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Nexium
Clinical Pharmacology
Nexium
The healing rates of NEXIUM 40 mg, NEXIUM 20 mg, and omeprazole 20 mg (the approved dose for this indication) were evaluated in patients with endoscopically diagnosed erosive esophagitis in four multicenter, double-blind, randomized studies. The healing rates at weeks 4 and 8 were evaluated and are shown in the table below:
Table 10: Erosive Esophagitis Healing Rate (Life-Table Analysis)
| Study | No. of Patients | Treatment Groups | Week 4 | Week 8 | Significance Level * |
| 1 | 588 | NEXIUM 20 mg | 68.7% | 90.6% | N.S. |
| 588 | Omeprazole 20 mg | 69.5% | 88.3% | ||
| 2 | 654 | NEXIUM 40 mg | 75.9% | 94.1% | p < 0.001 |
| 656 | NEXIUM 20 mg | 70.5% | 89.9% | p < 0.05 | |
| 650 | Omeprazole 20 mg | 64.7% | 86.9% | ||
| 3 | 576 | NEXIUM 40 mg | 71.5% | 92.2% | N.S. |
| 572 | Omeprazole 20 mg | 68.6% | 89.8% | ||
| 4 | 1216 | NEXIUM 40 mg | 81.7% | 93.7% | p < 0.001 |
| 1209 | Omeprazole 20 mg | 68.7% | 84.2% | ||
| * log-rank test vs omeprazole 20 mg N.S. = not significant (p > 0.05). |
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In these same studies of patients with erosive esophagitis, sustained heartburn resolution and time to sustained heartburn resolution were evaluated and are shown in the table below:
Table 11: Sustained Resolution‡ of Heartburn (Erosive Esophagitis Patients)
| Cumulative Percent# with Sustained Resolution | |||||
| Study | No. of Patients | Treatment Groups | Day 14 | Day 28 | Significance Level * |
| 1 | 573 | NEXIUM 20 mg | 64.3% | 72.7% | N.S |
| 555 | Omeprazole 20 mg | 64.1% | 70.9% | ||
| 2 | 621 | NEXIUM 40 mg | 64.8% | 74.2% | p < 0.001 |
| 620 | NEXIUM 20 mg | 62.9% | 70.1% | N.S. | |
| 626 | Omeprazole 20 mg | 56.5% | 66.6% | ||
| 3 | 568 | NEXIUM 40 mg | 65.4% | 73.9% | N.S. |
| 551 | Omeprazole 20 mg | 65.5% | 73.1% | ||
| 4 | 1187 | NEXIUM 40 mg | 67.6% | 75.1% | p < 0.001 |
| 1188 | Omeprazole 20 mg | 62.5% | 70.8% | ||
| ‡Defined as 7 consecutive
days with no heartburn reported in daily patient diary. # Defined as the cumulative proportion of patients who have reached the start of sustained resolution * log-rank test vs omeprazole 20 mg N.S. = not significant (p > 0.05). |
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Generic Name: Esomeprazole Magnesium
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