RABEPRAZOLE SODIUM (Page 8 of 10)

14.2 Long-Term Maintenance of Healing of Erosive or Ulcerative GERD in Adults

The long-term maintenance of healing in patients with erosive or ulcerative GERD previously healed with gastric antisecretory therapy was assessed in two U.S., multicenter, randomized, double-blind, placebo-controlled studies of identical design of 52 weeks duration. The two studies randomized 209 and 285 patients, respectively, to receive either 10 mg or 20 mg of Rabeprazole Sodium delayed-release tablets once daily or placebo. As demonstrated in Tables 9 and 10 below, patients treated with Rabeprazole Sodium delayed-release tablets were significantly superior to placebo in both studies with respect to the maintenance of healing of GERD and the proportions of patients remaining free of heartburn symptoms at 52 weeks. The recommended dosage of Rabeprazole Sodium delayed-release tablets is 20 mg once daily.

Table 9: Percent of Patients in Endoscopic Remission
*
(p<0.001 versus placebo)

Rabeprazole Sodium Delayed-Release Tablets

Placebo

10 mg once daily

20 mg once daily

Study 1

N=66

N=67

N=70

Week 4

83% *

96% *

44%

Week 13

79% *

93% *

39%

Week 26

77% *

93% *

31%

Week 39

76% *

91% *

30%

Week 52

73% *

90% *

29%

Study 2

N=93

N=93

N=99

Week 4

89% *

94% *

40%

Week 13

86% *

91% *

33%

Week 26

85% *

89% *

30%

Week 39

84% *

88% *

29%

Week 52

77% *

86% *

29%

COMBINED STUDIES

N=159

N=160

N=169

Week 4

87% *

94% *

42%

Week 13

83% *

92% *

36%

Week 26

82% *

91% *

31%

Week 39

81% *

89% *

30%

Week 52

75% *

87% *

29%

Table 10: Percent of Patients Without Relapse in Heartburn Frequency and Daytime and Nighttime Heartburn Severity at Week 52
*
p≤0.001 versus placebo
0.001<p<0.05 versus placebo

Rabeprazole Sodium Delayed-Release Tablets

Placebo

10 mg once daily

20 mg once daily

Heartburn Frequency

Study 1

46/55 (84%) *

48/52 (92%) *

17/45 (38%)

Study 2

50/72 (69%) *

57/72 (79%) *

22/79 (28%)

Daytime Heartburn Severity

Study 1

61/64 (95%) *

60/62 (97%) *

42/61 (69%)

Study 2

73/84 (87%)

82/87 (94%) *

67/90 (74%)

Nighttime Heartburn Severity

Study 1

57/61 (93%) *

60/61 (98%) *

37/56 (66%)

Study 2

67/80 (84%)

79/87 (91%)

64/87 (74%)

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