWDIloprost/bosentan, n=0Placebo/bosentan, n=0
Channick [17]3212Change in 6MWDBosentan, n=0Placebo, n=0
Rubin [18]BREATHE-121316Change in 6MWDBosentan, n=4Placebo, n=2
Galiè [19]EARLY18524Change in PVR and 6MWDBosentan, n=1Placebo, n=1
Galiè [20]BREATHE-55416Change in PVRBosentan, n=0Placebo, n=0
Humbert [21]BREATHE-23316Change in total pulmonary resistanceEpoprostenol plus bosentan, n=3+Epoprostenol plus placebo, n=0
Wilkins [22]SERAPH2616Changes in right ventricular massBosentan, n=0Sildenafil, n=1
Galiè [23]ARIES39412Change in 6MWDAmbrisentan, n=4Placebo, n=6
Barst [24]STRIDE-117812Change in peak oxygen consumptionSitaxentan, n=1Placebo, n=0
Barst [25]STRIDE-224718Change in 6MWDSitaxentan, n=0Placebo, n=2 Bosentan, n=0
Sandoval [26]STRIDE-49818Change in 6MWDSitaxentan, n=0Placebo, n=0
Sastry [27]2212Change in 6MWDSildenafil, n=0Placebo, n=1
Galiè [28]SUPER-127812Change in 6MWDSildenafil, n=3Placebo, n=1
Singh [29]208Change in 6MWDSildenafil, n=0Placebo, n=0
Simonneau [30]PACES26716Change in 6MWDSildenafil, n=0Placebo, n=7
Galiè [31]PHIRST40516Change in 6MWDTadalafil, n=2Placebo, n=1
Jing [32]EVALUATION6612 (+12 open label)Change in 6MWDVardenafil, n=1Placebo, n=2
Langleben [33]7112Change in 6MWDTerbogrel, n=1Placebo, n=0
Ghofrani [34]5924Change in 6MWDImatinib, n=3Placebo, n=3
Hoeper [35]IMPRES20224Change in 6MWDImatinib, n=5Placebo, n=5

  • 6MWD: 6-min walk distance; NYHA FC: New York Heart Association functional class; PVR: pulmonary vascular resistance. #: primary end-point not specified; : three patients were in the post 12-week treatment period; +: there was one death after withdrawal from study.