Esomeprazole Magnesium (Page 10 of 12)

14.2 Symptomatic Gastroesophageal Reflux Disease (GERD)

Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in a total of 717 patients comparing four weeks of treatment with esomeprazole magnesium delayed-release capsules, 20 mg or 40 mg once daily versus placebo for resolution of GERD symptoms. Patients had ≥ 6-month history of heartburn episodes, no erosive esophagitis by endoscopy, and heartburn on at least four of the seven days immediately preceding randomization.
The percentage of patients that were symptom-free of heartburn was significantly higher in the esomeprazole magnesium delayed-release capsules groups compared to placebo at all follow-up visits (Weeks 1, 2, and 4).
No additional clinical benefit was seen with esomeprazole magnesium delayed-release capsules 40 mg over esomeprazole magnesium delayed-release capsules 20 mg.
The percent of patients symptom-free of heartburn by day are shown in the Figures 4 and 5:
Figure 4: Percent of Patients Symptom-Free of Heartburn by Day (Study 225)

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Figure 5: Percent of Patients Symptom-Free of Heartburn by Day (Study 226)
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In three European symptomatic GERD trials, esomeprazole magnesium delayed-release capsules 20 mg and 40 mg and omeprazole 20 mg were evaluated. No significant treatment related differences were seen.

14.3 Pediatric Gastroesophageal Reflux Disease (GERD)

1 to 11 Years of Age
In a multicenter, parallel-group study, 109 pediatric patients with a history of endoscopically-proven GERD (1 to 11 years of age; 53 female; 89 Caucasian, 19 Black, 1 Other) were treated with esomeprazole magnesium delayed-release capsules once daily for up to 8 weeks to evaluate safety and tolerability. Dosing by patient weight was as follows:
weight < 20 kg: once daily treatment with esomeprazole magnesium 5 mg or 10 mg
weight > 20 kg: once daily treatment with esomeprazole magnesium 10 mg or 20 mg
Patients were endoscopically characterized as to the presence or absence of erosive esophagitis.
Of the 109 patients, 53 had erosive esophagitis at baseline (51 had mild, 1 moderate, and 1 severe esophagitis). Although most of the patients who had a follow up endoscopy at the end of 8 weeks of treatment healed, spontaneous healing cannot be ruled out because these patients had low grade erosive esophagitis prior to treatment, and the trial did not include a concomitant control.
12 to 17 Years of Age
In a multicenter, randomized, double-blind, parallel-group study, 149 adolescent patients (12 to 17 years of age; 89 female; 124 Caucasian, 15 Black, 10 Other) with clinically diagnosed GERD were treated with either esomeprazole magnesium delayed-release capsules 20 mg or esomeprazole magnesium delayed-release capsules 40 mg once daily for up to 8 weeks to evaluate safety and tolerability. Patients were not endoscopically characterized as to the presence or absence of erosive esophagitis.

14.4 Risk Reduction of NSAID-Associated Gastric Ulcer

Two multicenter, double-blind, placebo-controlled studies were conducted in patients at risk of developing gastric and/or duodenal ulcers associated with continuous use of non-selective and COX-2 selective NSAIDs. A total of 1,429 patients were randomized across the 2 studies. Patients ranged in age from 19 to 89 (median age 66 years) with 70.7% female, 29.3% male, 82.9% Caucasian, 5.5% Black, 3.7% Asian, and 8.0% others. At baseline, the patients in these studies were endoscopically confirmed not to have ulcers but were determined to be at risk for ulcer occurrence due to their age (>60 years) and/or history of a documented gastric or duodenal ulcer within the past 5 years. Patients receiving NSAIDs and treated with esomeprazole magnesium delayed-release capsules 20 mg or 40 mg once-a-day experienced significant reduction in gastric ulcer occurrences relative to placebo treatment at 26 weeks. See Table 11. No additional benefit was seen with esomeprazole magnesium delayed-release capsules 40 mg over esomeprazole magnesium delayed-release capsules 20 mg. These studies did not demonstrate significant reduction in the development of NSAID-associated duodenal ulcer due to the low incidence. Table 11: Cumulative Percentage of Patients without Gastric Ulcers at 26 Weeks:

Study No. of Patients Treatment Group % of Patients Remaining Gastric Ulcer Free 1
1 191 Esomeprazole magnesium delayed-release capsules 20 mg 95.4
194 Esomeprazole magnesium delayed-release capsules 40 mg 96.7
184 Placebo 88.2
2 267 Esomeprazole magnesium delayed-release capsules 20 mg 94.7
271 Esomeprazole magnesium delayed-release capsules 40 mg 95.3
257 Placebo 83.3

1. %= Life Table Estimate. Significant difference from placebo (p <0.01).

14.5 Helicobacter pylori (H. pylori) Eradication in Patients with Duodenal Ulcer Disease

Triple Therapy (esomepazole magnesium/amoxicillin/clarithromycin): Two multicenter, randomized, double-blind studies were conducted using a 10 day treatment regimen. The first study (191) compared esomepazole magnesium 40 mg once daily in combination with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily to esomepazole magnesium 40 mg once daily plus clarithromycin 500 mg twice daily. The second study (193) compared esomepazole magnesium 40 mg once daily in combination with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily to esomepazole magnesium 40 mg once daily. H. pylori eradication rates, defined as at least two negative tests and no positive tests from CLOtest®, histology and/or culture, at 4 weeks post-therapy were significantly higher in the esomepazole magnesium plus amoxicillin and clarithromycin group than in the esomepazole magnesium plus clarithromycin or esomepazole magnesium alone group. The results are shown in Table 12: Table 12: H. pylori Eradication Rates at 4 Weeks after 10 Day Treatment Regimen % of Patients Cured [95% Confidence Interval] (Number of Patients)

Study Treatment Group Per-Protocol 1 Intent-to-Treat 2
191 Esomeprazole magnesium delayed-release capsules plus amoxiciliin and clarithromycin 84% 3 [78, 89] (n=196) 77% 3 [71, 82] (n=233)
Esomeprazole magnesium delayed-release capsules plus clarithromycin 55% [48, 62] (n=187) 52% [45, 59] (n=215)
193 Esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin 85% 4 [74, 93] (n=67) 78% 4 [67, 87] (n=74)
Esomeprazole magnesium delayed-release capsules 5% [0, 23] (n=22) 4% [0, 21] (n=24)

1. Patients were included in the analysis if they had H. pylori infection documented at baseline, had at least one endoscopically verified duodenal ulcer ≥ 0.5 cm in diameter at baseline or had a documented history of duodenal ulcer disease within the past 5 years, and were not protocol violators. Patients who dropped out of the study due to an adverse reaction related to the study drug were included in the analysis as not H. pylori eradicated.
2. Patients were included in the analysis if they had documented H. pylori infection at baseline, had at least one documented duodenal ulcer at baseline, or had a documented history of duodenal ulcer disease, and took at least one dose of study medication. All dropouts were included as not H. pylori eradicated.
3. p < 0.05 compared to esomepazole magnesium plus clarithromycin.
4. p < 0.05 compared to esomepazole magnesium alone.
The percentage of patients with a healed baseline duodenal ulcer by 4 weeks after the 10 day treatment regimen in the esomepazole magnesium plus amoxicillin and clarithromycin group was 75% (n=156) and 57% (n=60) respectively, in the 191 and 193 studies (per-protocol analysis).

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