Patients’ characteristics at entry in the study—intention-to-treat population
| Sildenafil N=42 | Placebo N=41 | Overall N=83 | |
|---|---|---|---|
| Age (years) | 48.7±13.7 | 50.0±11.6 | 49.3±13.7 |
| Women | 31 (73.8%) | 34 (82.9%) | 65 (78.3%) |
| Time since first non-Raynaud symptom (years) | 9.6±7.7 | 4.1±2.5 | 6.9±6.6 |
| SSc subtype | |||
| Diffuse cutaneous SSc | 21 (50.0%) | 18 (43.9%) | 39 (47.0%) |
| Limited cutaneous SSc | 17 (40.5%) | 20 (48.8%) | 37 (44.6%) |
| Limited SSc | 4 (9.6%) | 3 (7.3%) | 7 (8.4%) |
| Modified Rodnan score | 12.2±8.6 | 14.0±8.5 | 13.1±8.5 |
| Anticentromere antibodies | 17 (40.5%) | 13 (31.7%) | 30 (36.1%) |
| Anti-Scl70 antibodies | 15 (35.7%) | 22 (53.7%) | 37 (44.6%) |
| History of renal crisis | 4 (9.5%) | 0 | 4 (4.8%) |
| PAH | 0 | 1 (2.4%) | 1 (1.2%) |
| Limited lung fibrosis (HRCT scan extension <20%) | 15 (35.7%) | 11 (26.8%) | 26 (31.3%) |
| Extensive lung fibrosis (HRCT scan extension >20%) | 4 (9.6%) | 4 (9.8%) | 8 (9.6%) |
| Current smoker | 7 (16.7%) | 9 (22.0%) | 16 (19.3%) |
| Occupational cold exposure | 7 (16.7%) | 12 (29.3%) | 19 (22.8%) |
| Use of vasoconstrictive drugs | 1 (2.4%) | 0 | 1 (1.2%) |
| Time since first DU episode (years) | 5.2±7.9 | 5.5±7.2 | 5.4±7.4 |
| Number of previous DU episodes | |||
| 0 | 4 (9.5%) | 4 (9.8%) | 8 (9.6%) |
| 1–4 | 13 (31.0%) | 11 (26.8%) | 24 (28.9%) |
| 5–9 | 13 (31.0%) | 9 (22.0%) | 22 (26.5%) |
| ≥10 | 12 (28.6%) | 17 (41.5%) | 29 (34.9%) |
| Number of DUs within 12 months prior study entry | 1.3±1.3 | 1.9±2.2 | 1.6±1.8 |
| Previous procedures | |||
| Digital sympathectomy | 2 (4.8%) | 1 (2.4%) | 3 (3.6%) |
| Wrist sympathectomy | 2 (4.8%) | 2 (4.9%) | 4 (4.8%) |
| Cervical sympathectomy | 1 (2.4%) | 0 | 1 (1.2%) |
| Surgical amputation | 0 | 2 (4.9%) | 2 (2.4%) |
| Auto-amputation | 3 (7.1%) | 5 (12.2%) | 8 (9.6%) |
| History of iloprost IV | 27 (64.3%) | 22 (53.7%) | 49 (59.0%) |
| Concomitant treatment with bosentan | 15 (35.7%) | 13 (31.7%) | 28 (33.7%) |
| Concomitant treatment with calcium channel blockers | 23 (45.1%) | 28 (54.9%) | 51 (61.5%) |
Results are expressed as mean±SD or N (%).
DU, digital ulcer; HRCT, high resolution CT; IV, intravenous; PAH, pulmonary arterial hypertension; SSc, systemic sclerosis.