Prescription Drug Information: ESOMEPRAZOLE MAGNESIUM (Page 8 of 10)

14 CLINICAL STUDIES

14.1 Healing of EE in Adults

The healing rates of esomeprazole magnesium delayed-release capsules 40 mg, esomeprazole magnesium delayed-release capsules 20 mg, and omeprazole 20 mg (the approved dose for this indication) once daily were evaluated in adult patients with endoscopically diagnosed EE in four multicenter, double-blind, randomized studies. The healing rates at Weeks 4 and 8 were evaluated and are shown in the Table 11:

Table 11:EE Healing Rate (Life-Table Analysis) in Adults with EE Treated with Esomeprazole Magnesium Delayed-Release Capsules or Omeprazole Delayed-Release Capsules Once Daily in Four Clinical Studies

1. log-rank test vs. omeprazole 20 mg

N.S. = not significant (p > 0.05).

Study No. of Patients Treatment Groups EE Healing Rates Significant Level 1
Week 4 Week 8
1 588 588 Esomeprazole Magnesium Delayed-Release Capsules 20 mg Omeprazole 20 mg 68.7% 69.5% 90.6% 88.3% N.S.
2 654 656 650 Esomeprazole Magnesium Delayed-Release Capsules 40 mg Esomeprazole Magnesium Delayed-Release Capsules 20 mg Omeprazole 20 mg 75.9% 70.5% 64.7% 94.1% 89.9% 86.9% p < 0.001 p < 0.05
3 576 572 Esomeprazole Magnesium Delayed-Release Capsules 40 mg Omeprazole 20 mg 71.5% 68.6% 92.2% 89.8% N.S.
4 1,216 1,209 Esomeprazole Magnesium Delayed-Release Capsules 40 mg Omeprazole 20 mg 81.7% 68.7% 93.7% 84.2% p < 0.001

In these same studies of patients with EE, sustained heartburn resolution and time to sustained heartburn resolution were evaluated and are shown in the Table 12:

Table 12: Sustained Resolution1 of Heartburn in Adults with EE Treated with Esomeprazole Magnesium Delayed-Release Capsules or Omeprazole Delayed-Release Capsules Once Daily in Four Clinical Studies

1. Defined as 7 consecutive days with no heartburn reported in daily patient diary.

2. Defined as the cumulative proportion of patients who have reached the start of sustained resolution.

3. log-rank test vs. omeprazole 20 mg.

N.S. = not significant (p > 0.05).

Cumulative Percent 2 with Sustained Resolution
Study No. of Patients Treatment Groups Day 14 Day 28 Significant Level 3
1 573 555 Esomeprazole Magnesium Delayed-Release Capsules 20 mg Omeprazole 20 mg 64.3% 64.1% 72.7% 70.9% N.S.
2 621 620 626 Esomeprazole Magnesium Delayed-Release Capsules 40 mg Esomeprazole Magnesium Delayed-Release Capsules 20 mg Omeprazole 20 mg 64.8% 62.9% 56.5% 74.2% 70.1% 66.6% p <0.001 N.S.
3 568 551 Esomeprazole Magnesium Delayed-Release Capsules 40 mg Omeprazole 20 mg 65.4% 65.5% 73.9% 73.1% N.S.
4 1,187 1,188 Esomeprazole Magnesium Delayed-Release Capsules 40 mg Esomeprazole Magnesium Delayed-Release Capsules 20 mg 67.6% 62.5% 75.1% 70.8% p <0.001

In these four studies, the range of median days to the start of sustained resolution (defined as 7 consecutive days with no heartburn) was 5 days for esomeprazole magnesium delayed-release capsules 40 mg, 7 to 8 days for esomeprazole magnesium delayed-release capsules20 mg and 7 to 9 days for omeprazole 20 mg.

There are no comparisons of 40 mg of esomeprazole magnesium delayed-release capsules with 40 mg of omeprazole in clinical trials assessing either healing or symptomatic relief of EE in adults.

14.2 Maintenance of Healing of EE in Adults

Two multicenter, randomized, double-blind placebo-controlled 4-arm trials were conducted in adult patients with endoscopically confirmed, healed EE to evaluate esomeprazole magnesium delayed-release capsules 40 mg (n=174), 20 mg (n=180), 10 mg (n=168) or placebo (n=171) once daily over six months of treatment.

No additional clinical benefit was seen with esomeprazole magnesium delayed-release capsules 40 mg over esomeprazole magnesium delayed-release capsules 20 mg. esomeprazole magnesium delayed-release capsules 40 mg once daily is not a recommended regimen for the maintenance of healing of EE in adults.

The percentages of patients that maintained healing of EE at the various time points are shown in the Figures 2 and 3:

Figure 2: Maintenance of Healing Rates by Month (Study 177)

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Figure 3:Maintenance of Healing Rates by Month (Study 178)

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Patients remained in remission significantly longer and the number of recurrences of EE was significantly less in patients treated with esomeprazole magnesium delayed-release capsules compared to placebo.

In both studies, the proportion of patients on esomeprazole magnesium delayed-release capsules who remained in remission and were free of heartburn and other GERD symptoms was well differentiated from placebo.

In a third multicenter open label study of 808 patients treated for 12 months with esomeprazole magnesium delayed-release capsules 40 mg, the percentage of patients that maintained healing of EE was 93.7% for six months and 89.4% for one year.

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