Sativex in a former observational study and clinical trial versus our study: comparison of key parameters
| Parameters | Observational study (n=300)16 | Clinical Trial (n=572)12 | Present study (n=1597) |
|---|---|---|---|
| N | 300 pts | 572 pts | 1597 |
| Male | 132 | 225 | 766 |
| Female (%) | 168 (60.9) | 347 (61) | 849 (52.6%) |
| Age (years, mean±SD) | 50±9.4 | 48.9±9.63 | 51±9.5 |
| Disease duration (years, mean±SD) | 15.4±9.0 | 12.4±7.66 | 17.5±8.6 |
| Baseline EDSS | 6.0 (1–9)* | 6.0±1.42† | 6.5 (1.5–9.5)* |
| NRS T0 in IR (mean±SD) | 6.4±1.8 | 6.9±1.2 | 7.6±1.4 |
| NRS T1 in IR (mean±SD) | 3.9±1.5 | 3.9±1.5 | 5.3±1.3 |
| Percentage of reduction T0-T1 | 40.2% | 43.5% | 30.3% |
| IR after 1 month | 42% | 47% | 70.5% |
| CRR after 3 months | 41% | 36% | 28.3% |
| Mean dose (sprays/day) | 6.7 | 8.3 | 6.8 |
| Adverse events (1 or more) | 15.4% | 46.9% | 16.3% |
*Median (min–max).
†Mean±SD.
CRR, clinical relevant response (30% NRS response); EDSS, expanded disability status scale; IR, initial response (20% NRS response); NRS, numerical rating scale for multiple sclerosis spasticity.