NEXIUM (Page 11 of 12)

14.2 Maintenance of Healing of EE in Adults

Two multicenter, randomized, double-blind placebo-controlled 4-arm studies were conducted in adult patients with endoscopically confirmed, healed EE to evaluate NEXIUM 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 NEXIUM 40 mg over NEXIUM 20 mg. NEXIUM 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 of EE in Adults by Month (Study 177)

Figure 2 : Maintenance of Healing Rates of EE in Adults by Month (Study 177)
(click image for full-size original)

s= scheduled visit

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

Figure 3 Maintenance of EE Healing Rates in Adults by Month (Study 178)
(click image for full-size original)

s= scheduled visit

Patients remained in remission significantly longer and the number of recurrences of EE was significantly less in patients treated with NEXIUM compared to placebo.

In both studies, the proportion of patients on NEXIUM 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 NEXIUM 40 mg, the percentage of patients that maintained healing of EE was 93.7% for six months and 89.4% for one year.

14.3 Symptomatic GERD in Adults

Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in a total of 717 adult patients comparing four weeks of treatment with NEXIUM delayed-release capsules 20 mg or 40 mg once daily versus placebo for resolution of GERD symptoms. Patients had at least a 6-month history of heartburn episodes, no EE 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 NEXIUM groups compared to placebo at all follow-up visits (Weeks 1, 2, and 4).

No additional clinical benefit was seen with NEXIUM 40 mg over NEXIUM 20 mg. NEXIUM 40 mg once daily is not a recommended regimen for the treatment of symptomatic GERD in adults.

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)

Figure 4 Percent of Patients Symptom-Free of Heartburn by Day (Study 225)
(click image for full-size original)

Figure 5: Percent of Patients Symptom-Free of Heartburn by Day (Study 226)

Figure 5 Percent of Patients Symptom-Free of Heartburn by Day (Study 226)
(click image for full-size original)

In three European symptomatic GERD trials, NEXIUM 20 mg and 40 mg and omeprazole 20 mg were evaluated. No significant treatment related differences were seen.

14.4 Pediatric GERD

1 Year to 11 Years of Age

In a multicenter, parallel-group study, 109 pediatric patients with a history of endoscopically-proven GERD (1 year to 11 years of age; 53 female; 89 Caucasian, 19 Black, 1 Other) were treated with NEXIUM for delayed-release oral suspension 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 NEXIUM for delayed-release oral suspension 5 mg or 10 mg
  • weight ≥ 20 kg: once daily treatment with NEXIUM for delayed-release oral suspension 10 mg or 20 mg

Patients were endoscopically characterized as to the presence or absence of EE.

Of the 109 patients, 53 had EE 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 EE prior to treatment, and the trial did not include a concomitant control.

12 Years 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 NEXIUM delayed-release capsules 20 mg or 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 EE.

14.5 Risk Reduction of NSAID-Associated Gastric Ulcer

Two multicenter, double-blind, placebo-controlled studies were conducted in adult 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 1429 patients were randomized across the 2 studies. Patients ranged in age from 19 to 89 (median age 66 years) with 71% female, 29% male; 83% Caucasian, 5% Black, 4% Asian, and 8% 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 (at least 60 years) and/or history of a documented gastric or duodenal ulcer within the past 5 years. Patients receiving NSAIDs and treated with NEXIUM delayed-release capsules 20 mg or 40 mg once daily experienced significant reduction in gastric ulcer occurrences relative to placebo treatment at 26 weeks. See Table 13. No additional benefit was seen with NEXIUM 40 mg over NEXIUM 20 mg. NEXIUM 40 mg once daily is not a recommended regimen for the risk reduction of NSAID-associated gastric ulcer in adults. These studies did not demonstrate significant reduction in the development of NSAID-associated duodenal ulcer due to the low incidence.

Table 13: Cumulative Percentage of Patients at Least 60 Years of Age Taking NSAIDS Without Gastric Ulcers at 26 Weeks in Two Randomized Placebo-Controlled Studies
*
%= Life Table Estimate. Significant difference from placebo (p<0.01).

Study

No. of Patients

Treatment Group

% of Patients Remaining Gastric Ulcer Free *

1

191

194

184

NEXIUM 20 mg

NEXIUM 40 mg

Placebo

95.4

96.7

88.2

2

267

271

257

NEXIUM 20 mg

NEXIUM 40 mg

Placebo

94.7

95.3

83.3

14.6 H. pylori Eradication in Adult Patients with Duodenal Ulcer Disease

Two multicenter, randomized, double-blind studies were conducted in adult patients using a 10-day treatment regimen of triple therapy (NEXIUM, amoxicillin and clarithromycin). The first study (191) compared NEXIUM delayed-release capsules 40 mg once daily in combination with amoxicillin 1000 mg twice daily and clarithromycin 500 mg twice daily to NEXIUM delayed-release capsules 40 mg once daily plus clarithromycin 500 mg twice daily. The second study (193) compared NEXIUM delayed-release capsules 40 mg once daily in combination with amoxicillin 1000 mg twice daily and clarithromycin 500 mg twice daily to NEXIUM delayed-release capsules 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 NEXIUM, amoxicillin and clarithromycin group than in the NEXIUM and clarithromycin group or the NEXIUM alone group. The results are shown in Table 14:

Table 14: H. pylori Eradication Rates at 4 Weeks after 10 Day Treatment Regimen % of Adult Patients Cured [95% Confidence Interval] (Number of Patients)
*
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.
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.
p < 0.05 compared to NEXIUM plus clarithromycin.
§
p < 0.05 compared to NEXIUM alone.

Study

Treatment Group

Per-Protocol *

Intent-to-Treat

191

NEXIUM, amoxicillin and clarithromycin

84%

[78, 89]

(n=196)

77%

[71, 82]

(n=233)

NEXIUM and clarithromycin

55%

[48, 62]

(n=187)

52%

[45, 59]

(n=215)

193

NEXIUM, amoxicillin and clarithromycin

85% §

[74, 93]

(n=67)

78% §

[67, 87]

(n=74)

NEXIUM

5%

[0, 23]

(n=22)

4%

[0, 21]

(n=24)

The percentage of patients with a healed baseline duodenal ulcer by 4 weeks after the 10-day treatment regimen in the NEXIUM, amoxicillin and clarithromycin group was 75% (n=156) and 57% (n=60) respectively, in the 191 and 193 studies (per-protocol analysis).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.