PRILOSEC (Page 10 of 13)

14.3 Active Benign 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)
*
(p < 0.01) PRILOSEC 40 mg or 20 mg versus placebo.
(p < 0.05) PRILOSEC 40 mg versus 20 mg.

PRILOSEC

20 mg once daily

(n = 202)

PRILOSEC

40 mg once daily

(n = 214)

Placebo

(n = 104)

Week 4

47.5*

55.6*

30.8

Week 8

74.8*

82.7*

48.1

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)
*
(p < 0.01) PRILOSEC 40 mg versus ranitidine.
(p < 0.01) PRILOSEC 40 mg versus 20 mg.

PRILOSEC

20 mg once daily

(n = 200)

PRILOSEC

40 mg once daily

(n = 187)

Ranitidine

150 mg twice daily

(n = 199)

Week 4

63.5

78.1*

56.3

Week 8

81.5

91.4*

78.4

14.4 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 EE. Results are shown below.

% Successful Symptomatic Outcome *
*
Defined as complete resolution of heartburn.
(p < 0.005) versus 10 mg.
(p < 0.005) versus placebo.

PRILOSEC

20 mg a.m.

PRILOSEC

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)

14.5 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:

*
(p < 0.01) PRILOSEC versus placebo.

20 mg

PRILOSEC

(n = 83)

40 mg

PRILOSEC

(n = 87)

Placebo

(n = 43)

Week 4

39*

45*

7

Week 8

74*

75*

14

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%).

14.6 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 to determine maintenance of healing of EE are shown below.

Life Table Analysis

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

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

70*

34

11

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

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

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

77*

58

46

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.

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