Table 4.
Changes in gastroparesis symptom scores by changes in gastric emptying diagnosis over 48-weeks of follow-up
| Functional Dyspepsia (FD) at Baseline* (N=60) | Gastroparesis (Gp) at Baseline* (N=189) | |||||
|---|---|---|---|---|---|---|
| FFD at 48-weeks (N=43) | Gp at 48-weeks (N=22) | P † | Gp at 48-weeks (N=110) | FD at 48-weeks (N=79) | P † | |
| Changes in PAGI-SYM symptom severity (0–5) scores at 48-weeks from baseline: | ||||||
| Gastroparesis Cardinal Symptom Index (GCSI)‡ | −0.2 (1.2) | −0.4 (0.6) | .82 | −0.3 (1.0) | −0.4 (1.1) | .21 |
| Nausea severity | 0.0 (1.3) | −0.2 (1.7) | .84 | −0.3 (1.5) | −0.7 (1.5) | .11 |
| Retching severity | 0.3 (1.6) | 0.2 (1.1) | .78 | −0.4 (1.6) | −0.5 (1.8) | .27 |
| Vomiting severity | 0.4 (1.6) | 0.2 (0.9) | .75 | −0.3 (1.8) | −0.5 (1.8) | .25 |
| Nausea subscale‡ | 0.2 (1.2) | 0.1 (0.8) | .70 | −0.4 (1.3) | −0.6 (1.4) | .13 |
| Feeling of stomach fullness severity | −0.3 (1.2) | −0.7 (1.1) | .45 | −0.3 (1.5) | −0.3 (1.7) | .70 |
| Inability to finish meal severity | −0.8 (1.7) | −0.9 (0.8) | .70 | −0.4 (1.6) | −0.5 (1.7) | .43 |
| Excessively full after meal severity | −0.4 (1.3) | −0.5 (1.0) | .78 | −0.3 (1.5) | −0.3 (1.6) | .65 |
| Loss of appetite severity | −0.8 (1.7) | −1.5 (1.2) | .32 | −0.3 (1.7) | −0.5 (1.7) | .45 |
| Post-prandial fullness subscale‡ | −0.6 (1.2) | −0.9 (0.7) | .43 | −0.3 (1.2) | −0.4 (1.3) | .48 |
| Visibly larger stomach severity | −0.2 (2.1) | 0.1 (1.1) | .86 | −0.2 (1.7) | −0.1 (1.5) | .58 |
| Bloating severity | −0.4 (1.7) | −0.5 (1.1) | .71 | −0.3 (1.5) | −0.3 (1.6) | .42 |
| Bloating subscale‡ | −0.3 (1.8) | −0.2 (.9) | .44 | −0.2 (1.5) | −0.2 (1.5) | .61 |
| Upper abdominal pain | −0.2 (1.5) | −0.9 (1.4) | .68 | −0.3 (1.7) | −0.5 (1.6) | .23 |
| Upper abdominal discomfort | −0.4 (1.4) | −0.7 (1.2) | .85 | −0.2 (1.7) | −0.6 (1.4) | .08 |
| Upper abdominal pain subscale‡ | −0.3 (1.3) | −0.8 (1.3) | .77 | −0.3 (1.6) | −0.6 (1.4) | .12 |
| GERD subscale‡ | −0.1 (0.9) | −0.2 (1.1) | .78 | −0.3 (1.1) | −0.5 (1.1) | .11 |
Data for symptom changes presented are means ± standard deviations. PAGI-SYM severity scores range from 0 to 5 indicating symptom severity of none to very severe over the past 2-weeks. Positive change in symptom severity at 48-weeks from baseline indicates worsening of the symptom and negative change indicates a decrease in severity.
Symptom changes were analyzed between converter status within 2 subgroups (FD or Gastroparesis (Gp) at baseline) using an ANCOVA regressing the change in symptom score on the subgroup indicator (change in DX at 48 weeks, or no change), adjusting for the baseline value of the symptom.
Definitions: Gastroparesis Cardinal Symptom Index = (nausea subscale + postprandial fullness subscale + bloating subscale)/3 where:
Nausea subscale = (nausea + retching + vomiting)/3
Postprandial fullness/early satiety subscale = (stomach fullness + inability to finish meal + excessively full + loss of appetite)/4
Bloating subscale = (bloating + large stomach)/2
GERD subscale = (heartburn day + heartburn lying down + chest discomfort day + chest discomfort night + reflux day + reflux night + bitter taste)/7
Upper abdominal pain subscale = (upper abdominal pain + upper abdominal discomfort)/2