Table 1.
Outcomes data by visit (the number of evaluable data per visit are used for calculations)
| Test treatment | Continued treatment | |||||
|---|---|---|---|---|---|---|
| Baseline | Visit 1 (± 4 weeks) |
Visit 2 (± 8 weeks) |
Optional visit (± 12 weeks) |
6 months | 12 months | |
| N | 238 | 238 | 230a | b | 180 | 113 |
| NRS | ||||||
| eN | 238 | 229 | 188 | 96 | 103 | 60 |
| Mean | 8.1 ± 1.08 | 5.2 ± 1.85 | 4.6 ± 1.69 | 4.1 ± 1.78 | 4.3 ± 1.77 | 4.0 ± 1.92 |
| Median | 7.55 (2–10) | 5 (0–10) | 5 (0–9) | 4 (0–9) | 5 (0–9) | 4 (0–9) |
| VAS | ||||||
| eN | 231 | 217 | 186 | 93 | 101 | 54 |
| Mean | 39 ± 22 | 52 ± 19 | 57 ± 20 | 59 ± 20 | 61 ± 18 | 64 ± 18 |
| Median | 40 (0–95) | 50 (5–95) | 60 (10–96) | 65 (10–93) | 65 (20–90) | 70 (30–99) |
| Number of sprays/day | ||||||
| eN | 124 | 147 | 85 | 86 | 50 | |
| Mean | 5.6 ± 2.31 | 5.9 ± 2.53 | 5.9 ± 2.39 | 6.0 ± 2.25 | 5.7 ± 2.08 | |
| Median | 6 (1–12) | 6 (1–12) | 6 (1–12) | 6 (1–12) | 6 (1–12) | |
aAccording to Belgian reimbursement criteria (period 01 January 2016–28 February 2020) patients were assessed for response after a minimal 8 weeks of treatment
b12-week assessment was mandatory only for patients with > 20 and < 30% NRS improvement from week 4 to week 8, thus not possible to predict N