
Compliance With Medication and Erosive Esophagitis Healing Rate at Weeks 2 and 4 in the Full Analysis Set and Per-protocol Set
Variables | Prior-to-meal group (n = 89) | After-meal group (n = 86) | P-value |
---|---|---|---|
Full analysis set | |||
Compliance with medication |
98.17 ± 4.13 | 99.34 ± 4.33 | 0.033 |
Range (%) | 81.25-107.14 | 78.95-110.71 | |
Acceptable compliance | 0.491 | ||
< 80% | 0 (0.00) | 1 (1.26) | |
≥ 80 % and ≤ 120% | 89 (100.00) | 85 (98.84) | |
> 120% | 0 (0.00) | 0 (0.00) | |
EE healing rate at weeks 2 | |||
Number of patients who underwent endoscopy | 71 | 70 | |
Number of completely healed patients | 68 (95.77) | 68 (97.14) | |
Common risk difference [95% CI] | 1.37% [–4.73%, 7.46%] | ||
EE healing rate at weeks 4 | |||
Number of patients who underwent | 81 | 80 | |
Number of completely healed patients | 80 (98.77) | 80 (100.00) | |
Common risk difference [95% CI] | 1.23% [–1.17%, 3.64%] |
Variables | Prior-to-meal group (n = 80) | After-meal group (n = 77) | P-value |
---|---|---|---|
Per-protocol set | |||
Compliance with medication |
98.54 ± 3.95 | 99.88 ± 3.70 | 0.012 |
Range (%) | 81.25-107.14 | 80.95-110.71 | |
Acceptable compliance | > 0.999 | ||
< 80% | 0 (0.00) | 0 (0.00) | |
≥ 80 % and ≤ 120% | 80 (100.00) | 77 (100.00) | |
> 120% | 0 (0.00) | 0 (0.00) | |
EE healing rate at weeks 2 | |||
Number of patients who underwent endoscopy | 69 | 67 | |
Number of completely healed patients | 67 (97.10) | 66 (98.51) | |
Common risk difference [95% CI] | 1.41% [–3.50%, 6.32%] | ||
EE healing rate at weeks 4 | |||
Number of patients who underwent endoscopy | 80 | 77 | |
Number of completely healed patients | 79 (98.75) | 77 (100.00) | |
Common risk difference [95% CI] | 1.25% [–1.18%, 3.68%] |
aCompliance of medication = The total number of tablets actually taken/the total number of tablets to be taken ×100.
bContinuous variables were summarized as mean ± SD and analyzed by the 2-sample t test or Wilcoxon rank sum test. All other data were presented as n (%) or n, and analyzed by the chi-square test. The non-inferiority analysis was performed by the Cochran-Mantel-Haenszel test.
EE, erosive esophagitis.