Table 2. Slope of Change in Percentage Predicted Slow Vital Capacity (SVC) From Baseline in EMPOWER Placebo Group.
Variable | Observations, No. | Slope (95% CI), Percentage Points per Montha | P Value |
---|---|---|---|
Overall | 2337 | −2.7 (−3.0 to −2.5) | <.001 |
Age, y | |||
<50 | 641 | −2.3 (−2.7 to −1.8) | .005b |
50-65 | 1164 | −2.6 (−2.9 to −2.3) | .007c |
>65 | 532 | −3.6 (−4.3 to −2.9) | NA |
Sex | |||
Male | 1541 | −2.6 (−2.9 to −2.3) | .21d |
Female | 796 | −3.0 (−3.3 to −2.6) | |
Riluzole use | |||
No | 517 | −3.1 (−3.7 to −2.5) | .65e |
Yes | 1820 | −2.7 (−2.9 to −2.4) | |
Baseline percentage predicted SVC | |||
<65% | 93 | −2.2 (−4.2 to −0.3) | .25f |
65%-75% | 295 | −2.8 (−3.6 to −2.1) | .88g |
>75% | 1949 | −2.7 (−3.0 to −2.5) | NA |
Site of ALS symptom onset | |||
Bulbar | 477 | −3.2 (−3.8 to −2.5) | .06h |
Other | 1860 | −2.6 (−2.9 to −2.3) | |
Baseline ALSFRS-R total score | |||
≤39 | 1095 | −3.1 (−3.4 to −2.8) | <.001i |
>39 | 1242 | −2.3 (−2.7 to −1.9) |
Abbreviations: ALS, amyotrophic lateral sclerosis; ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised; NA, not applicable.
The slope was estimated using a repeated-measures mixed model and adjustment for baseline SVC.
P value for <50 vs >65 years.
P value for 50-65 vs >65 years.
P value for male vs female.
P value for no riluzole use vs riluzole use.
P value for <65% vs >75%.
P value for 65%-75% vs >75%.
P value for bulbar compared with other.
P value for ≤39 vs >39.