Table 3.
Changes in other secondary outcomes by treatment
| Outcomes | Aprepitant | Placebo | Relative risk ratio or adjusted mean changes from baseline (95% CI) Aprepitant vs. placebo* | P* |
|---|---|---|---|---|
| No. evaluable patients† | 59 | 63 | ||
| Gastroparesis symptoms inventories PAGI-SYM Severity index (0=none to 5=very severe) | ||||
| Gastroparesis Cardinal Symptom Index (GCSI) score | −1.3 (1.0) | −0.7 (0.9) | −0.6 (−0.9, −0.3) | 0.001 |
| Substantial symptomatic improvement‡, No. (%) | 34 (60%) | 20 (32%) | 1.8 (1.2, 2.8) | 0.002 |
| Nausea/vomiting severity subscore | −1.7 (1.3) | −0.7 (1.1) | −0.8 (−1.2, −0.4) | <0.001 |
| Fullness/early satiety subscore | −1.0 (1.3) | −0.7 (1.0) | −0.3 (−0.7, 0.1) | 0.13 |
| Bloating subscore | −1.2 (1.2) | −0.6 (1.2) | −0.6 (−1.2, −0.2) | 0.004 |
| Upper abdominal pain subscore | −1.1 (1.5) | −0.6 (1.2) | −0.4 (−0.9, 0.1) | 0.08 |
| GERD subscore | −1.1 (1.3) | −0.6 (0.9) | −0.5 (−0.8, −0.1) | 0.007 |
| Daily Diary Gastroparesis Cardinal Symptom Index (GCSI-DD) (0=none to 4=very severe) | ||||
| GCSI total score | −0.5 (0.9) | −0.4 (0.5) | −0.2 (−0.4, 0.1) | 0.22 |
| Upper abdominal pain severity | −0.7 (0.9) | −0.3 (0.7) | −0.4 (−0.7, −0.1) | 0.01 |
| Vomiting (No. episodes) | −0.5 (1.0) | −0.4 (1.1) | −0.1 (−0.3, 0.3) | 0.94 |
| Retching (No. episodes) | −0.5 (1.5) | −0.7 (2.0) | 0.1 (−0.4, 0.6) | 0.73 |
| Overall symptom severity | −0.7 (0.8) | −0.4 (0.6) | −0.3 (−0.6, −0.1) | 0.02 |
| Gastrointestinal Symptom Rating Scale (GSRS) (0=no to 7=very severe discomfort) | ||||
| Total score | −0.8 (0.9) | −0.5 (0.9) | −0.4 (−0.7, 0.1) | 0.007 |
NOTE: The minimal important differences (MIDs) for: GCSI range from 0.75 to 1; GCSI-DD is 0.55.20
Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome. P-value, relative risk ratio and 95% confidence limits (CI) for substantial symptomatic improvement‡ were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.
There were 4 subjects missing all 28-day VAS scores or other symptom data.
In addition, 2 aprepitant subjects did not provide 28 day data (GSRS).
Substantial symptomatic improvement defined as a decrease of at least 1 point from baseline in GCSI score at 28-days. No. patients in analyses: 57 (aprepitant), 62 (placebo)