Table 2

Number of new DUs up to week 24 in predefined and post hoc subgroups of patients

Number of new DUs
nPlacebonBosentanTreatment effectp Value*
Planned subgroup analyses
 SSc classification:
 Diffuse372.7 (1.7 to 3.7)372.1 (1.4 to 2.9)−0.6 (−1.8 to 0.6)0.35
 Limited522.7 (1.7 to 3.7)591.7 (1.1 to 2.2)−1.0 (−2.1 to 0.0)0.06
 Time from diagnosis of DU to randomisation:
 ≤5 years492.7 (1.7 to 3.8)541.7 (1.2 to 2.2)−1.0 (−2.2 to 0.1)0.07
 >5 years392.7 (1.9 to 3.6)412.1 (1.2 to 2.9)−0.7 (−1.8 to 0.5)0.26
 Systemic antibiotics for DU:
 Yes115.0 (1.4 to 8.6)162.6 (1.1 to 4.0)−2.5 (−5.7 to 0.8)0.14
 No772.4 (1.8 to 3.0)761.7 (1.2 to 2.2)−0.7 (−1.5 to 0.1)0.07
 Local treatment for DU:
 Yes242.8 (1.7 to 3.9)332.1 (1.3 to 2.9)−0.7 (−2.0 to 0.6)0.28
 No642.7 (1.8 to 3.6)611.8 (1.2 to 2.3)−0.9 (−2.0 to 0.1)0.07
 Dose adjustment of treatment for Raynaud's phenomenon:
 Yes193.5 (1.8 to 5.3)221.8 (0.9 to 2.6)−1.8 (−3.6 to 0.1)0.05
 No692.5 (1.8 to 3.3)721.9 (1.4 to 2.4)−0.6 (−1.5 to 0.3)0.20
 Smoking habit at baseline:
 Never493.0 (2.1 to 4.0)582.2 (1.6 to 2.9)−0.8 (−1.9 to 0.3)0.15
 Previous203.3 (1.3 to 5.3)221.3 (0.7 to 2.0)−2.0 (−4.0 to −0.1)0.04
 Current191.3 (0.6 to 2.0)121.5 (0.4 to 2.6)0.2 (−1.0 to 1.3)0.82
Post hoc subgroup analyses
 Number DUs at baseline:
 <4601.9 (1.3 to 2.5)591.6 (1.1 to 2.0)−0.3 (−1.1 to 0.4)0.39
 ≥4294.4 (2.8 to 6.1)362.4 (1.5 to 3.2)−2.1 (−3.8 to −0.4)0.02
 Randomisation month:
 October 2003 to February 2004371.3 (0.7 to 1.9)290.7 (0.4 to 1.0)−0.6 (−1.3 to 0.1)0.12
 March 2004 to September 2004521.3 (0.7 to 1.8)640.8 (0.5 to 1.2)−0.4 (−1.0 to 0.2)0.20
  • Data are mean (95% CIs).

  • * Exploratory p value determined using the Pitman permutation.

  • Analysis confined to the first 12 weeks of treatment to avoid overlap of seasons.

  • DU, digital ulcer; SSc, systemic sclerosis.