Table 2.
Parameter | Rabeprazole 10 mg (d) | Esomeprazole 20 mg (d) | P | Result |
Primary efficacy variables | ||||
Time to 24-h symptom-free interval-HB | 8.5 d | 9 d | 0.265 | NS |
Time to 24-h symptom-free interval-RG | 6.0 d | 7.5 d | 0.405 | NS |
Secondary efficacy variables | ||||
Time to 48-h symptom-free interval-HB | 9.5 d | 8.5 d | 0.373 | NS |
Time to 48-h symptom-free interval-RG | 8.5 d | 11 d | 0.271 | NS |
W1-W4-satisfactory relief DT or NT-HB | >0.05 | NS | ||
W1-W4-satisfactory relief DT or NT-RG | >0.05 | NS | ||
W1-W4-satisfactory relief DT-HB & RG4 | 0.0454 | Rabeprazole superior4 | ||
W1-W4-complete relief DT or NT-HB | >0.05 | NS | ||
W1-W4-complete relief DT or NT-RG | >0.05 | NS | ||
W1-W4-belching | -0.41 | -0.42 | 0.631 | NS |
W1-W4-early satiety | -0.26 | -0.32 | 0.178 | NS |
W1-W4-bloating | -0.46 | -0.54 | 0.608 | NS |
W1-W4-nausea | -0.23 | -0.27 | 0.319 | NS |
W1-W4-vomiting | -0.34 | -0.21 | 0.808 | NS |
Symptom severity score-D1-5-DT HB | P<0.05 (D2-5)1 | P<0.05 (D3-5)1 | NS2 | |
Symptom severity score-D1-5-NT HB | P<0.05 (D2-5)1 | NS1 | NS3 | |
Symptom severity score-D1-5-DT RG | P<0.05 (D1-5)1 | P<0.05 (D1-5)1 | NS | |
Symptom severity score-D1-5-NT RG | P<0.05 (D5 only)1 | P<0.05 (D2 only)1 | NS | |
Patient’s global evaluation (%) | 96.4 | 87.9 | 0.823 | NS |
Antacid use-weekly average | 0.15 | 0.16 | 0.887 | NS |
Antacid use-% antacid free | 85.7 | 84.9 | 0.848 | NS |
Safety | ||||
Adverse events | 22 | 18.2 | >0.05 | NS |
HB-heartburn; RG-regurgitation; DT-day-time; NT-night-time; W1-wk 1; w4-wk 4;
Compared to baseline;
Rabeprazole statistically superior compared to baseline/pre-treatment from d 2 to 5 and esomeprazole statistically superior compared to baseline/pre-treatment from d 3 to 5;
Rabeprazole statistically superior compared to baseline/pre-treatment from d 2 to 5 and esomeprazole not statistically superior compared to baseline/pre-treatment from d 1 to 5;
Subgroup analysis.