Omeprazole (Page 9 of 11)

14.2 Gastric Ulcer

In a U.S. multicenter, double-blind, study of omeprazole 40 mg once daily, 20 mg once daily, and placebo in 520 patients with endoscopically diagnosed gastric ulcer, the following results were obtained.

Treatment of Gastric Ulcer % of Patients Healed (All Patients Treated)
Omeprazole20 mg once daily(n=202) Omeprazole40 mg once daily(n=214) Placebo(n=104)
Week 4 47.5 ** 55.6 ** 30.8
Week 8 74.8 ** 82.7 **,+ 48.1

**(p < 0.01) omeprazole 40 mg or 20 mg versus placebo

+ (p < 0.05) omeprazole 40 mg versus 20 mg

For the stratified groups of patients with ulcer size less than or equal to 1 cm, no difference in healing rates between 40 mg and 20 mg was detected at either 4 or 8 weeks. For patients with ulcer size greater than 1 cm, 40 mg was significantly more effective than 20 mg at 8 weeks.

In a foreign, multinational, double-blind study of 602 patients with endoscopically diagnosed gastric ulcer, omeprazole 40 mg once daily, 20 mg once daily, and ranitidine 150 mg twice a day were evaluated.

Treatment of Gastric Ulcer % of Patients Healed (All Patients Treated)
Omeprazole20 mg once daily(n=200) Omeprazole40 mg once daily(n=187) Ranitidine150 mg twice daily.(n=199)
Week 4 63.5 78.1 **,++ 56.3
Week 8 81.5 91.4 **,++ 78.4

** (p < 0.01) omeprazole 40 mg versus ranitidine

++ (p < 0.01) omeprazole 40 mg versus 20 mg

14.3 Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD

A placebo-controlled study was conducted in Scandinavia to compare the efficacy of omeprazole 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown below.

% Successful Symptomatic Outcomea
Omeprazole 20 mg a.m. Omeprazole 10 mg a.m. Placebo a.m.
All patients 46*,† (n=205) 31 (n=199) 13 (n=105)
Patients with confirmed GERD 56*,† (n=115) 36 (n=109) 14 (n=59)

a Defined as complete resolution of heartburn

*(p < 0.005) versus 10 mg

(p < 0.005) versus placebo

14.4 Erosive Esophagitis

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

Week

20 mg Omeprazole

(n=83)

40 mg Omeprazole

(n=87)

Placebo

(n=43)

4

39**

45**

7

8

74**

75**

14

** (p < 0.01) omeprazole versus placebo.

In this study, the 40 mg dose was not superior to the 20 mg dose of omeprazole in the percentage healing rate. Other controlled clinical trials have also shown that omeprazole is effective in severe GERD. In comparisons with histamine H2 -receptor antagonists in patients with erosive esophagitis, grade 2 or above, omeprazole 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 omeprazole 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%).

Long-Term Maintenance Of Healing of Erosive Esophagitis

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

Life Table Analysis
Omeprazole20 mg once daily(n=138) Omeprazole20 mg 3 days per week(n=137) Placebo(n=131)
Percent in endoscopic remission at 6 months * 70 34 11

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

In an international multicenter double-blind study, omeprazole 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 erosive esophagitis.

Life Table Analysis
Omeprazole20 mg once daily(n=131) Omeprazole10 mg once daily(n=133) Ranitidine150 mg twice daily(n=128)
Percent in endoscopic remission at 12 months * 77 58 46

*(p = 0.01) omeprazole 20 mg once daily versus omeprazole 10 mg once daily or Ranitidine.

(p = 0.03) omeprazole 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 omeprazole was effective, while 10 mg did not demonstrate effectiveness.

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