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Pediatric

Treatment of Erosive Esophagitis (EE) due to Acid-Mediated GERD

In an uncontrolled, open-label dose-titration study, for the treatment of EE in pediatric patients 1 to 16 years of age required doses that ranged from 0.7 to 3.5 mg/kg/day (80 mg/day). Doses were initiated at 0.7 mg/kg/day. Doses were increased in increments of 0.7 mg/kg/day (if intraesophageal pH showed a pH of < 4 for less than 6% of a 24-hour study). After titration, patients remained on treatment for 3 months. Forty-four percent of the patients were healed on a dose of 0.7 mg/kg body weight; most of the remaining patients were healed with 1.4 mg/kg after an additional 3 months’ treatment. EE was healed in 51 of 57 (90%) children who completed the first course of treatment in the healing phase of the study. In addition, after 3 months of treatment, 33% of the children had no overall symptoms, 57% had mild reflux symptoms, and 40% had less frequent regurgitation/vomiting.

Maintenance of Healing of EE due to Acid-Mediated GERD

In an uncontrolled, open-label study of maintenance of healing of EE in 46 pediatric patients 1 to 16 years of age, 54% of patients required half the healing dose. The remaining patients increased the healing dose (0.7 to a maximum of 2.8 mg/kg/day) either for the entire maintenance period, or returned to half the dose before completion. Of the 46 patients who entered the maintenance phase, 19 (41%) had no relapse during follow-up (range 4 to 25 months). In addition, maintenance therapy in EE patients resulted in 63% of patients having no overall symptoms.

See also Use in Specific Populations.

Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017

Adult

EE due to Acid-Mediated GERD

In a U.S. multicenter double-blind placebo controlled study of 20 mg or 40 mg of PRILOSEC delayed-release capsules in patients with symptoms of GERD and endoscopically diagnosed EE of grade 2 or above, the percentage healing rates (per protocol) were as follows:1,2

  20 mg PRILOSEC (n = 83) 40 mg PRILOSEC (n = 87) Placebo (n = 43)
Week 4 39a 45a 7
Week 8 74a 75a 14

a. (p < 0.01) PRILOSEC versus placebo.

In this study, the 40 mg dose was not superior to the 20 mg dose of PRILOSEC in the percentage healing rate. Other controlled clinical trials have also shown that PRILOSEC is effective in severe GERD. In comparisons with histamine H2-receptor antagonists in patients with EE, grade 2 or above, PRILOSEC in a dose of 20 mg was significantly more effective than the active controls. Complete daytime and nighttime heartburn relief occurred significantly faster (p < 0.01) in patients treated with PRILOSEC than in those taking placebo or histamine H2-receptor antagonists.

In this and five other controlled GERD studies, significantly more patients taking 20 mg omeprazole (84%) reported complete relief of GERD symptoms than patients receiving placebo (12%).

See also Use in Specific Populations.

References:

  1. PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017.
  2. Sontag SJ, Hirschowitz BI, Holt S, et al. Two doses of omeprazole versus placebo in symptomatic erosive esophagitis: the US Multicenter Study. Gastroenterology. 1992;102:109-118.

Maintenance of Healing of EE due to Acid-Mediated GERD

In a U.S. double-blind, randomized, multicenter, placebo controlled study, two dose regimens of PRILOSEC were studied in patients with endoscopically confirmed healed esophagitis. Results of maintenance of healing of EE are shown below:

Life Table Analysis

  PRILOSEC 20 mg once daily (n = 138) PRILOSEC 20 mg 3 days per week (n = 137) Placebo (n = 131)
Percent in endoscopic remission at 6 months 701 34 11

1. (p < 0.01) PRILOSEC 20 mg once daily versus PRILOSEC 20 mg 3 consecutive days per week or placebo.

In an international multicenter double-blind study, PRILOSEC 20 mg daily and 10 mg daily were compared with ranitidine 150 mg twice daily in patients with endoscopically confirmed healed esophagitis. The table below provides the results of this study for maintenance of healing of EE.

Life Table Analysis

  PRILOSEC 20 mg once daily (n = 131) PRILOSEC 10 mg once daily (n = 133) Ranitidine 150 mg twice daily (n = 128)
Percent in endoscopic remission at 12 months 771 582 46

1. (p = 0.01) PRILOSEC 20 mg once daily versus PRILOSEC 10 mg once daily or Ranitidine.
2. (p = 0.03) PRILOSEC 10 mg once daily versus Ranitidine.

In patients who initially had grades 3 or 4 erosive esophagitis, for maintenance after healing 20 mg daily of PRILOSEC was effective, while 10 mg did not demonstrate effectiveness.

See also Use in Specific Populations.

Reference: PRILOSEC [package insert]. Zug, Switzerland: Covis Pharma; 2017