Rabeprazole Sodium: Package Insert and Label Information (Page 5 of 7)

14 CLINICAL STUDIES

14.1 Healing of Erosive or Ulcerative GERD in Adults

In a U.S., multicenter, randomized, double-blind, placebo-controlled study, 103 patients were treated for up to eight weeks with placebo, 10 mg, 20 mg, or 40 mg rabeprazole sodium delayed-release tablets once daily. For this and all studies of GERD healing, only patients with GERD symptoms and at least grade 2 esophagitis (modified Hetzel-Dent grading scale) were eligible for entry. Endoscopic healing was defined as grade 0 or 1. Each rabeprazole dose was significantly superior to placebo in producing endoscopic healing after four and eight weeks of treatment.

The percentage of patients demonstrating endoscopic healing was as follows:

Table 7: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Percentage of Patients Healed

Week

Rabeprazole sodium delayed-release tablets

Placebo

N=25

10 mg once daily

N=27

20 mg once daily

N=25

40 mg once daily

N=26

4

63%*

56%*

54%*

0%

8

93%*

84%*

85%*

12%

* (p < 0.001 versus placebo)

In addition, there was a statistically significant difference in favor of the rabeprazole sodium 10 mg, 20 mg, and 40 mg doses compared to placebo at Weeks 4 and 8 regarding complete resolution of GERD heartburn frequency (p ≤ 0.026). All rabeprazole sodium groups reported significantly greater rates of complete resolution of GERD daytime heartburn severity compared to placebo at Weeks 4 and 8 (p ≤ 0.036). Mean reductions from baseline in daily antacid dose were statistically significant for all rabeprazole sodium groups when compared to placebo at both Weeks 4 and 8 (p ≤ 0.007).

In a North American multicenter, randomized, double-blind, active-controlled study of 336 patients, the percentage of patients healed at endoscopy after four and eight weeks of treatment was statistically superior in the patients treated with rabeprazole sodium delayed-release tablets compared to ranitidine:

Table 8: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Percentage of Patients Healed

Week

20 mg rabeprazole sodium delayed-

release tablets once daily

N=167

Ranitidine 150 mg

four times daily

N=169

4

59%*

36%

8

87%*

66%

* (p < 0.001 versus ranitidine)

A dose of 20 mg once daily of rabeprazole sodium delayed-release tablets was significantly more effective than ranitidine 150 mg four times daily in the percentage of patients with complete resolution of heartburn at Weeks 4 and 8 (p < 0.001). Rabeprazole sodium was also more effective in complete resolution of daytime heartburn (p ≤ 0.025), and nighttime heartburn (p ≤ 0.012) at both Weeks 4 and 8, with significant differences by the end of the first week of the study.

The recommended dosage of rabeprazole sodium delayed-release tablets is 20 mg once daily for 4 to 8 weeks.

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 10 and 11 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

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%

* (p < 0.001 versus placebo)

Table 10: Percent of Patients Without Relapse in Heartburn Frequency and Daytime and Nighttime Heartburn Severity at Week 52

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%)

* p ≤ 0.001 versus placebo

0.001 < p < 0.05 versus placebo

14.3 Treatment of Symptomatic GERD in Adults

Two U.S., multicenter, double-blind, placebo controlled studies were conducted in 316 adult patients with daytime and nighttime heartburn. Patients reported 5 or more periods of moderate to very severe heartburn during the placebo treatment phase the week prior to randomization. Patients were confirmed by endoscopy to have no esophageal erosions.

The percentage of heartburn free daytime and/or nighttime periods was greater with 20 mg rabeprazole sodium delayed-release tablets compared to placebo over the 4 weeks of study in Study RAB-USA-2 (47% vs. 23%) and Study RAB-USA-3 (52% vs. 28%). The mean decreases from baseline in average daytime and nighttime heartburn scores were significantly greater for rabeprazole sodium 20 mg as compared to placebo at week 4. Graphical displays depicting the daily mean daytime and nighttime scores are provided in Figures 2 to 5.

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In addition, the combined analysis of these two studies showed 20 mg of rabeprazole sodium delayed-release tablets significantly improved other GERD-associated symptoms (regurgitation, belching, and early satiety) by week 4 compared with placebo (all p values < 0.005).

A dose of 20 mg rabeprazole sodium delayed-release tablets also significantly reduced daily antacid consumption versus placebo over 4 weeks (p < 0.001).

The recommended dosage of rabeprazole sodium delayed-release tablets is 20 mg once daily for 4 weeks.

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