Characteristic | Placebo (n=90) | Bosentan (n=98) |
---|---|---|
Men/women, % of patients | 20/80 | 22/78 |
Age in years, mean (SD) | 50.7 (12.0) | 48.4 (12.9) |
Weight in kg, mean (SD) | 66.5 (15.8) | 64.7 (13.6) |
Caucasian/black/other,* % of patients | 83/6/11 | 87/7/6 |
Smoking status,† % of patients | ||
Never/previous/current | 56/23/22 | 64/23/13 |
SSc characteristics | ||
Limited/diffuse,‡ % of patients | 58/42 | 60/40 |
Time from diagnosis of scleroderma to randomisation in years, mean (SD) | 8.7 (7.7) | 8.7 (8.4) |
DU characteristics | ||
Number at baseline, mean (SD) | 3.6 (3.3) | 3.7 (4.4) |
Time from first occurrence of DUs to randomisation in years,† mean (SD) | 6.4 (7.1) | 7.4 (8.7) |
Selected concomitant medication at baseline, % of patients | ||
Calcium channel blockers | 56 | 50 |
Anti-inflammatory and antirheumatic products | 37 | 40 |
ACE inhibitors | 14 | 16 |
Peripheral vasodilators§ | 10 | 13 |
Angiotensin II receptor blockers | 9 | 8 |
Phosphodiesterase inhibitor (sildenafil) | 3 | 3 |
↵* Other races included Asian, Hispanic, Indian, Native American and mixed.
↵† Smoking status was available for 88 and 94 patients in the placebo and bosentan groups, respectively, and the time from first occurrence of DUs to randomisation for 89 and 98 patients, respectively.
↵‡ Limited=skin thickening only distal to the elbows and knees. Diffuse=skin thickening proximal to the elbows or knees or affecting the trunk.
↵§ As defined by the WHO Drug Dictionary and included pentoxifylline, buflomedil, ginkgo tree leaves extract and ginkgo biloba.
ACE, angiotensin-converting enzyme; DU, digital ulcer; SSc, systemic sclerosis.