Table 3.
Summary of main results
| Dronabinol (n=329) | Placebo (n=164) | Estimated treatment effect (95% CI) | p value | ||
|---|---|---|---|---|---|
| First EDSS score progression event, number of events (number of first progression events per patient-year*) | 145 (0·24) | 73 (0·23) | HR 0·92 (0·68 to 1·23)† | 0·57 | |
| MSIS-29-PHYS score, yearly change | 0·62 (3·29) | 1·03 (3·74) | −0·91 (−2·01 to 0·19)‡ | 0·11 | |
| MSFC score, yearly change | −0·17 (0·28) | −0·16 (0·30) | −0·03 (−0·19 to 0·09)‡ | 0·72 | |
| MSWS-12 score, yearly change | 0·37 (2·33) | 0·52 (2·68) | −0·19 (−0·97 to 0·60)‡ | 0·74 | |
| RMI, yearly change | −0·58 (0·96) | −0·72 (1·08) | 0·04 (−0·24 to 0·32)‡ | 0·76 | |
| MRI | n=182 | n=91 | |||
| PBVC, yearly change | −0·68 (0·95) | −0·66 (0·98) | −0·01% (−0·26 to 0·24)‡ | 0·94 | |
| New or enlarging T2 lesions | 60 (37%) | 34 (40%) | OR 0·89 (0·50 to 1·58)§ | 0·70 | |
| New or enlarging T1 lesions | 54 (34%) | 28 (33%) | OR 1·05 (0·59 to 1·88)§ | 0·87 | |
Data are n (%) or mean (SD) unless otherwise specified. EDSS=expanded disability status scale. HR=hazard ratio. MSIS-29-PHYS=29-item multiple sclerosis impact scale, physical impact subscale. MSFC=multiple sclerosis functional composite. MSWS-12=multiple sclerosis walking scale. RMI=Rivermead mobility index. PBVC=percentage brain volume change. OR=odds ratio.
Assuming progression events occur at the midpoint of the 6 months between follow-ups.
HR (dronabinol/placebo) according to Cox regression analysis (losses to follow-up regarded as censored observations); sensitivity analysis (losses to follow-up regarded as progression events) resulted in HR 1·11 (0·86–1·44), p value=0·41.
Estimated between-group difference (dronabinol–placebo) according to multilevel model.
Estimated OR according to logistic regression model (dronabinol/placebo).