efined 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)
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 NEXIUM 40 mg, 7 to 8 days for NEXIUM 20 mg and 7 to 9 days for omeprazole 20 mg.
There are no comparisons of 40 mg of NEXIUM with 40 mg of omeprazole in clinical trials assessing either healing or symptomatic relief of erosive esophagitis.
Long-Term Maintenance of Healing of Erosive Esophagitis
Two multicenter, randomized, double-blind placebo-controlled 4-arm trials were conducted in patients with endoscopically confirmed, healed erosive esophagitis to eva luate NEXIUM 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.
The percentages of patients that maintained healing of erosive esophagitis at the various time points are shown in the figures below:
Figure 2
Maintenance of Healing Rates by Month (Study 177)
s= scheduled visit
Figure 3
Maintenance of Healing Rates by Month (Study 178)
s= scheduled visit
Patients remained in remission significantly longer and the number of recurrences of erosive esophagitis 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 erosive esophagitis was 93.7% for six months and 89.4% for one year.
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 NEXIUM 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 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.
The percent of patients symptom-free of heartburn by day are shown in the figures below:
Figure 4
Percent of Patients Symptom-Free of Heartburn by Day
(Study 225)
Figure 5
Percent of Patients Symptom-Free of Heartburn by Day
(Study 226)
In three European symptomatic GERD trials, NEXIUM 20 mg and 40 mg and omeprazole 20 mg were eva luated. 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 NEXIUM once daily for up to 8 weeks to eva luate safety and tolerability. Dosing by patient weight was as follows:
weight < 20 kg:
